irbesartan: package leaflet

Aprovel belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten.
This results in an increase in blood pressure. Aprovel prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Aprovel slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Aprovel is used in adult patients
▪ to treat high blood pressure (essential hypertension)
▪ to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

Do not take Aprovel
▪ if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6) ▪ if you are more than 3 months pregnant. (It is also better to avoid Aprovel in early pregnancy – see pregnancy section) ▪ if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

Warning and precautions
Talk to your doctor before taking Aprovel and if any of the following apply to you:
if you get excessive vomiting or diarrhoea
▪ if you suffer from kidney problems
▪ if you suffer from heart problems
▪ if you receive Aprovel for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function ▪ if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heartbeat), particularly if you are being treated for diabetes.

▪ if you are going to have an operation (surgery) or be given anaesthetics
▪ if you are taking any of the following medicines used to treat high blood pressure:
o an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
o aliskiren.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Aprovel. Your doctor will decide on further treatment. Do not stop taking Aprovel on your own.

See also information under the heading “Do not take Aprovel”.

You must tell your doctor if you think you are (or might become) pregnant. Aprovel is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Children and adolescents
This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

Other medicines and Aprovel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Aprovel” and “Warnings and precautions”).

You may need to have blood checks if you take:
▪ potassium supplements
▪ salt substitutes containing potassium
▪ potassium-sparing medicines (such as certain diuretics)
▪ medicines containing lithium
▪ repaglinide (medication used for lowering blood sugar levels)

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Aprovel with food and drink
Aprovel can be taken with or without food.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Aprovel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Aprovel. Aprovel is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Aprovel is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines
Aprovel is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

Aprovel contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.

Aprovel contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration
Aprovel is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
You can take Aprovel with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Aprovel until your doctor tells you otherwise.

▪
Patients with high blood pressure
The usual dose is 150 mg once-a-day (two tablets a day). The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response.

▪
Patients with high blood pressure and type 2 diabetes with kidney disease
In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

Use in children and adolescents
Aprovel should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you take more Aprovel than you should
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Aprovel
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these effects may be serious and may require medical attention.

As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any

of these symptoms or get short of breath, stop taking Aprovel and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people

Side effects reported in clinical studies for patients treated with Aprovel were:
▪
Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.

▪
Common (may affect up to 1 in 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.

▪
Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

▪
Rare (may affect up to 1 in 1,000 people): intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea.

Some undesirable effects have been reported since marketing of Aprovel. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels.
Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Aprovel contains
▪
The active substance is irbesartan. Each tablet of Aprovel 75 mg contains 75 mg irbesartan.
▪
The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinized maize starch, and poloxamer 188. Please see section 2 “Aprovel contains lactose”.

What Aprovel looks like and contents of the pack
Aprovel 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.

Aprovel 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. Unidose blister packs of 56 x 1 tablet for delivery in hospitals are also available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Manufacturer:
SANOFI WINTHROP INDUSTRIE
1, rue de la Vierge
Ambarès & Lagrave
F-33565 Carbon Blanc Cedex - France

SANOFI WINTHROP INDUSTRIE
30-36 Avenue Gustave Eiffel, BP 7166
F-37071 Tours Cedex 2 – France

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131

Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη ΑΕΒΕ
Τηλ: +30 210 900 16 00

Österreich sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger: +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu/

Aprovel belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten.
This results in an increase in blood pressure. Aprovel prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Aprovel slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Aprovel is used in adult patients
▪ to treat high blood pressure (essential hypertension)
▪ to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

Do not take Aprovel
▪ if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6) ▪ if you are more than 3 months pregnant. (It is also better to avoid Aprovel in early pregnancy – see pregnancy section) ▪ if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

Warning and precautions
Talk to your doctor before taking Aprovel and if any of the following apply to you:
▪ if you get excessive vomiting or diarrhoea
▪ if you suffer from kidney problems
▪ if you suffer from heart problems
▪ if you receive Aprovel for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function ▪ if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heartbeat), particularly if you are being treated for diabetes.

▪ if you are going to have an operation (surgery) or be given anaesthetics
▪ if you are taking any of the following medicines used to treat high blood pressure:
o an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
o aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Aprovel. Your doctor will decide on further treatment. Do not stop taking Aprovel on your own.

See also information under the heading “Do not take Aprovel”.

You must tell your doctor if you think you are (or might become) pregnant. Aprovel is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Children and adolescents
This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

Other medicines and Aprovel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Aprovel” and “Warnings and precautions”).

You may need to have blood checks if you take:
▪ potassium supplements
▪ salt substitutes containing potassium
▪ potassium-sparing medicines (such as certain diuretics)
▪ medicines containing lithium
▪ repaglinide (medication used for lowering blood sugar levels)

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Aprovel with food and drink
Aprovel can be taken with or without food.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Aprovel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Aprovel. Aprovel is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Aprovel is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines
Aprovel is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

Aprovel contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.

Aprovel contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration
Aprovel is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
You can take Aprovel with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Aprovel until your doctor tells you otherwise.

▪
Patients with high blood pressure
The usual dose is 150 mg once-a-day. The dose may later be increased to 300 mg (two tablets a day) once daily depending on blood pressure response.

▪
Patients with high blood pressure and type 2 diabetes with kidney disease
In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

Use in children and adolescents
Aprovel should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you take more Aprovel than you should
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Aprovel
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these effects may be serious and may require medical attention.

As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any

of these symptoms or get short of breath, stop taking Aprovel and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people

Side effects reported in clinical studies for patients treated with Aprovel were:
▪
Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.

▪
Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.

▪
Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

▪
Rare (may affect up to 1 in 1,000 people): intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea.

Some undesirable effects have been reported since marketing of Aprovel. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels.
Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment.

What Aprovel contains
▪
The active substance is irbesartan. Each tablet of Aprovel 150 mg contains 150 mg irbesartan.
▪
The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinized maize starch, and poloxamer 188. Please see section 2 “Aprovel contains lactose”.

What Aprovel looks like and contents of the pack
Aprovel 150 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.

Aprovel 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. Unidose blister packs of 56 x 1 tablet for delivery in hospitals are also available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Manufacturer:
SANOFI WINTHROP INDUSTRIE
1, rue de la Vierge
Ambarès & Lagrave
F-33565 Carbon Blanc Cedex - France

SANOFI WINTHROP INDUSTRIE
30-36 Avenue Gustave Eiffel, BP 7166
F-37071 Tours Cedex 2 - France

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131
Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη ΑΕΒΕ
Τηλ: +30 210 900 16 00

Österreich sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger: +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu/

Aprovel belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten.
This results in an increase in blood pressure. Aprovel prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Aprovel slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Aprovel is used in adult patients
▪ to treat high blood pressure (essential hypertension)
▪ to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

Do not take Aprovel
▪ if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6) ▪ if you are more than 3 months pregnant. (It is also better to avoid Aprovel in early pregnancy – see pregnancy section) ▪ if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

Warning and precautions
Talk to your doctor before taking Aprovel and if any of the following apply to you:
▪ if you get excessive vomiting or diarrhoea
▪ if you suffer from kidney problems
▪ if you suffer from heart problems
▪ if you receive Aprovel for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function ▪ if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heartbeat), particularly if you are being treated for diabetes.

▪ if you are going to have an operation (surgery) or be given anaesthetics
▪ if you are taking any of the following medicines used to treat high blood pressure:
o an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
o aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Aprovel. Your doctor will decide on further treatment. Do not stop taking Aprovel on your own.

See also information under the heading “Do not take Aprovel”.

You must tell your doctor if you think you are (or might become) pregnant. Aprovel is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Children and adolescents
This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

Other medicines and Aprovel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Aprovel” and “Warnings and precautions”).

You may need to have blood checks if you take:
▪ potassium supplements
▪ salt substitutes containing potassium
▪ potassium-sparing medicines (such as certain diuretics)
▪ medicines containing lithium
▪ repaglinide (medication used for lowering blood sugar levels)

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Aprovel with food and drink
Aprovel can be taken with or without food.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Aprovel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Aprovel. Aprovel is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Aprovel is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines
Aprovel is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

Aprovel contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.

Aprovel contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration
Aprovel is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
You can take Aprovel with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Aprovel until your doctor tells you otherwise.

▪
Patients with high blood pressure
The usual dose is 150 mg once-a-day. The dose may later be increased to 300 mg once daily depending on blood pressure response.

▪
Patients with high blood pressure and type 2 diabetes with kidney disease
In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

Use in children and adolescents
Aprovel should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you take more Aprovel than you should
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Aprovel
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these effects may be serious and may require medical attention.

As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any

of these symptoms or get short of breath, stop taking Aprovel and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people

Side effects reported in clinical studies for patients treated with Aprovel were:
▪
Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.

▪
Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.

▪
Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

▪
Rare (may affect up to 1 in 1,000 people): intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea.

Some undesirable effects have been reported since marketing of Aprovel. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels.
Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment.

What Aprovel contains
▪
The active substance is irbesartan. Each tablet of Aprovel 300 mg contains 300 mg irbesartan.
▪
The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinized maize starch, and poloxamer 188. Please see section 2 “Aprovel contains lactose”.

What Aprovel looks like and contents of the pack
Aprovel 300 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2773 engraved on the other side.

Aprovel 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. Unidose blister packs of 56 x 1 tablet for delivery in hospitals are also available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Manufacturer:
SANOFI WINTHROP INDUSTRIE
1, rue de la Vierge
Ambarès & Lagrave
F-33565 Carbon Blanc Cedex - France

SANOFI WINTHROP INDUSTRIE
30-36 Avenue Gustave Eiffel, BP 7166
F-37071 Tours Cedex 2 - France

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275
Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131
Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη ΑΕΒΕ
Τηλ: +30 210 900 16 00

Österreich sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger: +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu/

Aprovel belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten.
This results in an increase in blood pressure. Aprovel prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Aprovel slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Aprovel is used in adult patients
▪ to treat high blood pressure (essential hypertension)
▪ to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

Do not take Aprovel
▪ if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6) ▪ if you are more than 3 months pregnant. (It is also better to avoid Aprovel in early pregnancy – see pregnancy section) ▪ if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

Warnings and precautions
Talk to your doctor before taking Aprovel and if any of the following apply to you:
▪ if you get excessive vomiting or diarrhoea
▪ if you suffer from kidney problems
▪ if you suffer from heart problems
▪ if you receive Aprovel for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function ▪ if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heartbeat), particularly if you are being treated for diabetes.

▪ if you are going to have an operation (surgery) or be given anaesthetics
▪ if you are taking any of the following medicines used to treat high blood pressure:
o an ACE-inhibitor ( for example enalapril, lisinopril, ramipril) in particular if you have diabetes-related kidney problems.
o aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Aprovel. Your doctor will decide on further treatment. Do not stop taking Aprovel on your own.

See also information under the heading “Do not take Aprovel”.

You must tell your doctor if you think you are (or might become) pregnant. Aprovel is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Children and adolescents
This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

Other medicines and Aprovel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Aprovel” and “Warnings and precautions”).

You may need to have blood checks if you take:
▪ potassium supplements
▪ salt substitutes containing potassium
▪ potassium-sparing medicines (such as certain diuretics)
▪ medicines containing lithium
▪ repaglinide (medication used for lowering blood sugar levels)

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Aprovel with food and drink
Aprovel can be taken with or without food.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Aprovel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Aprovel. Aprovel is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Aprovel is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines
Aprovel is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

Aprovel contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.

Aprovel contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration
Aprovel is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
You can take Aprovel with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Aprovel until your doctor tells you otherwise.

▪
Patients with high blood pressure
The usual dose is 150 mg once-a-day (two tablets a day). The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response.

▪
Patients with high blood pressure and type 2 diabetes with kidney disease
In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

Use in children and adolescents
Aprovel should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you take more Aprovel than you should:
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Aprovel:
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these effects may be serious and may require medical attention.

As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any

of these symptoms or get short of breath, stop taking Aprovel and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people

Side effects reported in clinical studies for patients treated with Aprovel were:
▪
Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.

▪
Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.

▪
Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

▪
Rare (may affect up to 1 in 1,000 people): intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea.

Some undesirable effects have been reported since marketing of Aprovel. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels.
Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Aprovel contains
▪
The active substance is irbesartan. Each tablet of Aprovel 75 mg contains 75 mg irbesartan.
▪
The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax. Please see section 2 “Aprovel contains lactose”.

What Aprovel looks like and contents of the pack
Aprovel 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.

Aprovel 75 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film- coated tablets. Unidose blister packs of 56 x 1 film-coated tablet for delivery in hospitals are also available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Manufacturer:
SANOFI WINTHROP INDUSTRIE
1, rue de la Vierge
Ambarès & Lagrave
F-33565 Carbon Blanc Cedex - France

SANOFI WINTHROP INDUSTRIE
30-36 Avenue Gustave Eiffel, BP 7166
F-37071 Tours Cedex 2 - France

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131
Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη ΑΕΒΕ
Τηλ: +30 210 900 16 00

Österreich sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger: +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu/

Aprovel belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten.
This results in an increase in blood pressure. Aprovel prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Aprovel slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Aprovel is used in adult patients
▪ to treat high blood pressure (essential hypertension)
▪ to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

Do not take Aprovel
▪ if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6) ▪ if you are more than 3 months pregnant. (It is also better to avoid Aprovel in early pregnancy – see pregnancy section) ▪ if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

Warnings and precautions
Talk to your doctor before taking Aprovel and if any of the following apply to you:
▪ if you get excessive vomiting or diarrhoea
▪ if you suffer from kidney problems
▪ if you suffer from heart problems
▪ if you receive Aprovel for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function ▪ if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heartbeat), particularly if you are being treated for diabetes.

▪ if you are going to have an operation (surgery) or be given anaesthetics
▪ if you are taking any of the following medicines used to treat high blood pressure:
o an ACE-inhibitor ( for example enalapril, lisinopril, ramipril) in particular if you have diabetes-related kidney problems.
o aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Aprovel. Your doctor will decide on further treatment. Do not stop taking Aprovel on your own.

See also information under the heading “Do not take Aprovel”.

You must tell your doctor if you think you are (or might become) pregnant. Aprovel is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Children and adolescents
This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

Other medicines and Aprovel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Aprovel” and “Warnings and precautions”).

You may need to have blood checks if you take:
▪ potassium supplements
▪ salt substitutes containing potassium
▪ potassium-sparing medicines (such as certain diuretics)
▪ medicines containing lithium
▪ repaglinide (medication used for lowering blood sugar levels)

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Aprovel with food and drink
Aprovel can be taken with or without food.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Aprovel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Aprovel. Aprovel is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Aprovel is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines
Aprovel is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

Aprovel contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.

Aprovel contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration
Aprovel is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
You can take Aprovel with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Aprovel until your doctor tells you otherwise.

▪
Patients with high blood pressure
The usual dose is 150 mg once-a-day. The dose may later be increased to 300 mg (two tablets a day) once daily depending on blood pressure response.

▪
Patients with high blood pressure and type 2 diabetes with kidney disease
In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

Use in children and adolescents
Aprovel should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you take more Aprovel than you should:
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Aprovel:
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these effects may be serious and may require medical attention.

As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any

of these symptoms or get short of breath, stop taking Aprovel and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people

Side effects reported in clinical studies for patients treated with Aprovel were:
▪
Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.

▪
Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.

▪
Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

▪
Rare (may affect up to 1 in 1,000 people): intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea.

Some undesirable effects have been reported since marketing of Aprovel. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels.
Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Aprovel contains
▪
The active substance is irbesartan. Each tablet of Aprovel 150 mg contains 150 mg irbesartan.
▪
The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax. Please see section 2 “Aprovel contains lactose”.

What Aprovel looks like and contents of the pack
Aprovel 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.

Aprovel 150 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film- coated tablets. Unidose blister packs of 56 x 1 film-coated tablet for delivery in hospitals are also available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Manufacturer:
SANOFI WINTHROP INDUSTRIE
1, rue de la Vierge
Ambarès & Lagrave
F-33565 Carbon Blanc Cedex - France

SANOFI WINTHROP INDUSTRIE
30-36 Avenue Gustave Eiffel, BP 7166
F-37071 Tours Cedex 2 - France

SANOFI-AVENTIS, S.A.
Ctra. C-35 (La Batlloria-Hostalric), km. 63.09
17404 Riells i Viabrea (Girona) - Spain

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131
Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη ΑΕΒΕ
Τηλ: +30 210 900 16 00

Österreich sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger: +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu/

Aprovel belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten.
This results in an increase in blood pressure. Aprovel prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Aprovel slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Aprovel is used in adult patients
▪ to treat high blood pressure (essential hypertension)
▪ to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

Do not take Aprovel
▪ if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6) ▪ if you are more than 3 months pregnant. (It is also better to avoid Aprovel in early pregnancy – see pregnancy section) ▪ if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

Warnings and precautions
Talk to your doctor before taking Aprovel and if any of the following apply to you:
▪ if you get excessive vomiting or diarrhoea
▪ if you suffer from kidney problems
▪ if you suffer from heart problems
▪ if you receive Aprovel for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function ▪ if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heartbeat), particularly if you are being treated for diabetes.
▪ if you are going to have an operation (surgery) or be given anaesthetics

▪ if you are taking any of the following medicines used to treat high blood pressure:
o an ACE-inhibitor ( for example enalapril, lisinopril, ramipril) in particular if you have diabetes-related kidney problems.
o aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Aprovel. Your doctor will decide on further treatment. Do not stop taking Aprovel on your own.

See also information under the heading “Do not take Aprovel”.

You must tell your doctor if you think you are (or might become) pregnant. Aprovel is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Children and adolescents
This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

Other medicines and Aprovel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Aprovel” and “Warnings and precautions”).

You may need to have blood checks if you take:
▪ potassium supplements
▪ salt substitutes containing potassium
▪ potassium-sparing medicines (such as certain diuretics)
▪ medicines containing lithium
▪ repaglinide (medication used for lowering blood sugar levels)

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Aprovel with food and drink
Aprovel can be taken with or without food.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Aprovel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Aprovel. Aprovel is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Aprovel is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines
Aprovel is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

Aprovel contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.

Aprovel contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration
Aprovel is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
You can take Aprovel with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Aprovel until your doctor tells you otherwise.

▪
Patients with high blood pressure
The usual dose is 150 mg once-a-day. The dose may later be increased to 300 mg once daily depending on blood pressure response.

▪
Patients with high blood pressure and type 2 diabetes with kidney disease
In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

Use in children and adolescents
Aprovel should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you take more Aprovel than you should:
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Aprovel:
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these effects may be serious and may require medical attention.

As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any

of these symptoms or get short of breath, stop taking Aprovel and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people

Side effects reported in clinical studies for patients treated with Aprovel were:
▪
Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.

▪
Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.

▪
Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

▪
Rare (may affect up to 1 in 1,000 people): intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea.

Some undesirable effects have been reported since marketing of Aprovel. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels.
Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Aprovel contains
▪
The active substance is irbesartan. Each tablet of Aprovel 300 mg contains 300 mg irbesartan.
▪
The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax. Please see section 2 “Aprovel contains lactose”.

What Aprovel looks like and contents of the pack
Aprovel 300 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.

Aprovel 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film- coated tablets. Unidose blister packs of 56 x 1 film-coated tablet for delivery in hospitals are also available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Manufacturer:
SANOFI WINTHROP INDUSTRIE
1, rue de la Vierge
Ambarès & Lagrave
F-33565 Carbon Blanc Cedex - France

SANOFI WINTHROP INDUSTRIE
30-36 Avenue Gustave Eiffel, BP 7166
F-37071 Tours Cedex 2 - France

SANOFI-AVENTIS, S.A.
Ctra. C-35 (La Batlloria-Hostalric), km. 63.09
17404 Riells i Viabrea (Girona) - Spain

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131
Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη ΑΕΒΕ
Τηλ: +30 210 900 16 00

Österreich sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger: +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00
Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: 800.536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300
Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu/

Irbesartan Zentiva belongs to a group of medicines known as angiotensin-II receptor antagonists.
Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan Zentiva prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Irbesartan Zentiva slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Irbesartan Zentiva is used in adult patients
 to treat high blood pressure (essential hypertension)
 to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

Do not take Irbesartan Zentiva
 if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6)  if you are more than 3 months pregnant. (It is also better to avoid Irbesartan Zentiva in early pregnancy – see pregnancy section)  if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor before taking Irbesartan Zentiva and if any of the following apply to you:
 if you get excessive vomiting or diarrhoea
 if you suffer from kidney problems
 if you suffer from heart problems
 if you receive Irbesartan Zentiva for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function  if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heartbeat), particularly if you are being treated for diabetes.

 if you are going to have an operation (surgery) or be given anaesthetics
 if you are taking any of the following medicines used to treat high blood pressure:
o an ACE-inhibitor (for example enalapril, lisinopril, ramipril) in particular if you have diabetes-related kidney problems.
o aliskiren.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.

See also information under the heading “Do not take Irbesartan Zentiva”.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Irbesartan Zentiva. Your doctor will decide on further treatment. Do not stop taking Irbesartan Zentiva on your own.

You must tell your doctor if you think you are (or might become) pregnant. Irbesartan Zentiva is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Children and adolescents
This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

Other medicines and Irbesartan Zentiva
Tell your doctor or pharmacist if you are taking,have recently taken or might take any other medicines.

Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan Zentiva” and “Warnings and precautions”).

You may need to have blood checks if you take:
 potassium supplements
 salt substitutes containing potassium
 potassium-sparing medicines (such as certain diuretics)
 medicines containing lithium
 repaglinide (medication used for lowering blood sugar levels)

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Irbesartan Zentiva with food and drink
Irbesartan Zentiva can be taken with or without food.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Irbesartan Zentiva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan Zentiva. Irbesartan Zentiva is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan Zentiva is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines
Irbesartan Zentiva is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

Irbesartan Zentiva contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Irbesartan Zentiva contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration
Irbesartan Zentiva is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan Zentiva with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Irbesartan Zentiva until your doctor tells you otherwise.


Patients with high blood pressure
The usual dose is 150 mg once a day (two tablets a day). The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response.


Patients with high blood pressure and type 2 diabetes with kidney disease
In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

Use in children and adolescents
Irbesartan Zentiva should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you take more Irbesartan Zentiva than you should:
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Irbesartan Zentiva:
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these effects may be serious and may require medical attention.

As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any

of these symptoms or get short of breath, stop taking Irbesartan Zentiva and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people

Side effects reported in clinical studies for patients treated with Irbesartan Zentiva were:

Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.


Common (may affect up to 1 in 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.


Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.


Rare (may affect up to 1 in 1,000 people): intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea.

Some undesirable effects have been reported since marketing of Irbesartan Zentiva. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Irbesartan Zentiva contains

The active substance is irbesartan. Each tablet of Irbesartan Zentiva 75 mg contains 75 mg irbesartan.

The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax. Please see section 2 “Irbesartan Zentiva contains lactose”.

What Irbesartan Zentiva looks like and contents of the pack
Irbesartan Zentiva 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.

Irbesartan Zentiva 75 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets. Unidose blister packs of 56 x 1 film-coated tablet for delivery in hospitals are also available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturer:
Sanofi Winthrop Industrie
1 Rue de la vierge
Ambarès et Lagrave
33 565 Carbon Blanc cedex
France

Sanofi Winthrop Industrie
30-36 Avenue Gustave Eiffel
37 100 Tours
France

Zentiva, k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
Zentiva, k.s.
Tél/Tel: +32 (78) 700 112
PV-Belgium@zentiva.com

Lietuva
Zentiva, k.s.
Tel: +370 52152025
PV-Lithuania@zentiva.com
България
Zentiva, k.s.
Тел: +35924417136
PV-Bulgaria@zentiva.com

Luxembourg/Luxemburg
Zentiva, k.s.
Tél/Tel: +352 208 82330
PV-Luxembourg@zentiva.com

Magyarország
Zentiva Pharma Kft.
Tel.: +36 1 299 1058
PV-Hungary@zentiva.com
Malta
Zentiva, k.s.
Tel: +356 2034 1796
PV-Malta@zentiva.com
Nederland
Zentiva, k.s.
Tel: +31 202 253 638
PV-Netherlands@zentiva.com
Norge
Zentiva Denmark ApS
Tlf: +45 787 68 400
PV-Norway@zentiva.com
Österreich
Zentiva, k.s.
Tel: +43 720 778 877
PV-Austria@zentiva.com
Polska
Zentiva Polska Sp. z o.o.
Tel: + 48 22 375 92 00
PV-Poland@zentiva.com
Česká republika
Zentiva, k.s.
Tel: +420 267 241 111
PV-Czech-Republic@zentiva.com
Danmark
Zentiva Denmark ApS
Tlf: +45 787 68 400
PV-Denmark@zentiva.com
Deutschland
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
PV-Germany@zentiva.com
Eesti
Zentiva, k.s.
Tel: +372 52 70308
PV-Estonia@zentiva.com
Ελλάδα
Zentiva, k.s.
Τηλ: +30 211 198 7510
PV-Greece@zentiva.com
España
Zentiva Spain S.L.U.
Tel: +34 671 365 828
PV-Spain@zentiva.com
France
Zentiva France
Tél: +33 (0) 800 089 219
PV-France@zentiva.com
Portugal
Zentiva Portugal, Lda
Tel: +351210601360
PV-Portugal@zentiva.com
Hrvatska
Zentiva d.o.o.
Tel: +385 1 6641 830
PV-Croatia@zentiva.com
Ireland
Zentiva, k.s.
Tel: +353 818 882 243
PV-Ireland@zentiva.com
România
ZENTIVA S.A.
Tel: +4 021 304 7597
PV-Romania@zentiva.com
Slovenija
Zentiva, k.s.
Tel: +386 360 00 408
PV-Slovenia@zentiva.com
Ísland
Zentiva Denmark ApS
Sími: +354 539 5025
PV-Iceland@zentiva.com
Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010
PV-Slovakia@zentiva.com
Italia
Zentiva Italia S.r.l.
Tel: +39 800081631
PV-Italy@zentiva.com
Suomi/Finland
Zentiva Denmark ApS
Puh/Tel: +358 942 598 648
PV-Finland@zentiva.com

Κύπρος
Zentiva, k.s.
Τηλ: +30 211 198 7510
PV-Cyprus@zentiva.com

Sverige
Zentiva Denmark ApS
Tel: +46 840 838 822
PV-Sweden@zentiva.com
Latvija
Zentiva, k.s.
Tel: +371 67893939
PV-Latvia@zentiva.com

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu/

Irbesartan Zentiva belongs to a group of medicines known as angiotensin-II receptor antagonists.
Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan Zentiva prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Irbesartan Zentiva slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Irbesartan Zentiva is used in adult patients
 to treat high blood pressure (essential hypertension)
 to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

Do not take Irbesartan Zentiva
 if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6)  if you are more than 3 months pregnant. (It is also better to avoid Irbesartan Zentiva in early pregnancy – see pregnancy section)  if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor before taking Irbesartan Zentiva and if any of the following apply to you:
 if you get excessive vomiting or diarrhoea
 if you suffer from kidney problems
 if you suffer from heart problems
 if you receive Irbesartan Zentiva for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function  if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heartbeat), particularly if you are being treated for diabetes.

 if you are going to have an operation (surgery) or be given anaesthetics
 if you are taking any of the following medicines used to treat high blood pressure:
o an ACE-inhibitor (for example enalapril, lisinopril, ramipril) in particular if you have diabetes-related kidney problems.
o aliskiren.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.

See also information under the heading “Do not take Irbesartan Zentiva”.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Irbesartan Zentiva. Your doctor will decide on further treatment. Do not stop taking Irbesartan Zentiva on your own.

You must tell your doctor if you think you are (or might become) pregnant. Irbesartan Zentiva is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Children and adolescents
This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

Other medicines and Irbesartan Zentiva
Tell your doctor or pharmacist if you are taking,have recently taken or might take any other medicines.

Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan Zentiva” and “Warnings and precautions”).

You may need to have blood checks if you take:
 potassium supplements
 salt substitutes containing potassium
 potassium-sparing medicines (such as certain diuretics)
 medicines containing lithium
 repaglinide (medication used for lowering blood sugar levels)

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Irbesartan Zentiva with food and drink
Irbesartan Zentiva can be taken with or without food.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Irbesartan Zentiva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan Zentiva. Irbesartan Zentiva is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan Zentiva is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines
Irbesartan Zentiva is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

Irbesartan Zentiva contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Irbesartan Zentiva contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration
Irbesartan Zentiva is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan Zentiva with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Irbesartan Zentiva until your doctor tells you otherwise.


Patients with high blood pressure
The usual dose is 150 mg once a day. The dose may later be increased to 300 mg (two tablets a day) once daily depending on blood pressure response.


Patients with high blood pressure and type 2 diabetes with kidney disease
In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

Use in children and adolescents
Irbesartan Zentiva should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you take more Irbesartan Zentiva than you should:
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Irbesartan Zentiva:
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these effects may be serious and may require medical attention.

As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any

of these symptoms or get short of breath, stop taking Irbesartan Zentiva and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people

Side effects reported in clinical studies for patients treated with Irbesartan Zentiva were:

Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.


Common (may affect up to 1 in 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.


Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.


Rare (may affect up to 1 in 1,000 people): intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea.

Some undesirable effects have been reported since marketing of Irbesartan Zentiva. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Irbesartan Zentiva contains

The active substance is irbesartan. Each tablet of Irbesartan Zentiva 150 mg contains 150 mg irbesartan.

The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax. Please see section 2 “Irbesartan Zentiva contains lactose”.

What Irbesartan Zentiva looks like and contents of the pack
Irbesartan Zentiva 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.

Irbesartan Zentiva 150 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets. Unidose blister packs of 56 x 1 film-coated tablet for delivery in hospitals are also available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturer:
Sanofi Winthrop Industrie
1 Rue de la vierge
Ambarès et Lagrave
33 565 Carbon Blanc cedex
France

Sanofi Winthrop Industrie
30-36 Avenue Gustave Eiffel
37 100 Tours
France

Zentiva, k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic

Sanofi-Aventis, S.A.
Ctra. C-35 (La Batlloria-Hostalric), km. 63.09
17404 Riells i Viabrea (Girona)
Spain

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
Zentiva, k.s.
Tél/Tel: +32 (78) 700 112
PV-Belgium@zentiva.com

Lietuva
Zentiva, k.s.
Tel: +370 52152025
PV-Lithuania@zentiva.com

Luxembourg/Luxemburg
Zentiva, k.s.
Tél/Tel: +352 208 82330
PV-Luxembourg@zentiva.com
Magyarország
Zentiva Pharma Kft.
Tel.: +36 1 299 1058
PV-Hungary@zentiva.com
Malta
Zentiva, k.s.
Tel: +356 2034 1796
PV-Malta@zentiva.com
Nederland
Zentiva, k.s.
Tel: +31 202 253 638
PV-Netherlands@zentiva.com
Norge
Zentiva Denmark ApS
Tlf: +45 787 68 400
PV-Norway@zentiva.com
Österreich
Zentiva, k.s.
Tel: +43 720 778 877
PV-Austria@zentiva.com
Polska
Zentiva Polska Sp. z o.o.
Tel: + 48 22 375 92 00
PV-Poland@zentiva.com
България
Zentiva, k.s.
Тел: +35924417136
PV-Bulgaria@zentiva.com
Česká republika
Zentiva, k.s.
Tel: +420 267 241 111
PV-Czech-Republic@zentiva.com
Danmark
Zentiva Denmark ApS
Tlf: +45 787 68 400
PV-Denmark@zentiva.com
Deutschland
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
PV-Germany@zentiva.com
Eesti
Zentiva, k.s.
Tel: +372 52 70308
PV-Estonia@zentiva.com
Ελλάδα
Zentiva, k.s.
Τηλ: +30 211 198 7510
PV-Greece@zentiva.com
España
Zentiva Spain S.L.U.
Tel: +34 671 365 828
PV-Spain@zentiva.com
France
Zentiva France
Tél: +33 (0) 800 089 219
PV-France@zentiva.com
Portugal
Zentiva Portugal, Lda
Tel: +351210601360
PV-Portugal@zentiva.com
Hrvatska
Zentiva d.o.o.
Tel: +385 1 6641 830
PV-Croatia@zentiva.com
Ireland
Zentiva, k.s.
Tel: +353 818 882 243
PV-Ireland@zentiva.com
România
ZENTIVA S.A.
Tel: +4 021 304 7597
PV-Romania@zentiva.com
Slovenija
Zentiva, k.s.
Tel: +386 360 00 408
PV-Slovenia@zentiva.com
Ísland
Zentiva Denmark ApS
Sími: +354 539 5025
PV-Iceland@zentiva.com
Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010
PV-Slovakia@zentiva.com

Italia
Zentiva Italia S.r.l.
Tel: +39 800081631
PV-Italy@zentiva.com
Suomi/Finland
Zentiva Denmark ApS
Puh/Tel: +358 942 598 648
PV-Finland@zentiva.com

Κύπρος
Zentiva, k.s.
Τηλ: +30 211 198 7510
PV-Cyprus@zentiva.com

Sverige
Zentiva Denmark ApS
Tel: +46 840 838 822
PV-Sweden@zentiva.com
Latvija
Zentiva, k.s.
Tel: +371 67893939
PV-Latvia@zentiva.com

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu/

Irbesartan Zentiva belongs to a group of medicines known as angiotensin-II receptor antagonists.
Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan Zentiva prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Irbesartan Zentiva slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Irbesartan Zentiva is used in adult patients
 to treat high blood pressure (essential hypertension)
 to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

Do not take Irbesartan Zentiva
 if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6)  if you are more than 3 months pregnant. (It is also better to avoid Irbesartan Zentiva in early pregnancy – see pregnancy section)  if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor before taking Irbesartan Zentiva and if any of the following apply to you:
 if you get excessive vomiting or diarrhoea
 if you suffer from kidney problems
 if you suffer from heart problems
 if you receive Irbesartan Zentiva for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function  if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heartbeat), particularly if you are being treated for diabetes.

 if you are going to have an operation (surgery) or be given anaesthetics
 if you are taking any of the following medicines used to treat high blood pressure:
o an ACE-inhibitor (for example enalapril, lisinopril, ramipril) in particular if you have diabetes-related kidney problems.
o aliskiren.
nšě
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.

See also information under the heading “Do not take Irbesartan Zentiva”.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Irbesartan Zentiva. Your doctor will decide on further treatment. Do not stop taking Irbesartan Zentiva on your own.

You must tell your doctor if you think you are (or might become) pregnant. Irbesartan Zentiva is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Children and adolescents
This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

Other medicines and Irbesartan Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan Zentiva” and “Warnings and precautions”).

You may need to have blood checks if you take:
 potassium supplements
 salt substitutes containing potassium
 potassium-sparing medicines (such as certain diuretics)
 medicines containing lithium
 repaglinide (medication used for lowering blood sugar levels)

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Irbesartan Zentiva with food and drink
Irbesartan Zentiva can be taken with or without food.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Irbesartan Zentiva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan Zentiva. Irbesartan Zentiva is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan Zentiva is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines
Irbesartan Zentiva is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

Irbesartan Zentiva contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Irbesartan Zentiva contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration
Irbesartan Zentiva is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan Zentiva with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Irbesartan Zentiva until your doctor tells you otherwise.


Patients with high blood pressure
The usual dose is 150 mg once a day. The dose may later be increased to 300 mg once daily depending on blood pressure response.


Patients with high blood pressure and type 2 diabetes with kidney disease
In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

Use in children and adolescents
Irbesartan Zentiva should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you take more Irbesartan Zentiva than you should:
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Irbesartan Zentiva:
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these effects may be serious and may require medical attention.

As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any

of these symptoms or get short of breath, stop taking Irbesartan Zentiva and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people

Side effects reported in clinical studies for patients treated with Irbesartan Zentiva were:

Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.


Common (may affect up to 1 in 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.


Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.


Rare (may affect up to 1 in 1,000 people): intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea.

Some undesirable effects have been reported since marketing of Irbesartan Zentiva. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Irbesartan Zentiva contains

The active substance is irbesartan. Each tablet of Irbesartan Zentiva 300 mg contains 300 mg irbesartan.

The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax. Please see section 2 “Irbesartan Zentiva contains lactose”.

What Irbesartan Zentiva looks like and contents of the pack
Irbesartan Zentiva 300 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.

Irbesartan Zentiva 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets. Unidose blister packs of 56 x 1 film-coated tablet for delivery in hospitals are also available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturer:
Sanofi Winthrop Industrie
1 Rue de la vierge
Ambarès et Lagrave
33 565 Carbon Blanc cedex
France

Sanofi Winthrop Industrie
30-36 Avenue Gustave Eiffel
37 100 Tours
France

Zentiva, k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic

Sanofi-Aventis, S.A.
Ctra. C-35 (La Batlloria-Hostalric), km. 63.09
17404 Riells i Viabrea (Girona)
Spain

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
Zentiva, k.s.
Tél/Tel: +32 (78) 700 112
PV-Belgium@zentiva.com

Lietuva
Zentiva, k.s.
Tel: +370 52152025
PV-Lithuania@zentiva.com

Luxembourg/Luxemburg
Zentiva, k.s.
Tél/Tel: +352 208 82330
PV-Luxembourg@zentiva.com
Magyarország
Zentiva Pharma Kft.
Tel.: +36 1 299 1058
PV-Hungary@zentiva.com
Malta
Zentiva, k.s.
Tel: +356 2034 1796
PV-Malta@zentiva.com
Nederland
Zentiva, k.s.
Tel: +31 202 253 638
PV-Netherlands@zentiva.com
Norge
Zentiva Denmark ApS
Tlf: +45 787 68 400
PV-Norway@zentiva.com
Österreich
Zentiva, k.s.
Tel: +43 720 778 877
PV-Austria@zentiva.com
Polska
Zentiva Polska Sp. z o.o.
Tel: + 48 22 375 92 00
PV-Poland@zentiva.com
България
Zentiva, k.s.
Тел: +35924417136
PV-Bulgaria@zentiva.com
Česká republika
Zentiva, k.s.
Tel: +420 267 241 111
PV-Czech-Republic@zentiva.com
Danmark
Zentiva Denmark ApS
Tlf: +45 787 68 400
PV-Denmark@zentiva.com
Deutschland
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
PV-Germany@zentiva.com
Eesti
Zentiva, k.s.
Tel: +372 52 70308
PV-Estonia@zentiva.com
Ελλάδα
Zentiva, k.s.
Τηλ: +30 211 198 7510
PV-Greece@zentiva.com
España
Zentiva Spain S.L.U.
Tel: +34 671 365 828
PV-Spain@zentiva.com
France
Zentiva France
Tél: +33 (0) 800 089 219
PV-France@zentiva.com
Portugal
Zentiva Portugal, Lda
Tel: +351210601360
PV-Portugal@zentiva.com
Hrvatska
Zentiva d.o.o.
Tel: +385 1 6641 830
PV-Croatia@zentiva.com
Ireland
Zentiva, k.s.
Tel: +353 818 882 243
PV-Ireland@zentiva.com
România
ZENTIVA S.A.
Tel: +4 021 304 7597
PV-Romania@zentiva.com
Slovenija
Zentiva, k.s.
Tel: +386 360 00 408
PV-Slovenia@zentiva.com
Ísland
Zentiva Denmark ApS
Sími: +354 539 5025
PV-Iceland@zentiva.com
Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010
PV-Slovakia@zentiva.com

Italia
Zentiva Italia S.r.l.
Tel: +39 800081631
PV-Italy@zentiva.com
Suomi/Finland
Zentiva Denmark ApS
Puh/Tel: +358 942 598 648
PV-Finland@zentiva.com

Κύπρος
Zentiva, k.s.
Τηλ: +30 211 198 7510
PV-Cyprus@zentiva.com

Sverige
Zentiva Denmark ApS
Tel: +46 840 838 822
PV-Sweden@zentiva.com
Latvija
Zentiva, k.s.
Tel: +371 67893939
PV-Latvia@zentiva.com

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu/

Karvea belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten.
This results in an increase in blood pressure. Karvea prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Karvea slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Karvea is used in adult patients
▪ to treat high blood pressure (essential hypertension)
▪ to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

Do not take Karvea
▪ if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6) ▪ if you are more than 3 months pregnant. (It is also better to avoid Karvea in early pregnancy – see pregnancy section) ▪ if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warning and precautions
Talk to your doctor before taking Karvea and if any of the following apply to you:
▪ if you get excessive vomiting or diarrhoea
▪ if you suffer from kidney problems
▪ if you suffer from heart problems
▪ if you receive Karvea for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function ▪ if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heartbeat), particularly if you are being treated for diabetes.
▪ if you are going to have an operation (surgery) or be given anaesthetics
▪ if you are taking any of the following medicines used to treat high blood pressure:

o an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
o aliskiren
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Karvea. Your doctor will decide on further treatment. Do not stop taking Karvea on your own.

See also information under the heading “Do not take Karvea”.

You must tell your doctor if you think you are (or might become) pregnant. Karvea is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Children and adolescents
This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

Other medicines and Karvea
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Karvea” and “Warnings and precautions”).

You may need to have blood checks if you take:
▪ potassium supplements
▪ salt substitutes containing potassium
▪ potassium-sparing medicines (such as certain diuretics)
▪ medicines containing lithium
▪ repaglinide (medication used for lowering blood sugar levels)

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Karvea with food and drink
Karvea can be taken with or without food.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Karvea before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Karvea. Karvea is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Karvea is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines
Karvea is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

Karvea contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.

Karvea contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration
Karvea is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
You can take Karvea with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Karvea until your doctor tells you otherwise.

▪
Patients with high blood pressure
The usual dose is 150 mg once-a-day (two tablets a day). The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response.

▪
Patients with high blood pressure and type 2 diabetes with kidney disease
In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

Use in children and adolescents
Karvea should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you take more Karvea than you should
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Karvea
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these effects may be serious and may require medical attention.

As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Karvea and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Side effects reported in clinical studies for patients treated with Karvea were:
▪
Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.

▪
Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.

▪
Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

▪
Rare (may affect up to 1 in 1,000 people): intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea.

Some undesirable effects have been reported since marketing of Karvea. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels.
Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment.

What Karvea contains
▪
The active substance is irbesartan. Each tablet of Karvea 75 mg contains 75 mg irbesartan.
▪
The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinized maize starch, and poloxamer 188. Please see section 2 “Karvea contains lactose”.

What Karvea looks like and contents of the pack
Karvea 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.

Karvea 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. Unidose blister packs of 56 x 1 tablet for delivery in hospitals are also available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Manufacturer:
SANOFI WINTHROP INDUSTRIE
1, rue de la Vierge
Ambarès & Lagrave
F-33565 Carbon Blanc Cedex - France

SANOFI WINTHROP INDUSTRIE
30-36 Avenue Gustave Eiffel, BP 7166
F-37071 Tours Cedex 2 - France

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131

Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη ΑΕΒΕ
Τηλ: +30 210 900 16 00

Österreich sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger: +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu/

Karvea belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten.
This results in an increase in blood pressure. Karvea prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Karvea slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Karvea is used in adult patients
▪ to treat high blood pressure (essential hypertension)
▪ to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

Do not take Karvea
▪ if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6) ▪ if you are more than 3 months pregnant. (It is also better to avoid Karvea in early pregnancy – see pregnancy section) ▪ if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warning and precautions
Talk to your doctor before taking Karvea and if any of the following apply to you:
▪ if you get excessive vomiting or diarrhoea
▪ if you suffer from kidney problems
▪ if you suffer from heart problems
▪ if you receive Karvea for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function ▪ if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heartbeat), particularly if you are being treated for diabetes.
▪ if you are going to have an operation (surgery) or be given anaesthetics
▪ if you are taking any of the following medicines used to treat high blood pressure:

o an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
o aliskiren
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Karvea. Your doctor will decide on further treatment. Do not stop taking Karvea on your own.

See also information under the heading “Do not take Karvea”.

You must tell your doctor if you think you are (or might become) pregnant. Karvea is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Children and adolescents
This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

Other medicines and Karvea
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Karvea” and “Warnings and precautions”).

You may need to have blood checks if you take:
▪ potassium supplements
▪ salt substitutes containing potassium
▪ potassium-sparing medicines (such as certain diuretics)
▪ medicines containing lithium
▪ repaglinide (medication used for lowering blood sugar levels)

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Karvea with food and drink
Karvea can be taken with or without food.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Karvea before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Karvea. Karvea is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Karvea is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines
Karvea is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

Karvea contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.

Karvea contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration
Karvea is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
You can take Karvea with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Karvea until your doctor tells you otherwise.

▪
Patients with high blood pressure
The usual dose is 150 mg once-a-day. The dose may later be increased to 300 mg (two tablets a day) once daily depending on blood pressure response.

▪
Patients with high blood pressure and type 2 diabetes with kidney disease
In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

Use in children and adolescents
Karvea should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you take more Karvea than you should
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Karvea
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these effects may be serious and may require medical attention.

As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Karvea and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people

Side effects reported in clinical studies for patients treated with Karvea were:
▪
Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.

▪
Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.

▪
Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

▪
Rare (may affect up to 1 in 1,000 people): intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea.

Some undesirable effects have been reported since marketing of Karvea. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels.
Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment.

What Karvea contains
▪
The active substance is irbesartan. Each tablet of Karvea 150 mg contains 150 mg irbesartan.
▪
The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinized maize starch, and poloxamer 188. Please see section 2 “Karvea contains lactose”.

What Karvea looks like and contents of the pack
Karvea 150 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.

Karvea 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. Unidose blister packs of 56 x 1 tablet for delivery in hospitals are also available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Manufacturer:
SANOFI WINTHROP INDUSTRIE
1, rue de la Vierge
Ambarès & Lagrave
F-33565 Carbon Blanc Cedex - France

SANOFI WINTHROP INDUSTRIE
30-36 Avenue Gustave Eiffel, BP 7166
F-37071 Tours Cedex 2 - France

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131
Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη ΑΕΒΕ
Τηλ: +30 210 900 16 00

Österreich sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger: +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu/

Karvea belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten.
This results in an increase in blood pressure. Karvea prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Karvea slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Karvea is used in adult patients
▪ to treat high blood pressure (essential hypertension)
▪ to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

Do not take Karvea
▪ if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6) ▪ if you are more than 3 months pregnant. (It is also better to avoid Karvea in early pregnancy – see pregnancy section) ▪ if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warning and precautions
Talk to your doctor before taking Karvea and if any of the following apply to you:
▪ if you get excessive vomiting or diarrhoea
▪ if you suffer from kidney problems
▪ if you suffer from heart problems
▪ if you receive Karvea for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function ▪ if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heartbeat), particularly if you are being treated for diabetes.
▪ if you are going to have an operation (surgery) or be given anaesthetics
▪ if you are taking any of the following medicines used to treat high blood pressure:

o an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
o aliskiren
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Karvea. Your doctor will decide on further treatment. Do not stop taking Karvea on your own.

See also information under the heading “Do not take Karvea”.

You must tell your doctor if you think you are (or might become) pregnant. Karvea is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Children and adolescents
This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

Other medicines and Karvea
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Karvea” and “Warnings and precautions”).

You may need to have blood checks if you take:
▪ potassium supplements
▪ salt substitutes containing potassium
▪ potassium-sparing medicines (such as certain diuretics)
▪ medicines containing lithium
▪ repaglinide (medication used for lowering blood sugar levels)

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Karvea with food and drink
Karvea can be taken with or without food.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Karvea before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Karvea. Karvea is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Karvea is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines
Karvea is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

Karvea contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.

Karvea contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration
Karvea is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
You can take Karvea with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Karvea until your doctor tells you otherwise.

▪
Patients with high blood pressure
The usual dose is 150 mg once-a-day. The dose may later be increased to 300 mg once daily depending on blood pressure response.

▪
Patients with high blood pressure and type 2 diabetes with kidney disease
In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

Use in children and adolescents
Karvea should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you take more Karvea than you should
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Karvea
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these effects may be serious and may require medical attention.

As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Karvea and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people

Side effects reported in clinical studies for patients treated with Karvea were:
▪
Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.

▪
Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.

▪
Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

▪
Rare (may affect up to 1 in 1,000 people): intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea.

Some undesirable effects have been reported since marketing of Karvea. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels.
Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment.

What Karvea contains
▪
The active substance is irbesartan. Each tablet of Karvea 300 mg contains 300 mg irbesartan.

▪
The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinized maize starch, and poloxamer 188. Please see section 2 “Karvea contains lactose”.

What Karvea looks like and contents of the pack
Karvea 300 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2773 engraved on the other side.

Karvea 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. Unidose blister packs of 56 x 1 tablet for delivery in hospitals are also available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Manufacturer:
SANOFI WINTHROP INDUSTRIE
1, rue de la Vierge
Ambarès & Lagrave
F-33565 Carbon Blanc Cedex - France

SANOFI WINTHROP INDUSTRIE
30-36 Avenue Gustave Eiffel, BP 7166
F-37071 Tours Cedex 2 - France

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131
Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη ΑΕΒΕ
Τηλ: +30 210 900 16 00

Österreich sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger: +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu/

Karvea belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten.
This results in an increase in blood pressure. Karvea prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Karvea slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Karvea is used in adult patients
▪ to treat high blood pressure (essential hypertension)
▪ to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

Do not take Karvea
▪ if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6) ▪ if you are more than 3 months pregnant. (It is also better to avoid Karvea in early pregnancy – see pregnancy section) ▪ if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor before taking Karvea and if any of the following apply to you:
▪ if you get excessive vomiting or diarrhoea
▪ if you suffer from kidney problems
▪ if you suffer from heart problems
▪ if you receive Karvea for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function ▪ if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heartbeat), particularly if you are being treated for diabetes.
▪ if you are going to have an operation (surgery) or be given anaesthetics
▪ if you are taking any of the following medicines used to treat high blood pressure:

o an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
o aliskiren
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Karvea. Your doctor will decide on further treatment. Do not stop taking Karvea on your own.

See also information under the heading “Do not take Karvea”.

You must tell your doctor if you think you are (or might become) pregnant. Karvea is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Children and adolescents
This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

Other medicines and Karvea
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Karvea” and “Warnings and precautions”).

You may need to have blood checks if you take:
▪ potassium supplements
▪ salt substitutes containing potassium
▪ potassium-sparing medicines (such as certain diuretics)
▪ medicines containing lithium
▪ repaglinide (medication used for lowering blood sugar levels)

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Karvea with food and drink
Karvea can be taken with or without food.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Karvea before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Karvea. Karvea is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Karvea is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines
Karvea is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

Karvea contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.

Karvea contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration
Karvea is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
You can take Karvea with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Karvea until your doctor tells you otherwise.

▪
Patients with high blood pressure
The usual dose is 150 mg once-a-day (two tablets a day). The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response.

▪
Patients with high blood pressure and type 2 diabetes with kidney disease
In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

Use in children and adolescents
Karvea should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you take more Karvea than you should:
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Karvea:
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these effects may be serious and may require medical attention.

As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Karvea and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Side effects reported in clinical studies for patients treated with Karvea were:
▪
Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.

▪
Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.

▪
Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

▪
Rare (may affect up to 1 in 1,000 people): intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea.

Some undesirable effects have been reported since marketing of Karvea. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels.
Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Karvea contains
▪
The active substance is irbesartan. Each tablet of Karvea 75 mg contains 75 mg irbesartan.
▪
The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax. Please see section 2 “Karvea contains lactose”.

What Karvea looks like and contents of the pack
Karvea 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.

Karvea 75 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film- coated tablets. Unidose blister packs of 56 x 1 film-coated tablet for delivery in hospitals are also available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Manufacturer:
SANOFI WINTHROP INDUSTRIE
1, rue de la Vierge
Ambarès & Lagrave
F-33565 Carbon Blanc Cedex - France

SANOFI WINTHROP INDUSTRIE
30-36 Avenue Gustave Eiffel, BP 7166
F-37071 Tours Cedex 2 - France

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131
Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη ΑΕΒΕ
Τηλ: +30 210 900 16 00

Österreich sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger: +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
România

Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu/

Karvea belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten.
This results in an increase in blood pressure. Karvea prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Karvea slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Karvea is used in adult patients
▪ to treat high blood pressure (essential hypertension)
▪ to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

Do not take Karvea
▪ if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6) ▪ if you are more than 3 months pregnant. (It is also better to avoid Karvea in early pregnancy – see pregnancy section) ▪ if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor before taking Karvea and if any of the following apply to you:
▪ if you get excessive vomiting or diarrhoea
▪ if you suffer from kidney problems
▪ if you suffer from heart problems
▪ if you receive Karvea for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function ▪ if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heartbeat), particularly if you are being treated for diabetes.
▪ if you are going to have an operation (surgery) or be given anaesthetics
▪ if you are taking any of the following medicines used to treat high blood pressure:

o an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
o aliskiren
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Karvea. Your doctor will decide on further treatment. Do not stop taking Karvea on your own.

See also information under the heading “Do not take Karvea”.

You must tell your doctor if you think you are (or might become) pregnant. Karvea is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Children and adolescents
This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

Other medicines and Karvea
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Karvea” and “Warnings and precautions”).

You may need to have blood checks if you take:
▪ potassium supplements
▪ salt substitutes containing potassium
▪ potassium-sparing medicines (such as certain diuretics)
▪ medicines containing lithium
▪ repaglinide (medication used for lowering blood sugar levels)

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Karvea with food and drink
Karvea can be taken with or without food.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Karvea before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Karvea. Karvea is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Karvea is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines
Karvea is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

Karvea contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.

Karvea contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration
Karvea is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
You can take Karvea with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Karvea until your doctor tells you otherwise.

▪
Patients with high blood pressure
The usual dose is 150 mg once-a-day. The dose may later be increased to 300 mg (two tablets a day) once daily depending on blood pressure response.

▪
Patients with high blood pressure and type 2 diabetes with kidney disease
In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

Use in children and adolescents
Karvea should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you take more Karvea than you should:
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Karvea:
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these effects may be serious and may require medical attention.

As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Karvea and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people

Side effects reported in clinical studies for patients treated with Karvea were:
▪
Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.

▪
Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.

▪
Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

▪
Rare (may affect up to 1 in 1,000 people): intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea.

Some undesirable effects have been reported since marketing of Karvea. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels.
Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Karvea contains
▪
The active substance is irbesartan. Each tablet of Karvea 150 mg contains 150 mg irbesartan.
▪
The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax. Please see section 2 “Karvea contains lactose”.

What Karvea looks like and contents of the pack
Karvea 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.

Karvea 150 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film- coated tablets. Unidose blister packs of 56 x 1 film-coated tablet for delivery in hospitals are also available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Manufacturer:
SANOFI WINTHROP INDUSTRIE
1, rue de la Vierge
Ambarès & Lagrave
F-33565 Carbon Blanc Cedex - France

SANOFI WINTHROP INDUSTRIE
30-36 Avenue Gustave Eiffel, BP 7166
F-37071 Tours Cedex 2 - France

SANOFI-AVENTIS, S.A.
Ctra. C-35 (La Batlloria-Hostalric), km. 63.09
17404 Riells i Viabrea (Girona) – Spain

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131
Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη ΑΕΒΕ
Τηλ: +30 210 900 16 00

Österreich sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger: +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu/

Karvea belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten.
This results in an increase in blood pressure. Karvea prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Karvea slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Karvea is used in adult patients
▪ to treat high blood pressure (essential hypertension)
▪ to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

Do not take Karvea
▪ if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6) ▪ if you are more than 3 months pregnant. (It is also better to avoid Karvea in early pregnancy – see pregnancy section) ▪ if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor before taking Karvea and if any of the following apply to you:
▪ if you get excessive vomiting or diarrhoea
▪ if you suffer from kidney problems
▪ if you suffer from heart problems
▪ if you receive Karvea for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function ▪ if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heartbeat), particularly if you are being treated for diabetes.
▪ if you are going to have an operation (surgery) or be given anaesthetics
▪ if you are taking any of the following medicines used to treat high blood pressure:

o an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
o aliskiren
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Karvea. Your doctor will decide on further treatment. Do not stop taking Karvea on your own.

See also information under the heading “Do not take Karvea”.

You must tell your doctor if you think you are (or might become) pregnant. Karvea is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Children and adolescents
This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

Other medicines and Karvea
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Karvea” and “Warnings and precautions”).

You may need to have blood checks if you take:
▪ potassium supplements
▪ salt substitutes containing potassium
▪ potassium-sparing medicines (such as certain diuretics)
▪ medicines containing lithium
▪ repaglinide (medication used for lowering blood sugar levels)

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Karvea with food and drink
Karvea can be taken with or without food.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Karvea before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Karvea. Karvea is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Karvea is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines
Karvea is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

Karvea contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.

Karvea contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration
Karvea is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
You can take Karvea with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Karvea until your doctor tells you otherwise.

▪
Patients with high blood pressure
The usual dose is 150 mg once-a-day. The dose may later be increased to 300 mg once daily depending on blood pressure response.

▪
Patients with high blood pressure and type 2 diabetes with kidney disease
In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

Use in children and adolescents
Karvea should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you take more Karvea than you should:
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Karvea:
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these effects may be serious and may require medical attention.

As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Karvea and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Side effects reported in clinical studies for patients treated with Karvea were:
▪
Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.

▪
Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.

▪
Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

▪
Rare (may affect up to 1 in 1,000 people): intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea.

Some undesirable effects have been reported since marketing of Karvea. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels.
Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Karvea contains
▪
The active substance is irbesartan. Each tablet of Karvea 300 mg contains 300 mg irbesartan.
▪
The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax. Please see section 2 “Karvea contains lactose”.

What Karvea looks like and contents of the pack
Karvea 300 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.

Karvea 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film- coated tablets. Unidose blister packs of 56 x 1 film-coated tablet for delivery in hospitals are also available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Manufacturer:
SANOFI WINTHROP INDUSTRIE
1, rue de la Vierge
Ambarès & Lagrave
F-33565 Carbon Blanc Cedex - France

SANOFI WINTHROP INDUSTRIE
30-36 Avenue Gustave Eiffel, BP 7166
F-37071 Tours Cedex 2 - France

SANOFI-AVENTIS, S.A.
Ctra. C-35 (La Batlloria-Hostalric), km. 63.09
17404 Riells i Viabrea (Girona) – Spain

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131

Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη ΑΕΒΕ
Τηλ: +30 210 900 16 00

Österreich sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger: +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu/