telmisartan: package leaflet

Micardis belongs to a class of medicines known as angiotensin II receptor blockers. Angiotensin II is a substance produced in your body which causes your blood vessels to narrow, thus increasing your blood pressure. Micardis blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.

Micardis is used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means that the high blood pressure is not caused by any other condition.

High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal range.

Micardis is also used to reduce cardiovascular events (i.e. heart attack or stroke) in adults who are at risk because they have a reduced or blocked blood supply to the heart or legs, or have had a stroke or have high risk diabetes. Your doctor can tell you if you are at high risk for such events.

Do not take Micardis
- if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
- if you are more than 3 months pregnant. (It is also better to avoid Micardis in early pregnancy – see pregnancy section.)
- if you have severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of the bile from the liver and gall bladder) or any other severe liver disease.
- if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

If any of the above applies to you, tell your doctor or pharmacist before taking Micardis.

Warnings and precautions
Talk to your doctor before taking Micardis if you are suffering or have ever suffered from any of the following conditions or illnesses:

• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
• Liver disease.
• Heart trouble.
• Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals).
• Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to e.g. diuretic therapy (‘water tablets’), low-salt diet, diarrhoea, or vomiting.
• Elevated potassium levels in your blood.
• Diabetes.

Talk to your doctor before taking Micardis:
- if you are taking any of the following medicines used to treat high blood pressure:
- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
- 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 Micardis”.
- if you are taking digoxin.

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

You must tell your doctor if you think you are (or might become) pregnant. Micardis 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).

In case of surgery or anaesthesia, you should tell your doctor that you are taking Micardis.

Micardis may be less effective in lowering the blood pressure in black patients.

Children and adolescents
The use of Micardis in children and adolescents up to the age of 18 years is not recommended.

Other medicines and Micardis
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may need to change the dose of these other medications or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below taken at the same time with Micardis:

• Lithium containing medicines to treat some types of depression.
• Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain ‘water tablets’), ACE inhibitors, angiotensin II receptor blockers, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
• Diuretics (‘water tablets’), especially if taken in high doses together with Micardis, may lead to excessive loss of body water and low blood pressure (hypotension).
• If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Micardis” and “Warnings and precautions”).

• Digoxin.

The effect of Micardis may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.

Micardis may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine).
Furthermore, low blood pressure may be aggravated by alcohol, barbiturates, narcotics or antidepressants. You may notice this as dizziness when standing up. You should consult with your doctor if you need to adjust the dose of your other medicine while taking Micardis.

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 Micardis before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Micardis. Micardis 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. Micardis 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
Some people may experience side effects such as fainting or a feeling of spinning (vertigo) when taking Micardis. If you experience these side effects, do not drive or operate machinery.

Micardis contains sorbitol.
This medicine contains 84.32 mg sorbitol in each tablet.

Micardis 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.

The recommended dose is one tablet a day. Try to take the tablet at the same time each day.
You can take Micardis with or without food. The tablets should be swallowed whole with some water or other non-alcoholic drink. It is important that you take Micardis every day until your doctor tells you otherwise. If you have the impression that the effect of Micardis is too strong or too weak, talk to your doctor or pharmacist.

For treatment of high blood pressure, the usual dose of Micardis for most patients is one 40 mg tablet once a day to control blood pressure over the 24-hour period. Your doctor has recommended a lower dose of one 20 mg tablet daily. Micardis may also be used in combination with diuretics (‘water tablets’) such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Micardis.

For reduction of cardiovascular events, the usual dose of Micardis is one 80 mg tablet once a day. At the beginning of the preventive therapy with Micardis 80 mg, blood pressure should be frequently monitored.

If your liver is not working properly, the usual dose should not exceed 40 mg once daily.

If you take more Micardis than you should
If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.

If you forget to take Micardis
If you forget to take a dose, do not worry. Take it as soon as you remember then carry on as before. If you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for forgotten individual doses.

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 side effects can be serious and need immediate medical attention
You should see your doctor immediately if you experience any of the following symptoms:

Sepsis* (often called “blood poisoning”, is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1 000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately. If these effects are not treated they could be fatal.

Possible side effects of Micardis
Common side effects (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in users treated for reduction of cardiovascular events.

Uncommon side effects (may affect up to 1 in 100 people):
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), dizziness, fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, pain in the belly, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment (including acute kidney failure), pain in the chest, feeling of weakness, and increased level of creatinine in the blood.

Rare side effects (may affect up to 1 in 1 000 people):
Sepsis* (often called “blood poisoning”, is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, discomfort in the belly, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience this side effect), rapid swelling of the skin and mucosa which can also lead to death (angioedema including fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood, low levels of sodium.

Very rare side effects (may affect up to 1 in 10 000 people):
Progressive scarring of lung tissue (interstitial lung disease)**.

Not known (frequency cannot be estimated from the available data):
Intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting, and diarrhoea has been reported after the use of similar products.

* The event may have happened by chance or could be related to a mechanism currently not known.

** Cases of progressive scarring of lung tissue have been reported during intake of telmisartan.
However, it is not known whether telmisartan was the cause.

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 after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from moisture. Remove your Micardis tablet from the blister only directly prior to intake.

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 Micardis contains
The active substance is telmisartan. Each tablet contains 20 mg telmisartan.
The other ingredients are povidone (K25), meglumine, sodium hydroxide, sorbitol (E420) and magnesium stearate.

What Micardis looks like and contents of the pack
Micardis 20 mg tablets are white, round and engraved with the code number ‘50H’ on one side and the company logo on the other side.

Micardis is available in blister packs containing 14, 28, 56 or 98 tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Manufacturer
Boehringer Ingelheim International GmbH
Binger Str. 173
55216 Ingelheim am Rhein
Germany
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
55216 Ingelheim am Rhein
Germany

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

België/Belgique/Belgien
Boehringer Ingelheim SComm
Tél/Tel: +32 2 773 33 11
Lietuva
Boehringer Ingelheim RCV GmbH & Co KG
Lietuvos filialas
Tel.: +370 5 2595942

България
Бьорингер Ингелхайм РЦВ ГмбХ и Ко. КГ - клон България
Тел: +359 2 958 79 98

Luxembourg/Luxemburg
Boehringer Ingelheim SComm
Tél/Tel: +32 2 773 33 11

Česká republika
Boehringer Ingelheim spol. s r.o.
Tel: +420 234 655 111
Magyarország
Boehringer Ingelheim RCV GmbH & Co KG
Magyarországi Fióktelepe
Tel.: +36 1 299 89 00

Danmark
Boehringer Ingelheim Danmark A/S
Tlf.: +45 39 15 88 88
Malta
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

Deutschland
Boehringer Ingelheim Pharma GmbH & Co. KG
Tel: +49 (0) 800 77 90 900
Nederland
Boehringer Ingelheim B.V.
Tel: +31 (0) 800 22 55 889

Eesti
Boehringer Ingelheim RCV GmbH & Co KG
Eesti filiaal
Tel: +372 612 8000

Norge
Boehringer Ingelheim Danmark
Norwegian branch
Tlf: +47 66 76 13 00

Ελλάδα
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.
Tηλ: +30 2 10 89 06 300
Österreich
Boehringer Ingelheim RCV GmbH & Co KG
Tel: +43 1 80 105-7870

España
Boehringer Ingelheim España, S.A.
Tel: +34 93 404 51 00

Polska
Boehringer Ingelheim Sp. z o.o.
Tel.: +48 22 699 0 699

France
Boehringer Ingelheim France S.A.S.
Tél: +33 3 26 50 45 33
Portugal
Boehringer Ingelheim Portugal, Lda.
Tel: +351 21 313 53 00

Hrvatska
Boehringer Ingelheim Zagreb d.o.o.
Tel: +385 1 2444 600

România
Boehringer Ingelheim RCV GmbH & Co KG
Viena - Sucursala Bucureşti
Tel: +40 21 302 28 00

Ireland
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620
Slovenija
Boehringer Ingelheim RCV GmbH & Co KG
Podružnica Ljubljana
Tel: +386 1 586 40 00

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Boehringer Ingelheim RCV GmbH & Co KG organizačná zložka
Tel: +421 2 5810 1211

Italia
Boehringer Ingelheim Italia S.p.A.
Tel: +39 02 5355 1
Suomi/Finland
Boehringer Ingelheim Finland Ky
Puh/Tel: +358 10 3102 800

Κύπρος
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.
Tηλ: +30 2 10 89 06 300
Sverige
Boehringer Ingelheim AB
Tel: +46 8 721 21 00

Latvija
Boehringer Ingelheim RCV GmbH & Co KG
Latvijas filiāle
Tel: +371 67 240 011

This leaflet was last revised in {MM/YYYY}.

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

Micardis belongs to a class of medicines known as angiotensin II receptor blockers. Angiotensin II is a substance produced in your body which causes your blood vessels to narrow, thus increasing your blood pressure. Micardis blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.

Micardis is used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means that the high blood pressure is not caused by any other condition.

High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal range.

Micardis is also used to reduce cardiovascular events (i.e. heart attack or stroke) in adults who are at risk because they have a reduced or blocked blood supply to the heart or legs, or have had a stroke or have high risk diabetes. Your doctor can tell you if you are at high risk for such events.

Do not take Micardis
- if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
- if you are more than 3 months pregnant. (It is also better to avoid Micardis in early pregnancy – see pregnancy section.)
- if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the liver and gall bladder) or any other severe liver disease.
- if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

If any of the above applies to you, tell your doctor or pharmacist before taking Micardis.

Warnings and precautions
Talk to your doctor before taking Micardis if you are suffering or have ever suffered from any of the following conditions or illnesses:

• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
• Liver disease.
• Heart trouble.
• Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals).
• Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to e.g. diuretic therapy (‘water tablets’), low-salt diet, diarrhoea, or vomiting.
• Elevated potassium levels in your blood.
• Diabetes.

Talk to your doctor before taking Micardis:
- if you are taking any of the following medicines used to treat high blood pressure:
- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
- 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 Micardis”.
- if you are taking digoxin.

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

You must tell your doctor if you think you are (or might become) pregnant. Micardis 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).

In case of surgery or anaesthesia, you should tell your doctor that you are taking Micardis.

Micardis may be less effective in lowering the blood pressure in black patients.

Children and adolescents
The use of Micardis in children and adolescents up to the age of 18 years is not recommended.

Other medicines and Micardis
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may need to change the dose of these other medications or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below taken at the same time with Micardis:

• Lithium containing medicines to treat some types of depression.
• Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain ‘water tablets’), ACE inhibitors, angiotensin II receptor blockers, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
• Diuretics (‘water tablets’), especially if taken in high doses together with Micardis, may lead to excessive loss of body water and low blood pressure (hypotension).
• If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Micardis” and “Warnings and precautions”).

• Digoxin.

The effect of Micardis may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.

Micardis may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine).
Furthermore, low blood pressure may be aggravated by alcohol, barbiturates, narcotics or antidepressants. You may notice this as dizziness when standing up. You should consult with your doctor if you need to adjust the dose of your other medicine while taking Micardis.

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 Micardis before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Micardis. Micardis 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. Micardis 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
Some people may experience side effects such as fainting or a feeling of spinning (vertigo) when taking Micardis. If you experience these side effects, do not drive or operate machinery.

Micardis contains sorbitol.
This medicine contains 168.64 mg sorbitol in each tablet.

Micardis 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.

The recommended dose is one tablet a day. Try to take the tablet at the same time each day.
You can take Micardis with or without food. The tablets should be swallowed whole with some water or other non-alcoholic drink. It is important that you take Micardis every day until your doctor tells you otherwise. If you have the impression that the effect of Micardis is too strong or too weak, talk to your doctor or pharmacist.

For treatment of high blood pressure, the usual dose of Micardis for most patients is one 40 mg tablet once a day to control blood pressure over the 24-hour period. However, sometimes your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Alternatively, Micardis may be used in combination with diuretics (‘water tablets’) such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Micardis.

For reduction of cardiovascular events, the usual dose of Micardis is one 80 mg tablet once a day. At the beginning of the preventive therapy with Micardis 80 mg, blood pressure should be frequently monitored.

If your liver is not working properly, the usual dose should not exceed 40 mg once daily.

If you take more Micardis than you should
If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.

If you forget to take Micardis
If you forget to take a dose, do not worry. Take it as soon as you remember then carry on as before. If you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for forgotten individual doses.

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 side effects can be serious and need immediate medical attention
You should see your doctor immediately if you experience any of the following symptoms:

Sepsis* (often called “blood poisoning”, is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1 000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately. If these effects are not treated they could be fatal.

Possible side effects of Micardis:
Common side effects (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in users treated for reduction of cardiovascular events.

Uncommon side effects (may affect up to 1 in 100 people):
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), dizziness, fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, pain in the belly, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment (including acute kidney failure), pain in the chest, feeling of weakness, and increased level of creatinine in the blood.

Rare side effects (may affect up to 1 in 1 000 people):
Sepsis* (often called “blood poisoning”, is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, discomfort in the belly, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience this side effect), rapid swelling of the skin and mucosa which can also lead to death (angioedema including fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood, low levels of sodium.

Very rare side effects (may affect up to 1 in 10 000 people):
Progressive scarring of lung tissue (interstitial lung disease)**.

Not known (frequency cannot be estimated from the available data):
Intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting, and diarrhoea has been reported after the use of similar products.

* The event may have happened by chance or could be related to a mechanism currently not known.

** Cases of progressive scarring of lung tissue have been reported during intake of telmisartan.
However, it is not known whether telmisartan was the cause.

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 after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from moisture. Remove your Micardis tablet from the blister only directly prior to intake.

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 Micardis contains
The active substance is telmisartan. Each tablet contains 40 mg telmisartan.
The other ingredients are povidone (K25), meglumine, sodium hydroxide, sorbitol (E420) and magnesium stearate.

What Micardis looks like and contents of the pack
Micardis 40 mg tablets are white, oblong-shaped, and engraved with the code number ‘51H’ on one side and the company logo on the other side.

Micardis is available in blister packs containing 14, 28, 56, 84 or 98 tablets, in unit dose blister packs containing 28 × 1, 30 × 1 or 90 × 1 tablets or in multipacks containing 360 (4 packs of 90 × 1) tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Manufacturer
Boehringer Ingelheim International GmbH
Binger Str. 173
55216 Ingelheim am Rhein
Germany
Boehringer Ingelheim Hellas Single Member S.A.
5th km Paiania – Markopoulo
Koropi Attiki, 19441
Greece

Rottendorf Pharma GmbH
Ostenfelder Straße 51 - 61
59320 Ennigerloh
Germany

Boehringer Ingelheim France
100-104 Avenue de France
75013 Paris
France

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

België/Belgique/Belgien
Boehringer Ingelheim SComm
Tél/Tel: +32 2 773 33 11
Lietuva
Boehringer Ingelheim RCV GmbH & Co KG
Lietuvos filialas
Tel.: +370 5 2595942

България
Бьорингер Ингелхайм РЦВ ГмбХ и Ко. КГ - клон България
Тел: +359 2 958 79 98

Luxembourg/Luxemburg
Boehringer Ingelheim SComm
Tél/Tel: +32 2 773 33 11

Česká republika
Boehringer Ingelheim spol. s r.o.
Tel: +420 234 655 111
Magyarország
Boehringer Ingelheim RCV GmbH & Co KG
Magyarországi Fióktelepe
Tel.: +36 1 299 89 00

Danmark
Boehringer Ingelheim Danmark A/S
Tlf.: +45 39 15 88 88
Malta
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

Deutschland
Boehringer Ingelheim Pharma GmbH & Co. KG
Tel: +49 (0) 800 77 90 900
Nederland
Boehringer Ingelheim B.V.
Tel: +31 (0) 800 22 55 889

Eesti
Boehringer Ingelheim RCV GmbH & Co KG
Eesti filiaal
Tel: +372 612 8000

Norge
Boehringer Ingelheim Danmark
Norwegian branch
Tlf: +47 66 76 13 00

Ελλάδα
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.
Tηλ: +30 2 10 89 06 300
Österreich
Boehringer Ingelheim RCV GmbH & Co KG
Tel: +43 1 80 105-7870

España
Boehringer Ingelheim España, S.A.
Tel: +34 93 404 51 00

Polska
Boehringer Ingelheim Sp. z o.o.
Tel.: +48 22 699 0 699

France
Boehringer Ingelheim France S.A.S.
Tél: +33 3 26 50 45 33
Portugal
Boehringer Ingelheim Portugal, Lda.
Tel: +351 21 313 53 00

Hrvatska
Boehringer Ingelheim Zagreb d.o.o.
Tel: +385 1 2444 600

România
Boehringer Ingelheim RCV GmbH & Co KG
Viena - Sucursala Bucureşti
Tel: +40 21 302 28 00

Ireland
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620
Slovenija
Boehringer Ingelheim RCV GmbH & Co KG
Podružnica Ljubljana
Tel: +386 1 586 40 00

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Boehringer Ingelheim RCV GmbH & Co KG organizačná zložka
Tel: +421 2 5810 1211

Italia
Boehringer Ingelheim Italia S.p.A.
Tel: +39 02 5355 1
Suomi/Finland
Boehringer Ingelheim Finland Ky
Puh/Tel: +358 10 3102 800

Κύπρος
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.
Tηλ: +30 2 10 89 06 300
Sverige
Boehringer Ingelheim AB
Tel: +46 8 721 21 00

Latvija
Boehringer Ingelheim RCV GmbH & Co KG
Latvijas filiāle
Tel: +371 67 240 011

This leaflet was last revised in {MM/YYYY}.

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

Micardis belongs to a class of medicines known as angiotensin II receptor blockers. Angiotensin II is a substance produced in your body which causes your blood vessels to narrow, thus increasing your blood pressure. Micardis blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.

Micardis is used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means that the high blood pressure is not caused by any other condition.

High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal range.

Micardis is also used to reduce cardiovascular events (i.e. heart attack or stroke) in adults who are at risk because they have a reduced or blocked blood supply to the heart or legs, or have had a stroke or have high risk diabetes. Your doctor can tell you if you are at high risk for such events.

Do not take Micardis
- if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
- if you are more than 3 months pregnant. (It is also better to avoid Micardis in early pregnancy – see pregnancy section.)
- if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the liver and gall bladder) or any other severe liver disease.
- if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

If any of the above applies to you, tell your doctor or pharmacist before taking Micardis.

Warnings and precautions
Talk to your doctor before taking Micardis if you are suffering or have ever suffered from any of the following conditions or illnesses:

• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
• Liver disease.
• Heart trouble.
• Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals).
• Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to e.g. diuretic therapy (‘water tablets’), low-salt diet, diarrhoea, or vomiting.
• Elevated potassium levels in your blood.
• Diabetes.

Talk to your doctor before taking Micardis:
- if you are taking any of the following medicines used to treat high blood pressure:
- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
- 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 Micardis”.
- if you are taking digoxin.

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

You must tell your doctor if you think you are (or might become) pregnant. Micardis 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).

In case of surgery or anaesthesia, you should tell your doctor that you are taking Micardis.

Micardis may be less effective in lowering the blood pressure in black patients.

Children and adolescents
The use of Micardis in children and adolescents up to the age of 18 years is not recommended.

Other medicines and Micardis
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may need to change the dose of these other medications or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below taken at the same time with Micardis:

• Lithium containing medicines to treat some types of depression.
• Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain ‘water tablets’), ACE inhibitors, angiotensin II receptor blockers, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
• Diuretics (‘water tablets’), especially if taken in high doses together with Micardis, may lead to excessive loss of body water and low blood pressure (hypotension).
• If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Micardis” and “Warnings and precautions”).

• Digoxin.

The effect of Micardis may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.

Micardis may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine).
Furthermore, low blood pressure may be aggravated by alcohol, barbiturates, narcotics or antidepressants. You may notice this as dizziness when standing up. You should consult with your doctor if you need to adjust the dose of your other medicine while taking Micardis.

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 Micardis before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Micardis. Micardis 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. Micardis 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
Some people may experience side effects such as fainting or a feeling of spinning (vertigo) when taking Micardis. If you experience these side effects, do not drive or operate machinery.

Micardis contains sorbitol.
This medicine contains 337.28 mg sorbitol in each tablet. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you take or receive this medicine.

Micardis 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.

The recommended dose is one tablet a day. Try to take the tablet at the same time each day.
You can take Micardis with or without food. The tablets should be swallowed whole with some water or other non-alcoholic drink. It is important that you take Micardis every day until your doctor tells you otherwise. If you have the impression that the effect of Micardis is too strong or too weak, talk to your doctor or pharmacist.

For treatment of high blood pressure, the usual dose of Micardis for most patients is one 40 mg tablet once a day to control blood pressure over the 24-hour period. However, sometimes your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Alternatively, Micardis may be used in combination with diuretics (‘water tablets’) such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Micardis.

For reduction of cardiovascular events, the usual dose of Micardis is one 80 mg tablet once a day. At the beginning of the preventive therapy with Micardis 80 mg, blood pressure should be frequently monitored.
If your liver is not working properly, the usual dose should not exceed 40 mg once daily.

If you take more Micardis than you should
If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.

If you forget to take Micardis
If you forget to take a dose, do not worry. Take it as soon as you remember then carry on as before. If you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for forgotten individual doses.

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 side effects can be serious and need immediate medical attention
You should see your doctor immediately if you experience any of the following symptoms:

Sepsis* (often called “blood poisoning”, is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1 000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately. If these effects are not treated they could be fatal.

Possible side effects of Micardis
Common side effects (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in users treated for reduction of cardiovascular events.

Uncommon side effects (may affect up to 1 in 100 people):
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), dizziness, fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, pain in the belly, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment (including acute kidney failure), pain in the chest, feeling of weakness, and increased level of creatinine in the blood.

Rare side effects (may affect up to 1 in 1 000 people):
Sepsis* (often called “blood poisoning”, is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, discomfort in the belly, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience this side effect), rapid swelling of the skin and mucosa which can also lead to death (angioedema including fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood, low levels of sodium.

Very rare side effects (may affect up to 1 in 10 000 people):
Progressive scarring of lung tissue (interstitial lung disease)**.

Not known (frequency cannot be estimated from the available data)
Intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting, and diarrhoea has been reported after the use of similar products.

* The event may have happened by chance or could be related to a mechanism currently not known.

** Cases of progressive scarring of lung tissue have been reported during intake of telmisartan.
However, it is not known whether telmisartan was the cause.

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 after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from moisture. Remove your Micardis tablet from the blister only directly prior to intake.

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 Micardis contains
The active substance is telmisartan. Each tablet contains 80 mg telmisartan.
The other ingredients are povidone (K25), meglumine, sodium hydroxide, sorbitol (E420) and magnesium stearate.

What Micardis looks like and contents of the pack
Micardis 80 mg tablets are white, oblong-shaped and engraved with the code number ‘52H’ on one side and the company logo on the other side.

Micardis is available in blister packs containing 14, 28, 56, 84 or 98 tablets, in unit dose blister packs containing 28 × 1, 30 × 1 or 90 × 1 tablets or in multipacks containing 360 (4 packs of 90 × 1) tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Manufacturer
Boehringer Ingelheim International GmbH
Binger Str. 173
55216 Ingelheim am Rhein
Germany
Boehringer Ingelheim Hellas Single Member S.A.
5th km Paiania – Markopoulo
Koropi Attiki, 19441
Greece

Rottendorf Pharma GmbH
Ostenfelder Straße 51- 61
59320 Ennigerloh
Germany

Boehringer Ingelheim France
100-104 Avenue de France
75013 Paris
France

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

België/Belgique/Belgien
Boehringer Ingelheim SComm
Tél/Tel: +32 2 773 33 11
Lietuva
Boehringer Ingelheim RCV GmbH & Co KG
Lietuvos filialas
Tel.: +370 5 2595942

България
Бьорингер Ингелхайм РЦВ ГмбХ и Ко. КГ - клон България
Тел: +359 2 958 79 98

Luxembourg/Luxemburg
Boehringer Ingelheim SComm
Tél/Tel: +32 2 773 33 11

Česká republika
Boehringer Ingelheim spol. s r.o.
Tel: +420 234 655 111
Magyarország
Boehringer Ingelheim RCV GmbH & Co KG
Magyarországi Fióktelepe
Tel.: +36 1 299 89 00

Danmark
Boehringer Ingelheim Danmark A/S
Tlf.: +45 39 15 88 88
Malta
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

Deutschland
Boehringer Ingelheim Pharma GmbH & Co. KG
Tel: +49 (0) 800 77 90 900
Nederland
Boehringer Ingelheim B.V.
Tel: +31 (0) 800 22 55 889

Eesti
Boehringer Ingelheim RCV GmbH & Co KG
Eesti filiaal
Tel: +372 612 8000

Norge
Boehringer Ingelheim Danmark
Norwegian branch
Tlf: +47 66 76 13 00

Ελλάδα
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.
Tηλ: +30 2 10 89 06 300
Österreich
Boehringer Ingelheim RCV GmbH & Co KG
Tel: +43 1 80 105-7870

España
Boehringer Ingelheim España, S.A.
Tel: +34 93 404 51 00

Polska
Boehringer Ingelheim Sp. z o.o.
Tel.: +48 22 699 0 699

France
Boehringer Ingelheim France S.A.S.
Tél: +33 3 26 50 45 33
Portugal
Boehringer Ingelheim Portugal, Lda.
Tel: +351 21 313 53 00

Hrvatska
Boehringer Ingelheim Zagreb d.o.o.
Tel: +385 1 2444 600

România
Boehringer Ingelheim RCV GmbH & Co KG
Viena - Sucursala Bucureşti
Tel: +40 21 302 28 00

Ireland
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620
Slovenija
Boehringer Ingelheim RCV GmbH & Co KG
Podružnica Ljubljana
Tel: +386 1 586 40 00

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Boehringer Ingelheim RCV GmbH & Co KG organizačná zložka
Tel: +421 2 5810 1211

Italia
Boehringer Ingelheim Italia S.p.A.
Tel: +39 02 5355 1
Suomi/Finland
Boehringer Ingelheim Finland Ky
Puh/Tel: +358 10 3102 800

Κύπρος
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.
Tηλ: +30 2 10 89 06 300
Sverige
Boehringer Ingelheim AB
Tel: +46 8 721 21 00

Latvija
Boehringer Ingelheim RCV GmbH & Co KG
Latvijas filiāle
Tel: +371 67 240 011

This leaflet was last revised in {MM/YYYY}.

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

ANNEX IV

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS
OF THE MARKETING AUTHORISATION(S)

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR(s) for hydrochlorothiazide / telmisartan, telmisartan, the scientific conclusions of the PRAC are as follows:

Dizziness
In view of available data on dizziness from clinical trial, literature, spontaneous reports, including 27 cases with a close temporal relationship, 12 cases with a positive de-challenge, 2 cases with a positive rechallenge and in view of a plausible mechanism of action and class effect, the PRAC Rapporteur considers a causal relationship between telmisartan and dizziness is at least a reasonable possibility.
The PRAC Rapporteur concluded that the product information of products containing telmisartan should be amended accordingly.

Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.

Grounds for the variation to the terms of the marketing authorisation(s)

On the basis of the scientific conclusions for hydrochlorothiazide / telmisartan, telmisartan the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing hydrochlorothiazide / telmisartan, telmisartan is unchanged subject to the proposed changes to the product information.

The CHMP recommends that the terms of the marketing authorisation(s) should be varied.