sevelamer carbonate: package leaflet

For patients

Package leaflet, verbatim

Renvela

Package leaflet: Renvela 800 mg film-coated tablets / sevelamer carbonate

1. What Renvela is and what it is used for

Renvela contains sevelamer carbonate as the active substance. It binds phosphate from food in the digestive tract and so reduces serum phosphorus levels in the blood.

This medicine is used to control hyperphosphataemia (high blood phosphate levels) in:
- adult patients on dialysis (a blood clearance technique). It can be used in patients undergoing haemodialysis (using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood);
- patients with chronic (long-term) kidney disease who are not on dialysis and have a serum (blood) phosphorus level equal to or above 1.78 mmol/l.

This medicine should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease.
Increased levels of serum phosphorus can lead to hard deposits in your body called calcification. These deposits can stiffen your blood vessels and make it harder for blood to be pumped around the body.
Increased serum phosphorus can also lead to itchy skin, red eyes, bone pain and fractures.

2. What you need to know before you take Renvela

Do not take Renvela if:
- you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
- you have low levels of phosphate in your blood (your doctor will check this for you)
- you have bowel obstruction

Warnings and precautions
Talk to your doctor before taking Renvela if any of the following applies to you:
• swallowing problems. Your doctor can rather prescribe Renvela powder for oral suspension • problems with motility (movement) in your stomach and bowel • being sick frequently • active inflammation of the bowel • have undergone major surgery on your stomach or bowel

Talk to your doctor while taking Renvela:
- if you experience severe abdominal pain, stomach or intestine disorders, or blood in the stool (gastrointestinal bleeding). These symptoms can be due to serious inflammatory bowel disease caused by sevelamer crystals deposit in your bowel. Contact your doctor who will decide on continuing the treatment or not.

Additional treatments
Due to either your kidney condition or your dialysis treatment you may:
• develop low or high levels of calcium in your blood. Since this medicine does not contain calcium your doctor might prescribe additional calcium tablets.
• have a low amount of vitamin D in your blood. Therefore, your doctor may monitor the levels of vitamin D in your blood and prescribe additional vitamin D as necessary. If you do not take multivitamin supplements you may also develop low levels of vitamins A, E, K and folic acid in your blood and therefore your doctor may monitor these levels and prescribe supplemental vitamins as necessary.
• have disturbed level of bicarbonate in your blood and increased acidity in the blood and other body tissue. Your doctor should monitor the level of bicarbonate in your blood.

Special note for patients on peritoneal dialysis
You may develop peritonitis (infection of your abdominal fluid) associated with your peritoneal dialysis.
This risk can be reduced by careful adherence to sterile techniques during bag changes. You should tell your doctor immediately if you experience any new signs or symptoms of abdominal distress, abdominal swelling, abdominal pain, abdominal tenderness, or abdominal rigidity, constipation, fever, chills, nausea or vomiting.

Children
The safety and efficacy in children (below the age of 6 years) have not been studied. Therefore this medicine is not recommended for use in children below the age of 6 years.

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

• Renvela should not be taken at the same time as ciprofloxacin (an antibiotic).

• If you are taking medicines for heart rhythm problems or for epilepsy, you should consult your doctor when taking Renvela.

• The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used to suppress the immune system) may be reduced by Renvela. Your doctor will advise you if you are taking these medicines.

• Thyroid hormone deficiency may uncommonly be observed in certain people taking levothyroxine (used to treat low thyroid hormone levels) and Renvela. Therefore your doctor may monitor the levels of thyroid stimulating hormone in your blood more closely.

• Medicines treating heartburn and reflux from your stomach or oesophagus, such as omeprazole, pantoprazole, or lansoprazole, known as “proton pump inhibitors”, may reduce the efficacy of Renvela. Your doctor may monitor the phosphate level in your blood.

Your doctor will check for interactions between Renvela and other medicines on a regular basis.

In some cases where Renvela should be taken at the same time as another medicine. Your doctor may advise you to take this medicine 1 hour before or 3 hours after Renvela intake. Your doctor may also consider monitoring the levels of that medicine in your blood.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
The potential risk of Renvela during human pregnancy is unknown. Talk to your doctor who will decide if you can continue the treatment with Renvela.

It is unknown whether Renvela is excreted in breast milk and may affect your baby. Talk to your doctor who will decide if you can breastfeed your baby or not, and if it is necessary to stop Renvela treatment.

Driving and using machines
Renvela is unlikely to affect your ability to drive or to use machines.

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

3. How to take Renvela

You must take Renvela as prescribed by your doctor. They will base the dose on your serum phosphorus level.

The recommended starting dose of Renvela tablets for adults and elderly is one to two tablets of 800 mg with each meal, 3 times a day. Check with your doctor, pharmacist or nurse if you are not sure.

Take Renvela after your meal or with food.

The tablets must be swallowed whole. Do not crush, chew or break into pieces.

Initially, your doctor will check the levels of phosphorus in your blood every 2-4 weeks and may adjust the dose of Renvela when necessary to reach an adequate phosphate level.

Follow the diet prescribed by your doctor.

If you take more Renvela than you should
In the event of a possible overdose you should contact your doctor immediately.

If you forget to take Renvela
If you have missed one dose, this dose should be omitted and the next dose should be taken at the usual time with a meal. Do not take a double dose to make up for a forgotten dose.

If you stop taking Renvela
Taking your Renvela treatment is important to maintain an appropriate phosphate level in your blood.
Stopping Renvela would lead to important consequences such as calcification in the blood vessels. If you consider stopping your Renvela treatment, contact your doctor or pharmacist first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Constipation is a very common side effect (may affect more than 1 in 10 people). It can be an early symptom of a blockage in your intestine. In case of constipation, please inform your doctor or pharmacist.

Some side effects could be serious. If you get any of the following side effects, seek immediate medical attention:

Allergic reaction (signs including rash, hives, swelling, trouble breathing). This is a very rare side effect (may affect up to 1 in 10,000 people).
Blockage in the intestine (signs include: severe bloating; abdominal pain, swelling or cramps; severe constipation) has been reported. Frequency is not known (frequency cannot be estimated from the available data).
Rupture in the intestinal wall (signs include: severe stomach pain, chills, fever, nausea, vomiting, or a tender abdomen) has been reported. Frequency is not known.
Serious inflammation of the large bowel (symptoms include: severe abdominal pain, stomach or intestine disorders, or blood in the stool [gastrointestinal bleeding]) and crystal deposit in the intestine have been reported. Frequency is not known.

Other side effects have been reported in patients taking Renvela:

Very common:
vomiting, upper abdominal pain, nausea

Common (may affect up to 1 in 10 people):
diarrhoea, stomach ache, indigestion, flatulence

Not known:
cases of itching, rash, slow intestine motility (movement)

Reporting of side effects
If you get any side effects, talk to your doctor. 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.

5. How to store Renvela

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

Do not use this medicine after the expiry date stated on the bottle and carton after the letters “EXP”. The expiry date refers to the last day of that month.

Keep the bottle container tightly closed in order to protect from moisture.
This medicine does not require any special storage conditions.

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.

6. Contents of the pack and other information

What Renvela contains

The active substance is sevelamer carbonate. Each film-coated tablet contains 800 mg of sevelamer carbonate - The other ingredients are microcrystalline cellulose, sodium chloride and zinc stearate. The tablet coating contains hypromellose (E464) and diacetylated monoglycerides.

What Renvela looks like and contents of the pack

Renvela film-coated tablets are white oval tablets with RV800 engraved on one side. The tablets are packed in high density polyethylene bottles with a polypropylene cap and an induction seal.

Pack sizes:
Each bottle contains 30 tablets or 180 tablets.
Packs of 1 bottle of 30 or 180 tablets (no outer carton) and a multipack containing 180 (6 bottles of 30) tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly
France

Manufacturer

Genzyme Ireland Limited
IDA Industrial Park
Old Kilmeaden Road
Waterford
Ireland

Sanofi Winthrop Industrie
1 rue de la Vierge
Ambares et Lagrave
33565 Carbon Blanc cedex
France

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

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

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

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

Magyarország
SANOFI-AVENTIS Zrt
Tel: +36 1 505 0050
Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

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

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

Nederland
Sanofi B.V.
Tel: +31 20 245 4000
Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: +49 (0)180 2 222010

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

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Österreich sanofi-aventis GmbH
Tel: + 43 1 80 185 - 0
Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 1600

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

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

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

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

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

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

Ireland sanofi-aventis Ireland Ltd T/A SANOFI
Tel: +353 (0) 1 4035 600

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

Ísland
Vistor hf.
Sími: +354 535 7000

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

Italia
Sanofi S.r.l.
Tel: 800 536 389
Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

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

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

United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +44 (0) 800 035 2525

This leaflet was last revised in

Other sources of information

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

Package leaflet: Renvela 0.8 g powder for oral suspension / sevelamer carbonate

1. What Renvela is and what it is used for

Renvela contains sevelamer carbonate as the active substance. It binds phosphate from food in the digestive tract and so reduces serum phosphorus levels in the blood.

This medicine is used to control hyperphosphataemia (high blood phosphate levels) in:
- adult patients on dialysis (a blood clearance technique). It can be used in patients undergoing haemodialysis (using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood);
- adult patients with chronic (long-term) kidney disease who are not on dialysis and have a serum (blood) phosphorus level equal to or above 1.78 mmol/l.
- paediatric patients with chronic (long-term) kidney disease above the age of 6 and above a certain height and weight (used to calculate body surface area by your physician).

2. What you need to know before you take Renvela

Warnings and precautions
Talk to you doctor before taking Renvela if any of the following applies to you:
• problems with motility (movement) in your stomach and bowel
• being sick frequently
• active inflammation of the bowel

• have undergone major surgery on your stomach or bowel

Children
The safety and efficacy in children (below the age of 6 years) have not been studied. Therefore this medicine is not recommended for use in children below the age of 6 years.

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

• Renvela should not be taken at the same time as ciprofloxacin (an antibiotic).

• If you are taking medicines for heart rhythm problems or for epilepsy, you should consult your doctor when taking Renvela.

Your doctor will check for interactions between Renvela and other medicines on a regular basis.

In some cases where Renvela should be taken at the same time as another medicine, your doctor may advise you to take this medicine 1 hour before or 3 hours after Renvela intake. Your doctor may also consider monitoring the levels of that medicine in your blood.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. The potential risk of Renvela during human pregnancy is unknown. Talk to your doctor who will decide if you can continue the treatment with Renvela.

Driving and using machines
Renvela is unlikely to affect your ability to drive or to use machines.

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

This medicine contains 8.42 mg propylene glycol in each 0.8 g sachet.

3. How to take Renvela

You must take Renvela as prescribed by your doctor. They will base the dose on your serum phosphorus level.

For a 0.8 g dose, the powder for oral suspension should be dispersed in 30 mL of water per sachet. Drink within 30 minutes of being prepared. It is important to drink all of the liquid and it may be necessary to rinse the glass with water and drink this as well to ensure that all of the powder is swallowed.
Instead of water, the powder may be pre-mixed with a small amount of cold beverage (about 120 ml or half a glass) or food (about 100 grams) and consumed within 30 minutes. Do not heat Renvela powder (e.g.
microwave) or add to hot foods or liquids.

The recommended starting dose of this medicine for adults and elderly is 2.4-4.8g per day equally divided over three meals. Check with your doctor, pharmacist or nurse if you are not sure. The exact starting dose and regimen will be determined by your doctor.

Take Renvela after your meal or with food.

(Instructions for presentation with dosing spoon)

For 0.4 g doses, the powder in the sachet may be divided. In this case the 0.4 g dose of Renvela powder must be measured using the dosing spoon provided in the carton.

Always use the dosing spoon provided in the carton.

(Instructions for presentation WITHOUT dosing spoon)

If a dose of 0.4 g is to be administered, please use the dedicated 0.8 g powder presentation with dosing spoon.

Use in children and adolescents
The recommended starting dose of Renvela for children is based on their height and weight (used to calculate body surface area by your physician). For children, the powder is preferred, as tablets are not appropriate in this population. This medicine should not be given on an empty stomach and should be taken with meals or snacks. The exact starting dose and regimen will be determined by your doctor.

For doses of less than 0.8 g, the powder in the sachet may be divided. The 0.4 g dose of Renvela powder must be measured using the dosing spoon provided in the carton.

Preparation using a dosing spoon

Use the provided dosing spoon for each 0.4 g dose of Renvela powder.

For a 0.4 g dose:
o Shake the sachet holding the top corner before opening, to move the powder to the bottom of the sachet o Open the sachet by tearing along the marked line.
o Ensure the dosing spoon is dry o Hold the dosing spoon horizontally and pour the powder out of the sachet into the dosing spoon.
o Fill the powder to the spoon level.
o Do not tap the dosing spoon to compact the powder.
o Mix the powder from the dosing spoon in 30 mL of water. Stir the suspension and drink it within 30 minutes of being prepared. It is important to drink all of the liquid to ensure that all of the powder is swallowed.
o Close the sachet by folding over twice.
o The remaining powder may be used within 24 hours for the next dose.
Discard sachets of powder that have been opened for more than 24 hours.

Initially, your doctor will check the levels of phosphorus in your blood every 2-4 weeks and may adjust the dose of Renvela when necessary to reach an adequate phosphate level.

Follow the diet prescribed by your doctor.

If you take more Renvela than you should
In the event of a possible overdose you should contact your doctor immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects could be serious. If you get any of the following side effects, seek immediate medical attention:
- Allergic reaction (signs including rash, hives, swelling, trouble breathing). This is a very rare side effect (may affect up to 1 in 10,000 people).
- Blockage in the intestine (signs include: severe bloating; abdominal pain, swelling or cramps; severe constipation) has been reported. Frequency is not known (frequency cannot be estimated from the available data).
- Rupture in the intestinal wall (signs include: severe stomach pain, chills, fever, nausea, vomiting, or a tender abdomen) has been reported. Frequency is not known - Serious inflammation of the large bowel (symptoms include: severe abdominal pain, stomach or intestine disorders, or blood in the stool [gastrointestinal bleeding]) and crystal deposit in the intestine have been reported. Frequency is not known.

Other side effects have been reported in patients taking Renvela:

Very common:
vomiting, upper abdominal pain, nausea

Common (may affect up to 1 in 10 people):
diarrhoea, stomach ache, indigestion, flatulence

Not known:
cases of itching, rash, slow intestine motility (movement)

5. How to store Renvela

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

Do not use this medicine after the expiry date stated on the sachet and carton after the letters “EXP”. The expiry date refers to the last day of that month.

The reconstituted suspension must be administered within 30 minutes of reconstitution.
This medicine does not require any special storage conditions.

(Instructions for presentation with dosing spoon)
Discard the sachet after 24 hours of opening.

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.

6. Contents of the pack and other information

What Renvela contains

The active substance is sevelamer carbonate. Each sachet contains 0.8 g of sevelamer carbonate.
The other ingredients are propylene glycol alginate (E405), citrus cream flavour, sodium chloride, sucralose and iron oxide yellow (E172).

What Renvela looks like and contents of the pack

Renvela powder for oral suspension is a pale yellow powder supplied in a foil sachet with a heat seal. The sachets are packaged in an outer carton.

(Instructions for presentation with dosing spoon)
A 0.4 g dosing spoon is provided in the carton.

Pack size:
90 sachets per carton

Marketing Authorisation Holder

Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly
France

Manufacturer

Genzyme Ireland Limited
IDA Industrial Park
Old Kilmeaden Road
Waterford
Ireland

ROVI Pharma Industrial Services, S.A.
Vía Complutense, 140, Alcalá de Henares,
Madrid, 28805, Spain

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

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

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

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

Magyarország
SANOFI-AVENTIS Zrt
Tel: +36 1 505 0050
Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

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

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

Nederland
Sanofi B.V.
Tel: +31 20 245 4000
Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: +49 (0)180 2 222010

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

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Österreich sanofi-aventis GmbH
Tel: + 43 1 80 185 - 0
Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 1600

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

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

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

France
România

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

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

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

Ireland sanofi-aventis Ireland Ltd T/A SANOFI
Tel: +353 (0) 1 4035 600

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

Ísland
Vistor hf.
Sími: +354 535 7000

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

Italia
Sanofi S.r.l.
Tel: 800 536 389

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

United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +44 (0) 800 035 2525

This leaflet was last revised in

Other sources of information

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

Package leaflet: Renvela 1.6 g powder for oral suspension / sevelamer carbonate