Renvela

Package leaflet: Information for the user

Renvela 800 mg film-coated tablets

sevelamer carbonate
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

1. What Renvela is and what it is used for
2. What you need to know before taking Renvela
3. How to take Renvela
4. Possible side effects
5. How to store Renvela
6. Contents of the pack and other information

1. What Renvela is and what it is used for

Renvela contains the active substance sevelamer carbonate, which acts in the digestive system by preventing the absorption of phosphate from food, thereby reducing phosphate levels in the blood.
This medicine is used to control hyperphosphataemia (high levels of phosphate in the blood) in:

• adult patients on dialysis (a blood purification technique). The medicine can be used in patients undergoing haemodialysis (using a machine to filter the blood) or peritoneal dialysis (in which fluid is pumped into the abdomen and an internal body membrane filters the blood);
• patients with chronic kidney disease (long-term) who are not on dialysis and who have a blood phosphate level equal to or greater than 1.78 mmol/L.

This medicine should be used together with other treatments, such as calcium and vitamin D supplements, to prevent the development of bone disease.
Elevated levels of phosphate in the blood can lead to the formation of solid deposits in the body called calcifications. These deposits can harden blood vessels and make blood circulation throughout the body more difficult. In addition, increased phosphate levels in the blood may cause skin itching, red eyes, bone pain, and fractures.

2. What you need to know before taking 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)
• if you have low levels of phosphate in the blood (your doctor will check this)
• if you have intestinal obstruction.

Warnings and precautions
Talk to your doctor before taking Renvela if any of the following apply to you:

• difficulty swallowing. Your doctor may alternatively prescribe Renvela oral suspension powder
• problems with motility (movement) of the stomach and intestines
• frequent malaise
• active inflammation of the intestine
• you have undergone major surgery on the stomach or intestines.

Talk to your doctor during treatment with Renvela:

• if you experience severe abdominal pain, stomach or intestinal problems, or if you notice blood in your stools (gastrointestinal bleeding). These symptoms may be due to a serious inflammatory bowel disease caused by deposition of sevelamer crystals in your intestine. Contact your doctor, who will decide whether or not to continue treatment.

Additional treatments
Due to kidney disease or dialysis treatment, you may:

• have low or high levels of calcium in the blood. Since this medicine does not contain calcium, your doctor may prescribe calcium supplements;
• have low levels of vitamin D in the blood. Therefore, your doctor may monitor your vitamin D levels and prescribe additional vitamin D as needed. If you do not take multivitamin supplements, you may also develop low levels of vitamin A, E, K, and folic acid in the blood, and therefore your doctor may monitor these levels and prescribe vitamin supplements as needed;
• have altered levels of bicarbonate in the blood and increased acidity in the blood and other body tissues. Your doctor will monitor your blood bicarbonate levels.

Special note for patients undergoing peritoneal dialysis
You may develop peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis.
This risk can be reduced by strictly maintaining sterile techniques when changing dialysis bags.
Inform your doctor immediately if you develop new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness or rigidity, constipation, fever, chills, nausea, or vomiting.
Children
The safety and efficacy in children (under 6 years of age) have not been established. Therefore, use of this
medicine should be avoided in children under 6 years of age.
Other medicines and Renvela
Inform your doctor if you are taking, have recently taken, or might take any other medicines.

• Renvela must not be taken at the same time as ciprofloxacin (an antibiotic).
• If you are taking medicines for heart rhythm disorders or for epilepsy, consult your doctor when taking Renvela.
• Renvela may reduce the effects of medicines such as cyclosporine, mycophenolate mofetil, and tacrolimus (medicines used to suppress the activity of the immune system). If you are taking these medicines, your doctor will advise you on how to proceed.
• In some patients, taking levothyroxine (a medicine used to treat low thyroid hormone levels) together with Renvela has uncommonly caused thyroid hormone deficiency. Therefore, your doctor may monitor your thyroid-stimulating hormone levels in the blood more closely.
• Medicines such as omeprazole, pantoprazole, or lansoprazole, known as "proton pump inhibitors", used to treat heartburn and gastroesophageal reflux, may reduce the effectiveness of Renvela. Your doctor may consider monitoring your blood phosphate levels. Your doctor will check regularly for possible interactions between Renvela and other medicines.

In some cases where Renvela must be taken together with another medicine, your doctor may advise you to take that medicine 1 hour before or 3 hours after taking Renvela. Your doctor may also consider monitoring blood levels of that medicine.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
The potential risk of Renvela during human pregnancy is unknown. Talk to your doctor, who will decide whether you can continue treatment with Renvela.
It is not known whether Renvela is excreted in breast milk and whether it could affect the infant. Inform your doctor, who will decide whether you can breastfeed and whether treatment with Renvela needs to be stopped.
Driving and using machines
It is unlikely that Renvela will affect your ability to drive or use machines.
Excipients
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially "sodium-free".

3. How to take Renvela

You must take Renvela exactly as instructed by your doctor. Your doctor will base the dose on your blood phosphate level.
The recommended starting dose of Renvela tablets for adults and elderly patients is one or two 800 mg tablets taken three times a day with the main meals. If you are unsure, check with your doctor, pharmacist, or nurse.
Take Renvela with food or immediately after a meal.
The tablets must be swallowed whole. Do not crush, chew, or break the tablets.
Initially, your doctor will monitor your blood phosphate levels every 2--4 weeks and may adjust the dose of Renvela, if necessary, to achieve the appropriate phosphate level.
Follow the diet prescribed by your doctor.

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

If you forget to take Renvela
If you miss a dose, take the next dose at the usual time with a meal. Do not take a double dose to make up for the missed dose.

If you stop taking Renvela
Continuing treatment with Renvela is important to maintain an appropriate blood phosphate level. Stopping Renvela could lead to serious consequences, such as calcification of blood vessels. If you are considering stopping treatment with Renvela, contact your doctor or pharmacist first.

If you have further questions about 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 may be an early sign of intestinal obstruction. If you experience constipation, inform your doctor or pharmacist.

Some side effects may be serious. If you experience any of the following side effects, contact your doctor immediately:

• Allergic reaction (signs include rash, hives, swelling, breathing problems). This is a very rare side effect (may affect up to 1 in 10,000 people).
• Intestinal blockage (signs include severe bloating, abdominal pain, swelling or cramps, severe constipation). Frequency is not known (cannot be estimated from the available data).
• Rupture of the intestinal wall (signs include severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain). Frequency is not known.
• Severe inflammation of the large intestine (symptoms include: severe abdominal pain, stomach or intestinal disturbances, or blood in the stool [gastrointestinal bleeding]) and deposition of crystals in the intestine. Frequency is not known.

Other side effects observed in patients taking Renvela include:
Very common:
vomiting, upper abdominal pain, nausea
Common (may affect up to 1 in 10 patients):
diarrhoea, stomach pain, indigestion, flatulence
Not known:
cases of itching sensation, rash, slow intestinal motility (movement) have been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. 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 "Exp".
The expiry date refers to the last day of that month.
Keep the container tightly closed to protect the medicine from moisture.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Renvela contains

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

Description of the appearance of Renvela 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, fitted with a polypropylene cap and an induction seal.
Pack sizes:
Each bottle contains 30 or 180 tablets.
Pack sizes of 1 bottle of 30 or 180 tablets (without outer carton) and a multiple pack containing 180 tablets (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 further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgium/Belgium/Belgium/Luxembourg/Luxembourg
Sanofi Belgium
Tél/Tel: +32 2 710 54 00

Bulgaria
Swixx Biopharma EOOD
Tel.: +359 (0)2 4942 480

Czech Republic
Sanofi s.r.o.
Tel: +420 233 095 111

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

Germany
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. from abroad: +49 69 305 21 131

Estonia
Swixx Biopharma OÜ
Tel: +372 640 10 30

Greece
Sanofi-Aventis M.Monomitopi AEBE
Tel: +30 210 900 1600

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

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
From abroad: +33 1 57 63 23 23

Croatia
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500

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

Iceland
Vistor hf.
Sími: +354 535 7000

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

Cyprus
C.A. Papaellinas Ltd.
Tel: +357 22 741741

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

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

Luxembourg
Sanofi Belgium
Tél/Tel: +32 2 710 54 00

Hungary
SANOFI-AVENTIS Zrt
Tel: +36 1 505 0050

Malta
Sanofi S.r.l.
Tel: +356 21493022

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

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

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

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

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

Romania
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

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

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

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

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

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

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

Package leaflet: Information for the user

Renvela 0.8 g oral suspension powder

sevelamer carbonate
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor. See section 4.

Contents of this leaflet:

1. What Renvela is and what it is used for
2. What you need to know before taking Renvela
3. How to take Renvela
4. Possible side effects
5. How to store Renvela
6. Contents of the pack and other information

1. What Renvela is and what it is used for

Renvela contains the active substance sevelamer carbonate, which acts in the digestive system by preventing the absorption of phosphate from food, thereby reducing phosphate levels in the blood.
This medicine is used to control hyperphosphataemia (high levels of phosphate in the blood) in:

• adult patients on dialysis (a blood purification technique). The medicine can be used in patients undergoing haemodialysis (using a machine to filter the blood) or peritoneal dialysis (in which fluid is pumped into the abdomen and an internal body membrane filters the blood);
• adult patients with chronic kidney disease (long-term) who are not on dialysis and who have a serum phosphate level equal to or greater than 1.78 mmol/L;
• paediatric patients with chronic kidney disease (long-term) above the age of 6 years and above a certain height and weight (used by the doctor to calculate body surface area).

This medicine should be used together with other treatments, such as calcium and vitamin D supplements, to prevent the development of bone disease.
Elevated levels of phosphate in the blood can lead to the formation of solid deposits in the body, known as calcifications. These deposits can harden blood vessels and make it more difficult for blood to circulate throughout the body. In addition, increased phosphate levels in the blood may cause skin itching, red eyes, bone pain and fractures.

2. What you need to know before taking 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)
• if you have low levels of phosphate in the blood (your doctor will check this)
• if you have intestinal obstruction.

Warnings and precautions
Talk to your doctor before taking Renvela if any of the following apply to you:

• problems with stomach or intestinal motility (movement)
• frequent nausea
• active inflammation of the intestine
• you have undergone major surgery on the stomach or intestines.

Talk to your doctor during treatment with Renvela:

• if you experience severe abdominal pain, stomach or intestinal problems, or notice blood in your stools (gastrointestinal bleeding). These symptoms may be due to a serious inflammatory bowel disease caused by deposition of sevelamer crystals in your intestine. Contact your doctor, who will decide whether or not to continue treatment.

Additional treatments
Due to kidney disease or dialysis treatment, you may:

• have low or high levels of calcium in the blood. Since this medicine does not contain calcium, your doctor may prescribe calcium supplements;
• have low levels of vitamin D in the blood. Therefore, your doctor may monitor your vitamin D levels and prescribe additional vitamin D as needed. If you do not take multivitamin supplements, you may also develop low levels of vitamin A, E, K, and folic acid in the blood, and therefore your doctor may monitor these levels and prescribe vitamin supplements as needed;
• have altered levels of bicarbonate in the blood and increased acidity in the blood and other body tissues. Your doctor must monitor your blood bicarbonate levels.

Special note for patients undergoing peritoneal dialysis
You may be at risk of peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis. This
risk can be reduced by strictly maintaining sterile techniques when changing dialysis bags. Inform your doctor immediately if you develop new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness or rigidity, constipation, fever, chills, nausea, or vomiting.
Children
The safety and efficacy in children (under 6 years of age) have not been established. Therefore, this medicine should be avoided in children under 6 years of age.
Other medicines and Renvela
Inform your doctor if you are taking, have recently taken, or might take any other medicines.

• Renvela must not be taken at the same time as ciprofloxacin (an antibiotic).
• If you are taking medicines for heart rhythm disorders or epilepsy, consult your doctor when taking Renvela.
• Renvela may reduce the effects of medicines such as cyclosporine, mycophenolate mofetil, and tacrolimus (medicines used to suppress the activity of the immune system). If you are taking these medicines, your doctor will advise you on how to proceed.
• In some patients, taking levothyroxine (a medicine used to treat low thyroid hormone levels) together with Renvela has uncommonly led to thyroid hormone deficiency. Therefore, your doctor may monitor your thyroid-stimulating hormone levels more closely.
• Medicines such as omeprazole, pantoprazole, or lansoprazole, known as "proton pump inhibitors", used to treat heartburn and gastroesophageal reflux, may reduce the effectiveness of Renvela. Your doctor may consider monitoring your blood phosphate levels.

Your doctor will regularly check for possible interactions between Renvela and other medicines.
In some cases where Renvela must be taken together with another medicine, your doctor may advise you to take that medicine 1 hour before or 3 hours after taking Renvela.
Your doctor may also consider monitoring blood levels of that medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
The potential risk of Renvela during human pregnancy is unknown. Talk to your doctor, who will decide whether you can continue treatment with Renvela.
It is not known whether Renvela is excreted in breast milk and whether it may affect the breastfed infant. Inform your doctor, who will decide whether you may breastfeed and whether treatment with Renvela needs to be discontinued.
Driving and using machines
It is unlikely that Renvela will affect your ability to drive or use machines.
Excipients
This medicine contains less than 1 mmol of sodium (23 mg) per sachet, i.e. essentially "sodium-free".
This medicine contains 8.42 mg of propylene glycol per 0.8 g sachet.

3. How to take Renvela

You must take Renvela exactly as instructed by your doctor. Your doctor will determine the dose based on your blood phosphate level.
For a 0.8 g dose, the oral suspension powder must be dissolved in 30 mL of water per sachet. Drink within 30 minutes of preparation. It is important to drink all the liquid, and you may need to rinse the glass with water and drink it again to ensure you ingest all the powder.
Instead of water, the powder may be mixed with a small amount of cold beverage (approximately 120 mL or half a glass) or cold food (approximately 100 g) and consumed within 30 minutes. Do not heat Renvela powder (e.g., in a microwave) and do not add it to hot food or liquids.

The recommended initial dose of this medicine for adults and elderly patients is 2.4–4.8 g/day, divided equally among the three main meals. Check with your doctor, pharmacist, or nurse if you are unsure.
Your doctor will decide the correct initial dose and dosing regimen.
Take Renvela after a meal or with food.

(Instructions for the pack 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 package.
Always use the dosing spoon provided in the package.

(Instructions for the pack WITHOUT dosing spoon)
If a 0.4 g dose needs to be administered, use the specific 0.8 g powder sachet with dosing spoon.

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

Preparation using the dosing spoon
Use the dosing spoon provided for each 0.4 g dose of Renvela powder.
For a 0.4 g dose:

• Shake the sachet, holding the top corner, before opening, to move the powder to the bottom of the sachet.
• Open the sachet by cutting along the marked line.
• Ensure the dosing spoon is dry.
• Hold the dosing spoon horizontally and pour the powder from the sachet into the dosing spoon.
• Fill the powder up to the level of the spoon.
• Do not tap or shake the dosing spoon to compact the powder.
• Pour the powder from the dosing spoon into 30 mL of water. Stir the suspension and drink within 30 minutes of preparation. It is important to drink all the liquid to ensure you ingest all the powder.
• Close the sachet by folding it over twice.
• The remaining powder may be used within 24 hours for the next dose.
• Discard any sachets that have been left open for more than 24 hours.

Initially, your doctor will monitor your blood phosphate levels every 2–4 weeks and may adjust your Renvela dose as necessary to achieve the appropriate phosphate level.
Follow the diet prescribed by your doctor.

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

If you forget to take Renvela
If you miss a dose, take the next dose at the usual time with a meal. Do not take a double dose to make up for the missed dose.

If you stop taking Renvela
Continuing treatment with Renvela is important to maintain an appropriate blood phosphate level. Stopping Renvela may lead to serious consequences such as vascular calcification. If you are considering stopping treatment with Renvela, contact your doctor or pharmacist first.

If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Constipation is a very common side effect (may affect more than 1 in 10 people). It may be an initial symptom of intestinal obstruction. If you experience constipation, inform your doctor or pharmacist.
Some side effects may be serious. If you experience any of the following side effects, consult your doctor immediately:

• Allergic reaction (signs include rash, hives, swelling, breathing problems). This is a very rare side effect (may affect up to 1 in 10,000 people).
• Intestinal blockage (signs include severe bloating, abdominal pain, swelling or cramps, severe constipation). Frequency is not known (frequency cannot be estimated from the available data).
• Perforation of the intestinal wall (signs include severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain). Frequency is not known.
• Severe inflammation of the colon (symptoms include: severe abdominal pain, stomach or intestinal disturbances, or blood in the stool [gastrointestinal bleeding]) and deposition of crystals in the intestine. Frequency is not known.

Other side effects observed in patients taking Renvela include:
Very common:
vomiting, upper abdominal pain, nausea
Common (may affect up to 1 in 10 patients):
diarrhoea, stomach pain, indigestion, flatulence
Not known:
cases of itching sensation, rash, and slow intestinal motility (movement) have been reported.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly through the national reporting system listed in Annex 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 sachet and carton after “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 the pack containing dosing spoon)
Discard the sachet after 24 hours from opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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 yellow iron oxide (E172).

Description of the appearance of Renvela and the contents of the pack
Renvela oral suspension powder is a pale yellow powder supplied in aluminium laminate sachets with a heat-sealed closure. The sachets are packed in an outer carton.
(Instructions for packaging with dosing spoon)
A 0.4 g dosing spoon is provided in the carton.
Pack:
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 further information on this medicinal product, 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: 0800 52 52 010
From abroad: +49 69 305 21 131

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
From abroad: +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

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

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

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Instructions for the user: package leaflet

Renvela 1.6 g oral suspension powder

sevelamer carbonate
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor. See section 4.

Contents of this leaflet:

1. What Renvela is and what it is used for
2. What you need to know before taking Renvela
3. How to take Renvela
4. Possible side effects
5. How to store Renvela
6. Contents of the pack and other information

1. What Renvela is and what it is used for

Renvela contains the active substance sevelamer carbonate, which acts in the digestive system by preventing the absorption of phosphate from food, thereby reducing phosphate levels in the blood.
This medicine is used to control hyperphosphataemia (high levels of phosphate in the blood) in:

• adult patients on dialysis (a blood purification technique). The medicine can be used in patients undergoing haemodialysis (using a machine to filter the blood) or peritoneal dialysis (in which fluid is pumped into the abdomen and an internal body membrane filters the blood);
• adult patients with chronic kidney disease (long-term) who are not on dialysis and have a serum phosphate level equal to or greater than 1.78 mmol/L;
• paediatric patients with chronic kidney disease (long-term) over 6 years of age and above a certain height and weight (used by the doctor to calculate body surface area).

This medicine should be used in combination with other treatments, such as calcium and vitamin D supplements, to prevent the development of bone disease.
Elevated phosphate levels in the blood can lead to the formation of solid deposits in the body, known as calcifications. These deposits can harden blood vessels and make it more difficult for blood to circulate throughout the body. In addition, increased phosphate levels in the blood may cause skin itching, red eyes, bone pain, and fractures.

2. What you need to know before taking Renvela

Do not take Renvela

• if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6)
• if you have low levels of phosphate in the blood (your doctor will check this)
• if you have intestinal obstruction.

Warnings and precautions
Talk to your doctor before taking Renvela if any of the following apply to you:

• problems with stomach or intestinal motility (movement)
• frequent malaise
• active inflammation of the intestine
• you have undergone major surgery on the stomach or intestines.

Talk to your doctor during treatment with Renvela:

• if you experience severe abdominal pain, stomach or intestinal problems, or if you notice blood in your stools (gastrointestinal bleeding). These symptoms may be due to a serious intestinal disease caused by deposition of sevelamer crystals in your intestine. Contact your doctor, who will decide whether or not to continue treatment.

Additional treatments
Due to kidney disease or dialysis treatment, you may:

• have low or high levels of calcium in the blood. Since this medicine does not contain calcium, your doctor may prescribe calcium supplements;
• have low levels of vitamin D in the blood. Consequently, your doctor may monitor your vitamin D levels and prescribe additional vitamin D as needed. If you do not take multivitamin supplements, you may also develop low levels of vitamin A, E, K, and folic acid in the blood, and therefore your doctor may monitor these levels and prescribe vitamin supplements as needed;
• have altered levels of bicarbonate in the blood and increased blood acidity (acidosis). Your doctor must monitor your blood bicarbonate levels.

Special note for patients undergoing peritoneal dialysis
You may be at risk of developing peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis. This risk can be reduced by strictly maintaining sterile techniques when changing dialysis bags. Inform your doctor immediately if you develop new signs or symptoms of abdominal discomfort, abdominal distension, abdominal pain, abdominal tenderness or rigidity, constipation, fever, chills, nausea, or vomiting.
Children
The safety and efficacy in children (under 6 years of age) have not been established. Therefore, this medicine should be avoided in children under 6 years of age.
Other medicines and Renvela
Inform your doctor if you are taking, have recently taken, or might take any other medicines.

• Renvela must not be taken at the same time as ciprofloxacin (an antibiotic).
• If you are taking medicines for heart rhythm disorders or epilepsy, consult your doctor when taking Renvela.
• Renvela may reduce the effects of medicines such as cyclosporine, mycophenolate mofetil, and tacrolimus (medicines used to suppress the immune system). If you are taking these medicines, your doctor will advise you on how to proceed.
• In some patients, taking levothyroxine (a medicine used to treat low thyroid hormone levels) together with Renvela has uncommonly led to thyroid hormone deficiency. Therefore, your doctor may monitor your thyroid-stimulating hormone (TSH) levels more closely.
• Medicines such as omeprazole, pantoprazole, or lansoprazole, known as "proton pump inhibitors", used to treat heartburn and gastroesophageal reflux, may reduce the effectiveness of Renvela. Your doctor may consider monitoring your blood phosphate levels.

Your doctor will regularly check for possible interactions between Renvela and other medicines.
In some cases where Renvela must be taken together with another medicine, your doctor may advise you to take that medicine 1 hour before or 3 hours after taking Renvela.
Your doctor may also consider monitoring blood levels of that medicine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
The potential risk of Renvela during human pregnancy is unknown. Talk to your doctor, who will decide whether you can continue treatment with Renvela.
It is not known whether Renvela is excreted in breast milk or whether it may affect the breastfed infant. Inform your doctor, who will decide whether you can breastfeed and whether treatment with Renvela needs to be stopped.
Driving and using machines
It is unlikely that Renvela will affect your ability to drive or use machines.
Excipients
This medicine contains less than 1 mmol of sodium (23 mg) per 1.6 g sachet, i.e., essentially "sodium-free".
This medicine contains 16.85 mg of propylene glycol per 1.6 g sachet.

3. How to take Renvela

You must take Renvela exactly as instructed by your doctor. Your doctor will base the dose on your blood phosphate level.
For a 1.6 g dose, the oral suspension powder must be dissolved in 40 mL of water per sachet. Drink within 30 minutes of preparation. It is important that you drink all the liquid, and you may need to rinse the glass with water and drink again to ensure you have ingested all the powder.
Instead of water, the powder may be mixed with a small amount of cold drink (approximately 120 mL or half a glass) or food (approximately 100 g) and consumed within 30 minutes. Do not heat Renvela powder (e.g., in a microwave) and do not add it to hot food or liquids.
The recommended initial dose of this medicine for adults and elderly patients is 2.4–4.8 g/day, divided equally among the three main meals. Check with your doctor, pharmacist, or nurse if you are unsure. Your doctor will decide the correct initial dose and dosing regimen.
Take Renvela after a meal or with food.
If a 0.4 g dose needs to be administered, use the 0.8 g powder sachet with the provided dosing spoon.

Use in children and adolescents
The recommended initial dose of Renvela for children is based on their height and weight (used by the doctor to calculate body surface area). The powder formulation is preferred for children, as tablets are not suitable for this population. This medicine must not be administered on an empty stomach and should be taken with meals or snacks. The correct initial dose and regimen will be determined by your doctor.
Initially, your doctor will monitor your blood phosphate levels every 2–4 weeks and may adjust the dose of Renvela as necessary to achieve the appropriate phosphate level.
Follow the diet prescribed by your doctor.

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

If you forget to take Renvela
If you miss a dose, take the next dose at the usual time with a meal. Do not take a double dose to make up for the missed dose.

If you stop taking Renvela
Continuing treatment with Renvela is important to maintain an appropriate blood phosphate level. Stopping Renvela may lead to serious consequences such as calcification of blood vessels. If you are considering stopping treatment with Renvela, contact your doctor or pharmacist first.

If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Constipation is a very common side effect (may affect more than 1 in 10 people). It may be an early sign of intestinal blockage. If you experience constipation, inform your doctor or pharmacist.

Some side effects may be serious. If you experience any of the following side effects, contact your doctor immediately:

• Allergic reaction (signs include rash, hives, swelling, breathing problems). This is a very rare side effect (may affect up to 1 in 10,000 people).
• Intestinal blockage (signs include severe bloating, abdominal pain, distension or cramps, severe constipation). Frequency is unknown (cannot be estimated from the available data).
• Rupture of the intestinal wall (signs include severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain). Frequency is unknown.
• Severe inflammation of the colon (symptoms include: severe abdominal pain, stomach or intestinal disturbances, or blood in the stool [gastrointestinal bleeding]) and deposition of crystals in the intestine. Frequency is unknown.

Other side effects observed in patients taking Renvela include:
Very common:
vomiting, upper abdominal pain, nausea
Common (may affect up to 1 in 10 patients):
diarrhoea, stomach pain, indigestion, flatulence
Frequency not known:
cases of itching sensation, skin rash, slow intestinal motility (movement) have been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system referred to in Annex 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 sachet and carton after “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.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Renvela contains

• The active substance is sevelamer carbonate. Each sachet contains 1.6 g of sevelamer carbonate.
• The excipients are propylene glycol alginate (E405), citrus cream flavour, sodium chloride, sucralose and yellow iron oxide (E172).

Description of the appearance of Renvela and contents of the pack
Renvela oral suspension powder is a pale yellow powder supplied in aluminium foil sachets with heat-sealed closures. The sachets are packed in an outer carton.
Pack sizes:
60 sachets per carton
90 sachets per carton
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

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

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

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

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

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

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. from abroad: +49 69 305 21 131

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 1600

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

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
From outside France: +33 1 57 63 23 23

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500

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

Ísland
Vistor hf.
Sími: +354 535 7000

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

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

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

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

Luxembourg/Luxemburg
Swixx Biopharma UAB
Tel: +370 5 236 91 40

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

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

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

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

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

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

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

România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

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

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

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

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

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

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Package leaflet: information for the user

Renvela 2.4 g oral suspension powder

sevelamer carbonate
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor. See section 4.

Contents of this leaflet:

1. What Renvela is and what it is used for
2. What you need to know before taking Renvela
3. How to take Renvela
4. Possible side effects
5. How to store Renvela
6. Contents of the pack and other information

1. What Renvela is and what it is used for

Renvela contains the active substance sevelamer carbonate, which acts in the digestive system by preventing the absorption of phosphate from food, thereby reducing phosphate levels in the blood.
This medicine is used to control hyperphosphataemia (high levels of phosphate in the blood) in:

• adult patients on dialysis (a blood purification technique). The medicine can be used in patients undergoing haemodialysis (using a machine to filter the blood) or peritoneal dialysis (in which fluid is pumped into the abdomen and an internal body membrane filters the blood);
• adult patients with chronic kidney disease (long-term) who are not on dialysis and have a serum phosphate level equal to or greater than 1.78 mmol/L;
• paediatric patients with chronic kidney disease (long-term) above 6 years of age and above a certain height and weight (used by the doctor to calculate body surface area).

This medicine should be used together with other treatments, such as calcium and vitamin D supplements, to prevent the development of bone disease.
Elevated levels of phosphate in the blood can lead to the formation of solid deposits in the body, known as calcifications. These deposits can harden blood vessels and make blood circulation throughout the body more difficult. In addition, increased phosphate levels in the blood may cause skin itching, red eyes, bone pain, and fractures.

2. What you should know before taking 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)
• if you have low levels of phosphate in the blood (your doctor will check this)
• if you have intestinal obstruction.

Warnings and precautions
Talk to your doctor before taking Renvela if any of the following apply to you:

• problems with stomach or intestinal motility (movement)
• frequent malaise
• active inflammation of the intestine
• you have undergone major surgery on the stomach or intestines.

Talk to your doctor during treatment with Renvela:

• if you experience severe abdominal pain, stomach or intestinal problems, or notice blood in your stool (gastrointestinal bleeding). These symptoms may be due to severe intestinal inflammation caused by deposition of sevelamer crystals in your intestine. Contact your doctor, who will decide whether or not to continue treatment.

Additional treatments
Due to kidney disease or dialysis treatment, you may:

• have low or high levels of calcium in the blood. Since this medicine does not contain calcium, your doctor may prescribe calcium supplements,
• have low levels of vitamin D in the blood. Therefore, your doctor may monitor your vitamin D levels and prescribe additional vitamin D as needed. If you do not take multivitamin supplements, you may also develop low levels of vitamin A, E, K, and folic acid in the blood, and your doctor may monitor these levels and prescribe vitamin supplements as needed,
• have altered levels of bicarbonate in the blood and increased acidity in the blood and other body tissues. Your doctor must monitor your blood bicarbonate levels.

Special note for patients undergoing peritoneal dialysis
You may develop peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis. This
risk can be reduced by strictly maintaining sterile techniques when changing dialysis bags. Inform your doctor immediately if you develop new signs or symptoms of abdominal discomfort,
abdominal swelling, abdominal pain, abdominal tenderness or rigidity, constipation, fever,
chills, nausea, or vomiting.
Children
The safety and efficacy in children (under 6 years of age) have not been studied. Therefore, use of this
medicine should be avoided in children under 6 years of age.
Other medicines and Renvela
Tell your doctor if you are taking, have recently taken, or might take any other
medicines.

• Renvela must not be taken at the same time as ciprofloxacin (an antibiotic).
• If you are taking medicines for heart rhythm problems or epilepsy, consult your doctor when taking Renvela.
• Renvela may reduce the effects of medicines such as cyclosporine, mycophenolate mofetil, and tacrolimus (medicines used to suppress the activity of the immune system). If you are taking these medicines, your doctor will advise you on how to proceed.
• In some patients, taking levothyroxine (a medicine used to treat low thyroid hormone levels) together with Renvela has uncommonly led to thyroid hormone deficiency. Therefore, your doctor may monitor your thyroid-stimulating hormone levels in the blood more closely.
• Medicines such as omeprazole, pantoprazole, or lansoprazole, known as "proton pump inhibitors," used to treat heartburn and gastroesophageal reflux, may reduce the effectiveness of Renvela. Your doctor may consider monitoring your blood phosphate levels.

Your doctor will regularly check for possible interactions between Renvela and other medicines.
In some cases where Renvela must be taken together with another medicine, your doctor
may advise you to take that medicine 1 hour before or 3 hours after taking Renvela.
Your doctor may also consider monitoring blood levels of that medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding,
ask your doctor for advice before taking this medicine.
The potential risk of Renvela during human pregnancy is unknown. Discuss with your doctor, who will decide whether you can continue treatment with Renvela.
It is not known whether Renvela is excreted in breast milk or whether it may affect the infant. Inform your doctor, who will decide whether you may breastfeed and whether treatment with Renvela needs to be discontinued.
Driving and using machines
It is unlikely that Renvela will affect your ability to drive or use machinery.
Excipients
This medicine contains less than 1 mmol of sodium (23 mg) per sachet, i.e., essentially "sodium-free".
This medicine contains 25.27 mg of propylene glycol per 2.4 g sachet.

3. How to take Renvela

You must take Renvela exactly as directed by your doctor. Your doctor will determine your dose based on your blood phosphate levels.
For a 2.4 g dose, the oral suspension powder must be dissolved in 60 mL of water per sachet. Drink the suspension within 30 minutes after preparation. It is important that you drink all of the liquid, and you may need to rinse the glass with water and drink again to ensure you have taken all the powder.
Instead of water, the powder may be mixed with a small amount of cold drink (approximately 120 mL or half a glass) or food (approximately 100 g) and consumed within 30 minutes. Do not heat Renvela powder (e.g. in a microwave) and do not add it to hot food or liquids.
The recommended initial dose of this medicine for adults and elderly patients is 2.4–4.8 g/day, divided equally among the three main meals. Consult your doctor, pharmacist, or nurse if you are unsure. Your doctor will decide the correct initial dose and dosing regimen.
Take Renvela after meals or with food.
If a 0.4 g dose needs to be administered, use the special 0.8 g powder pack with dosing spoon.

Use in children and adolescents
The recommended initial dose of Renvela for children is based on their height and weight (used by the doctor to calculate body surface area). The powder formulation is preferred for children, as the tablets are not suitable for this population. This medicine must not be taken on an empty stomach and should be taken with meals or snacks. The appropriate initial dose and regimen will be determined by your doctor.
Initially, your doctor will monitor your blood phosphate levels every 2–4 weeks and may adjust the dose of Renvela as necessary to achieve the appropriate phosphate level.
Follow the diet prescribed by your doctor.

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

If you forget to take Renvela
If you miss a dose, take the next dose at the usual time with a meal. Do not take a double dose to make up for the missed dose.

If you stop taking Renvela
Continuing treatment with Renvela is important to maintain appropriate phosphate levels in the blood. Stopping Renvela may lead to serious consequences, such as calcification of blood vessels. If you are considering stopping treatment with Renvela, contact your doctor or pharmacist first.
If you have any further questions about the use of this medicine, consult 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 may be an initial symptom of intestinal obstruction. If you experience constipation, inform your doctor or pharmacist.
Some side effects may be serious. If you experience any of the following side effects, consult your doctor immediately:

• Allergic reaction (signs include rash, hives, swelling, breathing problems). This is a very rare side effect (may affect up to 1 in 10,000 people).
• Intestinal blockage (signs include severe bloating, abdominal pain, distension or cramps, severe constipation). Frequency is not known (cannot be estimated from the available data).
• Rupture of the intestinal wall (signs include severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain). Frequency is not known.
• Severe inflammation of the colon (symptoms include: severe abdominal pain, stomach or intestinal disturbances, or blood in the stool [gastrointestinal bleeding]) and deposition of crystals in the intestine. Frequency is not known.

Other side effects observed in patients taking Renvela include:
Very common:
vomiting, upper abdominal pain, nausea.
Common (may affect up to 1 in 10 patients):
diarrhoea, stomach pain, indigestion, flatulence.
Not known:
cases of itching sensation, rash, and slow intestinal motility (movement) have been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system listed in Annex 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 which is stated on the sachet and carton after "Exp".
The expiry date refers to the last day of that month.
The reconstituted suspension must be administered within 30 minutes after reconstitution.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Renvela contains

• The active substance is sevelamer carbonate. Each sachet contains 2.4 g of sevelamer carbonate.
• The other ingredients are propylene glycol alginate (E405), citrus cream flavour, sodium chloride, sucralose, and yellow iron oxide (E172).

Description of the appearance of Renvela and contents of the pack
Renvela oral suspension powder is a pale yellow powder supplied in aluminium foil sachets with a heat-sealed closure. The sachets are packed in an outer carton box.
Pack sizes:
60 sachets per pack
90 sachets per pack
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
ROVI Pharma Industrial Services, S.A.
Vía Complutense, 140, Alcalá de Henares
Madrid, 28805, Spain

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

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

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

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

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

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. from abroad: +49 69 305 21 131

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 1600

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

France
Sanofi Winthrop Industrie
Tél : 0 800 222 555
From outside France: +33 1 57 63 23 23

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500

Ísland
Vistor hf.
Sími: +354 535 7000

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

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

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

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

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

Luxembourg/Luxemburg
Swixx Biopharma UAB
Tel: +370 5 236 91 40

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

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

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

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

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

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

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

România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

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

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

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

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

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

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.