Renagel

Package leaflet: Information for the user

Renagel 400 mg film-coated tablets

sevelamer hydrochloride
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, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Renagel is and what it is used for

Renagel contains the active substance sevelamer, which binds to phosphate in the digestive tract, thereby reducing phosphate levels in the blood.
Renagel is used to control serum phosphate levels in adult patients with renal insufficiency undergoing haemodialysis or peritoneal dialysis.
Adult patients with renal insufficiency who are undergoing haemodialysis or peritoneal dialysis are unable to regulate phosphate levels in the blood. As a result, phosphate levels rise (your doctor may refer to this condition as hyperphosphataemia). Elevated phosphate levels in the blood can lead to the formation of solid deposits in the body, known as calcifications. These deposits can stiffen 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.
Renagel may be used together with other medicinal products, such as calcium or vitamin D supplements, to help control the progression of renal bone disease.

2. What you need to know before taking Renagel

Do not take Renagel:

• if low levels of phosphate in the blood have been detected (your doctor will monitor this)
• if you have intestinal obstruction
• if you are allergic to sevelamer or to any of the other ingredients of this medicine (listed in section 6).

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

• if you are not undergoing dialysis
• if you have difficulty swallowing
• if you have stomach or intestinal motility problems (movement)
• if you experience symptoms of delayed stomach emptying, such as feeling full, nausea and/or vomiting
• if you have prolonged diarrhea or suffer from abdominal pain (symptoms of inflammatory bowel disease)
• if you have undergone major surgery on the stomach or intestines.

Talk to your doctor during treatment with Renagel:

• if you experience severe abdominal pain, stomach or intestinal problems, or notice blood in your stool (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 to continue or discontinue treatment.

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

• develop low or high levels of calcium in the blood. Since Renagel does not contain calcium, your doctor may prescribe calcium supplements.
• have low levels of vitamin D in the blood. For this reason, your doctor may monitor your vitamin D levels and prescribe additional vitamin D if necessary. If you do not take multivitamin supplements, you may also develop low blood levels of vitamin A, E, K, and folic acid; therefore, your doctor may monitor these levels and prescribe vitamin supplements as needed.

Change of treatment:
When switching from another phosphate binder to Renagel, your doctor may decide to monitor your blood bicarbonate levels more frequently, as Renagel may reduce 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 following aseptic techniques when changing dialysis bags. Inform your doctor immediately if you notice new signs or symptoms related to abdominal problems, such as abdominal swelling, abdominal pain, abdominal tenderness or rigidity, fever, chills, nausea, or vomiting. In addition, you will be monitored more closely for possible development of problems related to low levels of vitamin A, D, E, K, and folic acid.
Children and adolescents
The safety and efficacy in children (under 18 years of age) have not been established. Therefore, the use of Renagel is not recommended in this population.
Other medicines and Renagel
Inform your doctor if you are taking, have recently taken, or might take any other medicines.

• Renagel 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 Renagel.
• Renagel may reduce the effects of medicines such as cyclosporine, mycophenolate mofetil, and tacrolimus (medicines used in transplant patients). If you are taking these medicines, your doctor will advise you accordingly.
• In some people taking levothyroxine (a thyroid hormone) and Renagel, a very rare increase in thyroid-stimulating hormone (TSH) levels (a substance in your blood that helps regulate your body's chemical functions) may occur. Therefore, your doctor may monitor your TSH blood levels more closely.
• If you are taking medicines such as omeprazole, pantoprazole, or lansoprazole to treat heartburn, gastroesophageal reflux disease, or gastric ulcer, consult your doctor when taking Renagel.

At regular intervals, your doctor will check for possible interactions between Renagel and other medicines.
In some cases, when Renagel must be taken at the same time as another medicine, your doctor may advise you to take that medicine 1 hour before or 3 hours after taking Renagel, or may consider monitoring blood levels of that medicine.
Pregnancy and breastfeeding
The safety of Renagel during pregnancy or breastfeeding has not yet been established. Renagel must not be administered during pregnancy or breastfeeding unless clearly necessary.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Driving and using machines
It is unlikely that Renagel will affect your ability to drive or operate machinery.

3. How to take Renagel

Take this medicine exactly as directed by your doctor. Your doctor will determine the dose based on your blood phosphate levels. The recommended starting dose of Renagel for adults and elderly patients (over 65 years of age) is two to four tablets, taken three times a day with main meals. Initially, your doctor will monitor your blood phosphate levels every 2–3 weeks and may adjust the dose of Renagel as necessary (between 1 and 10 tablets of 400 mg with each meal) in order to achieve the appropriate blood phosphate level.

The tablets must be swallowed whole. Do not crush, chew, or break them before swallowing.

Patients taking Renagel must follow the prescribed diet and maintain adequate fluid intake.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Since constipation may be an early symptom of intestinal blockage, it is important to inform your doctor or pharmacist about these symptoms before or during treatment with Renagel.
The following side effects have been reported in patients taking Renagel:
Very common (may affect more than 1 in 10 people):
nausea, vomiting.
Common (may affect up to 1 in 10 people):
diarrhoea, indigestion, abdominal pain, constipation, flatulence.
Uncommon (may affect up to 1 in 100 people):
increased blood acidity.
Very rare (may affect up to 1 in 10,000 people):
hypersensitivity.
Not known (frequency cannot be estimated from the available data):
cases of itching, rash, abdominal pain, reduced intestinal motility (movement), inflammation of small abnormal pouches (called diverticula) in the large intestine, intestinal blockage (signs include severe bloating, abdominal pain, swelling or cramps, severe constipation), perforation of the intestinal wall (signs include severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain), 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.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You may 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 Renagel

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.
Do not store this medicine above 25°C. Keep the bottle tightly closed to protect the medicine from moisture.
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 Renagel contains

• The active substance is sevelamer hydrochloride. Each tablet contains 400 mg of sevelamer hydrochloride.
• The excipients are anhydrous colloidal silica and stearic acid, hypromellose (E464), diacetylated monoglycerides, black iron oxide (E172), and propylene glycol.

Description of the appearance of Renagel and pack contents
Renagel tablets are white to off-white, oval, film-coated tablets, with "Renagel 400" printed on one side.
The tablets are packed in high-density polyethylene bottles with a child-resistant closure made of polypropylene and a protective seal.
The following pack sizes are available:
1 bottle containing 360 tablets
Multicartoon pack containing 720 tablets (2 bottles of 360 tablets)
Multicartoon pack containing 1080 tablets (3 bottles of 360 tablets)
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 Authorization Holder.

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

България / Magyarország
Swixx Biopharma EOOD
SANOFI-AVENTIS Zrt
Тел.: +359 (0)2 4942 480
Tel: +36 1 505 0050

Česká republika / Malta
Sanofi s.r.o.
Tel: +420 233 086 111
Sanofi S.r.l.
Tel: +39 02 39394275

Danmark / Nederland
Sanofi A/S
Tlf: +45 45 16 70 00
Sanofi B.V.
Tel: +31 20 245 4000

Deutschland / Norge
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010 +49 (0)180 2 222010
Tel. aus dem Ausland: +49 69 305 21 131
sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Eesti / Österreich
Swixx Biopharma OÜ
Tel: +372 640 10 30
sanofi-aventis GmbH
Tel: +43 1 80 185 - 0

Ελλάδα / Polska
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 1600
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

España / Portugal
sanofi-aventis, S.A.
Tel: +34 93 485 94 00
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 / Slovenija
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
Tel: +386 1 235 51 00

Ireland / Slovenská republika
sanofi-aventis Ireland Ltd T/A SANOFI
Tel: +353 (0) 1 4035 600
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Ísland / Suomi/Finland
Vistor hf.
Sími: +354 535 7000
Sanofi Oy
Puh/Tel: +358 201 200 300

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

Κύπρος / United Kingdom (Northern Ireland)
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741
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 European Medicines Agency website: http://www.ema.europa.eu

Package leaflet: information for the user

Renagel 800 mg film-coated tablets

sevelamer hydrochloride
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 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Renagel is and what it is used for

Renagel contains the active substance sevelamer, which, within the digestive tract, binds phosphate from food, thereby reducing phosphate levels in the blood.
Renagel is used to control blood phosphate levels in adult patients with renal insufficiency undergoing haemodialysis or peritoneal dialysis.
Adult patients with renal insufficiency who are undergoing haemodialysis or peritoneal dialysis are unable to regulate phosphate levels in the blood. As a result, phosphate levels rise (your doctor may refer to this condition as hyperphosphataemia). Elevated phosphate levels in the blood can lead to the formation of solid deposits in the body, known as calcifications. These deposits can stiffen 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.
Renagel may be used together with other medicinal products, such as calcium or vitamin D supplements, to help control the progression of renal bone disease.

2. What you need to know before taking Renagel

Do not take Renagel:

• if low levels of phosphate in the blood have been detected (your doctor will monitor this)
• if you have intestinal obstruction
• if you are allergic to sevelamer or to any of the other ingredients of this medicine (listed in section 6).

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

• if you are not undergoing dialysis
• if you have difficulty swallowing
• if you have problems with stomach or intestinal motility (movement)
• if you experience symptoms of delayed stomach emptying, such as feeling full, nausea and/or vomiting
• if you have prolonged diarrhea or suffer from abdominal pain (symptoms of inflammatory bowel disease)
• if you have undergone major surgery on the stomach or intestines.

Talk to your doctor during treatment with Renagel:

• if you experience severe abdominal pain, stomach or intestinal problems, or notice blood in your stool (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 to continue or discontinue treatment.

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

• develop low or high levels of calcium in the blood. Since Renagel does not contain calcium, your doctor may prescribe calcium supplements.
• have low levels of vitamin D in the blood. For this reason, your doctor may monitor your vitamin D levels and prescribe additional vitamin D if necessary. If you do not take multivitamin supplements, you may also develop low blood levels of vitamin A, E, K, and folic acid; consequently, your doctor may monitor these levels and prescribe vitamin supplements as needed.

Change of treatment:
When switching from another phosphate binder to Renagel, your doctor may decide to monitor your blood bicarbonate levels more frequently, as Renagel may reduce 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 following aseptic techniques when changing dialysis bags. Inform your doctor immediately if you notice new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness or rigidity, fever, chills, nausea, or vomiting. In addition, you will be monitored more closely for possible development of problems related to low levels of vitamins A, D, E, K, and folic acid.
Children and adolescents
The safety and efficacy in children (under 18 years of age) have not been established. Therefore, the use of Renagel is not recommended in this population.
Other medicines and Renagel
Inform your doctor if you are taking, have recently taken, or might take any other medicines.

• Renagel 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 Renagel.
• Renagel may reduce the effects of medicines such as cyclosporine, mycophenolate mofetil, and tacrolimus (medicines used in transplant patients). If you are taking these medicines, your doctor will advise you on how to proceed.
• In some people taking levothyroxine (a thyroid hormone) and Renagel, a very rare increase in thyroid-stimulating hormone (TSH) levels (a substance in your blood that helps regulate your body's chemical functions) may occur. Therefore, your doctor may monitor your TSH blood levels more closely.
• If you are taking medicines such as omeprazole, pantoprazole, or lansoprazole to treat heartburn, gastroesophageal reflux disease, or gastric ulcer, consult your doctor when taking Renagel.

At regular intervals, your doctor will check for possible interactions between Renagel and other medicines.
In some cases, when Renagel must be taken together with another medicine, your doctor may advise you to take that medicine 1 hour before or 3 hours after taking Renagel, or may consider monitoring blood levels of that medicine.
Pregnancy and breastfeeding
The safety of Renagel during pregnancy and breastfeeding has not yet been established. Renagel must not be administered during pregnancy or breastfeeding unless clearly necessary.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Driving and using machines
It is unlikely that Renagel will affect your ability to drive or operate machinery.

3. How to take Renagel

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
Your doctor will determine the dose based on your blood phosphate levels. The recommended starting
dose of Renagel for adults and elderly patients (over 65 years of age) is one or two tablets, taken three
times a day with main meals.

Initially, your doctor will monitor your blood phosphate levels every 2–3 weeks and may adjust the
dose of Renagel when necessary (from 1 to 5 tablets of 800 mg with each meal) in order to achieve
adequate blood phosphate levels.

The tablets must be swallowed whole. Do not crush, chew, or break them before swallowing.

Patients taking Renagel should follow the prescribed diet and maintain adequate fluid intake.

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

If you forget to take Renagel
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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Since constipation may very rarely be an early sign of intestinal obstruction, it is important to inform your doctor or pharmacist about this symptom before or during treatment with Renagel.

The following side effects have been reported in patients taking Renagel:

Very common (may affect more than 1 in 10 people):
nausea, vomiting.

Common (may affect up to 1 in 10 people):
diarrhoea, indigestion, abdominal pain, constipation, flatulence.

Uncommon (may affect up to 1 in 100 people):
increased blood acidity.

Very rare (may affect up to 1 in 10,000 people):
hypersensitivity.

Not known (frequency cannot be estimated from the available data):
Cases of itching, rash, abdominal pain, reduced intestinal motility (movement), inflammation of small abnormal pouches (called diverticula) in the large intestine, intestinal blockage (signs include severe bloating, abdominal pain, swelling or cramps, severe constipation), rupture of the intestinal wall (signs include severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain), severe inflammation of the large intestine (symptoms include severe abdominal pain, stomach or intestinal problems, or blood in the stool (gastrointestinal bleeding)), and deposition of crystals in the intestine 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 RENAGEL

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.
Do not store this medicine above 25°C. Keep the bottle tightly closed to protect the medicine from moisture.
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 Renagel contains

• The active substance is sevelamer hydrochloride. Each tablet contains 800 mg of sevelamer hydrochloride.
• The excipients are colloidal anhydrous silica and stearic acid, hypromellose (E464), and diacetylated monoglycerides.

Description of the appearance of Renagel and package contents
Renagel tablets are whitish, oval, film-coated tablets, with the imprint "RG800" on one side.
The tablets are packaged in high-density polyethylene bottles with a child-resistant closure made of polypropylene and a protective seal.
The following pack sizes are available:
1 bottle containing 100 tablets
1 bottle containing 180 tablets
multi-pack containing 180 tablets (6 bottles of 30 tablets each)
multi-pack containing 360 tablets (2 bottles of 180 tablets each)
multi-pack containing 540 tablets (3 bottles of 180 tablets each)
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly
France

Manufacturers:
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 medicinal product, please contact the local representative of the Marketing Authorization Holder.

België/Belgique/Belgien / Luxembourg/Luxemburg
Swixx Biopharma UAB
Sanofi Belgium
Tel: +370 5 236 91 40
Tél/Tel: +32 2 710 54 00

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 +49 (0)180 2 222010
For calls 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
ηλ: +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
For calls 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