Renvella 800 mg film-coated tablets

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Renvela 800 mg film-coated tablets

sevelamer carbonate

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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 adverse 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 sevelamer carbonate as the active substance. It binds to dietary phosphate in the gastrointestinal tract and thereby reduces serum phosphate levels in the blood.

This medicine is used to control hyperphosphataemia (high blood phosphate levels) in:

• adult patients on dialysis (a blood-cleansing technique). It 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 (blood) phosphate level equal to or above 1.78 mmol/l.

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 serum phosphate levels may lead to hard deposits in the body known as calcifications. These deposits can harden blood vessels and make it more difficult for blood to be pumped through the body. Increased serum phosphate may also 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 for you)
• if you have intestinal obstruction.

Warnings and precautions

Talk to your doctor before taking Renvela if you are in any of the following situations:

• difficulty swallowing. Your doctor may prefer to prescribe Renvela as a powder for oral suspension
• problems with motility (movement) of the stomach and intestine
• you frequently experience vomiting
• active inflammation of the intestine
• you have undergone major surgery of the stomach or intestine.

Talk to your doctor while taking Renvela:

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

Additional treatments

Due to your kidney condition or dialysis treatment, you may:

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

Special note for patients on peritoneal dialysis

You may develop peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis. This risk may be reduced by careful use of sterile techniques during bag exchanges. You must inform your doctor immediately if you experience any new signs or symptoms of abdominal discomfort, abdominal bloating, abdominal pain, abdominal tenderness or rigidity, constipation, fever, chills, nausea, or vomiting.

Children

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

Other medicines and Renvela

Tell your doctor if you are taking, have recently taken, or might need to 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, you should consult your doctor when taking Renvela.

• The effects of medicines such as cyclosporine, 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.

• A deficiency of thyroid hormone may occasionally be observed in certain individuals taking levotiroxine (used to treat low thyroid hormone levels) and Renvela. Therefore, your doctor may monitor your blood levels of thyroid-stimulating hormone more closely.

• Medicines used to treat stomach acid and reflux in your stomach or esophagus, such as omeprazole, pantoprazole, or lansoprazole, known as "proton pump inhibitors", may reduce the effectiveness of Renvela. Your doctor must monitor your blood phosphate levels.

Your doctor will regularly check for interactions between Renvela and other medicines.

In some cases, when Renvela must be taken at the same time as another medicine, your doctor may instruct you to take that medicine 1 hour before or 3 hours after taking Renvela. Your doctor should even consider monitoring blood levels of that medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. The potential risk of Renvela during human pregnancy is unknown. Consult your doctor, who will decide whether you can continue treatment with Renvela.

It is unknown whether Renvela passes into breast milk and could affect your baby. Consult your doctor, who will decide whether you can breastfeed or not and whether treatment with Renvela needs to be interrupted.

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; essentially "sodium-free".

3. How to take Renvela

Renvela should be taken exactly as prescribed by your doctor. Your doctor will determine the dose based on your serum phosphorus levels.

The recommended starting dose of Renvela tablets for adults and elderly patients is one to two 800 mg tablets with each meal, three times a day. Consult your doctor, pharmacist, or nurse if you are unsure.

Take Renvela after a meal or with food.

The tablets must be swallowed whole. Do not crush, chew, or split them.

Initially, your doctor will monitor your blood phosphorus levels every 2 to 4 weeks and may adjust the dose of Renvela as needed to achieve an appropriate phosphorus 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, skip it and take the next dose at the usual time with food. Do not take a double dose to make up for a missed dose.

If you stop taking Renvela

Taking Renvela as directed is important to maintain appropriate phosphate levels in your blood. Stopping treatment with 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, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

Some adverse effects may be serious. If you experience any of the following, seek medical attention immediately:

• Allergic reaction (signs include rash, hives, swelling, difficulty breathing). This is a very rare adverse effect (may affect up to 1 in 10,000 patients).
• Intestinal obstruction has been reported (signs include: severe distension, abdominal pain, bloating or cramps, severe constipation). Frequency is not known (cannot be estimated from available data).
• Bowel wall perforation has been reported (signs include: severe stomach pain, chills, fever, nausea, vomiting, or tender or painful abdomen). Frequency is not known.
• Severe inflammation of the large intestine has been reported (symptoms include: severe abdominal pain, gastrointestinal or intestinal disorders, blood in stools [intestinal bleeding]) and crystal deposition in the intestine. Frequency is not known.

Other adverse effects reported in patients taking Renvela:

Very common:

vomiting, upper abdominal pain, nausea

Common (may affect up to 1 in 10 patients):

diarrhea, stomach pain, indigestion, flatulence

Frequency not known:

cases of itching, rash, slow intestinal motility (movement).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Renvela

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the bottle after the letters «EXP». The expiry date refers to the last day of the month indicated.

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

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist where to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

Composition of Renvela

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

Appearance of the product and contents of the container

Renvela film-coated tablets are white, oval tablets with “RV 800” 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 containing 30 or 180 tablets (without outer carton), and a multiple pack containing 180 tablets (6 bottles of 30 tablets).

Only some pack sizes may be marketed.

Marketing Authorization 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

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder.

Date of the most recent review of this leaflet:

Other sources of information

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