RENVELA 800 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for theuser

Renvela 800 mg film-coated tablets

sevelamer carbonate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What is Renvela and what is it used for

Renvela contains sevelamer carbonate as the active substance. It binds to phosphate in the food in the digestive tract and thereby reduces the phosphate levels in the blood.

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

• adult patients on dialysis (a technique for cleaning the blood). It can be used in patients undergoing haemodialysis (using a machine to filter the blood) or peritoneal dialysis (where fluid is pumped into the abdomen and a body membrane filters the blood);
• patients with chronic kidney disease (long-term) who are not on dialysis and have a serum phosphate level of 1.78 mmol/l or higher.

This medicine should be used with other treatments such as calcium and vitamin D supplements to prevent the development of bone disease.

High phosphate levels in the blood can cause hard deposits in the body called calcifications. These deposits can harden in the blood vessels and make it more difficult for the blood to be pumped through the body. High phosphate levels in the blood can also cause itching of the skin, red eyes, bone pain, and fractures.

2. What you need to know before you take Renvela

Do not take Renvela

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)
• if you have low phosphate levels 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:

• you have problems swallowing. Your doctor may prefer to prescribe Renvela powder for oral suspension for you
• you have problems with stomach and intestinal motility
• you vomit frequently
• you have active intestinal inflammation
• you have undergone major stomach or intestinal surgery.

Talk to your doctor while you are taking Renvela:

• if you experience severe abdominal pain, stomach or intestinal disorders, or blood in your stools (gastrointestinal bleeding). These symptoms can be due to a serious intestinal inflammatory disease caused by the 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 calcium levels in your blood. As this medicine does not contain calcium, your doctor may prescribe calcium supplement tablets for you
• have low vitamin D levels in your blood. Therefore, your doctor may check your vitamin D levels in your blood and prescribe a vitamin D supplement if necessary. If you do not take multivitamin supplements, your 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 necessary.
• have altered bicarbonate levels in your blood and increased acidity in your blood and other body tissues. Your doctor should monitor your bicarbonate levels in your blood.

Special note for patients on peritoneal dialysis

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

Children

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

Other medicines and Renvela

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

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

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

• The effects of medicines such as cyclosporin, 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 rare thyroid hormone deficiency has been observed in some people taking levothyroxine (used to treat low thyroid hormone levels) and Renvela. Therefore, your doctor may monitor your thyroid-stimulating hormone levels in your blood more closely.

• Medicines for treating stomach acid and reflux in your stomach or oesophagus, such as omeprazole, pantoprazole, or lansoprazole, known as "proton pump inhibitors", may reduce the efficacy of Renvela. Your doctor should monitor your phosphate levels in your blood.

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

In some cases, when Renvela needs to be taken with another medicine, your doctor may tell you to take this medicine 1 hour before or 3 hours after taking Renvela. Your doctor may also consider monitoring the levels of that medicine in your blood.

Pregnancy and breast-feeding

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

It is unknown whether Renvela passes into breast milk and may affect your baby. Talk to your doctor, who will decide whether you can breast-feed your baby or not and whether it is necessary to interrupt treatment with Renvela.

Driving and using machines

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

Excipients

This medicine contains less than 1 mmol sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Renvela

Renvela should be taken as directed by your doctor. The doctor will determine the dose based on your phosphate levels.

The recommended initial dose of Renvela tablets for adults and elderly patients is 1 to 2 tablets of 800 mg with each meal 3 times a day. Talk to your doctor, pharmacist, or nurse if you are not sure.

Take Renvela after a meal or with food.

The tablets should be swallowed whole. Do not crush, chew, or break them.

Initially, your doctor will check your phosphate levels in your blood every 2-4 weeks and may adjust the dose of Renvela as needed to achieve an adequate 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, it should be omitted, so the next dose should be taken at the usual time with a meal. Do not take a double dose to make up for forgotten doses.

If you stop taking Renvela

Taking your treatment with Renvela is important to maintain an appropriate phosphate level in your blood. Stopping treatment with Renvela would have significant consequences, such as calcification in the blood vessels. If you consider stopping your treatment with Renvela, contact your doctor or pharmacist first.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

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

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

Other side effects have been reported in patients taking Renvela:

Very common:

vomiting, upper abdominal pain, nausea

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

diarrhoea, stomach pain, indigestion, flatulence

Frequency not known:

cases of itching, rash, slow intestinal motility.

Reporting of side effects

If you experience any side effects, talk to your doctor, even if it is possible that they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 bottle after the letters "EXP". The expiry date is the last day of the month shown.

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Renvela

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

Appearance and packaging of the product

Renvela film-coated tablets are white, oval tablets engraved with "RV 800" on one side. The tablets are packaged in high-density polyethylene bottles with a polypropylene cap and an induction seal.

Package sizes:

Each bottle contains 30 tablets or 180 tablets

Pack sizes of 1 bottle of 30 or 180 tablets (without outer carton) and a multipack containing 180 (6 bottles of 30) tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Sanofi Winthrop Industrie

82 Avenue Raspail

94250 Gentilly

France

Manufacturer

Genzyme Ireland Limited

IDA Industrial Park

Old Kilmeaden Road

Waterford

Ireland

Sanofi Winthrop Industrie

1 rue de la Vierge

Ambares et Lagrave

33565 Carbon Blanc cedex

France

You can obtain further information on this medicine from the local representative of the marketing authorisation holder.

Date of last revision of this leaflet:

Other sources of information

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