RENAGEL 800 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Renagel 800 mg Film-Coated Tablets

Sevelamer Hydrochloride

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

1. What is Renagel and what is it used for

Renagel contains the active substance sevelamer. This active substance binds to phosphate in the digestive tract and reduces phosphate levels in the blood.

Renagel is used to control high blood phosphate levels in adult patients with chronic kidney disease who are on dialysis (haemodialysis or peritoneal dialysis).

Adult patients with kidney disease who are on dialysis cannot control their serum phosphate levels. As a result, phosphate levels increase (your doctor will call this hyperphosphataemia). High phosphate levels can cause hard deposits to form in the body called calcifications. These deposits can harden blood vessels and make it more difficult for blood to be pumped through the body. High phosphate levels can also cause itching of the skin, red eyes, bone pain, and fractures.

Renagel can be used with other medicines, including calcium or vitamin D supplements, to control the development of bone disease.

2. What you need to know before you take Renagel

Do not take Renagel:

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

Warnings and precautions

Tell your doctor before taking Renagel if you are in any of the following situations:

• if you are not on dialysis
• if you have swallowing problems
• if you have stomach or intestinal motility problems
• if you have symptoms of delayed emptying of stomach contents such as feeling full, nausea and/or vomiting
• if you have prolonged diarrhoea or abdominal pain (symptoms of inflammatory bowel disease)
• if you have had major stomach or intestinal surgery

Tell your doctor while you are taking Renagel:

• if you experience severe abdominal pain, stomach or intestinal disorders, or blood in your stools (gastrointestinal bleeding). These symptoms may be due to a severe inflammatory bowel 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 disease or dialysis treatment, you may experience:

• high or low calcium levels in your blood. Since Renagel does not contain calcium, your doctor may prescribe calcium supplement tablets
• low vitamin D levels in your blood. For this reason, your doctor may monitor your vitamin D levels 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 will monitor these levels and prescribe vitamin supplements if necessary.

Change of treatment:

When switching from another phosphate binder to Renagel, your doctor may need to monitor your bicarbonate levels more closely since Renagel can decrease bicarbonate levels.

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 have any new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness, or abdominal stiffness, constipation, fever, chills, nausea, or vomiting. Additionally, you may undergo more thorough checks to detect problems with low levels of vitamins A, D, E, K, and folic acid.

Children and adolescents

The safety and efficacy of Renagel in children (under 18 years) have not been established. Therefore, Renagel is not recommended for use in this population.

Using Renagel with other medicines

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

• Do not take Renagel at the same time as ciprofloxacin (an antibiotic).

• You should consult your doctor if you are taking medicines for heart rhythm disorders or for epilepsy while taking Renagel.

• Renagel may reduce the effects of medicines such as cyclosporin, mycophenolate mofetil, and tacrolimus (medicines used in transplant patients). Your doctor will advise you if you are taking these medicines.

• In some people taking levothyroxine (a thyroid hormone) and Renagel, an increase in thyroid-stimulating hormone (TSH) levels may be observed in rare cases. Therefore, your doctor may monitor your TSH levels more closely.

• If you are taking medicines such as omeprazole, pantoprazole, or lansoprazole to treat stomach acid, gastroesophageal reflux disease (GERD), or stomach ulcers, you should consult your doctor when taking Renagel.

Your doctor will check for possible interactions between Renagel and other medicines.

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

Pregnancy, breastfeeding, and fertility

The safety of Renagel in pregnant or breastfeeding women has not been established. Renagel should not be used in pregnant or breastfeeding women unless clearly necessary.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

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

3. How to take Renagel

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor. Your doctor will tell you the dose to take based on your serum phosphate levels. The recommended starting dose of Renagel for adults and the elderly (> 65 years) is 1 to 2 tablets 3 times a day with each meal.

Initially, your doctor will check your phosphate levels every 2-3 weeks and may adjust the dose of Renagel as needed (between 1 and 5 tablets of 800 mg per meal) to achieve an adequate phosphate level.

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

Patients taking Renagel should follow the diet and fluid intake prescribed by their doctor.

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, skip it and take the next dose when it is due, with your next meal. Do not take a double dose to make up for forgotten doses.

4. Possible side effects

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

Since constipation, very rarely, could be an early symptom of bowel obstruction, it is important to inform your doctor or pharmacist of 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.

Rare (may affect up to 1 in 10,000 people):

hypersensitivity.

Frequency not known (cannot be estimated from the available data):

cases of itching, rash, abdominal pain, slow intestinal movement, inflammation of small pouches in the intestine (diverticulitis), bowel obstruction (symptoms include severe swelling, abdominal pain, bloating, or cramps, severe constipation), rupture of the intestinal wall (symptoms include severe stomach pain, chills, fever, nausea, vomiting, or abdominal tenderness), severe inflammation of the large intestine (symptoms include severe abdominal pain, digestive or intestinal disorders, blood in the stool), and deposition of crystals in the intestine.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Renagel

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 carton and/or bottle after “EXP”. The expiry date is the last day of the month stated.

Do not store this medicine at a temperature above 25°C. Keep the bottle tightly closed to protect it from moisture.

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 Renagel

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

Appearance of the product and pack size

Renagel tablets are film-coated, white, oval, and engraved with RG800 on one side.

The tablets are packed in high-density polyethylene bottles with a child-resistant polypropylene cap and an induction seal.

The pack sizes are:

1 bottle of 100 tablets

1 bottle of 180 tablets

Multiple pack containing 180 tablets (6 bottles of 30 tablets)

Multiple pack containing 360 tablets (2 bottles of 180 tablets)

Multiple pack containing 540 tablets (3 bottles of 180 tablets)

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

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 by contacting 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 website: http://www.ema.europa.eu