Renagel 800 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Renagel 800 mg film-coated tablets

Sevelamer hydrochloride

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

• Keep this leaflet as 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 and must not be given to other people, even if they have the same symptoms as you. It may 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 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. This active substance binds to dietary phosphate in the gastrointestinal tract, thereby reducing phosphate levels in the blood.

Renagel is indicated for the control of serum phosphate levels in adult patients with renal insufficiency undergoing hemodialysis or peritoneal dialysis.

Adult patients whose kidneys do not function properly and who are undergoing hemodialysis or peritoneal dialysis cannot regulate serum phosphate concentration in the blood. As a result, the amount of phosphate increases (your doctor will refer to this as hyperphosphatemia). Elevated serum phosphate levels may lead to hard deposits in the body known as calcifications. These deposits can stiffen 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.

Renagel may be used together with other medications, including 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 you have low levels of phosphate in the blood (your doctor will check this for you)
• if you have intestinal obstruction
• if you are allergic to sevelamer or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

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

Talk to your doctor while taking Renagel:

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

Additional treatments:

Because you have kidney disease or due to dialysis treatment itself, it may occur that:

• your blood calcium levels are high or low. As Renagel does not contain calcium, your doctor may prescribe additional calcium tablets
• your blood vitamin D levels are low. 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, 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.

Treatment change:

When switching from another phosphate binder to treatment with Renagel, your doctor may consider it necessary to monitor blood bicarbonate levels more closely, as Renagel may reduce 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 by careful use of sterile techniques during bag exchanges. You should inform your doctor immediately if you experience any new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness or rigidity, constipation, fever, chills, nausea, or vomiting. In addition, more careful monitoring may be performed to detect problems related to low levels of vitamins A, D, E, K, and folic acid.

Children and adolescents

Safety and efficacy have not been established in children (under 18 years of age). Therefore, the use of Renagel is not recommended in this population.

Taking Renagel with other medicines

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

• Renagel must not be taken at the same time as ciprofloxacin (an antibiotic).

• You should consult your doctor if you are using medicines for heart rhythm disorders or epilepsy during treatment with Renagel.

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

• In some individuals taking levothyroxine (a thyroid hormone) and Renagel, an increase in thyroid-stimulating hormone (TSH) levels—a substance in the blood that helps regulate the body's chemical functions—could be observed in very rare cases. Therefore, your doctor may monitor your blood TSH levels more closely.

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

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

In some cases, when Renagel must be taken with another medicine, your doctor may instruct you to take that medicine 1 hour before or 3 hours after taking Renagel, or may consider monitoring blood levels of that medicine.

Pregnancy, breast-feeding and fertility

The safety of Renagel in pregnant or breast-feeding women has not been established. Renagel must not be administered to pregnant or breast-feeding women unless clearly indicated.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using 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

Follow exactly the instructions for use of this medicine given by your doctor. If you are unsure, consult your doctor. Your doctor will determine the dose you should take based on your serum phosphate levels. The recommended starting dose of Renagel for adults and elderly patients (> 65 years) is one to two tablets three times daily with each meal.

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

The tablets must be swallowed whole. They must not be crushed, chewed, or broken before administration.

Patients taking Renagel should follow the diet and fluid intake prescribed for them.

If you take more Renagel than you should

In case of a possible overdose, you must contact your doctor immediately.

If you forget to take Renagel

If you forget to take 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 forgotten doses.

4. Possible adverse effects

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

Since constipation, very rarely, could be an early symptom of intestinal obstruction, it is important that you inform your doctor or pharmacist about this symptom before or during the use of Renagel.

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

Very common (may affect more than 1 in 10 patients):

nausea, vomiting.

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

diarrhoea, indigestion, abdominal pain, constipation, flatulence.

Uncommon (may affect up to 1 in 100 patients):

increase in blood acidity.

Very rare (may affect up to 1 in 10,000 patients):

hypersensitivity.

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

cases of pruritus, rash, abdominal pain, slow intestinal motility, inflammation of abnormally small pouches (called diverticula) in the colon, intestinal obstruction (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 tender/abdominal pain), severe inflammation of the colon (symptoms include: severe abdominal pain, gastrointestinal or intestinal disturbances, blood in the stool [intestinal bleeding]), and deposition of crystals in the intestine have been reported.

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, 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 Renagel.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and/or bottle following "EXP". The expiry date refers to the last day of the month indicated.

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

Do not dispose of medicines via wastewater drains or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This 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 components are colloidal anhydrous silica and stearic acid, hypromellose (E464), diacetylated monoglycerides.

Appearance of the product and contents of the container

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

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

Pack sizes are:

1 bottle containing 100 tablets
1 bottle containing 180 tablets
Multiple pack containing 180 tablets (6 bottles of 30 tablets each)
Multiple pack containing 360 tablets (2 bottles of 180 tablets each)
Multiple pack containing 540 tablets (3 bottles of 180 tablets each)

Only certain 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

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:

Date of the most recent review of this package leaflet was

Other sources of information

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