Package Insert: Information for the User

Renagel 800 mg Film-Coated Tablets

Sevelamer Hydrochloride

Read this package insert carefully before you start taking this medicine because it contains important information for you.

• Keep this package insert, 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 should not be given to others,even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Renagel contains the active ingredient sevelamer. This active ingredient binds to the phosphorus in food in the digestive tract and, in this way, reduces the levels of phosphate in the blood.

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

Adult patients whose kidneys do not function and who are undergoing hemodialysis or peritoneal dialysis cannot control the concentration of serum phosphorus in the blood. Therefore, the amount of phosphorus (your doctor will call this hyperphosphatemia) increases. The increase in serum phosphorus levels can produce hard deposits in the body called calcifications. These deposits can harden your blood vessels and make it more difficult for blood to be pumped throughout the body. The increase in serum phosphorus also can produce itching skin, red eyes, bone pain, and fractures.

Renagel can be used with other medications that include calcium supplements or vitamin D, to control the development of renal bone disease.

Do not take Renagel:

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

Warnings and precautions

Consult 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 gastrointestinal motility 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 had major surgery of the stomach or intestine

Consult your doctor while taking Renagel:

• if you experience severe abdominal pain, gastrointestinal disturbances, or blood in your stool (gastrointestinal hemorrhage). 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 levels of calcium in your blood. Since Renagel does not contain calcium, your doctor may prescribe calcium supplements
• low levels of vitamin D in your blood. Your doctor may monitor your vitamin D levels and prescribe a vitamin D supplement if necessary. If you do not take multivitamin supplements, your doctor may also monitor your levels of vitamins A, E, K, and folic acid, and prescribe vitamin supplements if necessary.

Change of treatment:

When switching from a phosphate binder treatment to Renagel, your doctor may need to monitor your bicarbonate levels more closely, as Renagel may 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 the careful use of sterile techniques during bag changes. Inform your doctor immediately if you experience any new symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness, constipation, fever, chills, nausea, or vomiting. Additionally, your doctor may perform 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 have not been determined in children (under 18 years). Therefore, the use of Renagel in this population is not recommended.

Use of Renagel with other medications

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

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

• Consult your doctor if you are using medications for heart rhythm disorders or epilepsy during treatment with Renagel.

• Renagel may reduce the effects of medications such as cyclosporine, mycophenolate mofetil, and tacrolimus (medications used in transplant patients). Your doctor will advise you in this case.

• In rare cases, people taking levotiroxine (a thyroid hormone) and Renagel may experience an increase in thyroid-stimulating hormone (TSH) levels. Your doctor may monitor your TSH levels more closely.

• If you are taking medications such as omeprazole, pantoprazole, or lansoprazole for heartburn, GERD, or gastric ulcers, consult your doctor when taking Renagel.

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

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

Pregnancy, breastfeeding, and fertility

The safety of Renagel has not been determined in pregnant women or breastfeeding women. Renagel should not be administered to pregnant women or breastfeeding women unless clearly indicated.

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Driving and operating machinery

It is unlikely that Renagel will affect your ability to drive and operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor.Consult with your doctor if you are unsure.Your doctor will instruct you on the dosage to take based on your serum phosphate levels. The recommended starting dose of Renagel for adults and elderly individuals (> 65 years) is one to two tablets three times a day with each meal.

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

The tablets must be taken whole. They should not be crushed, chewed, or fragmented before administration.

Patients taking Renagel must follow the diet and fluid intake prescribed to them.

If you take more Renagel than you should

In the event of a possible overdose, you should contact your doctor immediately.

If you forget to take Renagel

If you forget to take a dose, it should be skipped, and you should take the next one when it is due and with a meal. Do not take a double dose to compensate for the missed doses.

Like all medications, this medication may have adverse effects, although not everyone may experience them.

Since constipation, very rarely, could be an early sign of intestinal obstruction, it is essential to inform your doctor or pharmacist of this symptom before or during the use of Renagel.

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

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

nausea, vomiting.

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

diarrhea, indigestion, abdominal pain, constipation, flatulence.

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

increased blood acidity.

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

hypersensitivity.

Unknown Frequency(cannot be estimated from available data):

cases of pruritus, rash, abdominal pain, slow intestinal motility, abnormal inflammation of small intestinal diverticula, intestinal obstruction (symptoms include: severe distension, abdominal pain, swelling or cramps, severe constipation), intestinal perforation (symptoms include: severe abdominal pain, chills, fever, nausea, vomiting, or abdominal tenderness or sensitivity), severe inflammation of the large intestine (symptoms include: severe abdominal pain, gastrointestinal or intestinal disturbances, bloody stools [intestinal bleeding]), and crystal deposition in the intestine.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and/or bottle after “CAD”. The expiration date is the last day of the month indicated.

Do not store this medication at a temperature above 25°C. Keep the bottle perfectly closed to protect it from humidity.

Do not throw away the medications through the drains or in the trash. Ask your pharmacist where to dispose of the medications that you no longer use. In this way, you will help protect the environment.

Composition of Renagel

-The active ingredient is hydrochloride of sevelamer. Each tablet contains 800 mg of hydrochloride of sevelamer.

-The other components are colloidal anhydrous silica and stearic acid, hypromellose (E464), diacetylated monoglycerides.

Appearance of the product and contents of the package

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

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

The package 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)

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

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 more information about this medicine, please contact the local representative of the marketing authorization holder:

The date of the last review of this leaflet was

Other sources of information

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