Package Leaflet: Information for the UserRenvela 800 mg Film-Coated Tablets

Sevelamer Carbonate

Read this 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. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1. What Renvela is and what it is 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 additional information

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

This medication is used to control hyperphosphatemia (high levels of phosphate in the blood) in:

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

This medication should be used with other treatments such as calcium supplements and vitamin D

to prevent the development of bone disease.

Increased serum phosphorus levels can produce hard deposits in the body called calcifications. These deposits can harden in blood vessels and make it more difficult for blood to be pumped throughout the body. Increased phosphorus levels can also produce itching skin, red eyes, bone pain, and fractures.

Do not take Renvela

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

Warnings and precautions

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

• difficulty swallowingYour doctor may prefer to prescribe Renvela in powder form for oral suspension
• problems with stomach and intestinal motility
• you frequently vomit
• you have active intestinal inflammation
• you have had major surgery on your stomach or intestines

Consult your doctor while taking Renvela:

• if you experience severe abdominal pain, gastrointestinal disturbances, or blood in your stool (gastrointestinal hemorrhage). These symptoms may be due to a severe 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 disease or dialysis treatment, you may:

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

Special note for patients on peritoneal dialysis

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

Children

Renvela has not been studied in children (under 6 years). Therefore, it is not recommended for use in children under 6 yearsold.

Other medications and Renvela

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

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

• If you are taking medications for heart rhythm problems or epilepsy, consult your doctor when taking Renvela

• The effects of medications such as ciclosporin, micofenolato mofetilo, and tacrolimus (medications used to suppress the immune system) may be reduced by Renvela. Your doctor will advise you if you are taking these medications

• There may be a rare deficiency of thyroid hormone in certain individuals taking levotiroxine (used to treat low thyroid hormone levels) and Renvela. Your doctor may monitor your thyroid hormone levels in the blood more closely

• Medications for treating stomach acid and reflux in your stomach or esophagus, such as omeprazol, pantoprazol, or lansoprazol, known as "proton pump inhibitors," may reduce the effectiveness of Renvela. Your doctor must monitor your phosphate levels in the blood

Your doctor will regularly check for interactions between Renvela and other medications

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

Pregnancy and breastfeeding

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

The safety of Renvela for use during breastfeeding is unknown. Consult your doctor, who will decide whether to continue treatment with Renvela or not and whether to stop breastfeeding

Driving and operating machinery

It is unlikely that Renvela will affect your ability to drive or operate machinery

Excipients

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

Renvela should be taken as directed by your doctor. Your doctor will establish the dose based on your serum phosphate levels.

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

Take Renvela after a meal or with food.

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

Initially, your doctor will check your blood phosphate concentrations 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, you should contact your doctor immediately.

If you forget to take Renvela

If you forget to take a dose, omit it, and take the next dose at the usual time with a meal. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Renvela

It is essential to continue your treatment with Renvela to maintain an appropriate level of phosphate in your blood. Stopping Renvela treatment may lead to serious consequences, such as vascular calcification. If you consider stopping your treatment with Renvela, contact your doctor or pharmacist first.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

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

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

- Allergic reaction (signs that include rash, hives, swelling, difficulty breathing). This is a very rare adverse effect (it may affect up to 1 in 10,000 patients).

- Intestinal obstruction has been reported (signs include: severe distension, abdominal pain, swelling or cramps, severe constipation). The frequency is unknown (it cannot be estimated from available data).

- Intestinal wall rupture has been reported (signs include: intense stomach pain, chills, fever, nausea, vomiting, or a painful or sensitive abdomen). The frequency is unknown.

- Severe inflammation of the large intestine has been reported (symptoms include: intense abdominal pain, digestive or intestinal disorders, blood in the stool [intestinal bleeding]) and crystal deposition in the intestine.The frequency is unknown.

Other adverse effects have been reported in patients taking Renvela:

Very frequent:

nausea, upper abdominal pain, vomiting

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

diarrhea, stomach pain, indigestion, flatulence

Unknown frequency::

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

Reporting 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 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 about 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 in the bottle after the letters «CAD». The expiration date is the last day of the month indicated.

Keep the bottle perfectly closed to protect it from moisture. This medication does not require special storage conditions.

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

Composition of Renvela

• The active ingredient 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 film coating of the tablet contains hypromellose (E464) and diacetyl monoglycerides.

Appearance of the product and contents of the pack

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

Size of pack:

Each bottle contains 30 tablets or 180 tablets.

Packs of 1 bottle of 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

Responsible Person

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 consult the representative of the marketing authorization holder in your country.

Last update of the summary of product characteristics:

Other sources of information

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