SEVELAMER CARBONATE WINTHROP 800 MG FILM-COATED TABLETS

2. What you need to know before you take Sevelamer Carbonate Winthrop

Do not take Sevelamer Carbonate Winthrop:

• 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 levels of phosphate in the blood (your doctor will check this for you)
• if you have intestinal obstruction.

Warnings and precautions

Tell your doctor before taking Sevelamer Carbonate Winthrop:

• if you have problems swallowing. Your doctor may prefer to prescribe Renvela powder for oral suspension for you
• if you have problems with stomach and intestinal motility (movement)
• if you have active inflammation of the intestine
• if you have had major stomach or intestinal surgery
• if you have severe inflammatory bowel disease.

Tell your doctor while you are taking Sevelamer Carbonate Winthrop:

• if you experience severe abdominal pain, stomach or intestinal disorders, or blood in your stools (gastrointestinal bleeding). These symptoms can be due to sevelamer crystals depositing 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 levels of calcium in your blood. As this medicine does not contain calcium, your doctor may prescribe calcium supplement tablets
• have low levels of vitamin D in your blood. Therefore, your doctor may monitor your vitamin D blood 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 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 may 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

Do not give this medicine to children under 6 years of age as the safety and efficacy have not been established in children (under 6 years of age).

Using Sevelamer Carbonate Winthrop with other medicines

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

• Sevelamer Carbonate Winthrop 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 consult your doctor when taking Sevelamer Carbonate Winthrop.

• The effects of medicines such as cyclosporin, mycophenolate mofetil, and tacrolimus (medicines used to suppress the immune system) may be reduced by Sevelamer Carbonate Winthrop. Your doctor will advise you if you are taking these medicines.

• A low level of thyroid hormone has been observed rarely in certain individuals taking levothyroxine (used to treat low thyroid hormone levels) and Sevelamer Carbonate Winthrop. Therefore, your doctor may monitor your thyroid-stimulating hormone levels in your blood more closely.

• Medicines to treat stomach acid and reflux in your stomach or oesophagus, such as omeprazole, pantoprazole, or lansoprazole, known as "proton pump inhibitors", may reduce the effectiveness of Sevelamer Carbonate Winthrop. Your doctor should monitor your phosphate levels in your blood.

Your doctor will check regularly for interactions between Sevelamer Carbonate Winthrop and other medicines.

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 should 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 Sevelamer Carbonate Winthrop during human pregnancy is unknown. Consult your doctor, who will decide whether you can continue treatment with Sevelamer Carbonate Winthrop.

It is unknown whether Sevelamer Carbonate Winthrop passes into breast milk and affects your baby. Consult your doctor, who will decide whether you can breast-feed your baby or not and whether it is necessary to interrupt treatment with Sevelamer Carbonate Winthrop.

Driving and using machines

Sevelamer Carbonate Winthrop 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 Sevelamer Carbonate Winthrop

Take this medicine exactly as your doctor has told you. Your doctor will decide on the dose based on your phosphate levels.

The recommended initial dose of this medicine for adults and elderly patients is one to two 800 mg tablets with each meal 3 times a day. Consult your doctor, pharmacist, or nurse if you are not sure.

Take Sevelamer Carbonate Winthrop 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 Sevelamer Carbonate Winthrop as needed to achieve an adequate phosphate level.

Continue with the diet that your doctor has prescribed for you.

If you take more Sevelamer Carbonate Winthrop than you should

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

If you forget to take Sevelamer Carbonate Winthrop

If you miss a dose, it should be omitted, so that 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 Sevelamer Carbonate Winthrop

Taking your treatment with Sevelamer Carbonate Winthrop is important to maintain an appropriate level of phosphate in your blood. Stopping treatment with Sevelamer Carbonate Winthrop would have significant consequences, such as calcification in the blood vessels. If you consider stopping your treatment with Sevelamer Carbonate Winthrop, 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. 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).

• Rupture of the intestinal wall has been reported (signs include severe stomach pain, chills, fever, nausea, vomiting, or a tender or sensitive abdomen). The frequency is not known.

• Severe inflammation of the large intestine has been reported (symptoms include severe abdominal pain, stomach or intestinal disorders, or blood in the stools [gastrointestinal bleeding]) and crystal deposits in the intestine. The frequency is not known.

Other side effects have been reported in patients taking Sevelamer Carbonate Winthrop:

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

• 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 movement (motility).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 Sevelamer Carbonate Winthrop

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 and/or carton after EXP. The expiry date refers to the last day of the month shown.

Keep the bottle tightly closed to protect 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 further information

Composition of Sevelamer Carbonate Winthrop

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

Appearance of the product and pack size

Sevelamer Carbonate Winthrop film-coated tablets are white to off-white oval tablets with "RV800" printed on one side. The tablets are packed in high-density polyethylene bottles with a child-resistant polypropylene cap and an induction seal.

Pack sizes:

Each bottle contains 30 tablets or 180 tablets.

Pack sizes of 1 bottle of 30 or 180 tablets without outer carton.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Sanofi Winthrop Industrie

82 Avenue Raspail

94250 Gentilly

France

Manufacturer:

Genzyme Ireland Ltd.

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 request more information about 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.