RENVELA 2.4 g ORAL SUSPENSION POWDER

Introduction

Package Leaflet: Information for the User

Renvela2.4 g oral powder for suspension

sevelamer carbonate

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 pack

1. What is Renvela and what is it 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 other information

1. What is Renvela and what is it used for

Renvela contains sevelamer carbonate as the active substance. It binds to phosphate in the digestive tract and reduces phosphate levels in the blood.

This medicine is used to control hyperphosphataemia (high phosphate levels in the blood) in:

• adult patients on dialysis (a technique to clean the blood). It can be used in patients undergoing haemodialysis (using a machine to filter the blood) or peritoneal dialysis (where fluid is pumped into the abdomen and a body membrane filters the blood);
• adult patients with chronic kidney disease (long-term) who are not on dialysis and have a serum phosphate level of 1.78 mmol/l or higher.
• paediatric patients over 6 years of age with chronic kidney disease (long-term) and with a certain height and weight (which your doctor will use to calculate the body surface area).

This medicine should be used with other treatments such as calcium and vitamin D supplements to prevent the development of bone disease.

High phosphate levels in the blood can cause hard deposits in the body called calcifications. These deposits can harden in the blood vessels and make it more difficult for blood to be pumped around the body. High phosphate levels in the blood can also cause itching of the skin, red eyes, bone pain, and fractures.

2. What you need to know before you take Renvela

Do not take Renvela

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

Warnings and precautions

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

• problems with stomach and intestine movement
• you vomit frequently
• active inflammation of the intestine
• you have had major stomach or intestine surgery.

Talk to your doctor while taking Renvela:

• if you experience severe abdominal pain, stomach or intestine problems, or blood in your stools (gastrointestinal bleeding). These symptoms can be due to a serious inflammatory bowel disease caused by the deposit of sevelamer crystals 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 calcium levels in your blood. As this medicine does not contain calcium, your doctor may prescribe calcium supplement tablets
• have low vitamin D levels in your blood. Therefore, 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 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 needed.
• 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 can be reduced with careful use of sterile techniques during bag changes. You should immediately inform your doctor if you experience any new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness, constipation, fever, chills, nausea, or vomiting.

Children

The safety and efficacy of Renvela have not been studied in children (under 6 years). Therefore, the use of this medicine is not recommended in children under 6 years.

Other medicines and Renvela

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

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

• If you are using other medicines for heart rhythm problems or for epilepsy, you should consult your doctor when taking Renvela.

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

• A low thyroid hormone level may occasionally be observed in certain individuals taking levothyroxine (used to treat low thyroid hormone levels) and Renvela. Therefore, your doctor may monitor your thyroid-stimulating hormone levels in the 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 Renvela. Your doctor should monitor your phosphate levels in your blood.

Your doctor will regularly check for interactions between Renvela 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 Renvela during human pregnancy is unknown. Talk to your doctor, who will decide whether you can continue treatment with Renvela.

It is unknown whether Renvela can pass into breast milk and affect the baby. Talk to your doctor, who will decide whether you can breast-feed your baby or not and whether it is necessary to interrupt treatment with Renvela.

Driving and using machines

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

Excipients

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

This medicine contains 25.27 mg of propylene glycol in each 2.4 g dose.

3. How to take Renvela

Renvela should be taken as directed by your doctor. The doctor will determine the dose based on your phosphate levels.

For the 2.4 g dose, the oral powder for suspension should be dispersed in 60 mL of water. Drink within 30 minutes of preparation. It is important to drink all the liquid and you may need to rinse the glass with water and drink it to make sure you take all the powder.

Instead of water, the powder can be mixed with a small amount of cold drink (about 120 mL or half a glass) or food (about 100 grams), and taken within 30 minutes. Do not heat Renvela powder (e.g. in the microwave) or add it to hot liquids or foods.

The recommended initial dose of this medicine for adults and elderly patients is 2.4-4.8 g per day, divided into three meals. Your doctor will determine the exact initial dose and administration schedule. Talk to your doctor, pharmacist, or nurse if you are unsure.

Take Renvela after a meal or with food.

If a 0.4 g dose is to be administered, please use the 0.8 g powder with a measuring spoon.

Use in children and adolescents

The recommended initial dose of Renvela for children is based on their height and weight (which your doctor will use to calculate the body surface area). For children, the powder formulation is preferred as tablets are not suitable for this population. This medicine should not be taken on an empty stomach and should be taken with meals or snacks. Your doctor will determine the exact initial dose and administration schedule.

Initially, your doctor will check your phosphate levels in the blood 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, contact your doctor immediately.

If you forget to take Renvela

If you miss a dose, it should be omitted, so 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 Renvela

Taking your treatment with Renvela is important to maintain an adequate phosphate level in your blood. Stopping treatment with Renvela would have significant consequences, such as calcification in the blood vessels. If you consider stopping your treatment with Renvela, contact your doctor or pharmacist first.

If you have any further questions on the use of this product, 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 (may affect more than 1 in 10 patients). It can be an early symptom of bowel 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).

• Bowel obstruction has been reported (signs include severe swelling, abdominal pain, bloating or cramps, severe constipation). The frequency is unknown (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 abdominal tenderness). The frequency is unknown.

• Severe inflammation of the large intestine has been reported (symptoms include severe abdominal pain, stomach problems or intestinal problems, blood in the stools [gastrointestinal bleeding]) and crystal deposits in the intestine. The frequency is unknown.

Other side effects have been reported in patients taking Renvela:

Very common:

vomiting, upper abdominal pain, nausea

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

diarrhoea, stomach pain, indigestion, flatulence

Frequency unknown:

cases of itching, rash, slow intestinal movement.

Reporting of side effects

If you experience any side effects, talk to your doctor, even if they are 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 Renvela

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 sachet after the letters "EXP". The expiry date refers to the last day of the month shown.

The reconstituted suspension should be taken within 30 minutes of reconstitution.

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 other information

Composition of Renvela

• The active substance is sevelamer carbonate. Each sachet contains 2.4 g of sevelamer carbonate.
• The other ingredients are propylene glycol alginate (E405), citrus cream flavour, sodium chloride, sucralose, and yellow iron oxide (E172).

Appearance of the product and pack size

Renvela oral powder for suspension is a pale yellow powder supplied in an aluminium foil sachet. The sachets are packed in an outer carton.

Pack sizes:

60 sachets per carton

90 sachets per carton

Not all pack sizes may be marketed.

Marketing authorisation holder

Sanofi Winthrop Industrie

82 Avenue Raspail

94250 Gentilly

France

Manufacturer

Genzyme Ireland Limited

IDA Industrial Park

Old Kilmeaden Road

Waterford

Ireland

ROVI Pharma Industrial Services, S.A.

Vía Complutense, 140, Alcalá de Henares,

Madrid, 28805

Spain

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/.