Renvella 0.8 g powder for oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Renvela 0.8 g powder for oral suspension

sevelamer carbonate

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 you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Renvela is and what it is used for
2. What you need to know before taking Renvela
3. How to take Renvela
4. Possible side effects
5. How to store Renvela
6. Contents of the pack and other information

1. What Renvela is and what it is used for

Renvela contains sevelamer carbonate as the active substance. It binds to dietary phosphate in the gastrointestinal tract and thereby reduces serum phosphate levels in the blood.

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

• adult patients on dialysis (a blood-cleansing technique). 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 an internal body membrane filters the blood);
• adult patients with chronic kidney disease (long-term) who are not on dialysis and have a serum (in blood) phosphate level equal to or above 1.78 mmol/l;
• paediatric patients over 6 years of age with chronic kidney disease (long-term) and with a certain height and weight (based on which the doctor will calculate the body surface area).

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

Elevated serum phosphate levels may lead to hard deposits in the body called calcifications. These deposits may harden 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.

2. What you need to know before taking Renvela

Do not take Renvela

• if you are allergic to the active substance or to any of the other components 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

• Consult your doctor before taking Renvela if you are in any of the following situations:
  • problems with stomach and intestinal motility (movement)
  • you frequently experience vomiting
  • active inflammation of the intestine
  • you have undergone major stomach or intestinal surgery.

Consult your doctor while taking Renvela:

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

Additional treatments

Due to your kidney condition or dialysis treatment, you may:

• have low or high levels of calcium in your blood. Since this medicine does not contain calcium, your doctor may prescribe additional calcium tablets.

• have low levels of vitamin D in your blood. Therefore, your doctor may monitor your blood 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 may monitor these levels and prescribe vitamin supplements as needed.

• have altered blood bicarbonate levels and increased acidity in the blood and other body tissues. Your doctor should monitor your blood bicarbonate levels.

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 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.

Children

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

Other medicines and Renvela

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

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

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

• The effects of medicines such as cyclosporine, 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 deficiency of thyroid hormone may rarely occur in certain individuals taking levothyroxine (used to treat low thyroid hormone levels) and Renvela. Therefore, your doctor may monitor your thyroid-stimulating hormone (TSH) blood levels more closely.

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

Your doctor will regularly check for interactions between Renvela and other medicines.

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

Pregnancy and breastfeeding

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

It is unknown whether Renvela passes into breast milk and could affect the baby. Consult your doctor, who will decide whether you can breastfeed or not and whether it is necessary to discontinue treatment with Renvela.

Driving and use of machines

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

Excipients

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

This medicine contains 8.42 mg of propylene glycol in each 0.8 g sachet.

3. How to take Renvela

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

For the 0.8 g oral suspension powder per sachet, the powder should be dispersed in 30 mL of water. It must be drunk within 30 minutes of preparation. It is important to drink all of the liquid, and you may need to rinse the glass with water and drink that as well to ensure you ingest all of the powder.

Instead of water, the powder may be mixed with a small amount of cold drink (approximately 120 mL or half a glass) or cold food (about 100 grams), and taken within the following 30 minutes. Do not heat Renvela powder (e.g., in a 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 equally into three doses with meals. Consult your doctor, pharmacist, or nurse if you are unsure. Your doctor will determine the exact initial dose and dosing regimen.

Take Renvela after a meal or with food.

(Instructions for the presentation with dosing spoon)

For 0.4 g doses, the sachet powder can be divided. In this case, the 0.4 g dose of Renvela powder should be measured using the dosing spoon provided in the package.

Always use the dosing spoon provided in the package.

(Instructions for the presentation WITHOUT dosing spoon)

If a 0.4 g dose needs to be administered, please use the 0.8 g powder presentation with dosing spoon.

Use in children and adolescents

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

For doses less than 0.8 g, the powder from the sachet can be divided. The 0.4 g dose of Renvela powder should be measured with the dosing spoon provided in the package.

Preparation using a dosing spoon:

Use the dosing spoon supplied for each 0.4 g dose of Renvela powder.

For a 0.4 g dose:

• Before opening the sachet, shake it from the top corner to move the powder to the bottom of the sachet.
• Open the sachet by tearing along the marked line.
• Ensure the dosing spoon is dry.
• Hold the spoon horizontally and pour the powder from the sachet into the dosing spoon.
• Fill the spoon to the spoon level with powder.
• Do not tap the dosing spoon to compact the powder.
• Mix the powder from the dosing spoon with 30 mL of water. Stir the suspension and drink it within 30 minutes of preparation. It is important to drink all of the liquid to ensure complete ingestion of the powder.
• Close the sachet by folding it twice.
• The remaining powder may be used for the next dose within 24 hours.
• Discard any remaining powder from the sachet if it has been open for more than 24 hours.

Initially, your doctor will monitor your blood phosphorus levels every 2–4 weeks and may adjust your Renvela dose as needed to achieve an appropriate phosphorus 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, skip it and take the next dose at the usual time with food. Do not take a double dose to make up for a missed dose.

If you stop taking Renvela

Taking Renvela as prescribed is important to maintain appropriate phosphate levels in your blood. Stopping Renvela treatment may lead to serious consequences, such as vascular calcification. If you are considering stopping your Renvela treatment, contact your doctor or pharmacist first.

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

4. Possible adverse effects

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

Constipation is a very common adverse effect (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 can be serious. If you experience any of the following, seek medical attention immediately:

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

• Intestinal obstruction has been reported (symptoms include: severe distension, abdominal pain, swelling or cramps, severe constipation). Frequency is unknown (cannot be estimated from available data).

• Perforation of the intestinal wall has been reported (symptoms include: severe stomach pain, chills, fever, nausea, vomiting, or tender or painful abdomen). Frequency is unknown.

• Severe inflammation of the large intestine has been reported (symptoms include: severe abdominal pain, digestive or intestinal disturbances, blood in the stool [intestinal bleeding]) and crystal deposition in the intestine. Frequency is unknown.

Other adverse effects reported in patients taking Renvela:

Very common:

vomiting, upper abdominal pain, nausea

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

diarrhea, stomach ache, indigestion, flatulence

Frequency not known:

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

Reporting of 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 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 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 indicated.

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

This medicine does not require any special storage conditions.

Instructions for the presentation with dosing spoon)

Discard the sachet 24 hours after opening.

Do not dispose of medicines via wastewater 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 Renvela

• The active substance is sevelamer carbonate. Each sachet contains 0.8 g of sevelamer carbonate.
• The other components are propylene glycol alginate (E405), citrus cream flavour, sodium chloride, sucralose and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Renvela oral suspension powder is a pale yellow powder supplied in heat-sealed aluminium sachets. The sachets are packed in an outer carton.

(Instructions for the presentation with dosing spoon)

One 0.4 g dosing spoon is included in the pack.

Pack size:

90 sachets per box.

Only certain pack sizes may be marketed.

Marketing Authorization Holder:

Sanofi Winthrop Industrie

82 Avenue Raspail

94250 Gentilly

France

Manufacturer responsible:

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

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder.

Date of the most recent review of this leaflet

Other sources of information

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