What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: EU/1/09/521/006.

Renvela 2.4mg powder for oral suspension

Package leaflet: Information for the user

Renvela 2.4 g powder for oral 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 further questions, ask your doctor or your 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. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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. 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 ingredient. It binds phosphate from food in the digestive tract and so reduces serum phosphorus levels in the blood.

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

  • adult patients on dialysis (a blood clearance technique). It can be used in patients undergoing haemodialysis (using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood);
  • adult patients with chronic (long-term) kidney disease who are not on dialysis and have a serum (blood) phosphorus level equal to or above 1.78 mmol/l.
  • paediatric patients with chronic (long-term) kidney disease above the age of 6 and above a certain height and weight (used to calculate body surface area by your physician).

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

Increased levels of serum phosphorus can lead to hard deposits in your body called calcification. These deposits can stiffen your blood vessels and make it harder for blood to be pumped around the body. Increased serum phosphorus can also lead to itchy skin, red eyes, bone pain and fractures.

2. What you need to know before you take Renvela

Do not take Renvela if:

  • you have low levels of phosphate in your blood (your doctor will check this for you)
  • you have bowel obstruction
  • you are allergic to the active substance or to any of the other ingredients of this medicine (listed in Section 6).

Warnings and Precautions

Talk to your doctor before taking Renvela if any of the following applies to you:

  • swallowing problems
  • problems with motility (movement) in your stomach and bowel
  • being sick frequently
  • active inflammation of the bowel
  • have undergone major surgery on your stomach or bowel.

Additional treatments:

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

  • develop low or high levels of calcium in your blood. Since Renvela does not contain calcium your doctor might prescribe additional calcium tablets.
  • have a low amount of vitamin D in your blood. Therefore, your doctor may monitor the levels of vitamin D in your blood and prescribe additional vitamin D as necessary. If you do not take multivitamin supplements you may also develop low levels of vitamins A, E, K and folic acid in your blood and therefore your doctor may monitor these levels and prescribe supplemental vitamins as necessary.

Special note for patients on peritoneal dialysis:

You may develop peritonitis (infection of your abdominal fluid) associated with your peritoneal dialysis. This risk can be reduced by careful adherence to sterile techniques during bag changes. You should tell your doctor immediately if you experience any new signs or symptoms of abdominal distress, abdominal swelling, abdominal pain, abdominal tenderness, or abdominal rigidity, constipation, fever, chills, nausea or vomiting.

You should expect to be monitored more carefully for problems with low levels of vitamins A, D, E, K and folic acid.

Children

The safety and efficacy in children (below the age of 6 years) have not been studied. Therefore Renvela is not recommended for use in children below the age of 6 years.

Other medicines and Renvela

Tell your doctor if you are taking or 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 taking 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.
  • Thyroid hormone deficiency may uncommonly be observed in certain people taking levothyroxine (used to treat low thyroid hormone levels) and Renvela. Therefore your doctor may monitor the levels of thyroid stimulating hormone in your blood more closely.
  • If you are taking medicine to treat heartburn, gastroesophageal reflux disease (GERD) or gastric ulcers, such as omeprazole, pantoprazole, or lansoprazole, you should consult your doctor when taking Renvela.

Your doctor will check for interactions between Renvela and other medicines on a regular basis.

In some cases where Renvela should be taken at the same time as another medicine. Your doctor may advise you to take this medicine 1 hour before or 3 hours after Renvela intake, or they may consider monitoring the blood levels of that medicine.

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. It is unknown whether Renvela has any affect on unborn babies.

Tell your doctor if you wish to breast-feed your baby. It is unknown whether Renvela may pass through breast milk and affect your baby.

Driving and using machines

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

3. How to take Renvela

You must take Renvela as prescribed by your doctor. They will base the dose on your serum phosphorus level.

For a 2.4 g dose, the powder for oral suspension should be dispersed in 60 mL of water per sachet. Drink within 30 minutes of being prepared. It is important to drink all of the liquid and it may be necessary to rinse the glass with water and drink this as well to ensure that all of the powder is swallowed.

Instead of water, the powder may be pre-mixed with a small amount of cold beverage (about 120 ml or half a glass) or food (about 100 grams) and consumed within 30 minutes. Do not heat Renvela powder (e.g. microwave) or add to hot foods or liquids.

The recommended starting dose of Renvela for adults is 2.4-4.8 g per day equally divided over three meals. The exact starting dose and regimen will be determined by your doctor.

Use in children and adolescents

The recommended starting dose of Renvela for children is based on their height and weight (used to calculate body surface area by your physician). For children, Renvela powder is preferred, as Renvela tablets are not appropriate in this population. Renvela should not be given on an empty stomach and should be taken with meals or snacks. The exact starting dose and regimen will be determined by your doctor.

For doses of less than 2.4 g, the Renvela powder in the sachet may be divided. The Renvela powder may be measured by volume (mL) using a measuring scoop or measuring spoon.

Sevelamer carbonate dose (g) Volume (mL)

0.4 g (400 mg) 1.0 mL

0.8 g (800 mg) 2.0 mL

1.2 g (1200 mg) 3.0 mL

1.6 g (1600 mg) 4.0 mL

Preparation using a 1 mL measuring scoop:

For a 0.4 g dose:

  • Open the sachet with scissors along the marked line.
  • Insert the scoop into the sachet.
  • Fill the scoop above the top edge.
  • Withdraw the scoop from the sachet using the top edge of the open sachet to level the powder with the top of the scoop. This allows excess Renvela powder to fall back into the sachet.
  • Disperse the 1.0 mL of the Renvela powder from the measuring scoop in 60 mL of water. Drink within 30 minutes of being prepared. It is important to drink all of the liquid and it may be necessary to rinse the glass with water and drink this as well to ensure that all of the powder is swallowed.
  • Close the sachet by folding over twice.
  • The remaining Renvela powder may be used within 24 hours for the next dose.
  • Discard sachets of Renvela powder that have been opened for more than 24 hours.

For a 0.8 g dose:

  • Follow the instructions above, filling the scoop twice for a total of 2.0 mL Renvela powder.

For a 1.2 g dose:

  • Follow the instructions above, filling the scoop three times for a total of 3.0 mL Renvela powder.

For a 1.6 g dose:

  • Follow the instructions above, filling the scoop four times for a total of 4.0 mL Renvela powder.

Preparation using a measuring spoon:

For a 0.4 g dose:

  • Open the sachet with scissors along the marked line.
  • Hold the measuring spoon vertically.
  • Pour the contents of the sachet into the measuring spoon to fill the spoon to 1.0 mL.
  • Do not tap the dosing spoon to compact the powder.
  • Disperse the 1.0 mL of the Renvela powder from the measuring spoon in 60 mL of water. Drink within 30 minutes of being prepared. It is important to drink all of the liquid and it may be necessary to rinse the glass with water and drink this as well to ensure that all of the powder is swallowed.
  • Close the sachet by folding over twice.
  • The remaining Renvela powder may be used within 24 hours for the next dose.
  • Discard sachets of Renvela powder that have been opened for more than 24 hours.

For a 0.8 g dose:

  • Follow the instructions above, filling the spoon twice for a total of 2.0 mL Renvela powder.

For a 1.2 g dose:

  • Follow the instructions above, filling the spoon three times for a total of 3.0 mL Renvela powder.

For a 1.6 g dose:

  • Follow the instructions above, filling the spoon four times for a total of 4.0 mL Renvela powder.

Initially, your doctor will check the levels of phosphorus in your blood every 2-4 weeks and they may adjust the dose of Renvela when necessary to reach an adequate phosphate level.

Patients taking Renvela should adhere to their prescribed diets.

If you take more Renvela than you should

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

If you forget to take Renvela

If you have missed one dose, this dose should be omitted and the next dose should be taken at the usual time with a meal. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Since constipation may be an early symptom of a blockage in your intestine, please inform your doctor or pharmacist.

The following side effects have been reported in patients taking Renvela:

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

vomiting, constipation, upper abdominal pain, nausea

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

diarrhoea, abdominal pain, indigestion, flatulence

Very rare (may affect up to 1 in 10000 people):

hypersensitivity.

Not known (frequency cannot be estimated from the available data):

cases of itching, rash, slow intestine motility (movement)/blockages in the intestine, and perforation in the intestine wall have been reported.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

United Kingdom

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Ireland

You can also report side effects directly via

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie

Malta

You can also report side effects directly via ADR Reporting www.medicinesauthority.gov.mt/adrportal

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Renvela

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

Do not use this medicine after the expiry date stated on the sachet and carton after the letters “EXP”. The reconstituted suspension must be administered within 30 minutes of reconstitution.

The medicinal product 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

What Renvela contains

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

What Renvela looks like and contents of the pack

Renvela powder for oral suspension is a pale yellow powder supplied in a foil sachet with a heat seal. The foil sachets are packaged in an outer carton.

Pack sizes:

60 sachets per carton

90 sachets per carton

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder:

Genzyme Europe B.V.
Gooimeer 10
1411 DD Naarden
The Netherlands

Manufacturer:

Genzyme Ireland Ltd.
IDA Industrial Park
Old Kilmeaden Road
Waterford
Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation holder.

United Kingdom
Sanofi
Tel: +44 (0) 845 372 7101

This leaflet was last revised in 02/2018

Other sources of information

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

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.