Patient Leaflet Updated 04-Jun-2024 | SANOFI
RENVELA 2.4 g Powder for oral suspension
Renvela® 2.4 g powder for oral suspension
sevelamer carbonate
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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
Renvela contains sevelamer carbonate as the active substance. It binds phosphate from food in the digestive tract and so reduces serum phosphorus levels in the blood.
This medicine is used to control hyperphosphataemia (high blood phosphate levels) in:
This medicine 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.
Talk to your doctor before taking Renvela if any of the following applies to you:
Talk to your doctor while taking Renvela:
Additional treatments
Due to either your kidney condition or your dialysis treatment you may:
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.
The safety and efficacy in children (below the age of 6 years) have not been studied.
Therefore, this medicine is not recommended for use in children below the age of 6 years.
Tell your doctor if you are taking or have recently taken or might take any other medicines.
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. Your doctor may also consider monitoring the levels of that medicine in your blood.
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 if you can continue the treatment with Renvela.
It is unknown whether Renvela is excreted in breast milk and may affect your baby. Talk to your doctor who will decide if you can breastfeed your baby or not, and if it is necessary to stop Renvela treatment.
Renvela is unlikely to affect your ability to drive or to use machines.
This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially ‘sodium-free’. This medicine contains 25.27mg propylene glycol in each 2.4g sachet.
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 premixed with a small amount of cold beverage (about 120 ml or half a glass) or food (about 100 g) 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 this medicine for adults and elderly 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. Check with your doctor, pharmacist or nurse if you are not sure.
Take Renvela after your meal or with food.
If a dose of 0.4 g is to be administered, please use the dedicated 0.8 g powder presentation with dosing spoon.
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, the powder is preferred, as tablets are not appropriate in this population.
This medicine 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.
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.
Follow the diet prescribed by your doctor.
In the event of a possible overdose, you should contact your doctor immediately.
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.
Taking your Renvela treatment is important to maintain an appropriate phosphate level in your blood. Stopping Renvela would lead to important consequences such as calcification in the blood vessels.
If you consider stopping your Renvela treatment, contact your doctor or pharmacist first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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 people). It can be an early symptom of a blockage in your intestine. In case of constipation, please inform your doctor or pharmacist.
Some side effects could be serious. If you get any of the following side effects, seek immediate medical attention:
Other side effects have been reported in patients taking Renvela:
Very common (may affect more than 1 in 10 people):
vomiting, upper abdominal pain, nausea
Common (may affect up to 1 in 10 people):
diarrhoea, stomach ache, indigestion, flatulence
Not known (frequency cannot be estimated from available data):
cases of itching, rash, slow intestine motility (movement)
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
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.
By reporting side effects you can help provide more information on the safety of this medicine.
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 expiry date refers to the last day of that month.
The reconstituted suspension must be administered 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.
Renvela powder for oral suspension is a pale yellow powder supplied in a foil sachet with a heat seal. The 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
Manufacturer
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in
January 2024
AIP539025B
Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
+44 (0)800 035 2525
