Patient Leaflet Updated 26-Sep-2023 | SANOFI
Renagel 800mg film-coated tablets
Renagel 800 mg film-coated tablets
sevelamer hydrochloride
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1. What Renagel is and what it is used for
2. What you need to know before you take Renagel
3. How to take Renagel
4. Possible side effects
5. How to store Renagel
6. Contents of the pack and other information
Renagel contains sevelamer as the active ingredient. It binds phosphate from food in the digestive tract and so reduces serum phosphate levels in the blood.
Renagel is used to control the levels of phosphate in the blood of adult kidney failure patients on haemodialysis or peritoneal dialysis treatment.
Adult patients whose kidneys have failed and who are undergoing haemodialysis or peritoneal dialysis are not able to control the level of serum phosphate in their blood. The amount of phosphate then rises (your doctor will call this hyperphosphataemia). 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.
Renagel may be used with other medicines which include calcium or vitamin D supplements to control the development of renal bone disease.
Talk to your doctor before taking Renagel if any of the following applies to you:
Talk to your doctor while taking Renagel:
Additional treatments:
Due to either your kidney condition or your dialysis treatment you may:
Changing treatment:
When you switch from another phosphate binder to Renagel, your doctor might consider monitoring the levels of bicarbonate in your blood more closely because Renagel may decrease the levels of bicarbonate.
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.
The safety and efficacy in children (below the age of 18 years) has not been studied. Therefore, Renagel is not recommended for use in this population.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Your doctor will check for interactions between Renagel and other medicines on a regular basis.
In some cases where Renagel 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 Renagel intake, or he/she may consider monitoring the blood levels of that medicine.
The safety of Renagel has not been established in pregnant or breast-feeding women. Renagel should only be given to pregnant or breast-feeding women if clearly needed.
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.
Renagel is unlikely to affect your ability to drive or to use machines.
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. He will base the dose on your serum phosphate level. The recommended starting dose of Renagel for adults and the elderly (>65 years) is one or two tablets with each meal 3 times a day.
Initially your doctor will check the levels of phosphate in your blood every 2-3 weeks and may adjust the dose of Renagel when necessary (between 1 and 5 tablets of 800 mg per meal) to reach an adequate phosphate level.
The tablets must be swallowed whole. Do not crush, chew or break into pieces prior to swallowing.
Patients taking Renagel should adhere to their prescribed diet and liquid intake.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Since constipation may be a preceding symptom in very rare cases of blockages in your intestine, it is important to inform your doctor or pharmacist of this symptom before or during the use of Renagel.
The following side effects have been reported in patients taking Renagel:
Very common (may affect more than 1 in 10 people):
nausea, vomiting.
Common (may affect up to 1 in 10 people):
diarrhoea, indigestion, abdominal pain, constipation, flatulence.
Uncommon (may affect up to 1 in 100 people):
increased acidity of the blood.
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, abdominal pain, slow intestine motility (movement), inflammation of abnormal small pouches (called diverticula) in the large intestine, blockages in the intestine (signs include: severe bloating; abdominal pain, swelling or cramps; severe constipation), rupture in the intestine wall (signs include: severe stomach pain, chills, fever, nausea, vomiting, or a tender abdomen),serious inflammation of the large bowel (symptoms include: severe abdominal pain, stomach or intestine disorders, or blood in the stool [gastrointestinal bleeding]) and crystal deposit in the intestine have been reported.
If you get any side effects, talk to your doctor. 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 carton and bottle after “EXP”. The expiry date refers to the last day of that month.
Do not store this medicine above 25 °C. Keep the bottle tightly closed in order to protect from moisture.
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 to protect the environment.
Renagel tablets are film coated, off white, oval tablets with RG800 engraved on one side. The tablets are packed in high density polyethylene bottles with a child resistant polypropylene closure and an induction seal.
Pack sizes are:
1 bottle of 100 tablets
1 bottle of 180 tablets
multipacks containing 180 tablets (6 bottles of 30 tablets)
multipacks containing 360 tablets (2 bottles of 180 tablets)
multipacks containing 540 tablets (3 bottles of 180 tablets)
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 May 2023
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+44 (0)800 035 2525
