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The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 17780/0880.
Sevelamer carbonate 800 mg film-coated tablets
Sevelamer carbonate 800 mg film-coated tablets
sevelamer carbonate
1. What Sevelamer is and what it is used for
2. What you need to know before you take Sevelamer
3. How to take Sevelamer
4. Possible side effects
5. How to store Sevelamer
6. Contents of the pack and other information
Sevelamer 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 Sevelamer if any of the following applies to you:
Talk to your doctor while taking Sevelamer if you experience:
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 Sevelamer and other medicines on a regular basis.
In some cases where Sevelamer 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 Sevelamer 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 sevelamer carbonate during human pregnancy is unknown. Talk to your doctor who will decide if you can continue the treatment with Sevelamer.
It is unknown whether Sevelamer 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 Sevelamer treatment.
Sevelamer is unlikely to affect your ability to drive or to use machines.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
You must take Sevelamer as prescribed by your doctor. They will base the dose on your serum phosphorus level.
The recommended starting dose of Sevelamer tablets for adults and elderly is 1-2 tablets of 800 mg with each meal, 3 times a day. Check with your doctor, pharmacist or nurse if you are not sure. Take Sevelamer after your meal or with food.
The tablets must be swallowed whole. Do not crush, chew or break into pieces.
Initially, your doctor will check the levels of phosphorus in your blood every 2-4 weeks and may adjust the dose of Sevelamer 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 a 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 Sevelamer treatment is important to maintain an appropriate phosphate level in your blood. Stopping Sevelamer would lead to important consequences such as calcification in the blood vessels. If you consider stopping your Sevelamer 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.
Other side effects have been reported in patients taking sevelamer carbonate:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Not known (frequency cannot be estimated from the available data):
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the MHRA 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 bottle and carton after the letters “EXP”. The expiry date refers to the last day of that month.
This 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.
Sevelamer tablets are oval, white to off-white film-coated tablets with the inscription ‘SVL’ on one side.
HDPE bottles with a polypropylene lid and a desiccant.
Pack sizes
180, 200 and 210 film-coated tablets (with or without outer carton).
Multipack containing 2 containers with 180, 200 or 210 film-coated tablets per container (2 containers in an outer package).
Multipack containing 3 containers with 180, 200 or 210 film-coated tablets per container (3 containers in an outer package).
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Manufacturer:
This leaflet was last revised in September 2022
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