Sevelamer Carbonate 2.4 G Powder For Oral Suspension
PACKAGE LEAFLET: INFORMATION FOR THE USER
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Sevelamer carbonate 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 any further questions, ask your doctor or 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
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
1. WHAT SEVELAMER IS AND WHAT IT IS USED FOR
Sevelamer 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.
Sevelamer 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);
• 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.
Sevelamer 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 SEVELAMER
Do not take Sevelamer 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 Sevelamer 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.
Children and adolescents
The safety and efficacy in children (below the age of 18 years) has not been studied. Therefore Sevelamer is not recommended for use in children.
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 Sevelamer 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.
Other medicines and Sevelamer
Tell your doctor if you are taking or have recently taken or might take any other medicines.
• Sevelamer 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 Sevelamer.
• The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used to suppress the immune system)
may be reduced by Sevelamer. 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 Sevelamer. 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 Sevelamer.
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, 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 advise before taking this medicine. It is unknown whether Sevelamer has any affect on unborn babies.
Tell your doctor if you wish to breast-feed your baby. It is unknown whether Sevelamer may pass through breast milk and affect your baby.
Driving and using machines
Sevelamer is unlikely to affect your ability to drive or to use machines.
3. HOW TO TAKE SEVELAMER
You must take Sevelamer as prescribed by your doctor. They will base the dose on your serum phosphorus level.
The 2.4 g 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.
The recommended starting dose for Sevelamer is 2.4-4.8g per day equally divided over three meals. 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 Sevelamer when necessary to reach an adequate phosphate level.
Patients taking Sevelamer should adhere to their prescribed diets.
If you take more Sevelamer than you should
In the event of a possible overdose you should contact your doctor immediately.
If you forget to take Sevelamer
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 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 Sevelamer:
Very common side effects (may affect more than 1 in 10 people)
• Vomiting
• Constipation
• Upper abdominal pain
• Nausea
Common side effects (may affect up to 1 in 10 people)
• Diarrhoea
• Abdominal pain
• Indigestion
• Flatulence
Very rare side effects (may affect up to 1 in 10,000 people)
• Hypersensitivity
Not known side effects (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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: Yellow Card Scheme Website: www.mhra.gov.uk/ yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE SEVELAMER
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 Sevelamer contains
• The active substance is sevelamer carbonate. Each Sevelamer sachet contains 2.4 g of sevelamer carbonate.
• The other ingredients ingredients are microcrystalline cellulose (E460), carmellose sodium, sucralose (E955), lemon flavour, orange flavour and iron oxide yellow (E172).
What Sevelamer looks like and contents of the pack
Sevelamer powder for oral suspension is an off-white to yellow powder supplied in a foil sachet. 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:
Genthon B.V.
Microweg 22, 6545 CM Nijmegen,
The Netherlands
Manufacturer:
Synthon Hispania S.L.
Castello 1, Poligono Las Salinas 08830 Sant Boi de Llobregat, Spain
Distributed by:
Consilient Health (UK) Ltd.,
No.1 Church Road, Richmond upon Thames, Surrey. TW9 2QE.
This leaflet was last revised in June 2016
P0416