Sevelamer Carbonate 800 Mg Film-Coated Tablets
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 you doctor. This includes any possible side effects not listed in this leaflet. See section 4.
Package leaflet: Information for the user
Sevelamer carbonate 800 mg Film-coated Tablets
(sevelamer carbonate)
m What is in this leaflet
1. What Sevelamer carbonate is and what it is used for
2. What you need to know before you take Sevelamer carbonate
3. How to take Sevelamer carbonate
4. Possible side effects
5. How to store Sevelamer carbonate
6. Contents of the pack and other information
1. What Sevelamer carbonate is and what it is used for
Sevelamer carbonate 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 carbonate 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 carbonate 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 carbonate
Do not take Sevelamer carbonate 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 carbonate 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.
The safety and efficacy in children (below the age of 18 years) has not been established. Therefore Sevelamer carbonate 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 carbonate 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 carbonate
Tell your doctor if you are taking or have recently taken or might take any other medicines.
Sevelamer carbonate 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 carbonate.
The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used to suppress the immune system) may be reduced by Sevelamer carbonate. Your doctor will advise you if you are taking these medicines.
Thyroid hormone deficiency may uncommonly be observed in certain people taking levothyroxine (used m
to treatment low thyroid hormone levels) and Sevelamer carbonate. Therefore your doctor may monitor the levels of thyroid stimulating hormone in your blood more closely.
Your doctor will check for interactions between Sevelamer carbonate and other medicines on a regular basis.
Sevelamer carbonate with food and drink
You must take Sevelamer carbonate tablets with meals.
Pregnancy, breast-feeding and fertility
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 Sevelamer carbonate has any effect on unborn babies.
Tell your doctor if you wish to breast-feed your baby.
It is unknown whether Sevelamer carbonate may pass through breast milk and affect your baby.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Sevelamer carbonate is unlikely to affect your ability to drive or to use machines.
Sevelamer carbonate contains lactose
Sevelamer carbonate contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Sevelamer carbonate
_ You must take Sevelamer carbonate as prescribed by
your doctor. They will base the dose on your serum phosphorus level.
The recommended starting dose of Sevelamer carbonate tablets for adults and the elderly (> 65 years) is one to two tablets of 800 mg with each meal, 3 times a day.
The tablets must be swallowed whole. Do not crush, chew or break into pieces.
In some cases where Sevelamer carbonate 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 carbonate intake, or they may consider monitoring the blood levels of that medicine.
Your doctor will check the levels of phosphorus in your blood periodically and they may adjust the dose of Sevelamer carbonate when necessary to reach an adequate phosphate level.
If you take more Sevelamer carbonate than you should
There are no reported overdoses in patients.
In the event of a possible overdose you should contact your doctor immediately.
If you forget to take Sevelamer carbonate
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.
Tell your doctor or pharmacist as soon as possible if you experience the following:
• severe allergic reactions, including swelling of the face, lips, tongue or throat, causing difficulty breathing or swallowing
• severe abdominal pain with blood in the stools or vomit, which may be signs of a perforation in the intestine wall
• constipation, which may be an early sign of a blockage in your intestine
Other side effects reported in patients taking sevelamer carbonate:
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
• abdominal pain
• indigestion
• flatulence
Not known (frequency cannot be estimated from the available data):
• itching
• rash
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 the Yellow Card Scheme at: 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 carbonate
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.
6. Contents of the pack and other information
What Sevelamer carbonate contains
• The active substance is sevelamer carbonate. Each tablet contains 800 mg of sevelamer carbonate.
• The other ingredients are lactose monohydrate, silica (colloidal anhydrous), zinc stearate. The tablet coating contains hypromellose (E464) and diacetylated monoglycerides.
What Sevelamer carbonate looks like and contents of the pack
Sevelamer carbonate 800 mg film-coated tablets are white to off-white, oval shaped tablets and are marked with 'SVL' on one side. The tablets are approximately 20 mm long and 7 mm wide.
The tablets are packed in high density polyethylene bottles with a polypropylene cap.
Each bottle contains 180, 200 or 210 tablets.
Packs containing 1,2 or 3 bottles are available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan
Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Manufacturer
Synthon Hispania SL Castello 1, Poligono Las Salinas,
08830 Sant Boi de Llobregat Spain
Mylan Hungary Kft H-2900 Komarom Mylan utca 1 Hungary
This leaflet was last revised in
03/2016
850513
