Patient leaflet - Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva)
1. What Sevelamer carbonate Winthrop is and what it is used for
Sevelamer carbonate Winthrop contains the active substance sevelamer carbonate. 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:
- 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.
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.
2. What you need to know before you take Sevelamer carbonate Winthrop
Do not take Sevelamer carbonate Winthrop:
- if you are allergic to sevelamer carbonate or any of the other ingredients of this medicine (listed in section 6).
- if you have low levels of phosphate in your blood (your doctor will check this for you).
- if you have bowel obstruction.
Warnings and precautions
Talk to your doctor before taking Sevelamer carbonate Winthrop:
- if you have swallowing problems. Your doctor can rather prescribe sevelamer carbonate powder for oral suspension.
- if you have problems with motility (movement) in your stomach and bowel
- if you have active inflammation of the bowel
if you have undergone major surgery on your stomach or bowel.
Talk to your doctor while taking Sevelamer carbonate Winthrop:
- if you experience severe abdominal pain, stomach or intestine disorders, or blood in the stool (gastrointestinal bleeding). These symptoms can be due to serious inflammatory bowel disease caused by sevelamer crystal deposit in your bowel. Contact your doctor who will decide on continuing the treatment or not.
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 this medicine 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.
- have disturbed level of bicarbonate in your blood and increased acidity in the blood and other body tissue. Your doctor should monitor the level of bicarbonate in your blood.
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.
Children
Do not give this medicine to children below the age of 6 years because the safety and efficacy in children (below the age of 6 years) have not been studied.
Other medicines and Sevelamer carbonate Winthrop
Tell your doctor if you are taking, have recently taken or might take any other medicines.
- Sevelamer carbonate Winthrop 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 Winthrop.
- The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used to suppress the immune system) may be reduced by Sevelamer carbonate Winthrop. 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 carbonate Winthrop. Therefore your doctor may monitor the levels of thyroid stimulating hormone in your blood more closely.
- Medicines treating heartburn and reflux from your stomach or oesophagus, such as omeprazole,
pantoprazole, or lansoprazole, known as “proton pump inhibitors”, may reduce the efficacy of Sevelamer carbonate Winthrop. Your doctor may monitor the phosphate level in your blood.
Your doctor will check for interactions between Sevelamer carbonate Winthrop and other medicines on a regular basis.
In some cases where Sevelamer carbonate Winthrop 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 Winthrop intake. Your doctor may also consider monitoring the levels of that medicine in your blood.
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 advice before taking this medicine.
The potential risk of Sevelamer carbonate Winthrop during human pregnancy is unknown. Talk to your doctor who will decide if you can continue the treatment with Sevelamer carbonate Winthrop.
It is unknown whether Sevelamer carbonate Winthrop 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 carbonate Winthrop treatment.
Driving and using machines
Sevelamer carbonate Winthrop is unlikely to affect your ability to drive or to use machines.
Excipients
This medicine contains less than 1 mmol sodium (23 mg) per tablet that is to say essentially ‘sodium-free’.
3. How to take Sevelamer carbonate Winthrop
Always take this medicine exactly as your doctor has told you. He will base the dose on your serum phosphorus level.
The recommended starting dose of this medicine for adults and elderly is one to two 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 carbonate Winthrop 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 carbonate Winthrop when necessary to reach an adequate phosphate level.
Follow the diet prescribed by your doctor.
If you take more Sevelamer carbonate Winthrop than you should
In the event of a possible overdose you should contact your doctor immediately.
If you forget to take Sevelamer carbonate Winthrop
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.
If you stop taking Sevelamer carbonate Winthrop
Taking your Sevelamer carbonate Winthrop treatment is important to maintain an appropriate phosphate level in your blood. Stopping Sevelamer carbonate Winthrop would lead to important consequences such as calcification in the blood vessels. If you consider stopping your Sevelamer carbonate Winthrop treatment, contact your doctor or pharmacist first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Constipation is a very common side effect. It can be an early symptom of a blockage in your intestine. In case of constipation, please inform your doctor or pharmacist if you experience it.
Some side effects could be serious. If you get any of the following side effects, seek immediate medical attention:
-
– Allergic reaction (signs including rash, hives, swelling, trouble breathing). This is a very rare side effect (may affect up to 1 in 10,000 people).
-
– Blockage in the intestine (signs include: severe bloating; abdominal pain, swelling or cramps; severe constipation) has been reported. Frequency is not known.
-
– Rupture in the intestinal wall (signs include: severe stomach pain, chills, fever, nausea, vomiting, or a tender abdomen) has been reported. Frequency is not known.
-
– 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. Frequency is not known.
Other side effects have been reported in patients taking Sevelamer carbonate Winthrop:
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 the available data):
- cases of itching,
- rash,
- slow intestine motility (movement).
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 national reporting system listed in By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Sevelamer carbonate Winthrop
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/or carton after “EXP”. The expiry date refers to the last day of that month.
Keep the bottle container tightly closed in order to protect from moisture.
This medicine does not require any special temperature 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 Winthrop contains
-
– The active substance is sevelamer carbonate. Each film-coated tablet contains 800 mg of sevelamer carbonate.
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– The other ingredients are microcrystalline cellulose, sodium chloride, zinc stearate, hypromellose (E464), diacetylated monoglycerides, iron oxide black (E172), isopropyl alcohol and propylene glycol.
What Sevelamer carbonate Winthrop looks like and contents of the pack
Sevelamer carbonate Winthrop film-coated tablets are white to off-white tablets with SC800 imprinted on one side. The tablets are packed in high density polyethylene bottles with a child-resistant polypropylene closure and an induction seal.
Pack sizes:
Each bottle contains 30 tablets or 180 tablets.
Packs of 1 bottle of 30 tablets or 180 tablets with no outer carton
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Genzyme Europe B.V.
Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands
Manufacturer
Genzyme Ireland Limited
IDA Industrial Park
Old Kilmeaden Road
Waterford
Ireland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
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This leaflet was last revised in
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: