Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva)
Authorised
This medicine is authorised for use in the European Union
sevelamer carbonate
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Sevelamer carbonate Winthrop is a medicine used to control hyperphosphataemia (high blood phosphate levels) in:
- adult patients on dialysis (a technique to remove unwanted substances from the blood);
- adults and children from 6 years of age with chronic (long term) kidney disease.
Sevelamer carbonate Winthrop should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease. It contains the active substance sevelamer carbonate.
Sevelamer carbonate Winthrop is available as tablets (800 mg) and as powder (800 mg and 2.4 g) to be taken 3 times a day with meals.
The dose to take depends on the patient’s level of blood phosphate and, for children, their height and weight. Sevelamer carbonate Winthrop must not be taken on an empty stomach and patients should keep to their prescribed diets.
The medicine can only be obtained with a prescription. For more information about using Sevelamer carbonate Winthrop, see the package leaflet or contact your doctor or pharmacist.
The active substance in Sevelamer carbonate Winthrop, sevelamer carbonate, is a phosphate binder. When taken with meals, it attaches in the gut to phosphate from the food, thereby preventing the phosphate from being absorbed into the body and helping to reduce phosphate levels in the blood.
Sevelamer carbonate Winthrop has been shown in studies to be effective at lowering levels of blood phosphate in patients with hyperphosphataemia.
In two main studies in 110 adults with kidney disease who were on dialysis, Sevelamer carbonate Winthrop brought phosphate levels down to around 1.5-1.6 mmol/l (which is within or close to the normal range) and was as effective as another approved medicine Renagel.
In a third main study in 49 adults who were not on dialysis, Sevelamer carbonate Winthrop reduced phosphate levels from 2.0 mmol/l to 1.6 mmol/l.
Finally, a main study also showed that Sevelamer carbonate Winthrop was effective at lowering phosphate levels in 100 children: children who took Sevelamer carbonate Winthrop had a greater reduction in phosphorous (0.87 mg/dl) than those taking placebo (a dummy treatment) who had a rise in phosphorous of 0.04 mg/dl.
The most common side effects with Sevelamer carbonate Winthrop (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting, upper abdominal (belly) pain and constipation. For the full list of side effects of Sevelamer carbonate Winthrop, see the package leaflet.
Sevelamer carbonate Winthrop must not be used in people with low blood phosphate levels or with bowel obstruction (a blockage in the gut). For the full list of restrictions, see the package leaflet.
Studies show that Sevelamer carbonate Winthrop is effective at reducing levels of blood phosphate in patients with hyperphosphataemia, and its side effects are considered manageable. The European Medicines Agency therefore decided that Sevelamer carbonate Winthrop’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sevelamer carbonate Winthrop have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Sevelamer carbonate Winthrop are continuously monitored. Side effects reported with Sevelamer carbonate Winthrop are carefully evaluated and any necessary action taken to protect patients.
Sevelamer carbonate Winthrop received a marketing authorisation valid throughout the EU on 15 January 2015. This authorisation was based on the authorisation granted to Renvela in 2009 (‘informed consent’).
Product information
Latest procedure affecting product information:
T/0038
12/12/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva)
- Active substance
- sevelamer carbonate
- International non-proprietary name (INN) or common name
- sevelamer carbonate
- Therapeutic area (MeSH)
- Hyperphosphatemia
- Renal Dialysis
- Anatomical therapeutic chemical (ATC) code
- V03AE02
Pharmacotherapeutic group
All other therapeutic productsTherapeutic indication
Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Sevelamer carbonate Winthrop is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus > 1.78 mmol/L.
Sevelamer carbonate Winthrop should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
News on Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva)
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