sevelamer carbonate
Renvela, Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva) · ATC code V03AE02
Also known as: Sevelamercarbonat · Brand names: Renvela, Sevelamer carbonate Winthrop, Sevelamer Ratiopharm, Sevelamer Sandoz, Sevelamercarbonat Medice, Sevelamercarbonat Stada, Sevelamercarbonat Al, Sevelamercarbonat Axiromed, Sevelamercarbonat Heumann, Sevelamercarbonat Hexal, Sevelamercarbonat Mylan, Sevelamercarbonat Ratiopharm, Sevelamercarbonate Ratiopharm, Sevemed, Karbolamer …
- Key facts
- Active substance
- sevelamer carbonate
- Drug class
- Antihyperkalemic agents
- ATC code
- V03AE02
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Renvela 800 mg film-coated tablets · Renvela 0.8 g powder for oral suspension / 2.QUALITATIVE AND QUANTITATIVE COMPOSITION / Each sachet contains 0.8 g sevelamer carbonate. · Renvela 1.6 g powder for oral suspension · Renvela 2.4 g powder for oral suspension · Sevelamer carbonate Winthrop 800 mg film-coated tablets · Sevelamer carbonate Winthrop 0.8 g powder for oral suspension · Sevelamer carbonate Winthrop 2.4 g powder for oral suspension
- Marketing authorisation holder
- Sanofi Winthrop Industrie
- Information as of
- 2026-10-27
Key facts
Sevelamer carbonate is a non-absorbed, calcium- and metal-free phosphate binder used to control hyperphosphataemia in chronic kidney disease.
What it is used for
- Hyperphosphataemia in adults receiving haemodialysis or peritoneal dialysis
- Hyperphosphataemia in adults with chronic kidney disease not on dialysis with serum phosphorus of 1.78 mmol/l or more
- Powder for oral suspension: also children over 6 years with a body surface area over 0.75 m²
- As part of a multiple therapeutic approach (e.g. with calcium or vitamin D) for renal bone disease
Dosing
- Adults: starting dose 2.4 g or 4.8 g per day based on clinical need and serum phosphorus, divided over three meals
- Titrate by 0.8 g three times per day (2.4 g/day) every 2-4 weeks until an acceptable phosphorus level is reached
- The average adult daily dose is expected to be approximately 6 g
- Switching from other phosphate binders gram for gram with phosphorus monitoring
- Children: dosing based on body surface area (details in the full text)
Contraindications
- Hypersensitivity to the active substance or any excipient
- Hypophosphataemia
- Bowel obstruction
Important warnings
- Not recommended in adults not on dialysis with serum phosphorus below 1.78 mmol/l
- Not studied in dysphagia, severe motility disorders, active inflammatory bowel disease or after major GI surgery
- Very rare intestinal obstruction and ileus; constipation may be a preceding symptom
- May reduce absorption of several vitamins, including folic acid
Side effects
- Very common: nausea, vomiting, upper abdominal pain, constipation
- Common: diarrhoea, dyspepsia, flatulence, abdominal pain
- Serious: intestinal obstruction, ileus, intestinal perforation, inflammatory GI disorders with sevelamer crystals, very rare hypersensitivity
Interactions
- Ciprofloxacin: bioavailability decreased by approximately 50%; do not take simultaneously
- Ciclosporin, mycophenolate mofetil, tacrolimus: reduced levels possible, consider monitoring
- Levothyroxine: monitor TSH more closely; separate dosing of anti-arrhythmics and anti-seizure medicines
- Proton pump inhibitors: very rare increased phosphate levels
Pregnancy and breastfeeding
- Use in pregnancy only if clearly needed after careful risk/benefit analysis
- Excretion in breast milk is unlikely; decide on breast-feeding based on benefit
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- RenvelaSanofi Winthrop Industrie · EMEA/H/C/000993
- Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva)Sanofi Winthrop Industrie · EMEA/H/C/003971
Source: European Medicines Agency (EMA), product information
Austria
- Sevelamer RatiopharmTeva B.V · 1 register entry
- Sevelamer SandozSandoz Gmbh · 1 register entry
- Sevelamercarbonat MediceMedice Arzneimittel Pütter Gmbh & Co. Kg · 1 register entry
- Sevelamercarbonat StadaStada Arzneimittel Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- Sevelamercarbonat AlAliud Pharma Gmbh · 1 register entry
- Sevelamercarbonat AxiromedMedical Valley Invest Ab · 1 register entry
- Sevelamercarbonat HeumannHeumann Pharma Gmbh & Co. Generica Kg · 1 register entry
- Sevelamercarbonat HexalHexal Ag · 1 register entry
- Sevelamercarbonat MylanViatris Germany Gmbh · 1 register entry
- Sevelamercarbonat RatiopharmRatiopharm Gmbh · 1 register entry
- Sevelamercarbonat StadaStadapharm Gmbh · 1 register entry
- Sevelamercarbonate RatiopharmRatiopharm Gmbh · 1 register entry
- SevemedMedice Arzneimittel Pütter Gmbh & Co. Kg · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- KarbolamerGEN İLAÇ VE SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş. · 1 register entry
- LamerisDAVİVA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- LemorinPOLPHARMA SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş. · 2 register entries
- PerfoseVEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- RanesevaHELBA İLAÇ İÇ VE DIŞ SAN. TİC. A.Ş. · 2 register entries
- RenadinDİNÇTAŞ İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- RenalamerDİNÇSA İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
- SevarenFARMA-TEK İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- SevyarCELTİS İLAÇ SAN. TİC. A.Ş. · 2 register entries
- TerolamTERRA İLAÇ VE KİMYA SAN. TİC. A.Ş. · 1 register entry
- VelarixABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 26 more European countries
- Belgium
- Sevelamer-Carbonaat Genthon, Sevelamer Carbonate Ab
- Bulgaria
- Sevelamer Sandoz, Севеламер Карбонат Heaton
- Croatia
- Sevelamer Sandoz, Sevelamerkarbonat Pliva
- Cyprus
- Sevelamer Ledpharm
- Czechia
- Sevelamer Carbonate Heaton, Sevelamer Carbonate Viatris
- Denmark
- Lovtelar, Sevelamer Sandoz, Sevelamercarbonat Aurobindo, Sevelamercarbonat Genthon, Sevelamercarbonat Medical Valley, Sevelamercarbonat Sandoz, Sevelamercarbonat Stada, Sevelamercarbonat Synthon, Sevelamercarbonat Viatris, Sevelamercarbonat Zentiva, Sevemed
- Estonia
- Sevelamer Auxilia
- Finland
- Sevelamer Avansor
- France
- Lovtelar, Sevelamer Carbonate Arrow, Sevelamer Carbonate Biogaran, Sevelamer Carbonate Sandoz, Sevelamer Carbonate Teva, Sevelamer Carbonate Viatris
- Greece
- Lovtelar, Sevelamer Demo, Sevelamer Faran
- Hungary
- Sevelamer Carbonate Pharmsol, Sevelamer Mensana Pharma, Szevelamer-Karbonatot Pharmsol Gmbh
- Iceland
- Renvela, Sevelamer Carbonate Winthrop, Sevelamercarbonat Stada, Sevelamercarbonat W&h, Sevelamerkarbonat Wh
- Ireland
- Sevelamer Carbonate Generics, Sevelamer Carbonate Genthon
- Italy
- Lovtelar, Sevelamer Aurobindo, Sevelamer Doc Generici, Sevelamer Eg, Sevelamer Mylan Pharma, Sevelamer Sandoz
- Latvia
- Sevelamer Carbonate Sandoz, Sevelamer Carbonate Synthon
- Liechtenstein
- Renvela, Sevelamer Carbonate Winthrop
- Luxembourg
- Sevemed
- Netherlands
- Sevelameercarbonaat Sandoz, Sevelameercarbonaat Viatris, Sevelameercarbonaat Xiromed, Sevelamer-Carbonaat Genthon, Sevelamer Carbonate Aurobindo, Sevemed
- Norway
- Renvela, Sevelamer Carbonate Winthrop, Sevelamer Sandoz, Sevelamer Viatris
- Poland
- Sewelameru Węglan Synthon
- Portugal
- Sevelâmero Generis, Sevelâmero Mylan, Sevelâmero Teva
- Romania
- Carbonat De Sevelamer Heaton
- Slovakia
- Sevelamer Carbonate Heaton, Sevelamer Carbonate Viatris
- Slovenia
- Sevelamer Lek
- Spain
- Fosquel, Lovtelar, Restafos, Sevelámero Kern Pharma, Sevelámero Ratiopharm, Sevelámero Stada, Sevelámero Teva, Sevelámero Viatris
- Sweden
- Sevelamer Medical Valley, Sevelamer Sandoz, Sevelamer Teva, Sevelamer Viatris
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
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Sources
- European Medicines Agency. Renvela – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/renvela-epar-product-information_en.pdf
- European Medicines Agency. Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva) – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/sevelamer-carbonate-winthrop-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC V03AE.
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.