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Colesevelam

Cholestagel · ATC code C10AC04

Brand names: Cholestagel, Colesevelamhydrochlorid Ascend, Kovel, Sartol, Sevexir, Zenum

Key facts
Active substance
Colesevelam
Drug class
Bile acid sequestrant
ATC code
C10AC04
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Cholestagel 625 mg film-coated tablets
Marketing authorisation holder
CHEPLAPHARM Arzneimittel GmbH
Information as of
2026-10-27

Key facts

Colesevelam is a bile acid sequestrant (lipid-lowering agent). It is used as an adjunct to diet in adults with primary hypercholesterolaemia, alone or with a statin and/or ezetimibe.

What it is used for

  • Primary hypercholesterolaemia in adults, combined with a statin when a statin alone is not adequate
  • Monotherapy when a statin is inappropriate or not well tolerated
  • In combination with ezetimibe, with or without a statin, including familial hypercholesterolaemia

Dosing

  • Combination therapy (with statin and/or ezetimibe): 4 to 6 tablets per day; maximum 6 tablets per day
  • Monotherapy: starting dose 6 tablets per day (3 tablets twice daily or 6 once daily with a meal); maximum 7 tablets per day
  • Take with a meal and liquid; swallow whole
  • Where an interaction cannot be excluded, give at least four hours before or after other medicines
  • No dose adjustment in the elderly; no posology recommendation in children

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Bowel or biliary obstruction

Important warnings

  • Diagnose and treat secondary causes of hypercholesterolaemia (e.g. diabetes, hypothyroidism, nephrotic syndrome) first
  • Ciclosporin: colesevelam reduces its bioavailability; monitor blood levels closely when starting or stopping
  • Effects on triglyceride levels should be considered
  • Check lipid levels periodically during treatment

Side effects

  • Very common: flatulence, constipation
  • Common: headache, vomiting, diarrhoea, dyspepsia, abdominal pain, nausea, serum triglycerides increased
  • Uncommon: dysphagia, myalgia, serum transaminases increased
  • Very rare: pancreatitis; not known: intestinal obstruction

Interactions

  • May reduce bioavailability of other medicines; separate by at least four hours where small changes in levels matter
  • Ciclosporin: reduced bioavailability, monitor levels

Pregnancy and breastfeeding

  • No clinical data in pregnant women; caution when prescribing in pregnancy and breast-feeding

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.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

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)

  • CholestagelCHEPLAPHARM Arzneimittel GmbH · EMEA/H/C/000512

Source: European Medicines Agency (EMA), product information

Germany

  • Colesevelamhydrochlorid AscendAscend Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • KovelSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • SartolALİ RAİF İLAÇ SAN. A.Ş. · 1 register entry
  • SevexirNEUTEC İLAÇ SAN. TİC. A.Ş · 10 register entries
  • ZenumİLKO İLAÇ SAN.VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Cholestagel
Liechtenstein
Cholestagel
Norway
Cholestagel

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

  1. European Medicines Agency. Cholestagel – EPAR, Product Information (Detailed information on this medicinal product is available ). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/cholestagel-epar-product-information_en.pdf
  2. 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
  3. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  4. Wikidata (CC0): ATC C10AC.

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.