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orlistat

Alli (previously Orlistat GSK), Xenical · ATC code A08AB01

Brand names: Alli, Xenical, Orloff, Thincal, Xenabi Forte

Key facts
Active substance
orlistat
Drug class
Anti-obesity medication
ATC code
A08AB01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
alli 60 mg hard capsules · Xenical 120 mg hard capsules
Marketing authorisation holder
Haleon Ireland Dungarvan Limited, CHEPLAPHARM Arzneimittel GmbH
Information as of
2026-10-27

Key facts

Orlistat is a lipase inhibitor that reduces intestinal absorption of dietary fat. It is used with a mildly hypocaloric diet for weight loss in overweight and obesity (alli 60 mg, Xenical 120 mg).

What it is used for

  • alli 60 mg: weight loss in overweight adults (BMI ≥28 kg/m²) with a mildly hypocaloric, lower-fat diet
  • Xenical 120 mg: obesity (BMI ≥30 kg/m²) or overweight (BMI >28 kg/m²) with associated risk factors, with a mildly hypocaloric diet

Dosing

  • alli: one 60 mg capsule three times daily; no more than three capsules in 24 hours; treatment should not exceed 6 months
  • alli: if no weight loss after 12 weeks, a doctor or pharmacist should be consulted
  • Xenical: one 120 mg capsule immediately before, during or up to one hour after each main meal
  • Xenical: discontinue after 12 weeks if at least 5 % of starting body weight has not been lost
  • Take with water at main meals; if a meal is missed or contains no fat, the dose is omitted
  • Diet with approximately 30 % of calories from fat, spread over three main meals

Contraindications

  • Chronic malabsorption syndrome
  • Cholestasis
  • Breast-feeding
  • alli additionally: pregnancy, concurrent ciclosporin, warfarin or other oral anticoagulants
  • Hypersensitivity

Important warnings

  • Gastrointestinal symptoms increase with a high-fat diet
  • Possible impaired absorption of fat-soluble vitamins (A, D, E, K)
  • Cases of rectal bleeding have been reported
  • An additional contraceptive method is recommended, as severe diarrhoea may cause oral contraceptive failure
  • With antidiabetics, antihypertensives, lipid-lowering drugs, levothyroxine, antiepileptics, amiodarone or antiretrovirals, dose adjustment or medical consultation may be needed

Side effects

  • Mainly gastrointestinal: oily spotting, flatus with discharge, faecal urgency, fatty/oily stool, flatulence, soft stools, abdominal pain
  • Generally mild and transient, mostly early in treatment
  • Very common with Xenical, among others: headache and influenza; hypoglycaemia in obese type 2 diabetic patients
  • Frequency not known: decreased prothrombin and increased INR, rectal bleeding

Interactions

  • Ciclosporin: decreased ciclosporin levels (alli: contraindicated; Xenical: not recommended)
  • Warfarin and other oral anticoagulants: INR may be affected
  • Levothyroxine: hypothyroidism or reduced control may occur
  • Antiepileptics: possible changes in seizure frequency
  • Acarbose: co-administration should be avoided
  • HIV antiretrovirals: absorption may be reduced

Pregnancy and breastfeeding

  • No clinical data in pregnancy; alli is contraindicated in pregnancy, Xenical requires caution
  • Contraindicated during breast-feeding, as it is not known whether orlistat passes into human milk

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)

Source: European Medicines Agency (EMA), product information

Germany

  • Orlistat1 A Pharma Gmbh, Ratiopharm Gmbh, Hexal Ag · 3 register entries

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

Turkey

  • OrloffWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • ThincalKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 2 register entries
  • Xenabi ForteAVİXA İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • XenicalBMED İLAÇ DANIŞMANLIK SAĞLIK ÜRÜN VE HİZMETLERİ TİC. LTD. ŞTİ. · 1 register entry

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

Brand names in 17 more European countries
Belgium
Orlistat Sandoz, Orlistat Teva, Orlistatorlistat Teva
Czechia
Orlistat
Denmark
Orlistat Accord, Orlistat Rivopharm, Orlistat Sandoz, Orlistat Teva
Estonia
Orlistat Sandoz
Finland
Orlistat Sandoz, Orlistat Stada
France
Orlistat Eg
Iceland
Alli, Xenical
Ireland
Orlistat Accord
Italy
Beacita
Latvia
Orlistat Polpharma
Liechtenstein
Alli, Xenical
Lithuania
Orlistat Polpharma
Netherlands
Orlistat Sandoz
Norway
Alli, Orlistat Accord, Xenical
Portugal
Orlistato Beacita, Orlistato Ciclum, Orlistato Ratiopharm, Orlistato Zentiva, Sthen
Spain
Beacita, Elimens, Linestat, Normofit, Normostat, Orlidunn Laboratorio Stada, Orliloss, Orlistat Aurovitas, Orlistat Cinfa, Orlistat Sandoz, Orlistat Stada, Orlistat Teva
Sweden
Beacita, Orlistat Accord, Orlistat Stada

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

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Sources

  1. European Medicines Agency. Alli (previously Orlistat GSK) – 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/alli-epar-product-information_en.pdf
  2. European Medicines Agency. Xenical – EPAR, Product Information (OF THE TEXT Detailed information on this product is availabl). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/xenical-epar-product-information_en.pdf
  3. 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
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC A08AB.

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.