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nalmefene

Selincro · ATC code N07BB05

Also known as: Nalmefen

Key facts
Active substance
nalmefene
ATC code
N07BB05
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Selincro 18 mg film-coated tablets
Marketing authorisation holder
H. Lundbeck A/S
Information as of
2026-10-28

Key facts

Nalmefene (Selincro, film-coated tablets) is an opioid system modulator. It is used to reduce alcohol consumption in adults with alcohol dependence.

What it is used for

  • Reduction of alcohol consumption in adults with alcohol dependence who have a high drinking risk level, without physical withdrawal symptoms and not needing immediate detoxification.
  • Only with continuous psychosocial support; start only if the drinking risk level remains high two weeks after initial assessment.

Dosing

  • As needed: on each day with a perceived risk of drinking, take one tablet, preferably 1-2 hours before the anticipated time of drinking; if drinking has started, take it as soon as possible.
  • Maximum dose: one tablet per day; with or without food.
  • Evaluate response regularly (e.g. monthly); caution if prescribed for more than 1 year.
  • No dose adjustment in elderly patients or in mild or moderate renal or hepatic impairment.

Contraindications

  • Hypersensitivity to the active substance or any of the excipients.
  • Patients taking opioid agonists or partial agonists (e.g. opioid analgesics, methadone, buprenorphine); current or recent opioid addiction, acute opioid withdrawal or suspected recent opioid use.
  • Severe hepatic impairment; severe renal impairment (eGFR <30 ml/min per 1.73 m2).
  • Recent acute alcohol withdrawal syndrome (including hallucinations, seizures, delirium tremens).

Important warnings

  • Not for patients whose treatment goal is immediate abstinence.
  • In an emergency, larger opioid doses may be needed; monitor for respiratory depression.
  • Stop 1 week before anticipated opioid use (e.g. elective surgery).
  • Caution with opioid-containing medicines (e.g. cough medicines) and with psychiatric comorbidity.

Side effects

  • Very common: nausea, dizziness, insomnia, headache; mostly mild or moderate, at treatment start and short-lived.
  • Common: decreased appetite, sleep disorder, confusional state, restlessness, tachycardia, vomiting, dry mouth, fatigue.
  • Uncommon: hallucinations and dissociation.

Interactions

  • Opioid-containing medicines: reduced effect; opioid agonists are contraindicated.
  • Potent UGT2B7 inhibitors (e.g. diclofenac, fluconazole) may increase nalmefene exposure with long-term use.
  • UGT inducers (e.g. dexamethasone, phenobarbital, rifampicin, omeprazole) may lower levels.

Pregnancy and breastfeeding

  • Not recommended during pregnancy.
  • Breast-feeding: a risk to the infant cannot be excluded; weigh breast-feeding against therapy.

Summary of the official product information, written with AI on 2026-10-29. 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

This product has no separate US patient information.

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)

  • SelincroH. Lundbeck A/S · EMEA/H/C/002583

Source: European Medicines Agency (EMA), product information

Germany

  • NalfinoAxunio Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • SelincroLUNDBECK İLAÇ TİC. LTD. ŞTİ. · 4 register entries

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

Brand names in 3 more European countries
France
Nalmefene Biogaran
Iceland
Selincro
Norway
Selincro

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

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Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Selincro – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/selincro-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. 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

Editorial: Medelix editorial team · last updated 2026-10-28 · 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.