Selincro

nalmefene

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This is a summary of the European public assessment report (EPAR) for Selincro. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Selincro.

What is Selincro?

Selincro is medicine that contains the active substance nalmefene. It is available as tablets (18 mg).

What is Selincro used for?

Selincro is used to help reduce alcohol consumption in adults with alcohol dependence who consume more than 60 g of alcohol per day (for men) or more than 40 g per day (for women).

It should only be used together with psychosocial support (counselling) and only in people who do not have physical withdrawal symptoms and who do not require immediate detoxification.

As a guide: a bottle of wine (750 ml; 12% alcohol by volume) contains approximately 70 g alcohol and a bottle of beer (330 ml; 5% alcohol by volume) contains approximately 13 g alcohol.

Selincro can only be obtained by prescription.

How is Selincro used?

Before starting treatment with Selincro, the patient is asked to record his or her level of alcohol consumption over a two-week period.

At the patient’s initial visit to their doctor, the patient’s overall health, alcohol dependence, and level of alcohol consumption (based on patient reporting) will be evaluated. Thereafter, the patient will be asked to record his or her alcohol consumption for approximately two weeks.

At the next visit (after the two weeks), Selincro may be started if the patient continues to have a high level of alcohol consumption (above 60 g per day for men and 40 g per day for women).

Treatment must also include counselling to help the patient reduce their drinking and keep to their treatment.

The patient should take one Selincro tablet by mouth ‘as needed’, which means when there is a risk that they would start drinking. Only one tablet can be taken on any given day and it should preferably be taken one to two hours before they are likely to start drinking. If the patient has started drinking without Selincro, a tablet should be taken as soon as possible.

Data on the use of Selincro from standard clinical studies are available for a period of six months to one year. Caution is advised if Selincro is prescribed for more than one year.

How does Selincro work?

The active substance in Selincro, nalmefene, attaches to certain opioid receptors in the brain. Opioid receptors play a role in addiction and, by attaching to them and modifying their activity, nalmefene helps reduce the urge to drink in people accustomed to large amounts of alcohol.

Selincro does not prevent the intoxicating effects of alcohol.

How has Selincro been studied?

The effects of Selincro were first tested in experimental models before being studied in humans. Selincro was compared with placebo (a dummy treatment) in two main studies involving 1,322 men and women with alcohol dependence. All patients also received counselling to help them reduce their drinking and keep to their treatment.

The main measures of effectiveness were the reduction in the number of heavy-drinking days and the average daily alcohol consumption after six months of treatment.

What benefit has Selincro shown during the studies?

Selincro was shown to be more effective than placebo in reducing the number of heavy drinking days and daily alcohol consumption.

Significant improvements, usually observed within the first four weeks of treatment, were seen in patients who were already consuming more than 60 g of alcohol per day (for men) or more than 40 g of per day (for women). In these patients, after six months, the number of heavy-drinking days a month with Selincro fell from 23 to 10 in the first study and from 23 to 11 in the second. Daily alcohol consumption with Selincro fell from 102 g to 44 g in the first study and from 113 g to 43 g in the second. These improvements were better than those seen with placebo by about 2.7 to 3.7 heavy-drinking days a month and about 10 to 18 g of alcohol a day.

What is the risk associated with Selincro?

The most common side effects (seen in more than 1 patient in 10) were nausea (feeling sick), dizziness, insomnia (difficulty sleeping) and headache. The majority of these reactions were mild or moderate and of short duration.

Selincro must not be used in people who are hypersensitive (allergic) to nalmefene or any of its other ingredients. It must not be used in patients taking opioid medicines, in patients who have a current or recent addiction to opioids, patients with acute opioid withdrawal symptoms, or in patients suspected to have used opioids recently.

It must also not be used in patients with severe liver or kidney impairment or a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures (fits) and tremors).

Why has Selincro been approved?

The CHMP noted that Selincro was shown to be effective in reducing alcohol consumption in men drinking more than 60 g and women drinking more than 40 g a day. With regard to safety, the side effects reported in the studies did not raise any major concerns. The CHMP decided that Selincro’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Selincro

The European Commission granted a marketing authorisation valid throughout the European Union for Selincro on 25 February 2013.

Name Language First published Last updated
Selincro : EPAR - Summary for the public BG = bălgarski 13/03/2013  
Selincro : EPAR - Summary for the public ES = español 13/03/2013  
Selincro : EPAR - Summary for the public CS = čeština 13/03/2013  
Selincro : EPAR - Summary for the public DA = dansk 13/03/2013  
Selincro : EPAR - Summary for the public DE = Deutsch 13/03/2013  
Selincro : EPAR - Summary for the public ET = eesti keel 13/03/2013  
Selincro : EPAR - Summary for the public EL = elliniká 13/03/2013  
Selincro : EPAR - Summary for the public EN = English 13/03/2013  
Selincro : EPAR - Summary for the public FR = français 13/03/2013  
Selincro : EPAR - Summary for the public IT = italiano 13/03/2013  
Selincro : EPAR - Summary for the public LV = latviešu valoda 13/03/2013  
Selincro : EPAR - Summary for the public LT = lietuvių kalba 13/03/2013  
Selincro : EPAR - Summary for the public HU = magyar 13/03/2013  
Selincro : EPAR - Summary for the public MT = Malti 13/03/2013  
Selincro : EPAR - Summary for the public NL = Nederlands 13/03/2013  
Selincro : EPAR - Summary for the public PL = polski 13/03/2013  
Selincro : EPAR - Summary for the public PT = português 13/03/2013  
Selincro : EPAR - Summary for the public RO = română 13/03/2013  
Selincro : EPAR - Summary for the public SK = slovenčina 13/03/2013  
Selincro : EPAR - Summary for the public SL = slovenščina 13/03/2013  
Selincro : EPAR - Summary for the public FI = suomi 13/03/2013  
Selincro : EPAR - Summary for the public SV = svenska 13/03/2013  

This EPAR was last updated on 29/03/2016 .

Authorisation details

Product details

Product details for Selincro
NameSelincro
Agency product numberEMEA/H/C/002583
Active substance

nalmefene hydrochloride dihydrate

International non-proprietary name (INN) or common name

nalmefene

Therapeutic area Alcohol-Related Disorders
Anatomical therapeutic chemical (ATC) code N07BB05
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Selincro
Marketing-authorisation holder

H. Lundbeck A/S

Revision5
Date of issue of marketing authorisation valid throughout the European Union25/02/2013

Contact address:

H. Lundbeck A/S
Ottiliavej 9
DK 2500 Valby
Denmark

Product information

Product information

28/01/2016  Selincro -EMEA/H/C/002583 -II/0015

Name Language First published Last updated
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016
Selincro : EPAR - Product Information SV = svenska 13/03/2013 29/03/2016

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015
Selincro : EPAR - All Authorised presentations SV = svenska 13/03/2013 10/02/2015

Pharmacotherapeutic group

Drugs used in alcohol dependence

Therapeutic indication

Selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking-risk level (see section 5.1), without physical withdrawal symptoms and who do not require immediate detoxification.

Selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption.

Selincro should be initiated only in patients who continue to have a high drinking-risk level two weeks after initial assessment.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Selincro : EPAR - Public assessment report SV = svenska 13/03/2013  
CHMP summary of positive opinion for Selincro SV = svenska 14/12/2012 17/12/2012

Authorised

This medicine is approved for use in the European Union