Država: Evropska unija
Jezik: angleščina
Source: EMA (European Medicines Agency)
Nalmefene hydrochloride dihydrate
H. Lundbeck A/S
N07BB05
nalmefene
Drugs used in alcohol dependence
Alcohol-Related Disorders
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.
Revision: 10
Authorised
2013-02-24
25 B. PACKAGE LEAFLET 26 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SELINCRO 18 MG FILM-COATED TABLETS nalmefene READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Selincro is and what it is used for 2. What you need to know before you take Selincro 3. How to take Selincro 4. Possible side effects 5. How to store Selincro 6. Contents of the pack and other information 1. WHAT SELINCRO IS AND WHAT IT IS USED FOR Selincro contains the active substance nalmefene. Selincro is used for the reduction of alcohol consumption in adult patients with alcohol dependence who still have a high level of alcohol consumption 2 weeks after the first consultation with their doctor. Alcohol dependence occurs when a person has a physical or psychological dependence on the consumption of alcohol. A high level of alcohol consumption is defined as drinking more than 60 g of pure alcohol per day for men and more than 40 g of pure alcohol per day for women. For example, 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. Your doctor has prescribed Selincro because you were not able to reduce your alcohol consumption on your own. Your doctor will provide you with counselling to help you keep to your treatment and thereby reduce your alcohol consumption. Selincro works by affecting processes in the brain that are responsible for your urge to continue drinking. A high level of alcohol consumption is associ Preberite celoten dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Selincro 18 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 18.06 mg nalmefene (as hydrochloride dihydrate). Excipient with known effect Each film-coated tablet contains 60.68 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) White, oval, biconvex, 6.0 x 8.75 mm film-coated tablet engraved with “S” on one side 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL) [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 DRL two weeks after initial assessment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology At an initial visit, the patient’s clinical status, alcohol dependence, and level of alcohol consumption (based on patient reporting) should be evaluated. Thereafter, the patient should be asked to record his or her alcohol consumption for approximately two weeks. At the next visit, Selincro may be initiated in patients who continued to have a high DRL (see section 5.1) over this two-week period, in conjunction with psychosocial intervention focused on treatment adherence and reducing alcohol consumption. Selincro is to be taken as-needed: On each day the patient perceives a risk of drinking alcohol, one tablet should be taken, preferably 1-2 hours prior to the anticipated time of drinking. If the patient has started drinking alcohol without taking Selincro, the patient should take one tablet as soon as possible. The maximum dose of Selincro is one tablet per day. Selincro can be taken with or without Preberite celoten dokument