Land: Israel
Sprog: engelsk
Kilde: Ministry of Health
NALMEFENE AS HYDROCHLORIDE DIHYDRATE
LUNDBECK ISRAEL LTD.
N07BB05
FILM COATED TABLETS
NALMEFENE AS HYDROCHLORIDE DIHYDRATE 18.06 MG
PER OS
Required
H.LUNDBECK A/S, DENMARK
NALMEFENE
Selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL), 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.
2019-01-31
PATIENT LEAFLET IN ACCORDANCE WITH PHARMACIST’S REGULATIONS (PREPARATIONS) 1986 The medicine is marketed according to doctor’s prescription only. SELINCRO 18 mg FILM-COATED TABLETS COMPOSITION Each tablet of Selincro contains 18.06 mg nalmefene as hydrochloride dihydrate. INACTIVE INGREDIENTS See section 6. - READ THE LEAFLET CAREFULLY UNTIL THE END BEFORE USING THE MEDICATION. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or the pharmacist. - This medicine was prescribed for you. Do not pass it on to others. It may harm them even if their medical condition seems similar to yours. - The safety and efficacy of this medicine has not been tested in children and adolescents below age of 18 years therefore this medicine should not be used in this age group . 1. WHAT IS THE MEDICINE FOR? 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 helps to reduce your alcohol consumption by affecting processes in the brain that are responsible for your urge to continue drinking. A high level of alcohol consumption is associated with an increased risk of health and social problems. Selincro can help you reduce the Læs hele dokumentet
1. NAME OF THE MEDICINAL PRODUCT Selincro 18mg 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 food (see section 5.2). During pivotal trials t Læs hele dokumentet