Krajina: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
BUPRENORPHINE
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
N07BC01
BUPRENORPHINE 0.4 mg
SUBLINGUAL TABLET
BUPRENORPHINE 0.4 mg
POM
OTHER NERVOUS SYSTEM DRUGS
Withdrawn
2013-10-07
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER ADDICTEX 0.4 MG SUBLINGUAL TABLETS ADDICTEX 2 MG SUBLINGUAL TABLETS ADDICTEX 8 MG SUBLINGUAL TABLETS buprenorphine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Addictex is and what it is used for 2. Before you take Addictex 3. How to take Addictex 4. Possible side effects 5. How to store Addictex 6. Further information 1. WHAT ADDICTEX IS AND WHAT IT IS USED FOR Addictex is a medicinal product used in opioid (narcotic) dependence. Addictex sublingual tablets are used as a part of a medical, social and psychological treatment programme for patients addicted to opiate (narcotic) drugs. A sublingual tablet is a tablet that is placed under your tongue and allowed to dissolve. Treatment is prescribed and monitored by physicians who are specialists in the treatment of drug dependence. Treatment with Addictex sublingual tablets is intended for use in adults and adolescents over 15 years of age. 2. BEFORE YOU TAKE ADDICTEX DO NOT TAKE ADDICTEX - if you are allergic (hypersensitive) to buprenorphine or any of the other ingredients of Addictex (see section 6 for a list of ingredients). - if you have serious breathing problems. - if you have serious problems with your liver. - if you are intoxicated due to alcohol or have delirium tremens (the “shakes” and hallucinations). TAKE SPECIAL CARE WITH ADDICTEX Page 2 of 8 Tell your doctor if you have any of the Prečítajte si celý dokument
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Addictex 0.4 mg sublingual tablets Addictex 2 mg sublingual tablets Addictex 8 mg sublingual tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sublingual tablet contains 0.4 mg of buprenorphine (as buprenorphine hydrochloride). Excipient: Each tablet contains 63.6 mg of lactose monohydrate. Each sublingual tablet contains 2 mg of buprenorphine (as buprenorphine hydrochloride). Excipient: Each tablet contains 43.9 mg of lactose monohydrate and 0.19 mg of sunset yellow (E110). Each sublingual tablet contains 8 mg of buprenorphine (as buprenorphine hydrochloride). Excipient: Each tablet contains 175.6 mg of lactose monohydrate and 0.76 mg of sunset yellow (E110). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sublingual tablet. 0.4 mg: Uncoated, white or almost white, 6 mm round, flat tablets with “B” on one side. 2 mg: Uncoated, light orange, 5x8 mm oval, biconvex tablets with “B” on one side. 8 mg: Uncoated, light orange, 7.35x13.35 mm oval, biconvex tablets with “B” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION TREATMENT MUST BE UNDER THE SUPERVISION OF A PHYSICIAN EXPERIENCED IN THE MANAGEMENT OF OPIATE DEPENDENCE/ADDICTION. Treatment with buprenorphine sublingual tablets is intended for use in adults and adolescents aged over 15 years who have agreed to be treated for addiction. When initiating buprenorphine treatment, the physician should be aware of the partial agonist profile of buprenorphine and that it can precipitate withdrawal symptoms in opioid-dependent patients. Buprenorphine binds to the µ (mu) and κ (kappa) opiate receptors. Page 2 of 11 Prečítajte si celý dokument