Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
buprenorphine, naloxone
Indivior Europe Limited
N07BC51
buprenorphine, naloxone
Other nervous system drugs
Opioid-Related Disorders
Substitution treatment for opioid-drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter intravenous misuse. Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.
Revision: 22
Authorised
2006-09-26
63 B. PACKAGE LEAFLET 64 PACKAGE LEAFLET: INFORMATION FOR THE USER SUBOXONE 2 MG/0.5 MG SUBLINGUAL TABLETS SUBOXONE 8 MG/2 MG SUBLINGUAL TABLETS SUBOXONE 16 MG/4 MG SUBLINGUAL TABLETS buprenorphine / naloxone 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 Suboxone is and what it is used for 2. What you need to know before you take Suboxone 3. How to take Suboxone 4. Possible side effects 5 How to store Suboxone 6. Contents of the pack and other information 1. WHAT SUBOXONE IS AND WHAT IT IS USED FOR Suboxone is used to treat dependence on opioid (narcotic) drugs such as heroin or morphine in drug addicts who have agreed to be treated for their addiction. Suboxone is used in adults and adolescents over 15 years of age, who are also receiving medical, social and psychological support. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SUBOXONE DO NOT TAKE SUBOXONE • if you are allergic to buprenorphine, naloxone or any of the other ingredients of this medicine (listed in section 6) • if you have SERIOUS BREATHING PROBLEMS • if you have SERIOUS PROBLEMS WITH YOUR LIVER • if you are intoxicated due to alcohol or have trembling, sweating, anxiety, confusion, or hallucinations caused by alcohol. • if you are taking naltrexone or nalmefene for the treatment of alcohol or opioid dependence. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR BEFORE TAKING SUBOXONE IF YOU HAVE: • ast hma or other breathing problems • problems with your liver such as hepatitis • low blood pressure • recently suf Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Suboxone 2 mg/0.5 mg sublingual tablets Suboxone 8 mg/2 mg sublingual tablets Suboxone 16 mg/4 mg sublingual tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Suboxone 2 mg/0.5 mg sublingual tablets Each sublingual tablet contains 2 mg buprenorphine (as hydrochloride) and 0.5 mg naloxone (as hydrochloride dihydrate). Excipients with known effect: Each sublingual tablet contains 42 mg lactose (as monohydrate) For the full list of excipients, see section 6.1. Suboxone 8 mg/2 mg sublingual tablets Each sublingual tablet contains 8 mg buprenorphine (as hydrochloride) and 2 mg naloxone (as hydrochloride dihydrate). Excipients with known effect: Each sublingual tablet contains 168 mg lactose (as monohydrate) For the full list of excipients, see section 6.1. Suboxone 16 mg/4 mg sublingual tablets Each sublingual tablet contains 16 mg buprenorphine (as hydrochloride) and 4 mg naloxone (as hydrochloride dihydrate). Excipients with known effect: Each sublingual tablet contains 156.64 mg lactose (as monohydrate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sublingual tablet Suboxone 2 mg/0.5 mg sublingual tablets White hexagonal biconvex tablets of 6.5 mm with “N2” debossed on one side. Suboxone 8 mg/2 mg sublingual tablets White hexagonal biconvex tablets of 11 mm with “N8” debossed on one side. Suboxone 16 mg/4 mg sublingual tablets White round biconvex tablets of 10.5 mm with “N16” debossed 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. The intention of the naloxone component is to deter intravenous misuse. Suboxone is indicated in adults and adolescents over 15 years of age who have agreed to be treated for addiction. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment must be under the supervision of a physician experienced in the management of opiate depe Lesen Sie das vollständige Dokument