Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Buprenorphine hydrochloride; Naloxone hydrochloride dihydrate
Indivior UK Ltd
N07BC51
Buprenorphine hydrochloride; Naloxone hydrochloride dihydrate
16mg ; 4mg
Sublingual tablet
Sublingual
Schedule 3 (CD No Register)
Valid as a prescribable product
BNF: ; GTIN: 5054792000088
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER 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 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. 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. Content 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 (hypersensitive) to buprenorphine, naloxone or any of the other ingredients of this medicine (see section 6) if you have SERIOUS BREATHING PROBLEMS if you have SERIOUS LIVER PROBLEMS 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: asthma or other breathing problems any liver disease such as hepatitis low blood pressure recently suffered a head injury or brain disease a urinary disorder (especially linked t Lire le document complet
OBJECT 1 SUBOXONE TABLETS 16MG/4MG Summary of Product Characteristics Updated 16-Aug-2016 | Indivior UK Limited 1. Name of the medicinal product Suboxone 16 mg/4 mg sublingual tablets 2. Qualitative and quantitative composition 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 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. Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction. 4.2 Posology and method of administration Treatment must be under the supervision of a physician experienced in the management of opiate dependence/addiction. _Precautions to be taken before induction_ Prior to treatment initiation, consideration should be given to the type of opioid dependence (i.e. long- or short-acting opioid), the time since last opioid use and the degree of opioid dependence. To avoid precipitating withdrawal, induction with buprenorphine/naloxone or buprenorphine only should be undertaken when objective and clear signs of withdrawal are evident (demonstrated e.g. by a score indicating mild to moderate withdrawal on the validated Clinical Opioid Withdrawal Scale, COWS). o For patients dependent upon heroin or short-acting opioids, the first dose of buprenorphine/naloxone should be taken when signs of withdrawal appear, but not less than 6 hours after the patient last used opioids. o For patients receiving methadone, the dose of methadone should be reduced to a maximum of 30 mg/day before beginning buprenorphine/naloxone therapy. The lon Lire le document complet