País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Buprenorphine hydrochloride
Dowelhurst Ltd
N07BC01
Buprenorphine hydrochloride
8mg
Sublingual tablet
Sublingual
Schedule 3 (CD No Register)
Valid as a prescribable product
BNF: 04100300
Package leaflet: Information for the user SUBUTEX ® 2MG SUBLINGUAL TABLETS SUBUTEX ® 8MG SUBLINGUAL TABLETS (buprenorphine hydrochloride) Your medicine is known by one of the above names, but will be referred to as Subutex throughout this leaflet. Subutex is also available in 0.4mg strength. PATIENT INFORMATION LEAFLET 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1) What Subutex is and what it is used for 2) Before you take Subutex 3) How to take Subutex 4) Possible side effects 5) How to store Subutex 6) Further information 1) WHAT SUBUTEX IS AND WHAT IT IS USED FOR Subutex is used to treat dependence on opiate (narcotic) drugs, such as morphine and heroin in drug addicts who have agreed to be treated for their addiction. Subutex is used in adults and adolescents over 16 years of age who are also receiving medical, social and psychological support. 2) BEFORE YOU TAKE SUBUTEX DO NOT TAKE SUBUTEX If you are a child under the age of 16 years. If you are allergic (hypersensitive) to buprenorphine or to 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 breast feeding a baby. TAKE SPECIAL CARE WITH SUBUTEX Tell your doctor before you start taking Subutex if you have: asthma or other breathing problems any liver disease such as hepatitis low blood pressure recently suffered head injury or brain disease a urinary disorder (especially lin Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Subutex 8mg sublingual tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 8mg buprenorphine (as buprenorphine hydrochloride). Excipient(s) with known effect: lactose For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Sublingual tablet Uncoated oval white flat bevelled edged tablet, nominal dimensions 14 mm x 7 mm, debossed with “B8” 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 Posology Treatment with Subutex sublingual tablets is intended for use in adults and children aged 16 years or over who have agreed to be treated for opioid dependence. _Precautions to be taken before dosing _ Prior to treatment induction, physicians should be aware of the partial agonist profile of buprenorphine to the opiate receptors, which may precipitate a withdrawal syndrome in opioid-dependent patients, and consideration should be given to the types 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 Subutex should be undertaken when objective and clear signs of withdrawal are evident e.g. a score higher than 12 on the Clinical Opioid Withdrawal Scale (COWS). • FOR PATIENTS DEPENDENT ON HEROIN OR SHORT-ACTING OPIOIDS, the first dose of buprenorphine should be started when objective signs of withdrawal appear, but not less than 6 hours after the patient last used opioids. • FOR PATIENTS RECEIVING METHADONE: before beginning Subutex therapy, the dose of methadone should be reduced to a maximum of 30mg/day. Subutex may precipitate symptoms of withdrawal in patients dependent on methadone. The first dose of buprenorphine should be started only when objective signs of withdrawal appear and generally not less than 24 hours afte Llegiu el document complet