国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Buprenorphine hydrochloride
Pilsco Ltd
N07BC01
Buprenorphine hydrochloride
8mg
Sublingual tablet
Sublingual
Schedule 3 (CD No Register)
Valid as a prescribable product
BNF: 04100300; GTIN: 05060669871323
PIL0212.5 PACKAGE LEAFLET: INFORMATION FOR THE USER SUBUTEX ® 8 MG SUBLINGUAL TABLETS (buprenorphine hydrochloride) The name of this product is Subutex 8 mg Sublingual Tablets but will be referred to as Subutex throughout this leaflet. This leaflet contains information about other strengths of Subutex that are available. 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 Subutex is and what it is used for 2. What you need to know before you take Subutex 3. How to take Subutex 4. Possible side effects 5. How to store Subutex 6. Contents of the pack and other information THIS MEDICINE CONTAINS BUPRENORPHINE WHICH IS AN OPIOID, WHICH CAN CAUSE ADDICTION. YOU CAN GET WITHDRAWAL SYMPTOMS IF YOU STOP TAKING IT SUDDENLY. 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. This medicine contains buprenorphine which belongs to a class of medicines called opioids. This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SUBUTEX DO NOT TA 阅读完整的文件
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 阅读完整的文件