Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Buprenorphine hydrochloride
Sun Pharma UK Ltd
N07BC01
Buprenorphine hydrochloride
8mg
Sublingual tablet
Sublingual
Schedule 3 (CD No Register)
Valid as a prescribable product
BNF: 04100300; GTIN: 8718309122454
V010 1 PACKAGE LEAFLET V010 2 PACKAGE LEAFLET: INFORMATION FOR THE USER BUPRENORPHINE 2 MG SUBLINGUAL TABLETS BUPRENORPHINE 8 MG SUBLINGUAL TABLETS Buprenorphine 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 Buprenorphine is and what it is used for 2. What you need to know before you take Buprenorphine 3. How to take Buprenorphine 4. Possible side effects 5. How to store Buprenorphine 6. Contents of the pack and other information 1. WHAT BUPRENORPHINE IS AND WHAT IT IS USED FOR Buprenorphine belongs to a group of medicines called opioid analgesics (also known as ‘opiates’ or ‘narcotics’). Opioid analgesics, such as morphine or diamorphine (heroin), are often subject to abuse, which can lead to dependence (addiction). If you are addicted to these drugs, you need a regular dose to feel ‘normal’, otherwise you will develop withdrawal symptoms within a day or so of the last dose. Withdrawal symptoms include sweating, feeling hot and cold, runny eyes and nose, feeling or being sick, diarrhoea, stomach cramps, poor sleep and just feeling awful. Buprenorphine is used as a substitution (replacement) treatment in patients who are addicted to opioid drugs such as heroin and morphine. The tablets prevent or reduce the unpleasant withdrawal symptoms experienced when addicts stop using opioid drugs. Treatment with Buprenorphine may form one aspect of a specialist support programme aimed at resolving opioid addiction. Treatment with Buprenorphine is intended for use in adults and adolescents a Belgenin tamamını okuyun
OBJECT 1 BUPRENORPHINE 8 MG SUBLINGUAL TABLETS Summary of Product Characteristics Updated 27-Apr-2018 | Ranbaxy (UK) Limited a Sun Pharmaceutical Company 1. Name of the medicinal product Buprenorphine 8 mg sublingual tablets 2. Qualitative and quantitative composition Buprenorphine 8mg: each tablet contains 8.62mg buprenorphine hydrochloride equivalent to 8mg buprenorphine. Excipients with known effect: Each tablet contains 119.40mg of lactose monohydrate and 1.00mg of butylhydroxyanisole (E320). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Sublingual tablet. 8 mg tablet: White to off-white, round, biconvex uncoated sublingual tablet debossed with “8” on one side and plain on the other 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 is intended for use in adults and adolescents aged 16 years or older who have agreed to be treated for addiction. _Induction therapy_ Baseline liver function tests and documentation of viral hepatitis status is recommended prior to commencing therapy. Patients who are positive for viral hepatitis, on concomitant medication (see section 4.5) and/or have existing liver dysfunction are at risk of accelerated liver injury. Regular monitoring of liver function is recommended (see section 4.4). _Induction_ Prior to treatment induction, 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 should be undertaken when objective and clear signs of withdrawal are evident. The initial dose is from 0.8mg to 4mg, administered as a single daily dose. 0.4mg dose strength of Buprenorphine is not available. If low dose is required, the patient should use tablets (0.4mg) of another brand. - for opioid-dependent Belgenin tamamını okuyun