Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Buprenorphine hydrochloride
Morningside Healthcare Ltd
N07BC01
Buprenorphine hydrochloride
2mg
Sublingual tablet
Sublingual
Schedule 3 (CD No Register)
Valid as a prescribable product
BNF: 04100300; GTIN: 5055132709418
PACKAGE LEAFLET: INFORMATION FOR THE USER Buprenorphine 2 mg and 8 mg Sublingual Tablets This medicine contains buprenorphine which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly. 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 Sublingual Tablets are and what they are used for 2. What you need to know before you take Buprenorphine Sublingual Tablets 3. How to take Buprenorphine Sublingual Tablets 4. Possible side effects 5. How to store Buprenorphine Sublingual Tablets 6. Contents of the pack and other information 1. What Buprenorphine Sublingual Tablets are and what they are used for This medicine has been prescribed for you for substitution (replacement) treatment in patients who are addicted to opioid drugs such as heroin and morphine. It contains the buprenorphine which belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been prescribed/provided 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. Buprenorphine Sublingual Tablets are used in adults and adolescents over 16 years of age who are also receiving medical, social and psychological support. 2. What you need to know before you take Buprenorphine Sublingual Tablets Do not take Buprenorphine Sublingual Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Buprenorphine 2 mg Sublingual Tablets Natzon 2 mg Sublingual Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg of buprenorphine (as buprenorphine hydrochloride). Excipient: Each tablet contains 20 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Sublingual tablet. Off-white to brownish, oval, biplane tablets marked with “B2” 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 Buprenorphine 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, physician 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 patient 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 buprenorphine therapy, the dose of methadone should be reduced to a maximum of 30mg/day. Buprenorphine 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 ge Prečítajte si celý dokument