País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Buprenorphine hydrochloride
Thornton & Ross Ltd
N07BC01
Buprenorphine hydrochloride
8mg
Sublingual tablet
Sublingual
Schedule 3 (CD No Register)
Valid as a prescribable product
BNF: 04100300
PCP HEADER BOX APPROVED BY DATE OPERATOR ARTWORK NO CRN FIX REASON F SUF OR CHANGE ISSUED BY DATE MHRA/IMB SUBMISSION REQUIRED Yes A gill.kennedy 630791 11845 & 11846 Removal of 0.4mg and alignment of SmPC with reference product (safety) MHRA HEADER BOX PRODUCT TITLE C FONTS USED OLOURS USED COMPONENT PACK SIZE IG CODE DIMENSIONS PROOF NO. DATE Leaflet 7's 24368803 160 x 480mm 9 02.02.2016 Process Black PANTONE 485 C Keyline (Does not print) Buprenorphine 2mg and 8mg Sublingual Tablets Dax Frutiger Helvetica LT PCP HEADER BOX APPROVED BY DATE OPERATOR ARTWORK NO CRN FIX REASON F SUF OR CHANGE ISSUED BY DATE MHRA/IMB SUBMISSION REQUIRED Yes A gill.kennedy 630791 11845 & 11846 Removal of 0.4mg and alignment of SmPC with reference product (safety) MHRA HEADER BOX PRODUCT TITLE C FONTS USED OLOURS USED COMPONENT PACK SIZE IG CODE DIMENSIONS PROOF NO. DATE Leaflet 7's 24368803 160 x 480mm 9 02.02.2016 Process Black PANTONE 485 C Keyline (Does not print) Buprenorphine 2mg and 8mg Sublingual Tablets Dax Frutiger Helvetica LT BUPRENORPHINE 2MG, 8MG SUBLINGUAL TABLETS Buprenorphine Hydrochloride 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 please ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it onto 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 2mg and 8mg Sublingual tablets are and what they are used for 2. What you need to know before you take Buprenorphine 2mg and 8mg Sublingual tablets 3. How to take the tablets 4. Possible side effects 5. How to store the tablets 6. Contents of the pack and other information 1. WHAT BUPRENORPHINE 2MG AND 8MG SUBLINGUAL TABLETS ARE AND WHAT THEY ARE USED FOR Buprenorphine 2mg and 8mg Subling Leia o documento completo
OBJECT 1 BUPRENORPHINE 8.0MG SUBLINGUAL TABLETS Summary of Product Characteristics Updated 03-Mar-2016 | Thornton & Ross Ltd 1. Name of the medicinal product Buprenorphine 8mg Sublingual Tablets 2. Qualitative and quantitative composition Each tablet contains buprenorphine hydrochloride 8.64mg equivalent to buprenorphine 8mg. Excipient 191.36mg of lactose monohydrate per tablet. For a full list of excipients see section 6.1. 3. Pharmaceutical form Sublingual tablet White, oval shaped, biconvex uncoated tablets with '8' embossed 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 Treatment with Buprenorphine Sublingual Tablets is intended for use in adults and children age 16 years or over who have agreed to be treated for addiction. When initiating treatment the physician should be aware of the partial agonist profile of buprenorphine and that it can precipitate withdrawal in opioid dependent patients. Buprenorphine binds to the µ and κ opiate receptors. Administration is sublingual. Physicians must advise patients that the sublingual route is the only effective and safe route of administration for this drug. The tablet should be kept under the tongue until dissolved which usually occurs within 5 to 10 minutes. INDUCTION THERAPY: the initial dose is from 0.8mg to 4mg, administered as a single daily dose. . FOR OPIOID-DEPENDENT DRUG ADDICTS WHO HAVE NOT UNDERGONE WITHDRAWAL: one dose of Buprenorphine Tablets administered sublingually at least 4 hours after the last use of the opioid, or when the first signs of craving appear. . 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 upon methadone. TITRATION TO A MAINTENANCE DOSE: The dosage should be individually titrated to each patien Leia o documento completo