Country: Велика Британија
Језик: Енглески
Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)
Buprenorphine hydrochloride
Accord-UK Ltd
N07BC01
Buprenorphine hydrochloride
8mg
Sublingual tablet
Sublingual
Schedule 3 (CD No Register)
Valid as a prescribable product
BNF: 04100300; GTIN: 5012617019547
Actavis BST - Packing Technical BSTCutterGuideReq@actavis.com Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Buprenorphine 0.4, 2 & 8mg x 7’s (UK) 296x210 (Reel Fed) 50929811 Leaflet for Blisters 3879 R.Wrey 04/04/17 296x210 Leaflet Reel Fed Bi Fold Profile (BST) * Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND UK-Eire-Artwork-Support@Actavis.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item no: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. BUPRENORPHINE 0.4MG, 2MG AND 8MG PIL, UK Black Profile BBBA0656 C.Grant 05/04/17 296x210 8pt Actavis UK N/A 01 page 4 page 1 50929811 BBBA0656 page 4 page 1 BUPRENORPHINE 0.4MG, 2MG AND 8MG SUBLINGUAL TABLETS 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. • The full name of this medicine is Buprenorphine 0.4mg, 2mg and 8mg Sublingual Tablets but within the leaflet it will be referred to as Buprenorphine tablets. WHAT IS IN THIS LEAFLET: 1 WHAT BUPRENORPHINE TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE BUPRENORPHINE TABLETS 3 HOW TO TAKE BUPRENORPHINE TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE BUPRENORPHINE TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT BUPRENORPHINE TABLETS ARE AND WHAT THEY ARE USED Прочитајте комплетан документ
OBJECT 1 BUPRENORPHINE 8MG SUBLINGUAL TABLETS Summary of Product Characteristics Updated 01-Mar-2016 | Accord-UK Ltd 1. Name of the medicinal product Buprenorphine 8mg Sublingual Tablets 2. Qualitative and quantitative composition Each sublingual tablet contains 8 mg of buprenorphine (as buprenorphine hydrochloride). Excipients with known effect: Each tablet contains 175.6 mg of lactose monohydrate and 0.76 mg of sunset yellow (E110). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Sublingual tablet. Uncoated, light orange, 7.35x13.35 mm oval, biconvex tablets with B 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 MUST BE UNDER THE SUPERVISION OF A PHYSICIAN EXPERIENCED IN THE MANAGEMENT OF OPIATE DEPENDENCE/ADDICTION. Treatment with buprenorphine sublingual tablets is intended for use in adults and adolescents aged over 15 years who have agreed to be treated for addiction. When initiating buprenorphine treatment, the physician should be aware of the partial agonist profile of buprenorphine and that it can precipitate withdrawal symptoms in opioid-dependent patients. Buprenorphine binds to the µ (mu) and κ (kappa) opiate receptors. _Adults:_ 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 medicinal products (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 obje Прочитајте комплетан документ