Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Baclofen
Accord-UK Ltd
M03BX01
Baclofen
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10020200; GTIN: 5012617005526
148x210 Leaflet Reel Fed Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Baclofen Tablets 10mg x 84 (UK) 148x210 (Reel Fed) 51003594 Leaflet for Blisters 1072 T. Hull 13/08/21 * 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 Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. EU-Artwork-Support@accord-healthcare.com BACLOFEN 10 MG TABLETS PIL - UK Black Profile BBBB2481 M.Doak 16/09/2021 21/10/2021 M.Doak 148 x 210mm 7pt Accord Barnstaple N/A N/A 3 Version 7 12.02.2020 German GTIN 14 (incorporating PZN): N/A Cartons and label leaflets only (labels only when specified) BACLOFEN 10MG TABLETS PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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, pharmacist or nurse. • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1 WHAT BACLOFEN TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE BACLOFEN TABLETS 3 HOW TO TAKE BACLOFEN TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE BACLOFEN TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT BACLOFEN TABLETS ARE AND WHAT THEY ARE USED FOR Baclofen is a muscle-relaxant drug. Baclofen Tablets are used to reduce and relieve the excessive tension in your muscles Đọc toàn bộ tài liệu
1 NAME OF THE MEDICINAL PRODUCT BACLOFEN TABLETS BP 10mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg Baclofen PhEur. Excipient with known effect:_ _Lactose PhEur 89.50mg _ _ For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM White to off-white uncoated tablets. White to off-white, circular, biconvex uncoated tablets impressed “C” on one face, and the identifying letters “B” “L” on either side of a central division line on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Baclofen is indicated for: 1) The relief of spasticity of voluntary muscle resulting from disorders such as multiple sclerosis and other spinal lesions, including tumours of the spinal cord, motor neurone disease, syringomyelia, transverse myelitis and traumatic partial section of the spinal cord. 2) Adults and children in the relief of spasticity of voluntary muscle arising from conditions such as cerebral palsy, cerebrovascular accidents, traumatic head injury and meningitis. Treatment with Baclofen should not be initiated until the spastic state has become stabilised and it should be administered selectively; it is most likely to be of benefit to patients whose spasticity constitutes a handicap to activities or physiotherapy. Treatment should not be commenced until the spastic state has become stabilised. Paediatric population Baclofen is indicated in patients 0 to <18 years for the symptomatic treatment of spasticity of cerebral origin, especially where due to infantile cerebral palsy, as well as following cerebrovascular accidents or in the presence of neoplastic or degenerative brain disease. Baclofen is also indicated for the symptomatic treatment of muscle spasms occurring in spinal cord diseases of infectious, degenerative, traumatic, neoplastic, or unknown origin such as multiple sclerosis, spastic spinal paralysis, amyotrophic lateral sclerosis, syringomyelia, transverse myelitis, traumatic paraplegia or paraparesis, and compression of the spinal cord. 4.2 POSOLOGY Đọc toàn bộ tài liệu