Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Baclofen
DE Pharmaceuticals
M03BX01
Baclofen
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10020200
Dimensions: 148 X 210 MM Created By: DTAWDE Artwork Code: A0030/O/PIL/A2 Bar Code: - Font Type: ARIAL NARROW Font Size: 7.5 PT Printing Colours: Non-Printing Colours: Black Profile Final Preparation Date For Submission: 06/03/2020 Packing Site Technical Approval: 00/00/0000 Authority Approval Date: 00/00/0000 Latest Implementation Deadline: 00/00/0000 Print Proof Approval: 00/00/0000 Product: MA Holder: ACTIVASE PL No.: 28444/0030 Pack Size: ALL Livery: ACTIVASE Manufacturer: - Market: UK Component: LEAFLET BACLOFEN 10 MG TABLETS OTHER SPECIAL WARNINGS Be careful when drinking alcohol - it may affect you more than usual Some people being treated with baclofen have had thoughts of harming or killing themselves or have tried to kill themselves. Most of these people also had depression, had been using alcohol excessively or were prone to having thoughts of killing themselves. If you have thoughts of harming or killing yourself at any time, speak to your doctor straightaway or go to a hospital. Also, ask a relative or close friend to tell you if they are worried about any changes in your behaviour and ask them to read this leaflet. Your doctor may want to give you a check up from time to time while you are taking Baclofen Tablets. If you are going to have an operation of any kind, make sure that the doctor knows that you are taking Baclofen Tablets. CHILDREN AND ADOLESCENTS: Baclofen tablets are not suitable for use in children under 33 kg body weight. OTHER MEDICINES AND BACLOFEN: Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines including medicines obtained without prescription: Check with your doctor before taking these tablets if you are taking any of the following; Medicines for depression, e.g. tricyclic antidepressants, such as imipramine or amitriptyline Medicines for muscle relaxation e.g. tizanidine Morphine Lithium Medicines for high blood pressure e.g. diltiazem Medicines for arthritis or pain, e.g. ibuprofen Olvassa el a teljes dokumentumot
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 Olvassa el a teljes dokumentumot