Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Baclofen
Crescent Pharma Ltd
M03BX01
Baclofen
1mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10020200; GTIN: 5017123013966
Package leaflet: Information for the patient Baclofen 5mg/5ml Oral Solution baclofen 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 Baclofen Solution is and what it is used for 2. What you need to know before you take Baclofen Solution 3. How to take Baclofen Solution 4. Possible side effects 5. How to store Baclofen Solution 6. Contents of the pack and other information 1. What Baclofen Solution is and what it is used for The full name of this medicine is Baclofen 5mg/5ml Oral Solution but within the leaflet it will be referred to as Baclofen Solution. This oral solution contains the active substance baclofen which is a muscle relaxant. It works by relaxing the muscles and preventing spasms, cramping or tightening so reducing any pain and discomfort. Your doctor has decided that you or your child needs this medicine to help treat your condition. Baclofen is used to reduce and relieve excessive tension in your muscles (spasms) occurring in various illnesses such as multiple sclerosis, cerebral palsy, cerebrovascular accidents, spinal cord diseases and other nervous system disorders. It is also used to relieve muscle spasms following injuries to the head or spine. 2. What you need to know before you take Baclofen Solution Do not take Baclofen Solution if: • You are allergic to baclofen or any of the other ingredients of this medicine (listed in section 6). • You have a peptic (stomach) ulcer. Warnings and precautions Talk to your doctor before taking Baclofen Solution if: • You suf Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Baclofen 5 mg/5 ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml of Baclofen Oral Solution contains 5mg baclofen. Excipients with known effect: Each 5 ml of oral solution contains 10 mg of Sodium methyl parahydroxybenzoate, 0.70mg of (E219); Sodium propyl parahydroxybenzoate and 1.250g of (E217); Liquid maltitol. (E965); 4.48 mg of Sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution. A clear, almost colourless solution with a raspberry odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of spasticity of voluntary muscle resulting from such disorders as: multiple sclerosis, other spinal lesions, _e.g._ tumours of the spinal cord, syringomyelia, motor neurone disease, transverse myelitis, traumatic partial section of the cord. Also for the relief of spasticity of voluntary muscle arising from _e.g._ cerebrovascular accidents, cerebral palsy, meningitis, traumatic head injury. Patient selection is important when initiating therapy; it is likely to be of most benefit in patients whose spasticity constitutes a handicap to activities and/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, tranverse myelitis, traumatic paraplegia or paraparesis, and compression of the spinal cord. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Before starting treatment with Les hele dokumentet