Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Baclofen
Sigma Pharmaceuticals Plc
M03BX01
Baclofen
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10020200
PACKAGE LEAFLET: INFORMATION FOR THE USER LIORESAL ® 10MG TABLETS (baclofen) This product is available using the above name Lioresal 10mg Tablets but will be referred to as Lioresal Tablets throughout this leaflet. WHAT YOU NEED TO KNOW ABOUT LIORESAL TABLETS Your doctor has decided that you or your child need this medicine to help treat your condition. PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR MEDICINE. IT CONTAINS IMPORTANT INFORMATION. Keep the leaflet in a safe place because you may want to read it again. If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist. This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Lioresal Tablets are and what they are used for 2. Things to consider before you start to take Lioresal Tablets 3. How to take Lioresal Tablets 4. Possible side effects 5. How to store Lioresal Tablets 6. Further information 1. WHAT LIORESAL TABLETS ARE AND WHAT THEY ARE USED FOR_ _ Lioresal Tablets contain 10mg of the active ingredient baclofen. Baclofen is a muscle-relaxant drug. Lioresal Tablets are used to reduce and relieve the excessive tension in your muscles (spasms) occurring in various illnesses such as cerebral palsy, multiple sclerosis, cerebrovascular accidents, spinal cord diseases and other nervous system disorders. _ _ 2. THINGS TO CONSIDER BEFORE YOU START TO TAKE LIORESAL TABLETS SOME PEOPLE MUST NOT TAKE LIORESAL TABLETS. TALK TO YOUR DOCTOR IF: you think you may be allergic to baclofen or to any of the other ingredients of the tablets, (These are listed at the end of the leaflet.) you have ever had a stomach ulcer. YOU SHOULD ALSO ASK YOURSELF THESE QUESTIONS BEFORE TAKING LIORESAL TABLETS: Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lioresal ® Tablets 10mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient is: β -(Aminomethyl)-p-chlorohydrocinnamic acid (= baclofen), a racemic mixture of the R,(-) and S, (+) isomers. One tablet contains 10mg baclofen Ph. Eur. For excipients see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Tablet, scored 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lioresal is indicated 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. Lioresal is also indicated in adults and children 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 Lioresal 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 Lioresal 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. Lioresal 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 AND METHOD OF ADMINISTRATION DOSAGE Lioresal is given orally in either tablet or liquid form. These two formulations are bioequivalent. The liquid may be particularly suita Przeczytaj cały dokument