Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
BACLOFEN
Generics (UK) Limited
M03BX01
BACLOFEN
10 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Other centrally acting agents
Authorised
1989-11-21
PAGE 1 OF 6 PACKAGE LEAFLET PAGE 2 OF 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BACLOPAR 10 MG TABLETS (baclofen) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD 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 Baclopar is and what it is used for 2. What you need to know before you take Baclopar 3. How to take Baclopar 4. Possible side effects 5. How to store Baclopar 6. Contents of the pack and other information 1. WHAT BACLOPAR IS AND WHAT IT IS USED FOR Baclopar contains the active ingredient, baclofen. Baclofen is a muscle-relaxant drug belonging to a group of medicines called antispasticity agents. Baclopar is used to reduce and relieve 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BACLOPAR DO NOT TAKE BACLOPAR: - if you are allergic to baclofen or any of the other ingredients of this medicine (listed in section 6) - if you suffer from pulmonary insufficiency, where blood backflows into the right side of the heart WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING BACLOPAR IF YOU - have porphyria (an inherited condition causing skin blisters, abdominal pain and brain or nervous system disorders). - have Parkinson’s disease - suffer from any mental health condition such as schizophrenia, psychosis, depressive or manic disorders or confusional states - recently had a stroke or have reduced blood flow to Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Baclopar 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of baclofen. Excipient with known effect: Each tablet contains 40mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets White flat bevel-edge tablet, marked “BN” breakline “10” on one side with “G” logo on the reverse. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Baclopar is indicated for the relief of voluntary muscle spasticity as occurs in conditions such as multiple sclerosis and spinal cord lesions including syringomyelia, transverse myelitis and motor neurone disease. Baclopar is also indicated in adults for the management of spasticity of cerebral origin including meningitis, cerebral palsy, traumatic head injury, cerebrovascular accident. Patient selection is important when initiating Baclopar therapy. It is of most benefit in relief of spasticity which is seriously interfering with activity. Treatment should not be commenced until the spastic state has been 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 AND METHOD OF ADMINISTRATION Posology Titration of the dose is necessary to meet the individual patients requirements while avoiding adverse effects or interference with function depending on the acti Lire le document complet