Baclofen Tablets 10mg

Ország: Málta

Nyelv: angol

Forrás: Medicines Authority

Aktív összetevők:

BACLOFEN

Beszerezhető a:

Generics UK Limited Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

ATC-kód:

M03BX01

INN (nemzetközi neve):

BACLOFEN 10 mg

Gyógyszerészeti forma:

TABLET

Összetétel:

BACLOFEN 10 mg

Recept típusa:

POM

Terápiás terület:

MUSCLE RELAXANTS

Engedélyezési státusz:

Withdrawn

Engedély dátuma:

2006-11-02

Betegtájékoztató

PACKAGE LEAFLET  
PACKAGE LEAFLET: INFORMATION FOR THE USER 

BACLOFEN TABLETS BP 10MG 
(Baclofen) 

PLEASE READ THIS PRODUCT INFORMATION CAREFULLY BEFORE YOU OR YOUR
CHILD IS GIVEN BACLOFEN 
SINCE IT CONTAINS IMPORTANT INFORMATION. 
- 
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. Do not pass it on
to others. It may harm them, 
even if their symptoms are 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 Baclofen is and what it is used for 
2. Before you take Baclofen 
3. How to take Baclofen 
4. Possible side effects 
5. How to store Baclofen 
6. Further information 

1. 
WHAT BACLOFEN IS AND WHAT IT IS USED FOR 

Your doctor has decided that you or your child needs this medicine
to help treat your 
condition. 
Baclofen is used to reduce and relieve the excessive tension
in your muscles (spasms) 
occurring in various illnesses such as cerebral palsy, multiple
scelrosis, cerebrovascular 
accidents, spinal cord diseases and other nervous system disorders. 

2. 
BEFORE YOU TAKE BACLOFEN 

DO NOT TAKE BACLOFEN IF  

  you are allergic to baclofen or any of the other ingredients
of Baclofen. 
  you have a stomach ulcer 

YOU MUST TELL YOUR DOCTOR BEFORE TAKING YOUR MEDICINE IF: 

  you have taken a medicine containing baclofen before and had
an unusual or allergic 
reaction to it such as a rash, itching, swelling of the face, lips,
throat or tongue. 
  you suffer from a mental disorder, especially if you are
taking lithium 
  you suffer from liver or kidney disease 
  you have breathing difficulties or lung disease 
  you have d

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
TRADE NAME OF THE MEDICINAL PRODUCT 

Baclofen Tablets BP 10 mg 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each tablet contains Baclofen EP 10 mg. 

3. 
PHARMACEUTICAL FORM 

Tablet for oral use.  

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

Baclofen 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. 

Baclofen 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. 

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. 

Patient selection is
important when initiating Baclofen 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 stabilized. 

4.2 
POSOLOGY AND METHOD OF ADMIN