Baclofen Thame 10mg/5ml Oral Solution

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

BACLOFEN

Dostępny od:

Syri Pharma Limited Floor 0 1 WML, 1 Windmill Lane Dublin 2, D02 F206, Ireland

Kod ATC:

M03BX01

INN (International Nazwa):

BACLOFEN 10 mg/5ml

Forma farmaceutyczna:

ORAL SOLUTION

Skład:

BACLOFEN 10 mg/5ml

Typ recepty:

POM

Dziedzina terapeutyczna:

MUSCLE RELAXANTS

Status autoryzacji:

Authorised

Data autoryzacji:

2019-09-12

Ulotka dla pacjenta

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
BACLOFEN THAME 10MG/5ML ORAL SOLUTION
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.
The name of your medicine is Baclofen Thame 10mg/5ml Oral Solution but
it will be referred
to as ‘Baclofen’ throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Baclofen is and what it is used for
2. What you need to know before you take Baclofen
3. How to take Baclofen
4. Possible side effects
5. How to store Baclofen
6. Contents of the pack and other information
1. WHAT BACLOFEN IS AND WHAT IT IS USED FOR
Baclofen contains active ingredient baclofen.
Baclofen is a muscle-relaxant drug. Baclofen is 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BACLOFEN
DO NOT TAKE BACLOFEN IF:

you think you may be allergic to baclofen or to any of the other
ingredients of the solution
(these are listed at the end of the leaflet)

you have ever had a stomach ulcer.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Baclofen if:

you have had a stroke

you suffer from epilepsy

you suffer from any mental illness

you are being treated for high blood pressure

you have Parkinson’s disease

you suffer from any liver, kidney or lung disease

you have diabetes

you have difficulties in urinating

you are pregnant

Charakterystyka produktu

VAR/IA-006
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Baclofen Thame 10mg/5ml Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of oral solution contains 10mg of Baclofen.
_Excipients with known effect:_
Each 5ml of oral solution contains 7mg methyl parahydroxybenzoate
(E218), 1.925gm
sorbitol (E420), 6.675mg propylene glycol (E1520) and 8.1mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral Solution
Clear, pale yellow to yellow colour solution with raspberry odour
Sugar Free
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.
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
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.
VAR/IA-006