Colmifen 10

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BACLOFEN

Available from:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC code:

M03BX01

INN (International Name):

BACLOFEN 10 mg

Pharmaceutical form:

TABLET

Composition:

BACLOFEN 10 mg

Prescription type:

POM

Therapeutic area:

MUSCLE RELAXANTS

Authorization status:

Authorised

Authorization date:

2007-02-15

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COLMIFEN 10 MG TABLETS
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 Colmifen is and what it is used for
2. What you need to know before you take Colmifen
3. How to take Colmifen
4. Possible side effects
5.
How to store Colmifen
6. Contents of the pack and other information
1.
WHAT IS COLMIFEN AND WHAT IT IS USED FOR
Colmifen contains the active substance baclofen.
Baclofen is a muscle-relaxant drug. Colmifen 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COLMIFEN
DO NOT TAKE COLMIFEN:
•
if you think you may be allergic to baclofen or any other ingredients
of the tablets
(listed in section 6).
•
if you have ever had a stomach ulcer.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking baclofen if you:
-
have a history of alcoholism, you drink alcohol to excess or you have
a history of
drug abuse or dependence.
Some people being treated with baclofen have had thoughts of harming
or killing
themselves or have tried to kill themselves. Most of these people also
had depression,
had been using alcohol excessively or were prone to having thoughts of
killing
themselves. If you have thoughts of harming or killing yourself at any
time, speak to your
doctor

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Colmifen 10 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg baclofen.
Excipient(s) with known effect
This product contains 67.3 mg lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
White, round, flat, scored tablets.
The tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Colmifen 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
spinal cord.
Colmifen 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 Colmifen 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
Colmifen 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.
Colmifen 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
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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
Colmifen is given orally in tablet