TEVA BACLOFEN 10 TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Teva Pharmaceuticals (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS BACLOFEN 10,0 mg

Authorization status:

Registered

Authorization date:

2008-10-10

Patient Information leaflet

TEVA PHARMACEUTICALS (PTY) LTD.
TEVA BACLOFEN 10, tablets
Each tablet contains 10 mg baclofen
Page
1
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APPROVED PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S4
TEVA BACLOFEN 10, TABLETS
BACLOFEN
CONTAINS SUGAR (LACTOSE MONOHYDRATE 65,2 MG PER TABLET)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN TEVA BACLOFEN
10:
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other healthcare provider.
•
TEVA BACLOFEN 10 has been prescribed for you personally and you should
not share your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
WHAT IS IN THIS LEAFLET:
1.
What TEVA BACLOFEN 10 is and what it is used for
2.
What you need to know before you take TEVA BACLOFEN 10
3.
How to take TEVA BACLOFEN 10
4.
Possible side effects
5.
How to store TEVA BACLOFEN 10
6.
Contents of the pack and other information
1.
WHAT TEVA BACLOFEN 10 IS AND WHAT IT IS USED FOR:
Baclofen belongs to a group of medicines called muscle relaxants.
These medicines work by acting on the central
nervous system and may be used for the relief of muscle spasms,
cramping or tightness
TEVA PHARMACEUTICALS (PTY) LTD.
TEVA BACLOFEN 10, tablets
Each tablet contains 10 mg baclofen
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caused by conditions such as:
• multiple sclerosis
• diseases of the spinal cord
• other injuries or diseases which affect the brain and nervous
system.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEVA BACLOFEN 10:
DO NOT TAKE TEVA BACLOFEN 10:
•
if you are hypersensitive (allergic) to baclofen or any of the other
ingredients of TEVA BACLOFEN 10
(listed in section 6).
•
if you are pregnant or breastfeeding your baby.
•
If you suffer from a condition known as porphyria
WARNINGS AND PRECAUTIONS:
TAKE SPECIAL CARE WITH TEVA BACLOFEN 10:
Check with your doctor or pharmacist before taking TEVA BACLOFEN 10 if
you:
•
have a history of drug abuse or dependence
•
suffer from any issues with your posture and balance
•
suffer from

Summary of Product characteristics

TEVA PHARMACEUTICALS (PTY) LTD.
TEVA BACLOFEN 10, tablets
Each tablet contains 10 mg baclofen
Page
1
of
18
APPROVED PROFESSIONAL INFORMATION
SCHEDULING STATUS
S4
1. NAME OF THE MEDICINE:
TEVA BACLOFEN 10 (Tablets)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each tablet contains baclofen 10 mg.
_Excipient with known effect:_
Contains sugar (lactose monohydrate 65,2 mg per tablet)
_ _
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM:
Tablets
White, round, plain, flat, bevelled edged tablets with breakline on
one side and engraved 3K2 on the
reverse.
The breakline can be used to divide the tablet into equal halves.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Spasticity of the skeletal muscle due to multiple sclerosis; spastic
conditions occurring in spinal-
cord diseases of infectious, degenerative, traumatic, neoplastic, or
unknown etiology, e.g. spastic
TEVA PHARMACEUTICALS (PTY) LTD.
TEVA BACLOFEN 10, tablets
Each tablet contains 10 mg baclofen
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spinal
paralysis,
amyotrophic
lateral
sclerosis,
syringomyelia,
transverse
myelitis,
traumatic
paraplegic or paraparesis, and compression of the spinal cord.
Spasticity of cerebral origin, e.g. following cerebrovascular
accidents or in the presence of neoplastic
or degenerative brain disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Treatment should always be initiated with small, gradually increasing
doses of TEVA BACLOFEN
10. The optimum daily dosage should be individually adapted to the
patient's requirements in such
a way that clonus, flexor and extensor spasms, and spasticity are
reduced, but that a sufficient degree
of muscle tone is maintained to permit active movements and adverse
effects are avoided as far as
possible.
In order to prevent excessive weakness and falling, TEVA BACLOFEN 10
should be used with
caution when spasticity is needed to sustain upright posture and
balance in locomotion or whenever
spasticity is used to maintain function. It may be important to
maintain some degree of muscle tone
and all