Baclofen 10mg tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Baclofen

可用日期:

Teva UK Ltd

ATC代码:

M03BX01

INN（国际名称）:

Baclofen

剂量:

10mg

药物剂型:

Oral tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 10020200; GTIN: 5017007112631

资料单张

BACLOFEN 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.
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
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 a muscle relaxant that acts on the
central nervous system.
Baclofen Tablets are used:
•
to treat muscle rigidity caused by brain injury
•
to reduce and relieve cramping, muscle rigidity,
the excessive tension in your muscles (spasms)
occurring in various illnesses such as cerebral
palsy, multiple sclerosis, cerebrovascular
accidents, spinal cord diseases, injuries to the
spinal cord and other nervous system disorders.
Your doctor may sometimes prescribe these tablets
for other reasons. If you have any questions ask
your doctor or pharmacist for information.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
BACLOFEN
DO NOT TAKE BACLOFEN IF YOU:
•
are allergic to baclofen or any of the other
ingredients of this medicine (listed in section 6)
•
suffer from stomach ulcers.
CHILDREN AND ADOLESCENTS:
Baclofen tablets are not suitable for use in children
under 33 kg body weight.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING
BACLOFEN IF YOU:
•
suffer from schizophrenia, psychotic, depressive
or manic disorders (any mental illness)
•
suffer from Parkinson’s diseas

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Baclofen 10 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of Baclofen.
Excipients with known effect:
Each tablet contains 65.2 mg lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, plain flat bevelled edged tablet. Engraving: Breakline: 3K2
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Baclofen tablets are indicated to relieve the spasticity of voluntary
muscle which may
arise when suffering from disorders such as multiple sclerosis and
other spinal lesions
eg: motor neurone disease, syringomyelia, transverse myelitis, tumours
and traumatic
partial section of the spinal cord.
Baclofen is also indicated for the relief of voluntary muscle
spasticity arising from, for
example, cerebrovascular accidents, cerebral palsy, meningitis and
traumatic head
injury.
Treatment with baclofen is likely to be most beneficial in patients
whose spasticity
makes activity and/or physiotherapy difficult. Treatment should not be
started until the
spastic state has 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 _
The overall degree of clinical improvement that the patient may expect
to achieve with
baclofen therapy should be evaluated before treatment is initiated.
Increases in dosage
MUST be carefully considered whil