Baclofen 10mg tablets

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Baclofen

متاح من:

Mawdsley-Brooks & Company Ltd

ATC رمز:

M03BX01

INN (الاسم الدولي):

Baclofen

جرعة:

10mg

الشكل الصيدلاني:

Oral tablet

طريقة التعاطي:

Oral

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 10020200

نشرة المعلومات

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 disea

خصائص المنتج

1
NAME OF THE MEDICINAL PRODUCT
BACLOFEN TABLETS BP 10mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg Baclofen PhEur.
Excipient with known effect:_ _Lactose PhEur 89.50mg
_ _
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
White to off-white uncoated tablets.
White to off-white, circular, biconvex uncoated tablets impressed
“C” on one face,
and the identifying letters “B” “L” on either side of a
central division line on the
reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Baclofen is indicated for:
1) The relief of spasticity of voluntary muscle resulting from
disorders such as multiple
sclerosis and other spinal lesions, including tumours of the spinal
cord, motor neurone
disease, syringomyelia, transverse myelitis and traumatic partial
section of the spinal cord.
2) Adults and children in the relief of spasticity of voluntary muscle
arising from conditions
such as cerebral palsy, cerebrovascular accidents, traumatic head
injury and meningitis.
Treatment with Baclofen should not be initiated until the spastic
state has become stabilised
and it should be administered selectively; it is most likely to be of
benefit to patients whose
spasticity constitutes a handicap to activities 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.
4.2
POSOLOGY