Lioresal 10mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Baclofen

Dostępny od:

DE Pharmaceuticals

Kod ATC:

M03BX01

INN (International Nazwa):

Baclofen

Dawkowanie:

10mg

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 10020200

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
LIORESAL
® 10MG TABLETS
(baclofen)
This product is available using the above name Lioresal 10mg
Tablets but will be referred to as Lioresal Tablets throughout this
leaflet.
WHAT YOU NEED TO KNOW ABOUT LIORESAL TABLETS
Your doctor has decided that you or your child need this medicine
to help treat your condition.
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU
START TO TAKE YOUR MEDICINE. IT CONTAINS
IMPORTANT INFORMATION.

Keep the leaflet in a safe place because you may want to
read it again.

If you have any other questions, or if there is something you
don’t understand, please ask your doctor or pharmacist.

This medicine has been prescribed for you. Never give it to
someone else. It may not be the right medicine for them
even if their symptoms seem to be the same as yours.

If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1.
What Lioresal Tablets are and what they are used for
2.
Things to consider before you start to take Lioresal Tablets
3.
How to take Lioresal Tablets
4.
Possible side effects
5.
How to store Lioresal Tablets
6.
Further information
1.
WHAT LIORESAL TABLETS ARE AND WHAT THEY
ARE USED FOR_ _
Lioresal Tablets contain 10mg of the active ingredient baclofen.
Baclofen is a muscle-relaxant drug. Lioresal 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.
THINGS TO CONSIDER BEFORE YOU START TO TAKE
LIORESAL TABLETS
SOME PEOPLE MUST NOT TAKE LIORESAL TABLETS. TALK
TO YOUR DOCTOR IF:

you think you may be allergic to baclofen or to any of the
other ingredients of the tablets, (These are listed at the end
of the leaflet.)

you have ever had a stomach ulcer.
YOU SHOULD ALSO ASK YOURSELF THESE QUESTIONS BEFORE
TAKING LIORESAL TABLETS:


Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lioresal
®
Tablets 10mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is:
β
-(Aminomethyl)-p-chlorohydrocinnamic acid (=
baclofen), a racemic mixture of the R,(-) and S, (+) isomers.
One tablet contains 10mg baclofen Ph. Eur.
For excipients see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Tablet, scored
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lioresal 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.
Lioresal 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 Lioresal 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
Lioresal 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.
Lioresal 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
DOSAGE
Lioresal is given orally in either tablet or liquid form. These two
formulations
are bioequivalent. The liquid may be particularly suita