Lioresal 10 mg Tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Baclofen

Saatavilla:

Novartis Ireland Limited

ATC-koodi:

M03BX; M03BX01

INN (Kansainvälinen yleisnimi):

Baclofen

Annos:

10 milligram(s)

Lääkemuoto:

Tablet

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

Other centrally acting agents; baclofen

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

1983-01-18

Pakkausseloste

PACKAGE LEAFLET: INFORMATION
FOR THE PATIENT LIORESAL® 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 onto
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 doctoor or pharmacist
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lioresal is and what it is used for
2.
What you need to know before you take Lioresal
3.
How to take Lioresal
4.
Possible side effects
5.
How to store Lioresal
6.
Contents of the pack and other information
1.
WHAT LIORESAL IS AND WHAT IT IS USED FOR
Lioresal contains the active ingredient, baclofen. Baclofen is a
muscle-relaxant drug.
Lioresal is used to relieve muscle rigidity (spasticity) or spasms in
adults and children, which may occur as
a result of 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 Lioresal
Do not take Lioresal if:

you are allergic (hypersensitive) to baclofen or any of
the other ingredients of Lioresal (listed in Section 6)
DO NOT TAKE LIORESAL IF ANY OF THE ABOVE APPLY TO YOU. IF YOU ARE NOT
SURE, TALK TO YOUR DOCTOR OR
PHARMACIST BEFORE TAKING LIORESAL.TAKE SPECIAL CARE
Check with your doctor or pharmacist before taking your
medicine if:
•
you have epilepsy
•
you have a mental illness such as schizophrenia,
psychosis, depressive or manic disorders or confusional
states
•
you have high blood pressure
•
you have Parkinson’s disease
•
you have any liver, kidney or lung disease
•
you have diabetes
•
you have difficulties in urinating
•
you have a disturbance of the blood circulation in
your brain

Valmisteyhteenveto

Health Products Regulatory Authority
28 January 2022
CRN00CS45
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lioresal 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg baclofen.
Excipient with known effect: wheat starch 61mg/tablet
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
Circular, flat, bevelled edged white to faintly yellowish tablet with
the letters ‘CG’ on one surface and ‘KJ’ on the other side
with
a single scoreline to facilitate breaking of the tablet for ease of
swallowing. The tablet can be divided into equal doses.
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. syringomyelia, motor neurone disease, transverse
myelitis.
Lioresal is also indicated in adults 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
Baclofen is indicated in patients below 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