LIORESAL 5 MG/5ml Oral Solution

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

BACLOFEN

Dostępny od:

Novartis Pharmaceuticals UK Ltd

Kod ATC:

M03BX01

INN (International Nazwa):

BACLOFEN

Dawkowanie:

5 MG/5ml

Forma farmaceutyczna:

Oral Solution

Typ recepty:

Product subject to prescription which may be renewed (B)

Dziedzina terapeutyczna:

Other centrally acting agents

Status autoryzacji:

Authorised

Data autoryzacji:

1994-04-18

Ulotka dla pacjenta

March 2018
LIORESAL 5 MG/5 ML
ORAL SOLUTION
(BACLOFEN)
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START
TAKING THIS MEDICINE.
• 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. Do not pass it onto
others. It may harm them even if their
symptoms are the same as yours.
• If any of the side effects affects you severely, or if you notice
any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
1. What Lioresal is and what it is used for
2. Before you take Lioresal
3. How to take Lioresal
4. Possible side effects
5. How to store Lioresal
6. Further 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. 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
• you have a history of alcoholism or you drink
alcohol to excess
• you have a disease of your blood pigment

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lioresal 5mg/5ml Oral solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The solution contains 1 mg/1 ml baclofen.
Excipients with known effect: 1.4 mg/ml methyl parahydroxybenzoate
(E218), 0.14 mg/ml propyl
parahydroxybenzoate (E216), 1.62 mg/ml sodium and 550mg/ml sorbital
(E420)
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
A clear, colourless to faintly yellowish slightly viscous solution.
Odour of raspberries.
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
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Lioresal is given orally in either tablet or liquid form. These two
formulations are bioequivalent. The liquid may be
particularly