LIORESAL 10 TABLET 10 mg

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

BACLOFEN

Διαθέσιμο από:

NOVARTIS (SINGAPORE) PTE LTD

Φαρμακολογική κατηγορία (ATC):

M03BX01

Δοσολογία:

10 mg

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

BACLOFEN 10 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

NOVARTIS FARMA S P A

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

1991-01-07

Φύλλο οδηγιών χρήσης

LIORESAL


Antispastic with spinal site of action 
DESCRIPTION AND COMPOSITION  
PHARMACEUTICAL FORMS 
Lioresal scored tablets: 10 mg of baclofen. 
ACTIVE SUBSTANCE 
Baclofen 
ACTIVE MOIETY 
Baclofen 
EXCIPIENTS 
TABLETS
: silica aerogel; cellulose, microcrystalline; magnesium stearate;
polyvidone; wheat 
starch. 
Pharmaceutical formulations may vary between countries. 
INDICATIONS 
ADULT AND PAEDIATRIC POPULATION (6-<18 YEARS)  
Lioresal is indicated 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.  
DOSAGE AND ADMINISTRATION 
DOSAGE 
Treatment should always be initiated with small,
gradually increasing doses of Lioresal. The 
lowest dose compatible with an optimal response is recommended.
The optimum daily dosage 
should be individualized in such a way that clonus, flexor and
extensor spasms and spasticity 
are reduced, but adverse effects are avoided as far as
possible. 
If no benefit is apparent within 6 to 8 weeks of
achieving the maximum dosage, a decision 
should be taken whether to continue with Lioresal.  
Novartis   Page 
2 
Country Specific Package Leaflet (Singapore)30 Jul 2012 
Lioresal 

Discontinuation of the treatment should always be
gradual by successively reducing the 
dosage over a period of approximately 1 to 2 weeks, except in
overdose-related emergencies, 
or where serio

Αρχείο Π.Χ.Π.

Lioresal Nov 2021.SIN
Page 1 of 11
LIORESAL

Antispastic with spinal site of action
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORMS
Lioresal scored tablets: 10 mg of baclofen.
ACTIVE SUBSTANCE
Baclofen
EXCIPIENTS
TABLETS
:
silica
colloidal
anhydrous;
cellulose,
microcrystalline;
magnesium
stearate;
povidone; wheat starch.
Pharmaceutical formulations may vary between countries.
INDICATIONS
ADULT AND PAEDIATRIC POPULATION (6-<18 YEARS)
Lioresal is indicated 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.
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
Treatment should always be initiated with small, gradually increasing
doses of Lioresal. The
lowest dose compatible with an optimal response is recommended. The
optimum daily dosage
should be adapted to each individual in such a way that clonus, flexor
and extensor spasms and
spasticity are reduced, but adverse effects are avoided as far as
possible.
If no benefit is apparent within 6 to 8 weeks of achieving the maximum
dosage, a decision
should be made whether to continue using Lioresal.
Discontinuation of treatment should always be gradual by successively
reducing the dosage
over a period of approximately 1 to 2 weeks, except in
overdose-related emergencies, or where
serious adverse effects have occurred (see section WARNINGS AND
PRECAUTIONS).
Lioresal Nov 2021.SIN
Page 2 of 11
ADULTS
Treatment should be started with a dosage of 15 mg daily, preferably
in 3 divided doses. The
dose should be titrated upwards cautiously by 1