LIORESAL 10MG TABLET

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

BACLOFEN

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

BACLOFEN

Unit dalam pakej:

50 Tablets

Dikeluarkan oleh:

NOVARTIS FARMA S.P.A.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
LIORESAL
® TABLET
Baclofen (10 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Lioresal is used for
2.
How Lioresal works
3.
Before you use Lioresal
4.
How to use Lioresal
5.
While you are using Lioresal
6.
Side effects
7.
Storage and Disposal of
Lioresal
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT LIORESAL IS USED FOR
Lioresal is one of a group of
medicines called muscle
relaxants.
Lioresal is used to reduce and
relieve the excessive stiffness
and/or spasms in your muscles
occurring in various conditions
such as multiple sclerosis,
diseases or injuries of the spinal
cord, and certain brain diseases.
HOW LIORESAL WORKS
Lioresal improves your ability to
move by relaxing your muscles
and relieving you from pain. This
makes it easier for you to carry
out your daily activities and helps
with physiotherapy.
If you have any questions about
how Lioresal works or why this
medicine has been prescribed to
you, ask your doctor.
BEFORE YOU USE LIORESAL
Follow all the doctor’s
instructions carefully. They may
differ from the general
information contained in this
leaflet.
_- When you must not use it _
Do not take Lioresal if you are
allergic (hypersensitive) to
Lioresal or any of the other
ingredients of Lioresal listed at
the end of this leaflet.
If any of these apply to you, tell
your doctor without taking
Lioresal.
If you think you may be allergic,
ask your doctor for advice.
_PREGNANCY AND BREAST-FEEDING _
Ask your doctor or pharmacist for
advice before taking any
medicine.
You should not use Lioresal
during pregnancy unless your
doctor advises you to do so. Tell
your doctor if you are pregnant,
or are planning to become
pregnant. He or she will discuss
with you the potential risk of
taking Lioresal during pregnancy.
If you have to take Lioresal
during pregnancy, your baby may
have convulsions and other
symptoms related to sudden stop
of treatment just after delivery
(see “Things you must not do”).
Only ve

Ciri produk

Novartis
Confidential
Page 2
Malaysian Package Leaflet
15-Nov-2021
Lioresal
LIORESAL

Antispastic with spinal site of action
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORMS
Lioresal scored tablets: 10 mg of baclofen.
ACTIVE SUBSTANCE
Baclofen
EXCIPIENTS
Silica colloidal anhydrous; cellulose microcrystalline; magnesium
stearate; povidone; wheat
starch.
DESCRIPTION
White to faintly yellowish round, flat tablet with a slightly bevelled
edge with one side
imprinted “CG” and the other side “K/J” and a score.
INDICATIONS
Spasticity of the skeletal muscles in multiple sclerosis.
Spastic conditions occurring in spinal cord diseases of infectious,
degenerative, traumatic,
neoplastic, or unknown origin: e.g. spastic spinal paralysis,
amyotrophic lateral sclerosis,
syringomyelia, transverse myelitits, traumatic paraplegia or
paraparesis, and compression of the
spinal cord; muscle spasticity of cerebral origin, especially where
due to infantile cerebral palsy.
In spasticity due to cerebrovascular accident or degenerative or
neoplastic brain disease,
Lioresal is less suitable owing to the likelihood of intolerance, but
it may be tried if administered
cautiously.
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
Treatment should be initiated with small doses of Lioresal, then
gradually increased. It is
recommended that the lowest effective dose be used. The optimum dosage
must be individually
adapted to the patient’s requirements so that clonus, flexor and
extensor spasms, and spasticity
are reduced, while avoiding adverse effects as far as possible.
In order to prevent excessive weakness and falling, Lioresal must be
used with caution when
spasticity is needed to maintain upright posture and balance in
locomotion or other functions.
It may be important to maintain a certain degree of muscle tone and
allow occasional spasms
to help support circulatory function and, possibly, prevent deep vein
thrombosis.
Novartis
Confidential
Page 3
Malaysian Package Leaflet
15-Nov-2021
Lioresal
Close monitoring is required at the