LIORESAL 10 TABLET

Država: Južnoafriška republika

Jezik: angleščina

Source: South African Health Products Regulatory Authority (SAHPRA)

Dostopno od:

Novartis South Africa (Pty) Ltd

Odmerek:

See ingredients

Farmacevtska oblika:

TABLET

Sestava:

EACH TABLET CONTAINS BACLOFEN 10 mg

Status dovoljenje:

Registered

Datum dovoljenje:

1974-04-04

Navodilo za uporabo

LIORESAL
(Baclofen)
10 mg and 25 mg, tablets
Patient Information Leaflet
Document status:
Final
Approval date:
12 May 2022
Novartis
Page 2 of 13
12 May 2022
Patient Information Leaflet
Lioresal
SCHEDULING STATUS: S4
LIORESAL 10 TABLETS
LIORESAL 25 TABLETS
Baclofen
PLEASE READ THIS LEAFLET CAREFULLY BEFORE USING LIORESAL

Keep this leaflet. You may need to read it again.

If you have any further questions, please ask your doctor or your
pharmacist.

LIORESAL has been prescribed for you personally and you should not
share your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
WHAT THIS LEAFLET CONTAINS:
1. What LIORESAL is and what it is used for
2. What you need to know before you take or use LIORESAL
3. How to take or use LIORESAL
4. Possible side effects
5. How to store LIORESAL
6. Contents of the pack and other information
Novartis
Page 3 of 13
12 May 2022
Patient Information Leaflet
Lioresal
1. WHAT LIORESAL IS AND WHAT IT IS USED FOR
WHAT LIORESAL IS
The active substance of LIORESAL tablets is baclofen.
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 tension (spasms)
in your muscles occurring in
various conditions such as multiple sclerosis, diseases or injuries of
the spinal cord, and certain brain
diseases.
Due to the relaxation of muscle and the consequent relief from pain,
LIORESAL improves your ability
to move, makes it easier for you to manage your daily activities and
facilitates physiotherapy.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OR USE LIORESAL
BEFORE TAKING THE MEDICINE:
It is important to tell your doctor if you have other medical problems
or if you are taking other
medicines
DO NOT TAKE LIORESAL
•
IF YOU ARE ALLERGIC to baclofen or any of the other ingredients of
LIORESAL listed in section 6
•
Porphyria
Novartis
Page 4 of 13
12 May 2022
Patient Information Leaflet
Lioresal
If you think you may be allergic, ask your doctor for advice
TAKE SPECIAL

Lastnosti izdelka

LIORESAL
(Baclofen)
10 mg and 25 mg, tablets
Professional Information
Document status:
Final
Approval date:
12 May 2022
Novartis
Page 2 of 19
12 May 2022
Professional Information
Lioresal
SCHEDULING STATUS: S4
1. NAME OF MEDICINAL PRODUCT
LIORESAL 10
®
Tablets
LIORESAL 25
®
Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
LIORESAL 10
®
: Tablets containing 10 mg baclofen.
LIORESAL 25
®
: Tablets containing 25 mg baclofen
For a full list of excipients see section 6.1 – List of excipients
3. PHARMACEUTICAL FORM
LIORESAL 10
®
:
White to faintly yellowish, round, flat tablets with a slightly
bevelled edge. One side carries the
debossment “CG”, the other the debossment “K”, score, “J”.
Diameter approximately 7 mm. Thickness
approximately 3 mm.
LIORESAL 25
®
:
White to faintly yellowish, round, flat tablets with a slightly
bevelled edge with the CG inscription on
one side and the UR inscription with brake scored on the other side.
Diameter approximately 8 mm.
Thickness approximately 3.2 mm.
Novartis
Page 3 of 19
12 May 2022
Professional Information
Lioresal
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
Spasticity of the skeletal muscle due to multiple sclerosis; spastic
conditions occurring in spinal-cord
diseases of infectious, degenerative, traumatic, neoplastic, or
unknown aetiology – e.g. spastic spinal
paralysis, amyotrophic lateral sclerosis, syringomyelia, transverse
myelitis, traumatic paraplegia or
paraparesis, and compression of the spinal cord.
Spasticity of cerebral origin, e.g. following cerebrovascular
accidents or in the presence of neoplastic
or degenerative brain disease.
4.2 POSOLOGY AND METHOD OF ADMINISTATION
Treatment should always be initiated with small, gradually increasing
doses of LIORESAL. The
optimum daily dosage should be individually adapted to the patient's
requirements in such a way that
clonus, flexor and extensor spasms, and spasticity are reduced, but
that a sufficient degree of muscle
tone is maintained to permit active movements and adverse effects are