LIORESAL TABLETS 10 MG

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

BACLOFEN

Disponible des:

NOVARTIS ISRAEL LTD

Codi ATC:

M03BX01

formulario farmacéutico:

TABLETS

Composición:

BACLOFEN 10 MG

Vía de administración:

PER OS

tipo de receta:

Required

Fabricat per:

NOVARTIS FARMA S.P.A., ITALY

Grupo terapéutico:

BACLOFEN

Área terapéutica:

BACLOFEN

indicaciones terapéuticas:

Muscle spasticity of various origins.

Data d'autorització:

2020-11-30

Informació per a l'usuari

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
THE MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY
LIORESAL
® 10 MG TABLETS
LIORESAL
® 25 MG TABLETS
COMPOSITION:
Each tablet contains:
Each tablet contains:
baclofen 10 mg
baclofen 25 mg
Inactive ingredients and allergens: see section 2 "Important
information about
some of this medicine's ingredients" and section 6 “Further
information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This
leaflet contains concise information about the medicine. If you have
further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not
pass it on to others. It may harm them even if it seems to you that
their
ailment is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Lioresal is intended for muscle spasms caused by different factors.
THERAPEUTIC GROUP:
Antispastic with spinal site attack.
Lioresal is used to reduce and relieve excessive muscle stiffness
and/or
spasms due to various diseases and conditions.
Muscle relaxation by Lioresal improves the ability to move and makes
it easier
to perform daily activities.
If you have questions about how Lioresal works or why this medicine
has
been prescribed for you, refer to the doctor.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
You are sensitive (allergic) to baclofen or to any of the other
ingredients
of the medicine, see section 6.
•
You have or have ever had a stomach ulcer.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH LIORESAL, TELL THE DOCTOR IF:
•
You had a stroke.
•
You have epilepsy.
•
You have any mental illness.
•
You are being treated for high blood pressure.
•
You have Parkinson’s disease.
•
You suffer from liver, kidney or lung disease.
•
You have diabetes.
•
You have difficulties in urinating.
•
You are pregnant or breastfeeding (see section “Pregnancy and
breastfeeding”).
•
You have an intolerance to wheat s

Fitxa tècnica

LIO
API JAN22 V1 Page 1 of 10
1.
NAME OF THE MEDICINAL PRODUCT
Lioresal
®
Tablets 10mg
Lioresal
®
Tablets 25mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is: Baclofen =
(β-(Aminomethyl)-p-chlorohydrocinnamic acid a
racemic mixture of the R,(-) and S, (+) isomers).
One tablet contains 10mg baclofen
One tablet contains 25mg baclofen
Excipient(s) with known effect:
Wheat starch (containing gluten)
For excipients see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lioresal is indicated for muscle spasticity of various origins.
4.2
POSOLOGY AND METHOD OF 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.
In order to prevent excessive weakness and falling, Lioresal should be
used with caution
when spasticity is needed to sustain upright posture and balance in
locomotion or
whenever spasticity is used to maintain function. It may be important
to maintain some
degree of muscle tone and allow occasional spasms to help support
circulatory function.
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.
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 serious adverse effects have occurred (see
Section 4.4).
ADULTS:
Treatment should be started with a dosage of 15 mg daily, preferably
in 2 to 4 divided
doses. Dose should be titrated upwards cautiously, by 15 mg/day
increments at 3-day
intervals until the requisite daily dosage has been attained. In
certain patients reacting
LIO
API JAN22 V1 Page 2 of 10
sens