LIORESAL 25 baclofen 25 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

baclofen, Quantity: 25 mg

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: colloidal anhydrous silica; wheat starch; microcrystalline cellulose; magnesium stearate; povidone

Administration route:

Oral

Units in package:

100

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Suppression of voluntary muscle spasm in: *Multiple sclerosis, *Spinal lesions of traumatic, infectious, degenerative, neoplastic and unknown origin, causing: - skeletal hypertonus - spastic and dyssynergic bladder dysfunction. Not recommended in Parkinson's disease or spasticity arising from strokes, cerebral palsy or rheumatoid disorders

Product summary:

Visual Identification: white scored tablet marked UR, CG on reverse; Container Type: Bottle; Container Material: HDPE; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-08-02

Patient Information leaflet

LIORESAL
® TABLETS
_Baclofen_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Lioresal.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Lioresal
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT LIORESAL IS USED
FOR
Lioresal belongs to a group of
medicines called muscle relaxants.
This medicine is used to reduce the
excessive stiffness and/or spasms in
your muscles. These spasms happen
in various illnesses such as multiple
sclerosis and diseases or injuries of
the spinal cord.
Because this medicine reduces
spasms and the pain that goes with
them, it helps to make you more
mobile and better able to manage
your daily activities.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY LIORESAL HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
Lioresal is only available with a
doctor's prescription.
BEFORE YOU TAKE
LIORESAL
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE LIORESAL IF YOU HAVE
EVER HAD AN ALLERGIC REACTION AFTER
TAKING:
•
baclofen (the active ingredient in
Lioresal)
•
any of the other ingredients listed
at the end of this leaflet
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing; swelling of the face, lip

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – LIORESAL (BACLOFEN)
TABLETS
1
NAME OF THE MEDICINE
The active ingredient of Lioresal is a gamma-aminobutyric acid
derivative, baclofen, or

-
(Aminomethyl)-p-chlorohydrocinnamic acid, a racaemic mixture of the
R(-) and S(+) isomers.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Baclofen is a white or almost white, odourless or practically
odourless, crystalline powder. It is
slightly soluble in water, very slightly soluble in methanol and
insoluble in chloroform.
Lioresal tablets contain 10 mg or 25 mg baclofen. The tablets also
contain the following excipients:
colloidal anhydrous silica, microcrystalline cellulose, magnesium
stearate, povidone, wheat starch.
Excipient with known effect: wheat starch. Wheat starch may contain
gluten, but only in trace
amounts.
3
PHARMACEUTICAL FORM
Tablets containing baclofen 10mg: white, round, flat with bevelled
edges; marked with KJ and score,
CG on reverse. Bottles of 100.
Tablets containing baclofen 25mg: white, round, flat with bevelled
edges; marked with UR and score,
CG on reverse. Bottles of 100 and blister packs of 50 and 100.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Suppression of voluntary muscle spasm in:
•
Multiple sclerosis
•
Spinal lesions of traumatic, infectious, degenerative, neoplastic and
unknown origin, causing:
-
skeletal hypertonus
-
spastic and dyssynergic bladder dysfunction
Not recommended in Parkinson's disease or spasticity arising from
strokes, cerebral palsy or
rheumatoid disorders.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Treatment with Lioresal should always be started in hospital, using
small doses which are then
gradually increased in a stepwise manner. The lowest dose compatible
with an optimal response is
recommended. The optimum daily dosage should be individualised so that
clonus, flexor and
extensor spasms, and spasticity are reduced, at the same time
retaining enough muscle tone to
permit active movements and avoiding adverse effects as far as
possible.
2
In order to prevent excessive weak