LIORESAL 25 baclofen 25 mg tablet blister pack

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

Administration route:

Oral

Units in package:

50 tablets, 100 tablets

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: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1999-03-18

Patient Information leaflet

LIORESAL
® TABLETS
L
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING LIORESAL?
Lioresal contains the active ingredient baclofen. Lioresal belongs to
a group of medicines called muscle relaxants.
Lioresal is used to reduce the stiffness or spasms in your muscles to
help make you more mobile and able to manage your daily
activities.
For more information, see Section 1. Why am I using Lioresal? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LIORESAL?
Do not use if you have ever had an allergic reaction to Lioresal or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Lioresal? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Lioresal and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE LIORESAL?
•
Your doctor will tell you exactly how many tablets of Lioresal to
take.
•
Do not exceed the recommended dose prescribed by your doctor.
•
Treatment is usually started in hospital with small doses of Lioresal.
The dose is then gradually increased to an amount that
works best for you
More instructions can be found in Section 4. How do I use Lioresal? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LIORESAL?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Lioresal.
•
Keep all doctor's appointments, so that your progress can be checked.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly, unless your doctor tells you
to
DRIVING
OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how Lioresal affects you

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