APO-BACLOFEN baclofen 10mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

baclofen, Quantity: 10 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose; maize starch

Administration route:

Oral

Units in package:

100 tablets

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 and spastic and dyssynergic bladder dysfunction.

Product summary:

Visual Identification: white, oval shaped, flat-faced, bevel-edged tablets scored and engraved "APO B10" on one side, plain on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2001-03-01

Patient Information leaflet

APO-BACLOFEN TABLETS
_Contains the active ingredient baclofen_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
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 THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Baclofen Tablets. It contains the
active ingredient baclofen.
It is used to treat:
•
multiple sclerosis
•
spinal cord damage resulting
from disease or physical injury
Baclofen belongs to a group of
medicines called muscle relaxants. It
is used to reduce excess tension in
your muscles which causes spasms.
Because this medicine reduces
spasms and the pain that goes with
them, it helps to make you more
mobile. This helps you to manage
your daily activities more easily.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
There is no evidence that this
medicine is addictive.
This medicine is available only with
a doctor's prescription.
_USE IN CHILDREN_
Baclofen should be used with
extreme caution in children under 16
years of age as only limited
information is available. Baclofen
should not be used in children who
weigh less than 33 kg.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
baclofen
•
any of the ingredients listed at the
end of this leaflet
Symptoms of an allergic reaction
may include:
•
cough, shortness of breath,
wheezing or difficulty breathing
•
swelling of the face, lips, tongue,
throat or other parts of the body
�

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-BACLOFEN (BACLOFEN) TABLETS
1
NAME OF THE MEDICINE
Baclofen
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg or 25 mg of baclofen.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APO-BACLOFEN 10 MG TABLETS
White, oval, flat-faced, bevel-edged tablets, scored and engraved
“APO B10” on one side.
APO-BACLOFEN 25 MG TABLETS
White, round, flat-faced, bevel-edged tablets, scored on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Suppression of voluntary muscle spasm in:
▪
Multiple sclerosis;
▪
Spinal lesions of traumatic, infectious, degenerative, neoplastic and
unknown origin,
causing skeletal hypertonus and spastic and dyssynergic bladder
dysfunction.
Baclofen is not recommended in Parkinson's disease or spasticity
arising from strokes,
cerebral palsy or rheumatoid disorders.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Baclofen 10 mg and 25 mg tablets are intended for oral
administration.
DOSAGE
Treatment with baclofen should always be started in hospital using
small doses, which are
then gradually increased stepwise. The lowest dose compatible with an
optimal response is
recommended. The optimum daily dosage should be individually adapted
to each patient's
requirements, so that clonus, flexor and extensor spasms, and
spasticity are reduced, while at
the same time retaining enough muscle tone to permit active movements,
and avoiding
adverse effects as far as possible.
In order to prevent excessive weakness and falling, baclofen 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.
2
Abrupt discontinuation of treatment should be avoided (see section 4.4
SPECIAL WARNINGS AND
PRECAUTIONS FOR USE).
Baclofen should be taken during