STELAX 10 baclofen 10mg tablet bottle

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

baclofen, Quantity: 10 mg

Dostępny od:

Arrotex Pharmaceuticals Pty Ltd

Forma farmaceutyczna:

Tablet, uncoated

Skład:

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

Droga podania:

Oral

Sztuk w opakowaniu:

100 tablets

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

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.

Podsumowanie produktu:

Visual Identification: Off-white, round, flat bevelled edged tablets, debossed with BL score line 10 on one side and plain on other.; Container Type: Bottle; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Status autoryzacji:

Licence status A

Data autoryzacji:

2003-01-09

Ulotka dla pacjenta

STELAX- Consumer Medicine Information
Page 1 of 5
STELAX
baclofen
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
STELAX.
It does not contain all of the
available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the risks of you taking STELAX
against the benefits they expect
it will have for you.
TALK TO YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY
CONCERNS ABOUT TAKING THIS
MEDICINE.
Keep this leaflet with your
medicine. You may need to read
it again.
WHAT STELAX IS USED FOR
STELAX is used to treat muscle
spasms that occur in various
illnesses such as multiple
sclerosis and diseases and
injuries of the spinal cord.
STELAX belongs to a group of
medicines called muscle
relaxants. These medicines
reduce excess tension in your
muscles that cause spasms and
pain.
Reducing these spasms may help
to increase your mobility and
make everyday activities easier
to manage.
Your doctor may have
prescribed this medicine for
another reason. Ask your doctor
if you have any questions about
why it has been prescribed for
you.
It is available only with a
doctor's prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE STELAX IF YOU ARE
ALLERGIC TO MEDICINES CONTAINING
BACLOFEN
OR ANY OF THE
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, lips, tongue or other
parts of the body; rash, itching
or hives on the skin.
DO NOT TAKE IT IF THE EXPIRY DATE
(EXP.) PRINTED ON THE PACK HAS
PASSED.
DO NOT TAKE IT IF THE PACKAGING
SHOWS SIGNS OF TAMPERING OR THE
TABLETS DO NOT LOOK QUITE RIGHT.
_BEFORE YOU START TO TAKE IT _
TELL YOUR DOCTOR IF YOU ARE
PREGNANT OR INTEND TO BECOME
PREGNANT OR YOU ARE
BREASTFEEDING.
There is very little information
on the use of this medicine in
pregnancy or while breast-
feeding. Your doctor can discuss
with you th

Charakterystyka produktu

1
AUSTRALIAN PRODUCT INFORMATION –
STELAX (BACLOFEN)
TABLETS
1
NAME OF THE MEDICINE
Baclofen.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Stelax tablets come in two strengths and contain either 10 mg or 25 mg
of baclofen.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
STELAX 10,
Round, off-white tablet, marked BL

10 on one side and plain on the other;
STELAX 25,
Round, off-white tablet, marked BL

25 on one side and plain on the other.
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:
o
Skeletal hypertonus
o
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 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, 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 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.
Abrupt discontinuation of treatment should be avoided (see section 4.4
SPECIAL WARNINGS AND
PRECAUTIONS FOR USE).
In adults baclofen should be given in at least three divided doses
daily.
DOSAGE REGIMEN
As a rule, treatment should be started with a dose of 5 mg three times
daily, subsequently in