CLOFEN 10 baclofen 10mg tablet bottle

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

baclofen, Quantity: 10 mg

Dostupné z:

Alphapharm Pty Ltd

Forma lieku:

Tablet, uncoated

Zloženie:

Excipient Ingredients: calcium hydrogen phosphate; sodium starch glycollate; lactose monohydrate; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica

Spôsob podávania:

Oral

Počet v balení:

100 tablets

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

The 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. Baclofen is not recommended in Parkinson's disease or spasticity arising from strokes, cerebral palsy or rheumatoid disorders.

Prehľad produktov:

Visual Identification: 7mm flat bevelled edges white tablet with BN over 10 scored tablet (BN/10) on one side and G on the reverse.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Stav Autorizácia:

Registered

Dátum Autorizácia:

1992-09-17

Príbalový leták

CLOFEN
C
L
O
F
E
N
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 CLOFEN?
CLOFEN contains the active ingredient baclofen. Baclofen belongs to a
group of medicines called muscle relaxants.
CLOFEN 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 CLOFEN? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CLOFEN?
Do not use if you have ever had an allergic reaction to baclofen 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
CLOFEN? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CLOFEN 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 CLOFEN?
•
Your doctor will tell you exactly how many tablets of CLOFEN to take.
•
Do not exceed the recommended dose prescribed by your doctor.
•
Treatment is usually started in hospital with small doses of CLOFEN.
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 CLOFEN? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CLOFEN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
CLOFEN.
•
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 CLOFEN affects you.
•
CLOFEN may cause sleepiness in some peopl

Súhrn charakteristických

AUSTRALIAN PRODUCT INFORMATION
CLOFEN
_baclofen tablet _
1
NAME OF THE MEDICINE
Baclofen
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each CLOFEN 10 and CLOFEN 25 tablet contains baclofen 10 mg and
baclofen 25 mg, as the active
ingredient, respectively.
Excipients with known effect: Sugars as lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
CLOFEN 10, 10mg tablet: white, flat bevelled edged, marked "BN"
breakline "10" on one side and "G" on
the other.
CLOFEN 25, 25mg tablet: white, flat bevelled edged, marked "BN"
breakline "25" on one side and "G" on
the other.
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
- 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
Treatment with baclofen 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 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.
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).
CLOFEN should be taken during meals