CLOBIUM clobazam 10 mg tablet bottle

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

clobazam, Quantity: 10 mg

Fáanlegur frá:

Pharmacor Pty Ltd

Lyfjaform:

Tablet, uncoated

Samsetning:

Excipient Ingredients: colloidal anhydrous silica; magnesium stearate; pregelatinised maize starch; lactose monohydrate; purified talc

Stjórnsýsluleið:

Oral

Einingar í pakka:

100 tablets - Hospital Packs only, 500 tablets - Hospital Packs only

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

Clobazam is indicated in Adults -Short term use (up to one month) for the symptomatic management of acute anxiety and sleep disturbances associated with anxiety and in Children (4 years of age and over) - As adjunctive therapy in patients with partial refractory and Lennox-Gastaut epilepsy types who are not adequately stabilized with their current anticonvulsant therapy.

Vörulýsing:

Visual Identification: White to off white oval shaped uncoated tablets with a functional score on one side and "C" and "10" debossed on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Leyfisstaða:

Registered

Leyfisdagur:

2020-06-22

Upplýsingar fylgiseðill

CLOBIUM
Ver 01
Page 1 of 4
CLOBIUM
_clobazam_
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CLOBIUM.
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 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 CLOBIUM IS
USED FOR
ADULTS
Used to treat anxiety and sleep
disturbances associated with
anxiety. Anxiety or tension
associated with the normal stress of
everyday life usually does not
require treatment with medicines.
CHILDREN
Used along with other medicines
to
treat
partial
refractory
and
Lennox- Gastaut epilepsy (fits) in
children 4 years of age or older.
CLOBIUM belongs to a group of
medicines called benzodiazepines.
They are thought to work by their
action on brain chemicals.
In general, benzodiazepines such as
CLOBIUM should be taken for short
periods only (up to one month).
Continuous long term use is not
recommended unless advised by
your doctor. The prolonged use of
benzodiazepines may lead to
dependence on the medicine.
Your doctor, however, may prescribe
CLOBIUM for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
CLOBIUM
_ _
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE CLOBIUM IF YOU
HAVE:

severe or chronic lung disease

a history of drug or alcohol abuse

severe muscle weakness
known as myasthenia gravis

sleep apnoea syndrome where
you snore heavily and stop
breathing during the night

severely reduced liver function.
DO NOT TAKE CLOBIUM (CLOBAZAM)
IF YOU ARE ALLERGIC TO IT OR ANY OTHER
MEDICINE FROM THE BENZODIAZEPINE
GROUP OF MEDICINES OR ANY OF THE
INGREDIENTS LISTED

Vara einkenni

CLOBIUM
Ver 01
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION -
CLOBIUM (CLOBAZAM) TABLETS
1.
NAME OF THE MEDICINE
Clobazam
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each CLOBIUM tablet contains 10 mg Clobazam.
Excipient with known effect(s): Lactose monohydrate
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
CLOBIUM tablets appear as white to off white oval shaped uncoated
tablets with a functional
score on one side and "C" and "10" debossed on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS
Short term use (up to one month) for the symptomatic management of
acute anxiety and sleep
disturbances associated with anxiety.
CHILDREN (4 YEARS OF AGE AND OVER)
As adjunctive therapy in patients with partial refractory and
Lennox-Gastaut epilepsy types
who are not adequately stabilized with their current anticonvulsant
therapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
Where
possible
benzodiazepines
should
not
be
administered
over
prolonged
periods.
CLOBIUM is approved for short term use only (up to one month) in the
treatment of anxiety
and sleep disorders.
The 10 mg tablets can be divided into equal halves of 5 mg.
CLOBIUM
Ver 01
Page 2 of 17
ANXIETY STATES AND SLEEP DISORDERS:
_ADULTS _
The usual dose is 10 to 30 mg daily (1 to 3 tablets) in a single or
divided dosage. Doses of up
to 60 to 80 mg daily have been used in the treatment of hospitalised
adult patients with severe
anxiety states. Due regard must be paid to the possibility of
interference with alertness and
reaction
time.
After
improvement
of
the
symptoms,
the
dose
may
be
reduced.
The
fundamental principle is to keep the dose as low as possible.
Geriatric
patients
may
be
given
one
10
mg
tablet
once
or
twice
daily.
Increased
responsiveness and higher susceptibility to adverse effects may be
present in elderly patients
and require low initial doses and gradual dose increments under
careful observation.
It should be kept in mind that after each change in dosage, a new
steady state plasma level
will no