Ease-A-Cold Cold & Congestion Day & Night

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

Echinacea purpurea,Valeriana officinalis,zinc citrate dihydrate

Saadav alates:

Pharmacare Laboratories Pty Ltd

INN (Rahvusvaheline Nimetus):

Echinacea purpurea,Valeriana officinalis,zinc citrate dihydrate

Klass:

Medicine Listed

Volitamisolek:

Listed

Infovoldik

FRISIUM
®
_clobazam_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Frisium.
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 FRISIUM 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.
Frisium belongs to a group of
medicines called benzodiazepines.
They are thought to work by their
action on brain chemicals.
In general, benzodiazepines such as
Frisium 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
Frisium 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
FRISIUM
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE FRISIUM 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 FRISIUM (CLOBAZAM) IF
YOU ARE ALLERGIC TO IT OR ANY OTHER
MEDICINE FROM THE BENZODIAZEPINE
GROUP OF MEDICINES OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Some

Toote omadused

frisium-ccdsv8-piv9-16jan20
1
AUSTRALIAN PRODUCT INFORMATION – FRISIUM (CLOBAZAM)
UNCOATED TABLET
1
NAME OF THE MEDICINE
Clobazam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
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
White, round, scored tablets marked B/GL with Hoechst logo on reverse.
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. Frisium
is approved for short term use only (up to one month) in the treatment
of anxiety and sleep
disorders.
The 10mg tablets can be divided into equal halves of 5mg.
frisium-ccdsv8-piv9-16jan20
2
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 not be reached for several days for clobazam itself and longer
for its principal metabolite.
Patients wi