Frisium

Država: Nova Zelandija

Jezik: angleščina

Source: Medsafe (Medicines Safety Authority)

Aktivna sestavina:

Clobazam 10mg

Dostopno od:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (mednarodno ime):

Clobazam 10 mg

Odmerek:

10 mg

Farmacevtska oblika:

Tablet

Sestava:

Active: Clobazam 10mg Excipient: Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Maize starch Purified talc

Enote v paketu:

Blister pack, 50, 50 tablets

Razred:

Class C5 Controlled Drug

Tip zastaranja:

Class C5 Controlled Drug

Izdeluje:

Sanofi-Aventis Deutschland GmbH

Terapevtske indikacije:

Adjunctive therapy in partial or generalised epilepsy and monotherapy in certain forms of epilepsy such as Lennox-Gastaut and catamenial epilepsy.

Povzetek izdelek:

Package - Contents - Shelf Life: Blister pack, 50 - 50 tablets - 36 months from date of manufacture stored at or below 30°C

Datum dovoljenje:

1983-04-27

Navodilo za uporabo

FRISIUM
®
1
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
Frisium is used to control certain
types of epilepsy. Epilepsy is a
neurological condition in which a
person may experience repeated
seizures (fits).
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 symptoms of an allergic
reaction include skin rash, itching,
shortness of breath or swelling of the
face, lips or tongue, which may cause
difficulty in swallowing or breathi

Lastnosti izdelka

frisium-ccdsv08-dsv11-20jun22
Page 1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Frisium
®
10mg Tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg of 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
Adjunctive therapy in partial or generalised epilepsy and monotherapy
in certain forms of
epilepsy such as Lennox-Gastaut and catamenial epilepsy.
4.2
DOSE AND METHOD OF ADMINISTRATION
Small doses should be used initially, 5-15mg/day, gradually increasing
to a maximum daily dose
of 60mg/day, as directed by the doctor. The possible interference with
alertness and reaction time
must be taken into account. After improvement of the symptoms, the
dose may be reduced. The
fundamental principle is to keep the dose as low as possible. Constant
doses, eg. 20mg/day and
intermittent therapy, discontinuing clobazam and subsequently
prescribing it again, have proved
effective. If the daily dose is divided, the higher proportion should
be taken at night.
Daily doses up to 30mg may be taken as a single dose at night.
frisium-ccdsv08-dsv11-20jun22
Page 2
ADULTS:
20 - 30 mg daily in divided doses or as a single dose at night.
Maximum dose 60 mg.
CHILDREN AND ELDERLY PATIENTS:
Half the adult dose.
Children over 3 years and elderly patients receive half the daily dose
recommended for adults.
Clobazam should not normally be given to children between the age of 6
months and 3 years,
unless it is strictly indicated.
In patients with impaired liver and kidney function, the dosage should
be reduced. Increased
responsiveness and higher susceptibility to adverse effects may be
present in patients with renal or
hepatic impairment, children and elderly patients and require low
initial doses and gradual dose
increments under careful observation (see Section 4.4 Special warnings
and precautions for use).
B