RIVOTRIL clonazepam 0.5mg tablet bottle

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

clonazepam

Tillgänglig från:

Roche Products Pty Ltd

Klass:

Medicine Registered

Bemyndigande status:

Registered

Bipacksedel

RIVOTRIL
®
_Contains the active ingredient clonazepam_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Rivotril.
It does not contain all 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 Rivotril
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 RIVOTRIL IS USED
FOR
Rivotril drops and tablets are used for
the treatment of epilepsy in infants,
children and adults.
Rivotril injection is also used to treat
status epilepticus (prolonged or
repeated fits or seizures without any
recovery between attacks).
Rivotril belongs to a group of
medicines called benzodiazepines.
They are thought to work by their
action on brain chemicals.
Your doctor, however, may have
prescribed Rivotril for another
reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY RIVOTRIL HAS BEEN
PRESCRIBED FOR YOU.
This medicine may be addictive. The
risks are greater for patients on
higher doses or on long term
treatment, or patients who have a
history of alcohol or drug abuse.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
RIVOTRIL
_DO NOT TAKE RIVOTRIL IF:_
1.
YOU HAVE HAD AN ALLERGIC
REACTION TO RIVOTRIL, ANY OTHER
BENZODIAZEPINE MEDICINE OR ANY
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET
Some symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty in
breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
2.
YOU HAVE SEVERE AND CHRONIC
LUNG DISEASE
3.
YOU HAVE SEVERE LIVER DISEASE
4.
YOU HAVE AN ADDICTION TO DRUGS
OR ALCOHOL
5.
THE PACKAGE IS TORN OR SHOWS
SIGNS OF TAMPERING
6.
THE EXPIRY DATE (EXP) PRINTED
ON THE PACK HAS PASSED. IF YOU TAKE THIS MEDICINE AFTER
THE EXPIRY D

Produktens egenskaper

Rivotril 190408
1
AUSTRALIAN PRODUCT INFORMATION
RIVOTRIL (CLONAZEPAM)
1.
NAME OF THE MEDICINE
Clonazepam
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clonazepam is a light yellow powder which is practically insoluble in
water.
Each Rivotril 0.5 mg tablet contains 0.5 mg clonazepam.
Each Rivotril 2.0 mg tablet each contains 2.0 mg clonazepam
Rivotril oral liquid contains 2.5 mg/mL clonazepam (one drop contains
0.1 mg clonazepam)
Rivotril concentrated injection solution ampoules (1 mL) each contain
1 mg clonazepam
Excipients with known effect
_Tablets _
Lactose monohydrate
_Injections _
Benzyl alcohol
Ethanol
_Oral liquid _
Saccharin sodium
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Rivotril 0.5 mg tablets contain 0.5 mg clonazepam and are round, pale
orange, with a score
break on one side and marked ROCHE 0.5 on the reverse.
Rivotril 2.0 mg tablets contain 2 mg clonazepam and are round, white,
with a score break on
one side and marked ROCHE 2 on the reverse.
Rivotril 2.5 mg/mL oral liquid is a clear, blue solution.
Rivotril 1 mg/mL concentrated injection solution is colourless to
slightly green-yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TABLETS
Most types of epilepsy in infants and children, especially absences
(petit mal), myoclonic
seizures and tonic clonic fits, whether due to primary generalised
epilepsy, or to secondary
generalisation of partial epilepsy.
In adults all varieties of generalised epilepsy (including myoclonic,
akinetic, tonic and tonic
clonic seizures), and in partial epilepsy (including psychomotor
seizures).
Rivotril 190408
2
INJECTION
Intravenous (IV) use, for status epilepticus.
Note: Efficacy by the intramuscular (IM) route has not been
demonstrated.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
WARNING: RIVOTRIL ORAL LIQUID
MEASURE THE PRESCRIBED DOSE OF RIVOTRIL ORAL LIQUID AS DROPS ONLY. DO
NOT
ADMINISTER DROPS DIRECTLY INTO THE MOUTH FROM THE BOTTLE. AFTER EACH
ADMINISTRATION,
ENSURE THAT THE DROPPER IS SECURE IN THE NECK