Rivotril 0.5 mg Tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Clonazepam

Tilgjengelig fra:

Roche Products (Ireland) Ltd

ATC-kode:

N03AE; N03AE01

INN (International Name):

Clonazepam

Dosering :

0.5 milligram(s)

Legemiddelform:

Tablet

Resept typen:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

Benzodiazepine derivatives; clonazepam

Autorisasjon status:

Marketed

Autorisasjon dato:

1977-04-01

Informasjon til brukeren

READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
● Keep this leaflet. You may need to read
it again.
● If you have any further questions, ask
your doctor or pharmacist.
● This medicine has been prescribed for
you only. Do not pass it on to others.
It may harm them, even if their signs of
illness are the same as yours.
● If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Rivotril is and what it is used for
2.
What you need to know before you take
Rivotril
3.
How to take Rivotril
4.
Possible side effects
5.
How to store Rivotril
6.
Contents of the pack and other
information
1.
WHAT RIVOTRIL IS AND WHAT IT
IS USED FOR
Rivotril contains the active substance
clonazepam, which belongs to a group of
medicines called benzodiazepines.
Rivotril is used to treat epilepsy in infants,
children and adults.
● It lowers the number of fits (seizures)
that you have.
● Any fits that you do have will be less
serious.
2.
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE RIVOTRIL
DO NOT TAKE RIVOTRIL IF YOU ARE ALLERGIC
(HYPERSENSITIVE) TO:
● Clonazepam or any of the other
ingredients of Rivotril (listed in
Section 6).
● Other benzodiazepine medicines, such
as diazepam, flurazepam and
temazepam.
Do not take Rivotril if any of the above
apply to you. If you are not sure, talk to
your doctor or pharmacist before taking
Rivotril.
DO NOT TAKE RIVOTRIL IF YOU HAVE:
● breathing problems or lung disease.
● severe liver problems.
● a condition called ‘sleep apnoea
syndrome’ (where your breathing stops
when you are asleep).
● problems with alcohol or drug
(prescription or recreational) use.
Do not take Rivotril if any of the above
apply to you. If you are not sure, talk to
your doctor or pharmacist before taking
Rivotril.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before
taking Rivotril.
A small number of people

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rivotril
0.5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 micrograms (0.5 mg) clonazepam.
Excipients: Also contains 40mg lactose monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
Round dull pinkish-buff tablets with ‘ROCHE 0,5’ imprinted on one
face and a single break mark on the other.
The tablets can be broken into equal halves to facilitate dosing.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rivotril is indicated, primarily as an adjunct or in refractory cases,
in most forms of epilepsy especially absence
seizures including atypical absence seizures; Lennox-Gastaut syndrome;
myoclonic and atonic seizures. For infantile
spasms (including West-Syndrome) and tonic-clonic seizures it is only
indicated as an adjunct or in refractory cases.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The scored 0.5 mg tablets facilitate the administration of lower daily
doses in the initial stages of treatment.
To break the tablet, hold it with the score facing up and apply
downward pressure.
Posology
_ADULTS_
Initial dosage should not exceed 1 mg/day. The maintenance dosage for
adults normally falls within the range 4 to 8
mg.
_ELDERLY_
The elderly are particularly sensitive to the effects of centrally
depressant drugs and may experience confusion. The
lowest possible dose should be used in the elderly. It is recommended
that the initial dosage of Rivotril should not
exceed 0.5 mg/day and particular care should be taken during
uptitration.
These are total daily dosages which should be divided into 3 or 4
doses taken at intervals throughout the day. If
necessary, larger doses may be given at the discretion of the
physician, up to a maximum of 20 mg daily. The
maintenance dose should be attained after 2 to 4 weeks of treatment.
_INFANTS AND CHILDREN_
To ensure optimum dosage adjustment, children should be given the 0.5
mg tablets.
Initial dosage should not exceed 0.25mg/day for infants