RIVOTRIL TABLET 0.5MG

国家: 马来西亚

语言: 英文

来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有效成分:

CLONAZEPAM

可用日期:

DKSH MALAYSIA SDN BHD

INN（国际名称）:

CLONAZEPAM

每包单位数:

60 Tablets; 60 Tablets

厂商:

Recipharm Leganes S.L.U.

资料单张

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
RIVOTRIL
®
_Clonazepam (0.5 mg, 2 mg) _
1
WHAT IS IN THE LEAFLET
1.
What Rivotril is used for
2.
How Rivotril works
3.
Before you take Rivotril
4.
How to take Rivotril
5.
While you are using Rivotril
6.
Side effects
7.
Storage and disposal of Rivotril
8.
Product Description
9.
Manufacturer & product
registration holder
10.
Date of revision
1. WHAT RIVOTRIL IS USED FOR
Rivotril
tablets
are
used
for
the
treatment
of
epilepsy
in
infants,
children and adults.
Your
doctor,
however,
may
have
prescribed
Rivotril
for
another
purpose.
Ask
your
doctor
if
you
have
any
questions
why
Rivotril
has
been
prescribed for you.
This medicine may be addictive.
This medicine is available only with a
doctor’s prescription.
2. HOW RIVOTRIL WORKS
Rivotril
belongs
to
a
group
of
medicines
called
benzodiazepines.
They
are
thought
to
work
by
their
action on brain chemicals.
3. BEFORE YOU TAKE RIVOTRIL
−
_When you must not take it _
1.
You have had an allergic reaction
to
Rivotril,
any
other
benzodiazepine medicine or any
ingredients listed at the end of this
leaflet.
Some
of
the
symptoms
of
an
allergic reaction may include:
•
Shortness of breath
•
Wheezing
or
difficulty
breathing
•
Swelling
of
the
face,
lips,
tongue or other parts of the
body
•
Rash, itching or hives on the
skin
2.
You have severe lung disease
3.
You have severe liver disease.
4.
The expiry date (EXP) printed on
the pack has passed.
If
you
take
this
medicine
after
the
expiry date has passed, it may not work
as well.
If you are not sure if you should be
taking Rivotril, talk to your doctor.
−
_Before you start to take it _
Tell your doctor if:
1.
If
you
are
pregnant
or
plan
to
become pregnant
It is not known whether Rivotril is
harmful to an unborn baby when
taken by a pregnant woman. If
there is a need to take Rivotril
when you are pregnant your doctor
will discuss the risks and benefits
to you and the unborn baby.
2.
If you are breastfeeding or plan to
breastfeed
Rivotril
passes
into
breast
milk
and theref

产品特点

Leaflet 0,5 mg Rivotril MY
DRAFT (DATE) 21.09.2021 [08:20 uhr] (2)
COLOURS Pantone Black linework
DIMENSIONS 148 x 420 mm PR003-1
MATERIAL NUMBER 90006115/10
FONT SIZE 6 pt
MATERIAL NUMBER RECIPHARM 50001105
LAETUS CODE 189
PACK INSERT FOR MALAYSIA
RIVOTRIL
®
Clonazepam
1. DESCRIPTION
1.1 THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG
Antiepileptic agent
1.2 TYPE OF DOSAGE FORM
Tablets
1.3 ROUTE OF ADMINISTRATION
Oral
1.4 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: _clonazepam.
_Tablets:_
0.5 mg (break-mark) and 2 mg (cross-break-mark)
The tablets are cylindrical, biplanar and of a white to slightly
yellowish
colour (2 mg) or of a pale orange colour (0.5 mg).
Rivotril tablets contain lactose. For warning related to lactose, see
2.4.1
General (Warnings and Precautions)).
2. CLINICAL PARTICULARS
2.1 THERAPEUTIC INDICATION(S)
Most clinical forms of epilepsy in infants and children, in particular
typical and atypical absences (Lennox-Gastaut syndrome), nodding
spasms, primary or secondary generalized tonic-clonic spasms.
Rivotril may also be used in adult epilepsy and focal seizures.
2.2 DOSAGE AND ADMINISTRATION
The dosage of Rivotril must be individually adjusted according to the
patient’s clinical response and tolerance. Rivotril tablets 0.5 mg
can be
divided into equal halves to facilitate dosing. Rivotril tablets 2 mg
can
be divided into equal halves or quarters to facilitate dosing. Tablets
are
scored to allow administration of lower doses. To break the tablet,
hold
it with the score facing up and apply downward pressure.
_Standard dosage in Epilepsy_
Before adding Rivotril to an existing anticonvulsant regimen, it
should
be considered that the use of multiple anticonvulsants may result in
an
increase of undesired effects. To ensure optimum dosage adjustment,
infants should be given the drops and children the 0.5 mg tablets. The
0.5 mg tablets facilitate the administration of lower daily doses to
adults
in the initial stages of treatment.
A single oral dose of Rivotril begins to take effect within