VALPARIN XR 500 TABLET

Država: Malezija

Jezik: angleščina

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

Aktivna sestavina:

VALPROIC ACID USP; SODIUM VALPROATE BP

Dostopno od:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (mednarodno ime):

VALPROIC ACID USP; SODIUM VALPROATE BP

Enote v paketu:

30Tablet Tablets; 100 Tablet Tablets; 10 Tablet Tablets

Izdeluje:

TORRENT PHARMACEUTICALS LTD

Navodilo za uporabo

VALPARIN XR 500 TABLET
_ _
Sodium valproate (500mg)
_ _
_ _
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What is Valparin XR used for
2.
How Valparin XR works
3.
Before you use Valparin XR
4.
How to use Valparin XR
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Valparin
XR
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT VALPARIN XR IS USED FOR
Valparin XR is used for:
•
The
treatment
of
generalised
or
partial
epilepsy,
particularly
with
the following patterns of seizures:
-
Absence
(short
period
of
“blanking out” or staring into
space).
-
Myoclonic
(brief
shock-like
jerks of a muscle).
-
Atonic (abrupt loss of muscle
tone).
-
Tonic-clonic
(loss
of
consciousness
and
violent
muscle contractions)
-
Mixed seizures.
•
Partial epilepsy:
-
Simple
(not
affecting
awareness or memory).
-
Complex seizures.
-
Secondary generalised seizures
(start in one area and spread to
both sides of the brain).
-
Specific
syndromes
(West,
Lennox-Gastaut).
HOW VALPARIN XR WORKS
Valparin
XR
contains
sodium
valproate.
It
belongs
to
a
group
of
medicines
called
anti-convulsants
or
anti-epileptic agents. These medicines
are thought to work by controlling brain
chemicals which send signals to nerves
so that seizures do not happen.
BEFORE YOU USE VALPARIN XR
WARNING
FOR WOMEN AND GIRLS
BEFORE YOU START TO USE IT:
This medicine can seriously harm an
unborn baby.
Always
use
effective
contraception
during treatment with sodium valproate.
If
you
are
thinking
about
becoming
pregnant, or if you are pregnant, contact
your doctor immediately.
You must CONTINUE taking sodium
valproate unless your doctor tell you to
stop.
-
_When you must not use it _
Do not take Valparin XR:
•
If you are allergic (hypersensitive)
to sodium valproate or any of the
other ingredients.
•
If you are having liver problems or
you or your family have a history
of liver problems.
•
If
you
are
having
a
rare
illness
called porphyria (a rare hereditary
disease in w

Lastnosti izdelka

PRODUCT NAME
:
ITEM / PACK
:
DESIGN STYLE
:
CODE
:
DIMENSIONS (MM)
:
ART WORK SIZE
:
DATE
:
Reviewed By
NO. OF COLORS: 1
COUNTRY : Malaysia
Front/Back
Valparin XR 500 mg Tablet
Insert
S/S
180 x 420
xxxxxxxxx-5253
Black
25-05-2021
PANTONE SHADE NOS.:
ACTIVITIES
DEPARTMENT
NAME
SIGNATURE
DATE
Prepared By
PKG.DEV
PKG.DEV
LOCATION :
Chhatral
QUALITY
Approved By
PANCREATITIS:
CASES OF LIFE-THREATENING PANCREATITIS HAVE BEEN REPORTED IN
BOTH CHILDREN AND ADULTS RECEIVING VALPROATE. SOME OF THE
CASES
HAVE
BEEN
DESCRIBED AS
HEMORRHAGIC
WITH A
RAPID
PROGRESSION FROM INITIAL SYMPTOMS TO DEATH. CASES HAVE BEEN
REPORTED SHORTLY AFTER INITIAL USE AS WELL AS AFTER SEVERAL
YEARS OF USE.
PATIENTS AND GUARDIANS SHOULD BE WARNED THAT ABDOMINAL
PAIN, NAUSEA, VOMITING AND/OR ANOREXIA CAN BE SYMPTOMS OF
PANCREATITIS
THAT
REQUIRE
PROMPT
MEDICAL
EVALUATION.
IF
PANCREATITIS IS DIAGNOSED; VALPROATE SHOULD BE DISCONTINUED
_WARNING AND PRECAUTIONS:_
Potential for an increase of suicidal thoughts or behaviours.
-
Liver
function
tests
should
be
carried
out
before
therapy
(see
“contraindications”), and periodically during the first 6 months
especially in
patients at risk (see “warnings”)
As with most antiepileptic drugs, mild increased liver enzymes may be
noted,
particularly at the beginning of the therapy; they are transient and
isolated,
without clinical sign.
More
extensive
biological
investigations
(including
prothrombin
rate)
are
recommended in those patients; an adjustment of dosage may be
considered
when appropriate and tests should be repeated as necessary.
-
Monotherapy is recommended in children under the age of 3 years when
prescribing Valparin XR 500 mg Tablet, but the potential benefit of
Valparin XR
500 mg Tablet should be weighed against the risk of liver damage in
such
patients prior to initiation of therapy (see “warnings”).
The concomitant use of salicylates should be avoided in those children
under 3
due to the risk of liver toxicity.
-
Blood tests (blood cell count, including platelet count, bleeding time
and