Unival Enteric Coated Tablet 200mg

Maa: Malesia

Kieli: englanti

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

Aktiivinen ainesosa:

SODIUM VALPROATE

Saatavilla:

MEDIDATA SDN BHD

INN (Kansainvälinen yleisnimi):

SODIUM VALPROATE

Kpl paketissa:

50 Tablets

Valmistaja:

United Pharmaceutical Company Mfg. Co. Ltd.

Pakkausseloste

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
UNIVAL
® SYRUP 200MG/5ML
UNIVAL
® ENTERIC COATED TABLET 200MG
Sodium Valproate
____________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET?
1. What UNIVAL® is used for
2. How UNIVAL® works
3. Before you use UNIVAL®
4. How to use UNIVAL®
5. While you are using it
6. Side effects
7. Storage and disposal of
UNIVAL®
8. Product description
9. Manufacturer and Product
Registration Holder
10. Date of Revision
WHAT UNIVAL® IS USED FOR
GENERALIZED SEIZURES:
Petit mal which includes:
-
Absence.
-
Myoclonic-astatic (Lennox).
-
Blitz-Nick-Salaam
(BNS)
syndrome.
Grand mal.
Grand mal and petit mal.
PARTIAL (FOCAL) SEIZURES:
Motor (Jackson, adversions).
Psychomotor.
HOW UNIVAL® WORKS
Sodium Valproate is an anti-
epileptic and anticonvulsive agent.
By inhibiting aminobutyrate
aminotransferase activity,
Valproate increases the level of y-
aminobutyric acid (GABA) in the
CNS. GABA inhibits pre- and post-
synaptic discharges. Valproate
contains no nitrogen atom thus
differing completely from the
structure of the commonly used
anticonvulsive agents.
BEFORE YOU USE UNIVAL®
- _When you must not use it _
Do not take sodium valproate if:

You are allergic (hypersensitive)
to sodium valproate or any of the
other ingredients of UNIVAL®.

You have liver problems or you
or your family have a history of
liver problems.

You have a rare illness known as
porphyria
(a
type
of
blood
disorders).

You are pregnant, unless nothing
else works for you.
Do not use this medicine if any of
the above apply to you. If you are
not
sure,
talk
to
your
doctor
or
pharmacist.
- _Before you start to use it_
A small number of people being
treated with sodium valproate have
had thoughts of harming or killing
themselves. If at any time you have
these thoughts, immediately contact
your doctor.
Check
with
your
doctor
before
taking this medicine if:

You have diabetes. This medicine
may affect the result of urine tests.

You have kidney

Valmisteyhteenveto

UNIVAL
®
ENTERIC COATED TABLET
200MG
Sodium valproate
NAME AND STRENGTH OF ACTIVE INGREDIENT
Sodium valproate 200mg
PRODUCT DESCRIPTION
White to off white 11mm biconvex enteric coated tablet.
PHARMACODYNAMIC
- Sodium valproate is an anticonvulsant.
- The most likely mode of action for sodium valproate is potentiation
of the
inhibitory action of gamma amino-butyric acid (GABA) through an action
on
the further synthesis or further metabolism of GABA.
- In certain in-vitro studies it was reported that sodium valproate
could stimu-
late HIV replication but studies on peripheral blood mononuclear cells
from
HIV-infected subjects show that sodium valproate does not have a
mitogen-
like effect on inducing HIV replication. Indeed, the effect of sodium
valproate
on HIV replication ex-vivo is highly variable, modest in quantity,
appears to
be unrelated to the dose and has not been documented in man.
PHARMACOKINETICS
The reported effective therapeutic range for plasma valproic acid
levels is
40 – 100 mg/L (278 – 694 µmol/L). This reported range may depend
on time
of sampling and presence of co-medication.
Distribution
The percentage of free (unbound) drug is usually between 6 – 15% of
the
total plasma levels. An increased incidence of adverse effects may
occur
with plasma levels above the effective therapeutic range.
The pharmacological (or therapeutic) effects of Epilim may not be
clearly
correlated with the total or free (unbound) plasma valproic acid
levels.
_Placental transfer_
_ _
Valproate crosses the placental barrier in animal species and in
humans:
• In animal species, valproate crosses the placenta to a similar
extent as
in humans.
• In humans, several publications assessed the concentration of
valproate in
the umbilical cord of neonates at delivery. Valproate serum
concentration in
the umbilical cord, representing that in the fetuses, was similar to
or slightly
higher than that in the mothers.
Metabolism
The major pathway of valproate biotransformation is glucuronidation (~
40%), mainly via UGT1A6, UG