TORLEVA 1000MG TABLET

Pajjiż: Malasja

Lingwa: Ingliż

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

Ingredjent attiv:

LEVETIRACETAM

Disponibbli minn:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (Isem Internazzjonali):

LEVETIRACETAM

Unitajiet fil-pakkett:

60Tablet Tablets; 10Tablet Tablets; 100Tablet Tablets

Manifatturat minn:

TORRENT PHARMACEUTICAL LIMITED

Fuljett ta 'informazzjoni

TORLEVA TABLET
_ _
Levetiracetam (500mg, 1000mg)
_ _
_ _
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is Torleva used for
2.
How Torleva works
3.
Before you use Torleva
4.
How to use Torleva
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Torleva
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT TORLEVA IS USED FOR
Torleva is used:
•
On
its
own
in
adults
and
adolescents from 16 years of age
with newly diagnosed epilepsy, to
treat partial onset seizures with or
without secondary generalisation.
•
As an add-on to other antiepileptic
medicines to treat:

Partial onset seizures with or
without
generalisation
in
adults,
adolescents
and
children from 4 years of age.

Myoclonic
seizures
in
adults
and adolescents from 12 years
of age with juvenile myoclonic
epilepsy.

Primary
generalised
tonic-
clonic seizures in adults and
adolescents from 12 years of
age
with
idiopathic
generalized epilepsy.
HOW TORLEVA WORKS
Torleva
is
used
to
control
epilepsy.
Epilepsy is a condition where you have
repeated
seizures.
There
are
many
different
types
of
seizures,
ranging
from mild to severe.
This medicine belongs to a group of
medicines called anti-epileptics. These
medicines
are
thought
to
work
by
controlling brain chemicals which send
signals to nerves so that seizures do not
happen.
-
_When you must not use it _
Do not take Torleva if:
•
You are allergic (hypersensitive) to
levetiracetam or any of the other
ingredients.
•
Pregnant or trying to get pregnant
or think you may be pregnant.
•
Breastfeeding.
_Pregnancy and lactation _
_ _
_ _
Do
not
take
Torleva
if
you
are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not take Torleva if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
-
_Before you start use it _
Talk
to
your
doctor
before
taking
Torleva:
•
If
you
suffer
from
kidney
problems,
follow
your
doctor’s
instructions. He/she may decide i

Karatteristiċi tal-prodott

Oral administration to pregnant rats during the period of
organogenesis resulted
in reduced fetal weight and increased incidence of embryofetal
mortality and
increased incidence of fetal skeletal variations at a dose of
3600mg/kg/day (11
times the maximal human dose on a mg/m
2
basis). The developmental no-effect
dose was 1200mg/kg/day (4 times the maximal human dose on a mg/m
2
basis).
There was no overt maternal toxicity.
Oral administration to pregnant mice during the period of
organogenesis did not
produce teratogenic or embryotoxic effects at doses up to
3000mg/kg/day. This
dose corresponds to approximately 5 times the maximal human dose on a
mg/m
2
basis.
Oral administration to rats during the late gestation and throughout
lactation
produced no adverse developmental or maternal effects at doses of up
to
1800mg/kg/day (6 times the maximal human dose on a mg/m
2
basis).
To date, no clinical data on exposed pregnancies are available.
TORLEVA should
be used during pregnancy only if the potential benefit justifies the
potential risk to
the fetus.
USE IN LACTATION
Levetiracetam and/or its metabolites are excreted in milk in lactating
rats; peak
milk concentrations occurred 3 hours after oral administration (milk:
plasma ratio
0.9). Levetiracetam is excreted in breast milk. Because of the
potential for serious
adverse reactions in breastfeeding infants from TORLEVA, a decision
should be
made whether to discontinue breastfeeding or discontinue the drug,
taking into
account the importance of the drug to the mother.
INTERACTIONS WITH OTHER DRUGS
_In vitro_, levetiracetam and its major metabolite (ucb L057) have
been shown not
to
inhibit
the
major
human
liver
cytochrome
P450
isoforms,
glucuronyl
transferase,
(valproic
acid)
and
epoxide
hydroxylase
activities.
In
human
hepatocytes in culture, levetiracetam did not cause enzyme induction.
The
interaction of TORLEVA with other drugs, or vice versa, is considered
unlikely.
Probenecid has been shown to inhibit the renal clearance of the major
metabolite
(ucb L057) but not