EPSYLAM DT 100 Lamotrigine Dispersible Tablets 100 mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LAMOTRIGINE

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

LAMOTRIGINE

Unit dalam pakej:

30 Tablets; 100 Tablets

Dikeluarkan oleh:

Aurobindo Pharma Limited (Unit III),

Risalah maklumat

EPSYLAM DT DISPERSIBLE TABLETS
Lamotrigine (50mg, 100mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What EPSYLAM DT is used for
2.
How EPSYLAM DT works
3.
Before you use EPSYLAM DT
4.
How to use EPSYLAM DT
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of EPSYLAM
DT
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT EPSYLAM DT
IS USED FOR
EPSYLAM DT is used for the treatment
of two types of the diseases: seizures and
bipolar disorder.
HOW EPSYLAM DT WORKS
EPSYLAM
DT
works
to
prevent
the
depression in bipolar disorder. It is not
known
how
Lamotrigine
works in the
brain to provide the above effects.
BEFORE YOU USE EPSYLAM DT
-
_When you must not use it_
Do not take EPSYLAM DT if:
•
If you are allergic to lamotrigine or
any other ingredient in the product.
_Pregnancy and lactation _
Do not take EPSYLAM DT if you are
pregnant, trying to get pregnant or think
you
may
be
pregnant.
However,
in
therapy with Lamotrigine is considered
necessary during pregnancy, the lowest
possible
therapeutic
dose
is
recommended.
Do not take EPSYLAM DT if you are
breast-feeding.
Ask
your
doctor
or
pharmacist for advice before taking any
medicine.
-
_Before you start to use it_
Inform your doctor if you have any of
the following conditions:
•
you
have
ever
had
a
rash
while
taking lamotrigine
•
you
have
suicidal
behavior
or
thoughts
•
you
are
taking
hormonal
contraceptives
to
prevent
pregnancies
•
you suffer from kidney failure
•
you have bipolar disorder
-
_Taking other medicines_
Tell your doctor if you are taking any
other
medicines,
including
any
that
you buy without a prescription from a
pharmacy, supermarket or health food
shop.
Tell your doctor if you are particularly
taking:
•
Valproate
(medicine
used
to
treat
epilepsy and bipolar disorder and to
prevent migraine headaches)
•
Carbamazepine,
phenytoin,
primidone,
phenobarbitone
(medicines
used
to
prevent
and
control seizures)
•
Rifampicin (medicine used to treat
bact

Ciri produk

A) ADJUNCT THERAPY WITH INHIBITORS OF LAMOTRIGINE GLUCURONIDATION E.G.
VALPROATE
In patients taking glucuronidation inhibiting concomitant drugs such
as valproate the initial
Lamotrigine dose is 25 mg every alternate day for two weeks, followed
by 25 mg once a day for
two weeks. The dose should be increased to 50 mg once a day (or in two
divided doses) in
week 5. The usual target dose to achieve optimal response is 100
mg/day given once a day or
in two divided doses. However, the dose can be increased to a maximum
daily dose of
200 mg, depending on clinical response.
B) ADJUNCT THERAPY WITH INDUCERS OF LAMOTRIGINE GLUCURONIDATION IN
PATIENTS NOT
TAKING INHIBITORS SUCH AS VALPROATE. THIS DOSAGE REGIMEN SHOULD BE
USED WITH
PHENYTOIN, CARBAMAZEPINE, PHENOBARBITONE, PRIMIDONE AND OTHER DRUGS
KNOWN TO
INDUCE LAMOTRIGINE GLUCURONIDATION (SEE INTERACTION WITH OTHER
MEDICAMENTS).
In those patients currently taking drugs that induce Lamotrigine
glucuronidation and not taking
valproate, the initial Lamotrigine dose is 50 mg once a day for two
weeks, followed by 100
mg/day given in two divided doses for two weeks. The dose should be
increased to 200
mg/day given as two divided doses in week 5. The dose may increased in
week 6 to 300
mg/day however, the usual target dose to achieve optimal response is
400 mg/day given in
two divided doses which may be given from week 7.
C) MONOTHERAPY WITH LAMOTRIGINE OR ADJUNCTIVE THERAPY IN PATIENTS
TAKING LITHIUM,
BUPROPION, OLANZAPINE, OXCARBAZEPINE, OR OTHER AGENTS KNOWN NOT TO
SIGNIFICANTLY
INDUCE OR INHIBIT LAMOTRIGINE GLUCURONIDATION.
The initial Lamotrigine dose in patients who are taking lithium,
bupropion, olanzapine,
oxcarbazepine and are not taking inducers or inhibitors of Lamotrigine
glucuronidation or are
taking Lamotrigine in monotherapy, is 25 mg once a day for two weeks,
followed by 50 mg
once a day (or in two divided doses) for two weeks. The dose should be
increased to 100
mg/day in week 5. The usual target dose to achieve optimal response is
200 mg/day given
once a day