LAMICTAL DISPERSIBLE TABLET 2 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

LAMOTRIGINE

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

N03AX09

Dosage:

2 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

LAMOTRIGINE 2 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

GLAXOSMITHKLINE LLC

Authorization status:

ACTIVE

Authorization date:

2001-08-29

Patient Information leaflet

 
1 

LAMICTAL™ 
LAMOTRIGINE  

QUALITATIVE AND QUANTITATIVE COMPOSITION 
LAMICTAL TABLETS: 
Each film-coated tablet contains 25, 50 and 100 mg lamotrigine. 
LAMICTAL_ _DISPERSIBLE/CHEWABLE TABLETS: 
Each tablet contains 2 and 5 mg lamotrigine, which
may be chewed, dispersed in a liquid 
or swallowed whole. 
PHARMACEUTICAL FORM 
Tablets. 
Dispersible/chewable tablets.  
CLINICAL PARTICULARS 
INDICATIONS 
EPILEPSY 
•  ADULTS (OVER 12 YEARS OF AGE) 
_LAMICTAL _is indicated
for use as adjunctive or monotherapy in the treatment of 
epilepsy, for partial seizures and generalised seizures,
including tonic-clonic seizures and 
the seizures associated with Lennox-Gastaut Syndrome. 
•  CHILDREN (2 TO 12 YEARS OF AGE) 
_LAMICTAL _is indicated as adjunctive therapy in
the treatment of epilepsy, for partial 
seizures and generalised seizures including tonic-clonic
seizures and the seizures 
associated with Lennox-Gastaut syndrome. 
Initial monotherapy treatment in
newly diagnosed paediatric patients is not 
recommended. 
After epileptic control has been achieved
during adjunctive therapy, concomitant anti-
epileptic drugs (AEDs) may be withdrawn and patients continued
on _LAMICTAL_ 
monotherapy. 
BIPOLAR DISORDER  
•  ADULTS (18 YEARS OF AGE AND OVER) 

2 

_LAMICTAL_ is indicated for the prevention
of depressive episodes in patients with bipolar 
disorder. Safety and efficacy of _LAMICTAL_ in
the acute treatment of mood episodes has 
not been established. The physician who
elects to use _LAMICTAL_ for periods extending 
beyond 18 months should
periodically re-evaluate the long-term usefulness of the drug 
for the individual patient. 
DOSAGE AND ADMINISTRATION 
_LAMICTAL_ tablets should be swallowed whole, and should
not be chewed or crushed. 
_LAMICTAL_ dispersible/chewable tablets may be chewed, dispersed
in a small vol

Summary of Product characteristics

1
LAMICTAL
LAMOTRIGINE
QUALITATIVE AND QUANTITATIVE COMPOSITION
_LAMICTAL_ TABLETS:
Each film-coated tablet contains 25, 50 and 100 mg lamotrigine.
_LAMICTAL _DISPERSIBLE/CHEWABLE TABLETS:
Each tablet contains 2 and 5 mg lamotrigine, which may be chewed,
dispersed in a liquid
or swallowed whole.
PHARMACEUTICAL FORM
Tablets.
Dispersible/chewable tablets.
CLINICAL PARTICULARS
INDICATIONS
EPILEPSY
•
ADULTS (OVER 12 YEARS OF AGE)
_LAMICTAL _
is indicated for use as adjunctive or monotherapy in the treatment of
epilepsy, for partial seizures and generalised seizures, including
tonic-clonic seizures and
the seizures associated with Lennox-Gastaut syndrome.
•
CHILDREN (2 TO 12 YEARS OF AGE)
_LAMICTAL _
is indicated as adjunctive therapy in the treatment of epilepsy, for
partial
seizures and generalised seizures including tonic-clonic seizures and
the seizures
associated with Lennox-Gastaut syndrome.
Initial monotherapy treatment in newly diagnosed paediatric patients
is not
recommended.
After epileptic control has been achieved during adjunctive therapy,
concomitant anti-
epileptic drugs (AEDs) may be withdrawn and patients continued on
_LAMICTAL_
monotherapy.
BIPOLAR DISORDER
•
ADULTS (18 YEARS OF AGE AND OVER)
2
_LAMICTAL_
is indicated for the prevention of depressive episodes in patients
with bipolar
disorder. Safety and efficacy of
_LAMICTAL_
in the acute treatment of mood episodes has
not been established. The physician who elects to use
_LAMICTAL_
for periods extending
beyond 18 months should periodically re-evaluate the long-term
usefulness of the drug
for the individual patient.
DOSAGE AND ADMINISTRATION
_LAMICTAL_
tablets should be swallowed whole, and should not be chewed or
crushed.
_LAMICTAL_
dispersible/chewable tablets may be chewed, dispersed in a small
volume of
water (at least enough to cover the whole tablet) or swallowed whole
with a little water.
If a calculated dose of
_LAMICTAL,_
e.g. for use in children (epilepsy only) or patients
with hepatic impairment, cannot be divided into multiple lowe