LAMICTAL DISPERSIBLE TABLET 5 mg

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

LAMOTRIGINE

Διαθέσιμο από:

GLAXOSMITHKLINE PTE LTD

Φαρμακολογική κατηγορία (ATC):

N03AX09

Δοσολογία:

5 mg

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

LAMOTRIGINE 5 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

Delpharm Poznań Spółka Akcyjna

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

1996-12-18

Φύλλο οδηγιών χρήσης

 
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epileptic drugs (AEDs) may be withdrawn and patients continued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

Αρχείο Π.Χ.Π.

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 5 mg lamotrigine, which may be chewed, dispersed
in a liquid or
swallowed whole.
CLINICAL INFORMATION
INDICATIONS
EPILEPSY

ADULTS AND ADOLESCENTS (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.
_LAMICTAL_ 2 mg dispersible/chewable tablet is not available locally.
If the calculated
dose in children is less than 2.5 mg daily, then _LAMICTAL_ cannot be
used. DO NOT
attempt to administer partial quantities of the dispersible/chewable
tablets.
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
Pharmaceutical form: Tablets and Dispersible/Chewable tablets.
_LAMICTAL_ tablets should be swallowed whole, and should not be chewed
or crushed.
_LAMICTAL_ dispersible/chewable tablets may be chewed, dispersed