LAMICTAL

Страна: Индонезия

Язык: индонезийский

Источник: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Активный ингредиент:

LAMOTRIGINE

Доступна с:

GLAXO WELLCOME INDONESIA - Indonesia

ИНН (Международная Имя):

LAMOTRIGINE

дозировка:

5 MG

Фармацевтическая форма:

TABLET DISPERSIBLE

Штук в упаковке:

DUS, 1 BOTOL @ 30 TABLET DISPERSIBEL

Производитель:

GLAXOSMITHKLINE PHARMACEUTICALS S.A. - Poland

Дата Авторизация:

2021-07-09

Характеристики продукта

ERS_leaLAM_Update PI GDS50IPI27_circ1_17May2021
_Page 1 of 22_
LAMICTAL
LAMOTRIGINE
1.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TABLETS:
_LAMICTAL _50 mg and 100 mg
DISPERSIBLE/CHEWABLE TABLETS:
_LAMICTAL _5 mg and 25 mg
2. CLINICAL INFORMATION
2.1 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 patient 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(AEDs) may be withdrawn and patients continued on _LAMICTAL_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.
If _LAMICTAL_ 2 mg dispersible/chewable tablet is not available and
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)
_LAMICTAL_ is indicated for the prevention of mood episodes in
patients with bipolar disorder,
predominantly by preventing depressive episodes.
2.2 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 in a
small volume of water (at
least enough to cover the whole tablet) or swallowed whole with a
little water.
DO NOT attempt to administer partial quantities of the
dispersible/chewable tablets.
If a calculated dose of _LAMICTAL,_ e.g. for use in children (epilepsy
only) or patients with hepatic
impai