LAMICTAL lamotrigine 5 mg dispersible/chewable tablet blister pack

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

lamotrigine, Quantity: 5 mg

Disponible des:

Aspen Pharmacare Australia Pty Ltd

formulario farmacéutico:

Tablet

Composición:

Excipient Ingredients: magnesium stearate; aluminium magnesium silicate; calcium carbonate; saccharin sodium; povidone; sodium starch glycollate; hyprolose; Flavour

Vía de administración:

Oral

Unidades en paquete:

56 tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Lamictal is an anti-epileptic drug for the treatment of partial and generalised seizures in adults and children. There is extensive experience with Lamictal used initially as add-on therapy. The use of Lamictal has also been found to be effective as monotherapy following withdrawal of concomitant anti-epileptic drugs. Initial monotherapy treatment in newly diagnosed paediatric patients is not recommended (see CLINICAL TRIALS). Lamictal is indicated for the prevention of depressive episodes in patients with bipolar disorder.

Resumen del producto:

Visual Identification: white to off-white tablet with odour of blackcurrant. Elongated, biconvex, scored. Branded "GSCL2" on one side and scored on the other. The tablet may be slightly mottled.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Estat d'Autorització:

Registered

Data d'autorització:

1995-04-26

Fitxa tècnica

LAMICTAL (lamotrigine) – Product Information
Page 1 of 35
AUSTRALIAN PRODUCT INFORMATION
LAMICTAL (LAMOTRIGINE) DISPERSIBLE/CHEWABLE TABLETS
LAMICTAL (LAMOTRIGINE) TABLETS
1
NAME OF THE MEDICINE
Lamotrigine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LAMICTAL dispersible/chewable tablets and LAMICTAL tablets (uncoated)
contain
lamotrigine.
List of excipients with known effect: saccharin (for LAMICTAL
dispersible/chewable tablets)
and sugars as lactose (for LAMICTAL uncoated tablets)
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
LAMICTAL DISPERSIBLE/CHEWABLE TABLETS*
2 MG BOTTLES [AUST 77098]: White to off-white round tablets with an
odour of blackcurrant.
They are marked "LTG2" on one side and engraved with two overlapping
super-ellipses on
the other.
5 MG BLISTER PACKS [AUST R 51547]: White to off-white, elongated,
biconvex, unscored
tablets with an odour of blackcurrant. They are marked "GSCL2” on
one side and ‘5’ on the
other. The tablets may be slightly mottled.
5 MG BOTTLES [AUST R 51718]: White to off-white caplet shaped biconvex
tablet embossed
with ‘5’ on one side and plain on the other side.
25 MG BLISTER PACKS [AUST R 51548]: White to off-white tablet
multifaceted super elliptical
unscored plain on one side and ‘25’ on the other side.
25 MG BOTTLES [AUST R 51739]: White to off-white, multi-faceted,
superelliptical, unscored
tablets with an odour of blackcurrant. They are marked "GSCL5" on one
side and “25” on the
other. The tablets may be slightly mottled.
50 MG BLISTER PACKS [AUST R 57190]: White to off-white tablet
multifaceted super elliptical
unscored plain on one side and ‘50’ on the other side.
Severe, potentially life-threatening rashes have been reported in
association with the use of
lamotrigine, particularly in children. Accordingly, lamotrigine should
be discontinued at the
first sign of rash unless the rash is clearly not drug related (see
Section 4.2, DOSE AND
METHOD OF ADMINISTRATION.)
LAMICTAL (lamotrigine) – Product I