LAMICTAL lamotrigine 200 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lamotrigine, Quantity: 200 mg

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; povidone; sodium starch glycollate; microcrystalline cellulose; iron oxide yellow; lactose monohydrate

Administration route:

Oral

Units in package:

56 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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.

Product summary:

Visual Identification: Pale yellowish brown, multifaceted, superelliptical unscored tablet, branded 'GSEE7' on one side, with '200' on the reverse.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1993-12-02

Summary of Product characteristics

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