Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
lamotrigine, Quantity: 200 mg
Aspen Pharmacare Australia Pty Ltd
Tablet, uncoated
Excipient Ingredients: magnesium stearate; povidone; sodium starch glycollate; microcrystalline cellulose; iron oxide yellow; lactose monohydrate
Oral
56 tablets
(S4) Prescription Only Medicine
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.
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
Registered
1993-12-02
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 Прочитать полный документ