Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2021 Publisher: GlaxoSmithKline NZ Limited, Private Bag 106600, Downtown, Auckland, NEW ZEALAND, Phone: (09) 367 2900, Facsimile: (09) 367 2910
LAMICTAL lamotrigine 2 mg, 5 mg, 25 mg, 50 mg, 100 mg dispersible/chewable tablets.
| Pharmaceutical Form |
|---|
|
Dispersible/chewable tablets. 2 mg: white to off-white, round tablets with ‘LTG’ over ‘2’ on one side and scored on the other. 5 mg: white to off-white, elongated, biconvex, unscored tablets with ‘GS CL2’ on one side and ‘5’ on the other. 25 mg: white to off-white, multi-faceted, superelliptical, unscored tablet with “GSCL5” on one side and “25” on the other. The tablets may be slightly mottled. 50 mg: white to off-white, multi-faceted, superelliptical, unscored tablet with “GSCX7” on one side and “50” on the other. The tablets may be slightly mottled. 100 mg: white to off-white, multi-faceted, superelliptical, unscored tablet with “GSCL7” on one side and “100” on the other. The tablets may be slightly mottled. |
Each tablet contains 2 mg, 5 mg, 25 mg, 50 mg, or 100 mg of lamotrigine.
For the full list of excipients, see section 6.1 List of excipients.
| Active Ingredient | Description | |
|---|---|---|
| Lamotrigine |
Lamotrigine is a use and voltage dependent blocker of voltage gated sodium channels. It inhibits sustained repetitive firing of neurons and inhibits release of glutamate (the neurotransmitter which plays a key role in the generation of epileptic seizures). |
| List of Excipients |
|---|
|
Calcium carbonate PhEur |
25 mg, 50 mg, 100 mg:
Blister packs of 56 tablets
Child resistant PVC/PVdC/aluminium foil/paper blister.
5 mg:
Blister packs of 28 or 30 tablets
PVC/PVdC/aluminium foil blister.
HDPE bottle packs of 30 tablets
HDPE bottles with a child resistant/tamper evident or
continuous thread closure.
2 mg:
HDPE bottle packs of 30 tablets
HDPE bottles with a child resistance/tamper evident closure.
Not all strengths, packs sizes or container types may be distributed in New Zealand.
GlaxoSmithKline NZ Limited, Private Bag 106600, Downtown, Auckland, NEW ZEALAND, Phone: (09) 367 2900, Facsimile: (09) 367 2910
Date of publication in the New Zealand Gazette of consent to distribute the medicine: 14 December 1995
| Drug | Countries | |
|---|---|---|
| LAMICTAL | Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States |
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