LAMOTRIX Tablet Ref.[28157] Active ingredients: Lamotrigine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2023  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Lamotrix, 25 mg, tablets.
Lamotrix, 50 mg, tablets.
Lamotrix, 100 mg, tablets.
Lamotrix, 200 mg, tablets.

Pharmaceutical Form

Tablet.

Lamotrix 25 mg tablets are beige coloured, round, flat, marked MC at one side and have a diameter of 6 mm.
Lamotrix 50 mg tablets are beige coloured, round, flat and scored and have a diameter of 8 mm.
Lamotrix 100 mg tablets are beige coloured, round, flat and scored and have a diameter of 9.5 mm.
Lamotrix 200 mg tablets are beige coloured, round, flat and flat and scored and have a diameter of 12.7 mm.

The tablets can be divided into equal parts, except for the 25 mg tablets, which are not scored.

Qualitative and quantitative composition

Lamotrix 25 mg tablets: each tablet contains 25 mg of lamotrigine.
Lamotrix 50 mg tablets: each tablet contains 50 mg of lamotrigine.
Lamotrix 100 mg tablets: each tablet contains 100 mg of lamotrigine.
Lamotrix 200 mg tablets: each tablet contains 200 mg of lamotrigine.

Excipient with known effect: lactose monohydrate.

Each tablet of Lamotrix 25 mg tablets contains 24.7mg lactose monohydrate (equal to 23.47 mg lactose).
Each tablet of Lamotrix 50 mg tablets contains 49.4 mg lactose monohydrate (equal to 46.93 mg lactose).
Each tablet of Lamotrix 100 mg tablets contains 98.8 mg lactose monohydrate (equal to 93.86 mg lactose).
Each tablet of Lamotrix 200 mg tablets contains 197.6 mg lactose monohydrate (equal to 187.73 mg lactose).

For the full list of excipients, see section 6.1.

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

All strengths of lamotrigine tablets contain lactose monohydrate, cellulose microcrystalline, sodium starch glycolate, povidone, magnesium stearate and iron oxide yellow (E172) as the inactive ingredients.

Pack sizes and marketing

All strengths are packed in PVC-Al blisters of 10 tablets in packs of 20, 30, 50, 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Lamotrix 25mg tablets: 18540
Lamotrix 50mg tablets: 18538
Lamotrix 100mg tablets: 18541
Lamotrix 200mg tablets: 18539

Lamotrix 25mg tablets: 12.01.2000 / 20.12.2010
Lamotrix 50mg tablets: 12.01.2000 / 20.12.2010
Lamotrix 100mg tablets: 12.01.2000 / 20.12.2010
Lamotrix 200mg tablets: 12.01.2000 / 20.12.2010

Drugs

Drug Countries
LAMOTRIX Cyprus, Ecuador, Hong Kong, Poland, Romania, Singapore

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.