LAMOTRIGINE / MYLAN Dispersible tablets Ref.[7288] Active ingredients: Lamotrigine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Generics [UK] Limited t/a Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Product name and form

Lamotrigine Mylan 100 mg Dispersible Tablets.

Pharmaceutical Form

Dispersible Tablet.

Lamotrigine Mylan 100 mg tablets are white to off white, round, flat faced, bevelled edge tablets marked “LY” over “100” on one side and plain on the other side.

Qualitative and quantitative composition

Each tablet contains 100 mg lamotrigine.

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

Cellulose, microcrystalline
Sodium starch glycolate (Type A)
Povidone
Silica, colloidal anhydrous
Saccharin sodium
Mannitol
Magnesium stearate
Artificial blackcurrant flavouring containing glyceryl triacetate and sulfite ammonia caramel

Pack sizes and marketing

Lamotrigine Mylan Dispersible Tablets will be packed in PVdC/PVC/Aluminium blister strips.

Pack sizes: 14, 21, 28, 30, 46, 56, 100 tablets.

* Not all pack sizes may be marketed.

Marketing authorization holder

Generics [UK] Limited t/a Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 04569/1210

28/10/2005 / 03/03/2010

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