NEURONTIN Capsule, hard Ref.[6828] Active ingredients: Gabapentin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom

Product name and form

Neurontin 100 mg hard capsules.

Pharmaceutical Form

Capsule, hard.

A two-piece, white opaque hard gelatin capsule, imprinted with ‘Neurontin 100 mg’ and ‘PD’ and containing a white to off-white powder.

Qualitative and quantitative composition

Each 100 mg hard capsule contains 100 mg of gabapentin.

Excipients with known effect: Each 100 mg hard capsule contains 13 mg lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Gabapentin

Gabapentin readily enters the brain and prevents seizures in a number of animal models of epilepsy. Gabapentin binds with high affinity to the α2δ (alpha-2-delta) subunit of voltage-gated calcium channels and it is proposed that binding to the α2δ subunit may be involved in gabapentin’s anti-seizure effects in animals.

List of Excipients

Each hard capsule contains the following excipients:

Lactose monohydrate
Maize starch
Talc

Capsule shell:

Gelatin
Purified water
Sodium laurilsulfate

The 100 mg hard capsules contain the colouring E171 (titanium dioxide).

The printing ink used on all hard capsules contains shellac, E171 (titanium dioxide) and E132 (indigo carmine aluminium salt).

Pack sizes and marketing

PVC/PVDC/aluminium foil blister packs

Supplied in packs of 20, 30, 50, 60, 84, 90, 98, 100, 200, 500 or 1000 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom

Marketing authorization dates and numbers

PL 00057/0853

28th May 2007

Drugs

Drug Countries
NEURONTIN Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Mexico, Netherlands, New Zealand, Poland, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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