GABENIL Hard capsule Ref.[28301] Active ingredients: Gabapentin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Gabenil 100 mg hard capsules.

Gabenil 300 mg hard capsules.

Gabenil 400 mg hard capsules.

Pharmaceutical Form

Hard capsules.

Gabenil 100 mg hard capsules: White / white capsules.

Gabenil 300 mg hard capsules: Yellow / yellow capsules.

Gabenil 400 mg hard capsules: Orange / orange capsules.

Qualitative and quantitative composition

Gabenil 100 mg hard capsules:

Each Gabenil 100 mg hard capsule contains 100 mg gabapentin.

Gabenil 300 mg hard capsules:

Each Gabenil 300 mg hard capsule contains 300 mg gabapentin.

Gabenil 400 mg hard capsules:

Each Gabenil 400 mg hard capsule contains 400 mg gabapentin.

Excipients with known effect:

Gabenil 100 mg hard capsules:

Each Gabenil 100 mg hard capsule contains 16.8 mg lactose.

Gabenil 300 mg hard capsules:

Each Gabenil 300 mg hard capsule contains 50.5 mg lactose.

Gabenil 400 mg hard capsules:

Each Gabenil 400 mg hard capsule contains 67.3 mg lactose.

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

Core excipients:

Lactose
Maize Starch
Talc

Excipients of capsule:

Gabenil 100 mg hard capsules:

Titanium Dioxide E171
Gelatin

Gabenil 300 mg hard capsules:

Quinoline Yellow E104
Erythrosin-FD & C Red 3
Titanium Dioxide E171
Gelatin

Gabenil 400 mg hard capsules:

Quinoline Yellow E104
Erythrosin-FD & C Red 3
Titanium Dioxide E171
Gelatin

Pack sizes and marketing

Gabenil 100 mg hard capsules:

PVC/PVDC-Aluminium blisters. Pack size of 50 hard capsules.

Gabenil 300 mg hard capsules:

PVC/PVDC-Aluminium blisters. Pack sizes of 50, 100 and 1000 hard capsules.

Gabenil 400 mg hard capsules:

PVC/PVDC-Aluminium blisters. Pack size of 50 hard capsules.

Not all pack sizes may be marketed

Marketing authorization holder

Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

Gabenil 100 mg hard capsules: 20133
Gabenil 300 mg hard capsules: 20134
Gabenil 400 mg hard capsules: 20135

Date of first authorization: 20 October 2006
Date of latest renewal: 17 December 2012

Drugs

Drug Countries
GABENIL Cyprus, Hong Kong

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