CONVULEX Gastro-resistant capsule Ref.[27927] Active ingredients: Valproic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria

Product name and form

Convulex 150 mg Capsules.

Pharmaceutical Form

Gastro-resistant capsule, soft.

Old-rose coloured, oblong gelatine capsules with enteric coating.

Qualitative and quantitative composition

1 capsule contains: Valproic Acid 150.00 mg

For the full list of excipients, see section 6.1.

Active Ingredient Description
Valproic acid

Valproic acid is anti-convulsant. The most likely mode of action for valproate is potentiation of the inhibitory action of gamma amino butyric acid (GABA) through an action on the further synthesis or further metabolism of GABA.

List of Excipients

Gelatine
Glycerol 85%
Dry substance of Karion 83 (70%)
Titanium dioxide
Red ferric oxide (E 172)
Hydrochloric acid
Methacrylic acid-ethylacrylate copolymer (1:1)-dispersion 30%
Triethyl citrate
Macrogol 6000
Glycerol monostearate 44-55 Type II

Pack sizes and marketing

Blister packs:

Upper: PVC/PVDC or PVC-foil
Lower: aluminium foil
Outer box: carton folding box

Pack size: 100, 30

Marketing authorization holder

G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria

Marketing authorization dates and numbers

PL 21597/0004

11 October 1991 / 16 October 1998 / 2 July 2004

Drugs

Drug Countries
CONVULEX Austria, Germany, Estonia, Lithuania, Poland, Romania, Turkey, United Kingdom, South Africa

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