ZONEGRAN Hard capsule Ref.[9541] Active ingredients: Zonisamide

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Amdipharm Limited, 3 Burlington Road, Dublin 4, D04 RD68, Ireland

Product name and form

Zonegran 25 mg hard capsules.

Pharmaceutical Form

Hard capsule.

A white opaque body and a white opaque cap printed with a logo and “ZONEGRAN 25” in black.

Qualitative and quantitative composition

Each hard capsule contains 25 mg of zonisamide.

Excipient with known effect: Each hard capsule contains 0.75 mg hydrogenated vegetable oil (from soyabean).

For the full list of excipients, see section 6.1.

Active Ingredient Description

Zonisamide is a benzisoxazole derivative with antiepileptic and anticonvulsant activity. The mechanism of action of zonisamide is not fully elucidated, but it appears to act on voltage-sensitive sodium and calcium channels, thereby disrupting synchronised neuronal firing, reducing the spread of seizure discharges and disrupting subsequent epileptic activity.

List of Excipients

Capsule contents:

Microcrystalline cellulose
Hydrogenated vegetable oil (from soyabean)
Sodium laurilsulfate

Capsule shells:

Titanium dioxide (E171)
Propylene glycol
Potassium hydroxide
Black iron oxide (E172)

Pack sizes and marketing

PVC/PVDC/aluminium blisters, packs of 14, 28, 56 and 84 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Amdipharm Limited, 3 Burlington Road, Dublin 4, D04 RD68, Ireland

Marketing authorization dates and numbers


Date of first authorisation: 10/03/2005
Date of latest renewal: 21/12/2009


Drug Countries
ZONEGRAN Austria, Australia, Cyprus, Germany, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States

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