Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Amdipharm Limited, 3 Burlington Road, Dublin 4, D04 RD68, Ireland
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. |
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 |
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 Capsule shells: Gelatin |
PVC/PVDC/aluminium blisters, packs of 14, 28, 56 and 84 hard capsules.
Not all pack sizes may be marketed.
Amdipharm Limited, 3 Burlington Road, Dublin 4, D04 RD68, Ireland
EU/1/04/307/001
EU/1/04/307/005
EU/1/04/307/002
EU/1/04/307/013
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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