Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom
EPANUTIN 30 MG/5 ML ORAL SUSPENSION.
| Pharmaceutical Form |
|---|
|
Oral suspension. Viscous cherry red coloured oral suspension. |
Each 5 ml of suspension contains 30 mg phenytoin.
Excipients with known effect: Each 5 ml also contains 1.044 g Sucrose, 24.66 microlitres Ethanol, 0.316 mg Carmoisine (E122), 0.1 mg Sunset Yellow FCF (E110).
For the full list of excipients see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Phenytoin |
Phenytoin is effective in various animal models of generalised convulsive disorders, reasonably effective in models of partial seizures but relatively ineffective in models of myoclonic seizures. It appears to stabilise rather than raise the seizure threshold and prevents spread of seizure activity rather than abolish the primary focus of seizure discharge. |
| List of Excipients |
|---|
|
Aluminium magnesium silicate |
Amber glass bottle with 3 piece tamper evident child resistant closure fitted with a polyethylene faced liner containing 125 ml or 500 ml. Finished pack will either have a label/leaflet or be enclosed in a carton with a separate PIL.
Not all pack sizes may be marketed.
Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom
PL 00057/0528
Date of latest renewal: 1 April 2003
| Drug | Countries | |
|---|---|---|
| EPANUTIN | Austria, Cyprus, Spain, Ireland, Israel, Malta, Netherlands, Poland, Turkey, United Kingdom, South Africa |
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