Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, UK
Isotretinoin 20mg Capsules.
Rizuderm 20mg Capsules.
| Pharmaceutical Form |
|---|
|
Capsules, soft. Red/orange soft capsules marked ‘P20’. |
Each capsule contains 20mg isotretinoin.
Excipients with known effect: Contains soya bean oil (refined, hydrogenated and partially hydrogenated) maltitol and sorbitol.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Isotretinoin |
Isotretinoin is a stereoisomer of all-trans retinoic acid (tretinoin). The exact mechanism of action of isotretinoin has not yet been elucidated in detail, but it has been established that the improvement observed in the clinical picture of severe acne is associated with suppression of sebaceous gland activity and a histologically demonstrated reduction in the size of the sebaceous glands. Furthermore, a dermal anti-inflammatory effect of isotretinoin has been established. |
| List of Excipients |
|---|
|
Capsule contents: Refined soya-bean oil Capsule shell: Gelatin Printing ink: Brilliant blue FCF dye |
PVC/PE/PVdC aluminium blisters in cardboard carton containing either 30 or 56 capsules
Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, UK
PL 16853/0133
18/10/2004 / 01/06/2016
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