ISOTRETINOIN Capsules, soft Ref.[6940] Active ingredients: Isotretinoin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, UK

Product name and form

Isotretinoin 20mg Capsules.

Rizuderm 20mg Capsules.

Pharmaceutical Form

Capsules, soft.

Red/orange soft capsules marked ‘P20’.

Qualitative and quantitative composition

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 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
Yellow beeswax
Hydrogenated soya-bean oil
Partially hydrogenated vegetable oil

Capsule shell:

Ttitanium dioxide E171
Ferric oxide red E172
Ferric oxide yellow E172

Printing ink:

Brilliant blue FCF dye

Pack sizes and marketing

PVC/PE/PVdC aluminium blisters in cardboard carton containing either 30 or 56 capsules

Marketing authorization holder

Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, UK

Marketing authorization dates and numbers

PL 16853/0133

18/10/2004 / 01/06/2016

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.