Leading the way to safer medication
 Crosscheck  Recommender

TOCTINO Capsule, soft (2020)

Active ingredients: Alitretinoin

Product Name and Form

Toctino 10 mg capsules, soft.
Toctino 30 mg capsules, soft.

Pharmaceutical form

Capsule, soft.

The Toctino 10 mg capsule is a brown oval capsule approximately 11 mm in length and 7 mm in width marked with “A1”.

The Toctino 30 mg capsule is a red-brown oval capsule approximately 13 mm in length and 8 mm in width marked with “A3”.

Qualitative and Quantitative Composition

Each capsule, soft contains 10 mg or 30 mg of alitretinoin.

Excipients with known effect:

Soya-bean oil.

Each 10 mg capsule contains 176.50 mg soya-bean oil.
Each 30 mg capsule contains 282.40 mg soya-bean oil.

Sorbitol.

Each 10 mg capsule contains 20.08 mg sorbitol.
Each 30 mg capsule contains 25.66 mg sorbitol.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Alitretinoin

Alitretinoin is a naturally-occurring endogenous hormone related to vitamin A, binds to and activates all known intracellular retinoid receptor subtypes (RAR, RAR, RAR, RXR, RXR, RXR). The efficacy of alitretinoin in treating KS lesions may be related to the demonstrated ability of alitretinoin to inhibit the in vitro growth of KS cells.

List of excipients

Capsule content:

Soya-bean oil, refined
Partially hydrogenated soya-bean oil
Triglycerides, medium chain
Beeswax, yellow
All-rac-α-tocopherol

Capsule shell:

Gelatin
Glycerol
Sorbitol, liquid (non-crystallising)
Water purified
Iron oxide, red (E172)
10mg – Iron oxide, black (E172)
30mg – Iron oxide, yellow (E172)

Pack sizes and Marketing

PVC/PE/PVDC/Aluminum blisters. Pack sizes of 30 capsules, soft.

Marketing authorization holder
Authorization dates

GlaxoSmithKline UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS
Trading as Stiefel

Date of first authorisation: 31 May 2013
Date of latest renewal: 30 July 2013

Marketing authorization number:

10mg, 30 capsules PL 19494/0252
30mg, 30 capsules PL 19494/0253