ACITRETIN Capsule, hard

Active ingredients: Acitretin

Product name and form

Acitretin 10 mg Capsules.

Pharmaceutical Form

Capsule, hard.

Acitretin 10 mg consists of a white to off-white body and a brown cap, printed in black with “A10” on the capsule body and filled with a yellow powder.

Qualitative and quantitative composition

Each capsule, hard of Acitretin 10 mg contains 10 mg acitretin.

For the full list of excipients, see section 6.1

Active Ingredient
Description

Acitretin, a synthetic aromatic derivative of retinoic acid, has a favourable therapeutic ratio, with a greater and more specific inhibitory effect on psoriasis and disorders of epithelial keratinisation. The usual therapeutic response to acitretin consists of desquamation (with or without erythema) followed by more normal re-epithelialisation. Acitretin is the main active metabolite of etretinate.

List of Excipients

Capsule filling:

Maltodextrin
Sodium ascorbate
Microcrystalline cellulose

Capsule shell:

Gelatin
Propylene glycol
Sodium laurilsulfate
Titanium dioxide (E171)
Iron oxide yellow (E172)
Iron oxide black (E172)
Iron oxide red (E172)
Shellac

Pack sizes and marketing

PVC/PVDC aluminium blister packs

Pack sizes: 30 and 60 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK

Marketing authorization dates and numbers

PL 06831/0251

31/10/2015