ACITRETIN Capsule, hard Ref.[6069] Active ingredients: Acitretin

Acitretin should only be prescribed by doctors, who have experience in treatment with systemic retinoids and who are aware of the teratogenic risk associated with acitretin (see sections 4.4 and 4.6).

The dosage is based on the clinical appearance of the disorder and the tolerability of the product. The treating physician must determine the dosage individually for each patient. The following information can serve as a guide.

This product is available in two strengths:

Acitretin 10 mg capsules
Acitretin 25 mg capsules

Adults

An initial daily dose of 25 or 30 mg acitretin (i.e. 1 capsule of Acitretin 25 mg or 3 capsules of Acitretin 10 mg) for 2 to 4 weeks is recommended. After this initial phase, it may be necessary in some cases to increase the dose up to a maximum of 75 mg acitretin per day (i.e. 3 capsules of Acitretin 25 mg). This maximum dose should not be exceeded.

In patients with Darier’s disease a starting dose of 10mg may be appropriate. The dose should be increased cautiously as isomorphic reactions may occur.

The maintenance dose must be adjusted to the therapeutic response and the tolerability. In general, a daily dose of 30 mg acitretin for a further 6 to 8 weeks allows an optimum therapeutic effect to be achieved in psoriasis. In keratinisation disorders, the maintenance dose should be kept as low as possible (possibly less than 10 mg acitretin per day). It should not on any account exceed 30 mg acitretin per day.

Therapy can generally be discontinued in patients with psoriasis whose lesions have improved sufficiently. Long-term therapy is not recommended in psoriasis patients. Relapses are treated in the same way.

Patients with severe congenital ichthyosis and severe Darier’s disease may require therapy beyond 3 months. The lowest effective dosage, not exceeding 50mg/day, should be given.

Elderly

Dosage recommendations are the same as for other adults.

Combination therapy

If the administration of acitretin is combined with other forms of treatment, it may be possible to reduce the dose of acitretin according to the therapeutic result. Other dermatological therapy, particularly with keratolytics, should normally be stopped before administration of acitretin. However, the use of topical corticosteroids or bland emollient ointment may be continued if indicated.

Additional topical treatments, including purely skincare treatments, during the administration of acitretin must be discussed with the doctor.

Method of administration

Acitretin hard capsules are for oral administration.

The hard capsules are taken whole once daily with meals or with milk. It is absolutely essential to keep to the dose of acitretin calculated by the doctor.

Overdose of Acitretin leads to the signs and symptoms of acute hypervitaminosis A, with headache, nausea and/or vomiting, drowsiness, irritability and pruritus.

In the event of acute overdose, the use of Acitretin must be stopped. No further specific measures are necessary because of the low acute toxicity of the product.

Shelf life: 2.5 years.

Do not store above 30°C. Store in the original package, in order to protect from moisture.

PVC/PVDC aluminium blister packs

Pack sizes: 30 and 60 hard capsules.

Not all pack sizes may be marketed.

Any unused product or waste material should be disposed of in accordance with local requirements.