ZORAC Gel Ref.[8690] Active ingredients: Tazarotene

Posology

ZORAC gel is available in two concentrations.

To initiate a treatment with ZORAC, it is advisable to start with ZORAC 0.05% in order to evaluate the skin response and tolerance before progressing to ZORAC 0.1% if necessary.

Treatment with the lower concentration gel is associated with a somewhat lower incidence of local adverse events (see sections 4.8 Undesirable effects and 5. Pharmacological Properties).

Treatment with the higher concentration gel gives a faster and numerically higher response rate. The physician should choose the concentration to be used based on clinical circumstances and the principle of using the least concentration of drug to achieve the desired effect.

Individual variations with respect to efficacy and tolerability are possible. It is thus advisable for patients to consult their physician on a weekly basis when initiating therapy.

Paediatric population

The safety and efficacy of ZORAC gel in children under the age of 18 years has not been established.

Method of administration

A thin film of the gel should be applied once daily in the evening; care should be taken to apply it only to areas of affected skin, avoiding application to healthy skin or in skin folds. Treatment is limited to 10% body surface area (approximately equivalent to the total skin area of one arm).

If the patient experiences more drying or irritation, an effective greasy emollient (without pharmaceutically active ingredients) can be applied to the areas of the skin to be treated to improve tolerability. Healthy skin around the psoriatic plaques can be covered by using zinc paste, for example, to prevent irritation.

Usually, the treatment period is up to 12 weeks. Clinical experience, particularly on tolerability, is available on periods of use of up to 12 months.

Excessive dermal use of ZORAC may result in marked redness, peeling, or local discomfort.

Inadvertent ingestion of ZORAC is a theoretical possibility. In such a case, the signs and symptoms associated with hypervitaminosis A (severe headache, nausea, vomiting, drowsiness, irritability, and pruritus) may occur. However, it is likely that these symptoms would prove to be reversible.

3 years.

After first opening of the container: 6 months.

Do not store above 30°C.

10g, 15g, 30g, 50g, 60g and 100g in tube (aluminium, internally lacquered epoxyphenolic) with white polypropylene cap.

Not all pack sizes may be marketed.

No special requirements.