ZORAC Gel Ref.[8690] Active ingredients: Tazarotene

Care should be taken to ensure that ZORAC is applied only to psoriatic lesions, as application to normal, eczematous or inflamed skin or skin affected by other pathologies may cause irritation.

Patients should be advised to wash their hands after application of the gel to avoid accidental transfer to the eyes.

If psoriatic areas on the skin of the hands are being treated, particular care should be taken to ensure that no gel is transferred to facial skin or the eyes.

If skin irritation develops, treatment with ZORAC should be interrupted.

The safety of use on more than 10% of the body surface area has not been established. There is limited experience of application to up to 20% of the body surface area.

Patients should be advised to avoid excessive exposure to UV light (including sunlight, use of a solarium, PUVA or UVB therapy) during treatment with ZORAC (see section 5.3 Preclinical safety data).

Tazarotene should be administered with caution if the patient is also taking drugs known to be photosensitizers (e.g. thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the increased possibility of augmented photosensitivity.

No therapeutic studies using ZORAC under occlusion or concomitantly with other antipsoriatic agents (including tar shampoos) have been carried out. To minimise interference with absorption and to avoid unnecessary spreading of the medication, topical application of emollients and cosmetics should not be applied within 1 hour of applying ZORAC.

This medicinal product contains butylhydroxyanisole and butylhydroxytoluene and therefore may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

Concomitant use of pharmaceutical and cosmetic preparations which cause irritation or have a strong drying effect should be avoided.

Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result into low systemic exposure due to minimal dermal absorption. However, there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure.

Pregnancy

ZORAC gel is contraindicated (see section 4.3) in pregnancy, or in women planning a pregnancy. If the product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient apprised of the potential hazard to the foetus. Women of child-bearing potential should be warned of the potential risk and use adequate birth control measures when ZORAC gel is used. The possibility that a woman of childbearing potential is pregnant at the time of institution of therapy should be considered. A negative result for pregnancy test having a sensitivity down to at least 50 mIU/mL for human chorionic gonadotropin (hCG) should be obtained within 2 weeks prior to ZORAC gel therapy, which should begin during a normal menstrual period.

Although in animals no malformations were observed after dermal application, skeletal alterations were seen in the foetuses, which may be attributable to systemic retinoid effects. Teratogenic effects were observed after oral administration.

Lactation

Although no data are available on the excretion of tazarotene in human milk, animal data indicate that excretion into milk is possible. For that reason ZORAC gel should not be used during breast-feeding.

None known.

The frequency of adverse reactions arising from clinical experience is given. The frequency is defined as follows: Very Common (≥ 1/10); Common (≥ 1/100 to <1/10); Uncommon (≥ 1/1,000 to <1/100); Rare (≥ 1/10,000 to <1/1,000); Very Rare (<1/10,000), not known (cannot be estimated from the available data).

Skin and subcutaneous tissue disorders

Very common: Pruritus, burning, erythema, and irritation

Common: Desquamation, non-specific rash, irritant contact dermatitis, skin pain, worsening of psoriasis, stinging and inflamed and dry skin.

The incidence of adverse reactions appears to be concentration-related and dependent on duration of use.

The higher concentration gel (0.1%) may cause up to 5% more cases of severe skin irritation than the lower concentration gel (0.05%), especially during the first 4 weeks of use.

Post-marketing Experience

The following adverse reactions have been identified during post-marketing use of ZORAC gel in clinical practice. Because they are reported voluntarily from a population of unknown size, it is not possible to reliably estimate their frequency or establish a causal relationship.

Skin and subcutaneous tissue disorders

Blister, skin discoloration (including skin hyperpigmentation or skin hypopigmentation).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme; Website: www.mhra.gov.uk/yellowcard.

Tazarotene is susceptible to oxidising agents and may undergo ester hydrolysis when in contact with bases.