Adaferin Cream

/ A.M.I. MEDICAL TECHNOLOGIES LIMITED, ISRAEL

Should be applied to the acne affected areas once a day before retiring and after washing. A thin film of cream should be applied, with the fingertips, avoiding the eyes and lips. Ensure that the affected areas are dry before application.
Since it is customary to alternate therapies in the treatment of acne, it is recommended to assess the patient’s improvement after three months of treatment.

Treatment of acne vulgaris, where comedones, papules and postules predominate. Acne of the face, chest or back is appropriate for treatment.
The treatment is limited up to six months in adolescents over 12 years.

* Pregnancy, women planning a pregnancy
* Hypersensitivity to the active substance or to any of the excipients

In the event of a sensitivity reaction or severe irritation, treatment should be discontinued. If the degree of local irritation warrants, patients should be
directed to use the medication less frequently, to discontinue use temporarily until symptoms subside or to discontinue use altogether. This medical product should not come into contact with the eyes, mouth, angles of the nose or mucous membranes.
If product enters the eye, wash immediately with warm water. The product should not be applied to either broken (cuts and abrasions), sunburnt or eczematous skin, nor should it be used in patients with severe acne, or acne involving large areas of the body.
Exposure to sunlight and artificial UV irradiation, including sunlamps, should be
minimised during use of adapalene. Patients who normally experience high levels of sun exposure and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products and protective clothing over treated areas are recommended when exposure cannot be avoided.
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions which can possibly be delayed.

Common: Dry skin, skin irritation, skin burning sensation, erythema.
See prescribing information for full details.

There are no known interactions with other medications that may be used cutaneously and concurrently; however, other retinoids or drugs with a similar mode of action should not be used concurrently with adapalene.
This medical product has a potential for mild local irritation, and therefore it is possible that concomitant use of peeling agents, astringents or irritant products may produce additive irritant effects. However, cutaneous antiacne treatment e.g. erythromycin (up to 4%) or clindamycin phosphate (1% as the base) solutions or benzoyl peroxide water based gels up to 10% may be used in the morning when adapalene is used at night as there is no mutual degradation or cumulative irritation.
See prescribing information for full details.

Pregnancy: Contraindicated in pregnancy, or in women planning a
pregnancy. Clinical experience with locally applied adapalene in pregnancy is limited but the few available data do not indicate harmful effects on pregnancy or on the health of the foetus exposed in early pregnancy. Due to the limited available data and because a very weak cutaneous passage of adapalene is possible, adapalene should not be used during pregnancy. If the product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued.
Lactation: No study on animal or human milk transfer was conducted after cutaneous
application of adapalene. No effects on the suckling child are anticipated since the systemic exposure of the breast-feeding woman to adapalene is negligible. This medical product can be used during breastfeeding. To avoid contact exposure of the infant, application of adapalene to the chest should be avoided when used during breast-feeding.

For cutaneous use only. If the medication is applied excessively, no more rapid or better results will be obtained
and marked redness, peeling or discomfort may occur.
See prescribing information for full details.