Presentation and Status in Health Basket
Adaferin Cream 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 that the physician assess the continued improvement of the patient after three months of treatment with Adaferin Cream. With patients for whom it is necessary to reduce the frequency of application or to temporarily discontinue treatment, frequency of application may be restored or therapy resumed once it is judged that the patient can again tolerate the treatment. If patients use cosmetics, these should be non-comedogenic and non-astringent.
Paediatric population: The safety and effectiveness of Adaferin Cream have not been studied in children below 12 years of age.
Hypersensitivity to the active substance or to any of the excipients listed and children under 12 years of age.
If a reaction suggesting sensitivity or severe irritation occurs, use of the medication should be discontinued. If the degree of local irritation warrants, patients should be directed to use the medication less frequently, to discontinue use temporarily, or to discontinue use altogether. Adaferin Cream 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 is recommended when exposure cannot be avoided. Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions which can possibly be delayed.
Skin and subcutaneous tissue disorders: Dry skin, skin irritation, skin burning sensation, erythema.
For full details see prescribing information.
There are no known interactions with other medications which might be used cutaneously and concurrently with Adaferin Cream; however, other retinoids or drugs with a similar mode of action should not be used concurrently with adapalene. Adapalene is essentially stable to oxygen and light and is chemically non-reactive. Whilst extensive studies in animals and man have shown neither phototoxic nor photoallergic potential for adapalene, the safety of using adapalene during repeated exposure to sunlight or UV irradiation has not been established in either animals or man. Exposure to excessive sunlight or UV irradiation should be avoided. Absorption of adapalene through human skin is low and therefore interaction with systemic medications is unlikely. There is no evidence that the efficacy of oral drugs such as contraceptives and antibiotics is influenced by the cutaneous use of Adaferin Cream. Adaferin Cream 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 Adaferin Cream is used at night as there is no mutual degradation or cumulative irritation.
Pregnancy and Lactation
Pregnancy: Animal studies by the oral route have shown reproductive toxicity at high systemic exposure. 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, Adaferin should not be used during pregnancy. In case of unexpected pregnancy, treatment should be discontinued.
Breast-feeding: No study on animal or human milk transfer was conducted after cutaneous application of Adaferin. No effects on the suckling child are anticipated since the systemic exposure of the breast-feeding woman to Adaferin is negligible. Adaferin can be used during breastfeeding. To avoid contact exposure of the infant, application of Adaferin to the chest should be avoided when used during breast-feeding.
Adaferin Cream is not to be taken orally and is 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. The acute oral dose of Adaferin Cream required to produce toxic effects in mice is greater than 10 mg/kg. Nevertheless, unless the amount accidentally ingested is small, an appropriate method of gastric emptying should be considered.