AKLIEF CREAM 50mcg/g

CREAM

**4.2 DOSE AND METHOD OF ADMINISTRATION** **Dosage** Apply a thin layer of Aklief cream to the affected areas of the face and/or trunk once a day, in the evening, on clean and dry skin. It is recommended that the physician assesses the continued improvement of the patient after three months of treatment. The duration of treatment should be determined by the doctor based on the clinical response. _Special populations_ _Elderly patients_ The safety and efficacy of Aklief in geriatric patients aged 65 years and above have not been established. **Renal impairment and Hepatic impairment** Aklief has not been studied in patients with renal and hepatic impairment. _Paediatric population_ The safety and efficacy of Aklief in children below 12 years old have not been established. Method of administration For topical use only. Before using the pump for the first time, prime it by pressing down several times until a small amount of medicine is dispensed (up to 10 times maximum). The pump is now ready to use. Apply a thin layer of Aklief cream to the affected areas of the face (forehead, nose, chin and right and left cheeks) and all affected areas of the trunk once a day, in the evening, on clean and dry skin: - One pump actuation should be enough to cover the face (i.e. forehead, cheeks, nose, and chin). - Two pump actuations should be enough to cover the upper trunk (i.e. reachable upper back, shoulders and chest). One additional pump actuation may be used for middle and lower back if acne is present. Patients should be instructed to avoid contact with the eyes, eyelids, lips and mucous membranes and to wash their hands after applying the medicinal product. The use of a moisturiser is recommended as needed from the initiation of treatment, while allowing sufficient time before and after the application of Aklief cream to allow the skin to dry.