AKLIEF CREAM 50MCG/G [SIN16571P]

Product Info

AKLIEF CREAM 50MCG/G

[SIN16571P]

4.1 THERAPEUTIC INDICATIONS

Aklief is indicated for the topical treatment of Acne Vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones, papules and/or pustules are present.

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.

4.3 CONTRAINDICATIONS

• Pregnancy (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Women planning a pregnancy

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.