AKLIEF

Posology 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.

Special populations Elderly patients The safety and efficacy of Aklief in geriatric patients aged 65 years and above have not been established. Renal 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 cutaneous 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. e. forehead, cheeks, nose, and chin). 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 moisturizer 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.

Summary of safety profile Local cutaneous reactions (such as erythema, scaling, dryness, and stinging/burning) were collected separately from other adverse events as a measure of local tolerance. 2% of patients, respectively on the face.

2% of patients had mild, moderate and severe reactions respectively. 4). 5% of patients treated with Aklief cream in clinical studies.

Tabulated summary of adverse reactions:

Adverse reactions reported in the 12-week vehicle-controlled Phase 3 studies in 1220 patients treated with Aklief cream (and for which the rate for Aklief cream exceeds the rate for vehicle cream) are presented in Table 1. The adverse reactions are classified by System Organ Class and frequency, using the following convention: 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).

Table 1 Adverse reactions System Organ Class Frequency Adverse reactions Common Application site irritation Application site pruritus Uncommon Application site pain Application site dryness Application site discolouration Application site erosion Application site rash Application site swelling General disorders and administration site conditions Rare Application site erythema Application site urticaria Application site vesicles Injury, poisoning and procedural complications Common Sunburn Uncommon Skin irritation Acne Dermatitis allergic Erythema Skin and subcutaneous tissue disorders Rare Eczema asteatotic Seborrheic dermatitis Skin burning sensation Skin fissures Skin hyperpigmentation Eye disorders Rare Eyelid exfolliation Eyelid oedema Gastrointestinal disorders Rare Cheilitis Vascular disorders Rare Flushing 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

8). To mitigate the risk of such reactions, patients should be instructed to use a moisturizer from the initiation of treatment, and, if appropriate, reduce the frequency of application of Aklief cream, or suspend use temporarily. Despite mitigation measures, if severe reactions persist the treatment may be discontinued.

The product should not be applied to cuts, abrasions, eczematous or sunburned skin. As with other retinoids, use of “waxing” as a depilatory method should be avoided on skin treated with Aklief. If a reaction suggesting sensitivity to any component of the formula occurs, the use of Aklief should be discontinued.

Caution should be exercised if cosmetics or acne medications with desquamative, irritant or drying effects are concomitantly used with the medicinal product, as they may produce additive irritant effects. Aklief should not come into contact with the eyes, eyelids, lips, or mucous membranes.

If the product enter the eye, wash immediately and abundantly with luke warm water. Excessive exposure to sunlight, including sunlamps or phototherapy should be avoided during the treatment. Use of a broad-spectrum, water-resistant sunscreen with a Sun Protection Factor (SPF) of 30 or higher and protective clothing over treated areas is recommended when exposure cannot be avoided.

This product contains propylene glycol (E1520) that may cause skin irritation. Aklief also contains 50 mg alcohol (ethanol) in each gram which is equivalent to 5% w/w. It may cause burning sensation on damaged skin.

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