Acnelyse 0.05% 20 g Cream

Acnelyse 0, cream

Acnelyse 0 composition

1 g of cream contains 0.575 mg retinoic acid. Excipients: butyl hydroxytoluene (E321), white paraffin (vaseline), polysorbate 60, cetyl alcohol, methyl-parahydroxybenzoate (E218), propylparahydroxybenzoate (E216), propylene glycol, sorbitan stearate (span 60), stearyl alcohol, purified water. It should not be used simultaneously with oxidizing agents such as benzoyl peroxide, to which there is a pre-existing hypersensitivity to any of the excipients in the composition of the medicinal product, because such agents may reduce the effect of topical tretinoin. If both products are to be used, they should be used at different times of the day (benzoyl peroxide in the morning, tretinoin in the evening). Acnelyse may reduce the concentration/effect of oral contraceptives containing progestogens (mini-pills) and may increase the permeability of other topically used preparations, leading to effects in populations

Indications for use

This medicinal product is used for the treatment of acne (acne vulgaris) accompanied by comedones, papules, and pustules.

Use during pregnancy and lactation

Women of reproductive potential / Contraception Women of reproductive potential should determine whether they are pregnant by performing a pregnancy test before starting treatment; if pregnancy is present, treatment should be postponed until pregnancy ends. During use, it is recommended to protect against pregnancy using one or two reliable contraceptive methods. This medicinal product should not be used in women who are using oral contraceptives that may reduce their concentration/effect, or in women planning pregnancy. Retinoids used are prescribed according to their indications associated with congenital anomalies. Since topical retinoids are usually absorbed minimally through the skin, they cause less systemic effect; however, individual factors that may increase systemic exposure (e.g., damaged skin barrier, excessive use) may also occur. If the medicinal product is prescribed and the patient becomes pregnant while using this medicinal product, treatment should be discontinued. Lactation It is not known whether orally administered retinoids and their metabolites pass into breast milk; therefore, this medicinal product should not be used in women during lactation. No information is available.

Effect on the ability to drive vehicles and operate other potentially hazardous machinery

No information is available

Acnelyse 0 usage instructions and dosage

Acnelyse should be applied once daily at night to the skin. If temporary warmth and itching sensations may occur on the skin after application, it is possible to stop treatment or adjust the dose to a dose that the patient can tolerate by reducing the frequency of use. In the first weeks, an increase in inflammatory lesions may be observed. This is related to the effect of the medicinal product on the lesions. If the patient tolerates the product well, discontinuation may not be required; however, if excessive irritation (redness, peeling, or discomfort) is observed, the frequency of use should be reduced and/or treatment should be temporarily discontinued. After the irritation decreases, normal frequency of use should be resumed. If it continues, treatment should be stopped.

If treatment results are observed after 2–3 weeks, although full improvement may require more than 6 weeks, once improvement is observed, the medicinal product can be applied less frequently. The product should be applied in a thin layer to the areas of the skin with washed and well-dried acne, and gently massaged with the fingertips. After applying to the skin, wash your hands.

Patients using Acnelyse may use cosmetics, but the skin should be thoroughly cleansed before applying the medicinal product. Populations Kidney/liver impairment Is dose adjustment required? Populations Pediatric use: no information is available. In children over 12 years and adolescents, the dosage used in adults is recommended.

In children under 12 years, use of this medicinal product is not recommended. Dose adjustment is not required.

Pharmacological properties

Mechanism of action Tretinoin activates three members of the nuclear retinoic acid receptor (RAR) (RARα, ẞ, …) and this effect leads to changes in gene expression, followed by protein synthesis and growth and differentiation of epithelial cells. These clinical effects are included in the activation of retinoic acid receptors, and other mechanisms have not been demonstrated. Retinoic acid (tretinoin) in the product reduces adhesion of follicular epithelial cells and the formation of microcomedones, and also increases renewal of follicular epithelial cells, stimulating mitotic activity. Acnelyse, prepared with a special gel base that is easily absorbed, has the following effects: it regulates blood circulation in the skin, narrows pores, strengthens skin tissue, stimulates production, and tightens and thins the upper layer of the skin.

Reduces melanin synthesis.

Special warnings and precautions

• For topical use only; not intended for oral or intravaginal use. • Topical use may cause local erythema and peeling of the skin, and irritation may lead to pain and dryness due to irritation at the application site. If irritation continues with the same intensity, patients should be advised to use the medicinal product less frequently and/or take a temporary break from use, or discontinue it completely. • In the first applications, it should be applied to a smaller area of skin, because it may cause intolerance accompanied by temporary swelling and eczema. If a reaction or severe irritation is observed, treatment should be discontinued.

Interactions with other medicinal products

In addition, if treatment for local acne is carried out concurrently, caution is recommended, because a cumulative irritant effect may develop and/or inflammation may occur in the skin; in such cases, the frequency of use should be reduced and/or treatment should be temporarily discontinued. After reduction, treatment should be resumed. If it continues, treatment should be stopped. Due to the irritant properties of this medicinal product, it is recommended to avoid the use of all products that may cause local irritation, such as astringent cosmetics (including perfumed and/or alcohol-containing products). It is also necessary to avoid concurrent treatment. When used together with therapeutic soaps and cleansers, its drying effect may increase.

Adverse effects

Very often (≥1/10), often (≥1/100 to <1/10), sometimes (≥1/1000 to <1/100), rarely (≥1/10000 to <1/1000), very rarely (<1/10000), not known (cannot be assessed based on available data). Disorders of the immune system Very rare: hypersensitivity reactions, including difficulty breathing, swelling of the face, tongue, and lips. Disorders in the subcutaneous tissue Very often: itching, rash, skin irritation, burning sensation. Often: changes in skin color (hypo-/hyperpigmentation), skin irritation, photosensitivity. Sometimes: dryness of the skin, erythema, peeling. Rare: itchy rashes accompanied by contact dermatitis and diffuse erythema. Very rare: temporary irritation of the skin disappears when treatment is stopped or a break is taken.

Additional adverse effects that occur during the use of topical tretinoin resolve on their own 3–5 days after discontinuation of treatment.