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Components:
Adapalene
Method of action:
Antiacne, Anti-Inflammatory, Comedonolitic
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Medically reviewed by Fedorchenko Olga Valeryevna, Pharmacy-Provisor. Last updated on 2019.11.15

Name of the medicinal product

Acnelec

Qualitative and quantitative composition

Adapalene

Therapeutic indications

The information provided in Therapeutic indications of Acnelec is based on data of another medicine with exactly the same composition as the Acnelec of the medicine (Adapalene). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Acnelec directly from the package or from the pharmacist at the pharmacy.
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Acnelec Cream is proposed for the cutaneous treatment of mild to moderate acne vulgaris where comedones, papules and pustules predominate. Acnelec Cream is best suited for use on dry and fair skin. Acne of the face, chest or back is appropriate for treatment.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Acnelec is based on data of another medicine with exactly the same composition as the Acnelec of the medicine (Adapalene). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Acnelec directly from the package or from the pharmacist at the pharmacy.
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Acnelec 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 (see 4.4 Special warnings and special precautions for use, below). 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 Acnelec 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 Acnelec Cream have not been studied in children below 12 years of age.

Contraindications

The information provided in Contraindications of Acnelec is based on data of another medicine with exactly the same composition as the Acnelec of the medicine (Adapalene). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Acnelec directly from the package or from the pharmacist at the pharmacy.
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Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Acnelec is based on data of another medicine with exactly the same composition as the Acnelec of the medicine (Adapalene). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Acnelec directly from the package or from the pharmacist at the pharmacy.
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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 until symptoms subside or to discontinue use altogether. Acnelec 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 (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions which can possibly be delayed.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Acnelec is based on data of another medicine with exactly the same composition as the Acnelec of the medicine (Adapalene). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Acnelec directly from the package or from the pharmacist at the pharmacy.
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Acnelec Cream has no influence on the ability to drive and use machines.

Undesirable effects

The information provided in Undesirable effects of Acnelec is based on data of another medicine with exactly the same composition as the Acnelec of the medicine (Adapalene). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Acnelec directly from the package or from the pharmacist at the pharmacy.
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Acnelec may cause the following adverse drug reactions:

Body System (MeDRA)

Frequency

Adverse Drug Reaction

Skin and subcutaneous tissue disorders

Common (>1/100 to <1/10)

Dry skin, skin irritation, skin burning sensation, erythema

Uncommon (>1/1000 to <1/100)

Dermatitis contact, skin discomfort, sunburn, pruritus, skin exfoliation, acne

Unknown*

Dermatitis allergic (allergic contact dermatitis), pain of skin, skin swelling,

Eye disorders

Unknown*

eyelid irritation, eyelid erythema, eyelid pruritus, eyelid swelling

*Post marketing surveillance data

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard

Overdose

The information provided in Overdose of Acnelec is based on data of another medicine with exactly the same composition as the Acnelec of the medicine (Adapalene). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Acnelec directly from the package or from the pharmacist at the pharmacy.
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Acnelec 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 Acnelec Cream required to produce toxic effects in mice is greater than 10 g/kg. Nevertheless, unless the amount accidentally ingested is small, an appropriate method of gastric emptying should be considered.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Acnelec is based on data of another medicine with exactly the same composition as the Acnelec of the medicine (Adapalene). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Acnelec directly from the package or from the pharmacist at the pharmacy.
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Pharmacotherapeutic Group: D10A Anti-Acne Preparations for Topical Use

ATC code: D10AD03

Adapalene is a retinoid-like compound which in, in vivo and in vitro models of inflammation, has been demonstrated to possess anti-inflammatory properties. Adapalene is essentially stable to oxygen and light and is chemically non-reactive. Mechanically, adapalene binds like tretinoin to specific retinoic acid nuclear receptors but, unlike tretinoin not to cytosolic receptor binding proteins.

Adapalene applied cutaneously is comedolytic in the rhino mouse model and also has effects on the abnormal processes of epidermal keratinisation and differentiation, both of which are present in the pathogenesis of acne vulgaris. The mode of action of adapalene is suggested to be a normalisation of differentiation of follicular epithelial cells resulting in decreased microcomedone formation.

Adapalene is superior to reference retinoids in standard anti-inflammatory assays, both in vivo and in vitro. Mechanistically, it inhibits chemotactic and chemokinetic responses of human polymorphonuclear leucocytes and also the metabolism by lipoxidation of arachidonic acid to pro-inflammatory mediators. This profile suggests that the cell mediated inflammatory component of acne may be modified by adapalene. Studies in human patients provide clinical evidence that cutaneous adapalene is effective in reducing the inflammatory components of acne (papules and pustules).

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Acnelec is based on data of another medicine with exactly the same composition as the Acnelec of the medicine (Adapalene). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Acnelec directly from the package or from the pharmacist at the pharmacy.
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Absorption of adapalene through human skin is low, in clinical trials measurable plasma adapalene levels were not found following chronic cutaneous application to large areas of acneic skin with an analytical sensitivity of 0.15 ng/ml.

After administration of [14C]-adapalene in rats (IV, IP, oral and cutaneous), rabbits (IV, oral and cutaneous) and dogs (IV and oral), radioactivity was distributed in several tissues, the highest levels being found in liver, spleen, adrenals and ovaries. Metabolism in animals has been tentatively identified as being mainly by O-demethylation, hydroxylation and conjugation, and excretion is primarily by the biliary route.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Acnelec is based on data of another medicine with exactly the same composition as the Acnelec of the medicine (Adapalene). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Acnelec directly from the package or from the pharmacist at the pharmacy.
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D10A Anti-Acne Preparations for Topical Use

Preclinical safety data

The information provided in Preclinical safety data of Acnelec is based on data of another medicine with exactly the same composition as the Acnelec of the medicine (Adapalene). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Acnelec directly from the package or from the pharmacist at the pharmacy.
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In animal studies, adapalene was well tolerated on cutaneous application for periods of up to six months in rabbits and for up to two years in mice. The major symptoms of toxicity found in all animal species by the oral route were related to an hypervitaminosis A syndrome, and included bone dissolution, elevated alkaline phosphatase and a slight anaemia. Large oral doses of adapalene produced no adverse neurological, cardiovascular or respiratory effects in animals. Adapalene is not mutagenic. Lifetime studies with adapalene have been completed in mice at cutaneous doses of 0.6, 2 and 6 mg/kg/day and in rats at oral doses of 0.15, 0.5 and 1.5 mg/kg/day. The only significant finding was a statistically significant increase of benign phaeochromocytomas of the adrenal medulla among male rats receiving adapalene at 1.5 mg/kg/day. These changes are unlikely to be of relevance to the cutaneous use of adapalene.

Adapalene produces teratogenic effects by the oral route in rats and rabbits. At cutaneous doses up to 200 fold the therapeutic dose, producing circulating plasma levels of adapalene at least 35 to 120 times higher than plasma levels demonstrated in therapeutic use, adapalene increased the incidence of additional ribs in rats and rabbits, without increasing the incidence of major malformations.

It is not known whether adapalene is secreted in animal or human milk. In animal studies, infant rats suckled by mother with circulating levels of adapalene at least 300 times those demonstrated in clinical use developed normally.

Incompatibilities

The information provided in Incompatibilities of Acnelec is based on data of another medicine with exactly the same composition as the Acnelec of the medicine (Adapalene). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Acnelec directly from the package or from the pharmacist at the pharmacy.
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Not applicable

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Acnelec is based on data of another medicine with exactly the same composition as the Acnelec of the medicine (Adapalene). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Acnelec directly from the package or from the pharmacist at the pharmacy.
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A thin film of the cream should be applied, avoiding eyes, lips and mucous membranes.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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