Skinoren gel 15%, 15 g

Acne, rosacea.

Outwardly.

Before applying the gel, wash the skin thoroughly with water or a mild cosmetic cleanser, then dry it, or use a mild cosmetic cleanser. Do not use occlusive dressings. Hands should be washed after each application of the gel to the skin.

The gel is applied in a thin layer to the affected areas of the skin 2 times a day (morning and evening), lightly rubbing into the skin (2.5 cm of gel is enough for the entire surface of the face). In children from 12 to 18 years of age, SkinorenЃ is used in the treatment of acne; dose adjustment is not required. The efficacy and safety of the drug in children under 12 years of age in the treatment of acne has not been established. The efficacy and safety of the drug in children under 18 years of age in the treatment of rosacea has not been established. It is important that SkinorenЃ is used regularly throughout the entire treatment period.

The duration of treatment is individual and depends on the severity of the disease. Improvement occurs, as a rule, after 4 weeks of treatment, if necessary, SkinorenЃ can be used for several months. If within 1 month in the treatment of acne and 2 months in the treatment of rosacea there is no improvement or an exacerbation of the disease has occurred, then you should stop using SkinorenЃ and consult a doctor. If irritation occurs on the skin, the amount of gel should be reduced with each application or the frequency of application of the gel should be reduced to 1 time per day. Possible short-term cancellation of the drug, followed by resumption after the disappearance of symptoms of irritation in the recommended dose.

Use the drug only according to the method of administration and in the doses indicated in the instructions. If necessary, please consult your doctor before using this medication.

for 1 g of gel for external use :

active substance : azelaic acid (micronized) - 0.15 g.

excipients : propylene glycol, polysorbate 80, lecithin, polyacrylic acid, triglycerides, sodium hydroxide, disodium edetate, benzoic acid, purified water.

Hypersensitivity to the components of the drug.

Hypersensitivity to azelaic acid and other components of the drug; children under 12 years old (acne), up to 18 years old (rosacea).

With care : Bronchial asthma.

Skinoren

International non-proprietary name:

azelaic acid

Dosage form:

gel for external use

Composition for 1 g of gel for external use :

active substance : azelaic acid (micronized) - 0.15 g.

excipients : propylene glycol, polysorbate 80, lecithin, polyacrylic acid, triglycerides, sodium hydroxide, disodium edetate, benzoic acid, purified water.

Description
opaque gel from white to white with a yellowish sheen.

Pharmacotherapeutic group
Acne rash treatment.

Pharmacological properties

Pharmacodynamics

Azelaic acid normalizes the disturbed processes of keratinization in the follicles of the sebaceous glands, and also reduces the content of free fatty acids in skin lipids. Shows antimicrobial activity against Propionibacterium acnes and Staphyloccocus epidermidis. Azelaic acid has a dose-dependent and time-dependent suppressive effect on the growth and viability of abnormal melanocytes.

The drug is practically not absorbed into the systemic circulation (about 3.6% when 5 g of gel is applied). Part of the absorbed acid is excreted by the kidneys unchanged, part - in the form of dicarboxylic acids (C7, C5), formed as a result of beta-oxidation.

Indications for use

Acne, rosacea.

Contraindications

Hypersensitivity to the components of the drug.

Hypersensitivity to azelaic acid and other components of the drug; children under 12 years old (acne), up to 18 years old (rosacea).

With care : Bronchial asthma.

Application during pregnancy and during breastfeeding

The use of the drug during pregnancy and lactation is possible after consultation with your doctor. Adequate and strictly controlled studies with the external use of azelaic acid in pregnant women have not been conducted. Animal studies have shown no adverse effects of azelaic acid on pregnancy, intrauterine fetal development, childbirth, or postnatal development. The potential risk to humans is unknown. During pregnancy, SkinorenЃ is used only if the intended benefit to the mother outweighs the potential risk to the fetus. It is not known exactly whether azelaic acid passes into breast milk. Given the low systemic absorption of acid when applied externally, SkinorenЃ is used during breastfeeding only ifif the intended benefit to the mother outweighs the potential risk to the child. When breastfeeding, it is necessary to avoid applying the drug to the area of ??the mammary glands before feeding; children should not be allowed to come into contact with the skin, including the skin of the mammary glands, after applying SkinorenЃ.

Method of administration and dosage

Outwardly. Before applying the gel, wash the skin thoroughly with water or a mild cosmetic cleanser, then dry it, or use a mild cosmetic cleanser. Do not use occlusive dressings. Hands should be washed after each application of the gel to the skin. The gel is applied in a thin layer to the affected areas of the skin 2 times a day (morning and evening), lightly rubbing into the skin (2.5 cm of gel is enough for the entire surface of the face). In children from 12 to 18 years of age, SkinorenЃ is used in the treatment of acne; dose adjustment is not required. The efficacy and safety of the drug in children under 12 years of age in the treatment of acne has not been established. The efficacy and safety of the drug in children under 18 years of age in the treatment of rosacea has not been established. It is important that SkinorenЃ is used regularly throughout the entire treatment period.The duration of treatment is individual and depends on the severity of the disease. Improvement occurs, as a rule, after 4 weeks of treatment, if necessary, SkinorenЃ can be used for several months. If within 1 month in the treatment of acne and 2 months in the treatment of rosacea there is no improvement or an exacerbation of the disease has occurred, then you should stop using SkinorenЃ and consult a doctor. If irritation occurs on the skin, the amount of gel should be reduced with each application or the frequency of application of the gel should be reduced to 1 time per day. Possible short-term cancellation of the drug, followed by resumption after the disappearance of symptoms of irritation in the recommended dose. Use the drug only according to the method of administration and in the doses indicated in the instructions. If necessary, pleaseconsult your doctor before using this medication.

Side effect

Observed in clinical studies and during post-registration observation, the most common side effects were: itching, burning and pain at the site of application. Immune system disorders: frequency unknown - hypersensitivity reactions (including angioedema, eye edema, facial edema, shortness of breath), exacerbation of bronchial asthma. Violation of the skin and subcutaneous tissues: infrequently - contact dermatitis, acne (acne). General disorders and disorders at the site of application: very often - at the site of application: itching, burning, pain; often - at the site of application: dryness, rash, paresthesia, edema * ; 4 rarely - at the site of application: erythema (redness), desquamation (detachment of the epidermis), a feeling of warmth, depigmentation (discoloration) of the skin, discomfort * , urticaria; frequency unknown: skin irritation, urticaria. If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor. Footnotes: - for acne, * - for rosacea.

Overdose

The phenomena of overdose when applied externally have not been established.

Interaction with other medicinal products

No clinically significant interactions have been identified with Skinoren.

special instructions

For external use only. Avoid getting the gel in the eyes, mouth and other mucous membranes. In case of accidental contact of the drug on the mucous membranes, including the eyes, mouth, it is necessary to rinse them with plenty of water. If eye irritation persists, seek medical attention. Hands should be washed after each use of SkinorenЃ. During treatment with SkinorenЃ rosacea, it is recommended to stop using cosmetics containing alcohol, alcohol solutions and astringents, abrasive or exfoliating agents (for peeling). SkinorenЃ contains benzoic acid, which can cause skin irritation, irritation of the eyes and mucous membranes, and propylene glycol, which can irritate the skin. During post-registration observation,rarely reported an exacerbation in patients with bronchial asthma with external use of azelaic acid. Read the instructions carefully before you start using the drug. Retain the instructions, you may need them again. If you have any questions ask your doctor. The medicinal product with which you are being treated is intended for you personally and should not be passed on to others, since it can harm them even if they have the same symptoms as you.because it can harm them even if they have the same symptoms as you.because it can harm them even if they have the same symptoms as you.

Release form:

Gel for external use 15% 5 g, 15 g, 30 g or 50 g in an aluminum tube laminated with polyethylene, sealed with a membrane, with a screw cap. A tube with instructions for use is placed in a cardboard box.

Shelf life is
3 years.
Do not use after the expiration date.

Storage conditions
At a temperature not exceeding 25 ? —.
Keep out of the reach of children.

Leave from pharmacies
Without a doctor's prescription.

Manufacturer

Marketing authorization holder: LEO Pharma A / S, Denmark Produced by: LEO Pharma Manufacturing Italy S.r.l., Italy Via E. Schering, 21, 20090 Segrate (Milan), Italy