Skin clear gel 15%, 30 g

Х Common acne (acne vulgaris);

Х Hyperpigmentation such as melasma, such as chloasma.

Outwardly. The maximum duration of therapy depends on the individual picture of the disease and the severity of symptoms and is set by the attending physician.

For adults and children over 12 years old, the cream is applied evenly with a thin layer 2 times / day. (morning and evening) on ??previously cleansed (mild cleansers and water) and dried areas of the face and, if necessary, the neck and upper chest affected by acne.

For the entire surface of the face, about a 2.5 cm column of cream is enough.

The drug should be used regularly throughout the course of treatment, the duration of which depends on the severity of the disease.

The minimum duration of treatment for melasma is 3 months.

During the period of melasma treatment, it is imperative to use sunscreen (UV B and UV A) in order to prevent an exacerbation of the disease and / or re-pigmentation of the skin under the influence of the sun.

In patients with acne vulgaris, a marked improvement is usually observed after 4 weeks. For best results, use of the drug should be continued for several months.

for 100 g of cream:

Active substance: azelaic acid - 15.00 g;

Excipients: benzoic acid - 0.20 g, glyceryl stearate and macrogol-30 stearate - 5.00 g, glyceryl stearate and cetostearyl alcohol and cetyl palmitate and coconut oil fatty acid glycerides - 7.00 g, cetearyl ethylhexanoate - 3.00 g, propylene - 12.50 g, glycerin (glycerol) - 1.50 g, purified water - up to 100.00 g.

Х Hypersensitivity to azelaic acid and other components of the drug;

Х Children under 12 years of age.

Trade name: Skinclear

International non-proprietary name : azelaic acid

Dosage form: cream for external use

Composition for 100 g of cream:

Active substance: azelaic acid - 15.00 g;

Excipients: benzoic acid - 0.20 g, glyceryl stearate and macrogol-30 stearate - 5.00 g, glyceryl stearate and cetostearyl alcohol and cetyl palmitate and coconut oil fatty acid glycerides - 7.00 g, cetearyl ethylhexanoate - 3.00 g, propylene - 12.50 g, glycerin (glycerol) - 1.50 g, purified water - up to 100.00 g.

Description: white cream.

Pharmacotherapeutic group: acne rash treatment.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

Causes a moderate cytostatic effect (by inhibiting the synthesis of cellular proteins), manifested in the normalization of keratinization processes in the wall of the follicles of the sebaceous glands; has an antimicrobial effect (primarily against Propionibacterium acnes and Staphylococcus epidermidis) both on the surface of the skin and in the sebaceous glands, as well as anti-inflammatory effect (reducing the metabolism of neutrophilic granulocytes and their production of free radical forms of oxygen - important factors in maintaining the inflammatory process).

With prolonged use of the drug, resistance of microorganisms is not formed. Azelaic acid dose-dependently inhibits the growth and viability of abnormal melanocytes. The therapeutic effect in hyperpigmentation (melasma) is due to inhibition of DNA synthesis and / or suppression of cellular respiration of abnormal melanocytes.

Pharmacokinetics

Suction

After application to the skin, azelaic acid penetrates the epidermis and dermis. After applying 1 g of azelaic acid to the skin (which corresponds to 5 g of cream), about 4% of the dose is absorbed into the systemic circulation.

Withdrawal

Part of the absorbed azelaic acid is excreted by the kidneys unchanged, and part in the form of dicarboxylic acids (C5, C7), formed from azelaic acid as a result of beta-oxidation.

INDICATIONS FOR USE

Х Common acne (acne vulgaris);

Х Hyperpigmentation such as melasma, such as chloasma.

CONTRAINDICATIONS

Х Hypersensitivity to azelaic acid and other components of the drug;

Х Children under 12 years of age.

APPLICATION DURING PREGNANCY AND DURING BREASTFEEDING

During pregnancy and during breastfeeding, the drug should be used only if the intended benefit to the mother outweighs the possible risk to the fetus and child. It is necessary to avoid applying cream to the area of ??the mammary glands before feeding.

DOSAGE AND APPLICATION

Outwardly. The maximum duration of therapy depends on the individual picture of the disease and the severity of symptoms and is set by the attending physician.

For adults and children over 12 years old, the cream is applied evenly with a thin layer 2 times / day. (morning and evening) on ??previously cleansed (mild cleansers and water) and dried areas of the face and, if necessary, the neck and upper chest affected by acne.

For the entire surface of the face, about a 2.5 cm column of cream is enough.

The drug should be used regularly throughout the course of treatment, the duration of which depends on the severity of the disease.

The minimum duration of treatment for melasma is 3 months.

During the period of melasma treatment, it is imperative to use sunscreen (UV B and UV A) in order to prevent an exacerbation of the disease and / or re-pigmentation of the skin under the influence of the sun.

In patients with acne vulgaris, a marked improvement is usually observed after 4 weeks. For best results, use of the drug should be continued for several months.

SIDE EFFECT

Skin and subcutaneous tissue disorders:

Uncommon: seborrhea, acne, skin depigmentation;

Rarely: cheilitis;

General disorders and disorders at the injection site:

Very often: itching, burning, erythema at the site of application;

Often: peeling, pain, dryness, discoloration, irritation at the site of application;

Uncommon: paresthesia, dermatitis, discomfort, edema at the site of application;

Rarely: vesicular eruptions, eczema, warmth, rash at the site of application;

Immune system disorders:

Rarely: drug hypersensitivity, worsening of bronchial asthma.

As a rule, local skin irritations go away on their own during treatment.

OVERDOSE

Currently, no cases of cream overdose have been described.

INTERACTION WITH OTHER DRUGS

The interaction of the drug with other drugs is not known to date.

SPECIAL INSTRUCTIONS

The drug is intended for external use only.

Avoid getting it on the mucous membrane of the eyes, nose, mouth, as it can cause irritation.

In case of accidental contact of the drug in the eyes, they should be immediately rinsed with running water.

In cases of severe skin irritation in the first weeks of treatment, Skinoclear can be used 1 time / day or the amount of cream applied to the skin can be reduced; short-term drug withdrawal is also possible.

After the symptoms of skin irritation disappear, regular use of the drug should be resumed at the recommended dose.

Dermal melasma is insensitive to drug treatment.

For differential diagnostics, a Wood lamp is used.

Skinoclear can be used in combination with other acne therapies.

In this case, it is possible to correct the dosage regimen of simultaneously used drugs.

Influence on the ability to drive vehicles and work with mechanisms

The drug does not affect driving and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

RELEASE FORM

Cream for external use 15%.

10 or 30 g in aluminum tubes.

10, 15, 20, 25, 30 or 50 g in dark glass jars of BTS type made of molten glass with stretch lids. A self-adhesive label is attached to the jar.

Each tube or can, together with the instructions for use, is placed in a cardboard package (pack) made of cardboard for consumer packaging.

A complete set of 2 or 3 cardboard packages (packs) in group packaging and (shipping container) from cardboard for consumer packaging is allowed.

Storage conditions

In a dark place at a temperature not exceeding 25 ? C.

Keep out of the reach of children.

Shelf life

3 years.

Do not use after the expiration date.

Vacation conditions

Without recipe.