Skinoren gel d / nar. approx. 15% tube 15g

Release form, composition and packaging

Gel for external use 15% from white to white with a yellowish sheen, opaque.

1 g

azelaic acid (micronized) 150 mg

propylene glycol - 120 mg, polysorbate 80 - 15 mg, lecithin - 10 mg, polyacrylic acid - 10 mg, triglycerides - 10 mg, sodium hydroxide - 2 mg, disodium edetate - 1 mg, benzoic acid - 1 mg, purified water - 681 mg ...

5 g - laminated aluminum tubes (1) - cardboard packs.

15 g - laminated aluminum tubes (1) - cardboard packs.

30 g - laminated aluminum tubes (1) - cardboard packs.

50 g - laminated aluminum tubes (1) - cardboard packs.

pharmachologic effect

A drug for the treatment of acne.

Azelaic acid normalizes disturbed processes of keratinization in the follicles of the sebaceous glands, reduces the content of free fatty acids in the lipids of the skin and reduces its fat content.

Shows antimicrobial activity against Propionibacterium acnes and Staphylococcus epidermidis.

The anti-inflammatory effect is also due to a decrease in neutrophil metabolism and a decrease in the production of free radical forms of oxygen.

Azelaic acid has a dose and time dependent suppressive effect on the growth and viability of abnormal melanocytes.

Pharmacokinetics

Suction

After application to the skin, azelaic acid is practically not absorbed into the systemic circulation (no more than 3.6% with a single application of 5 g of gel or cream).

Withdrawal

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

Indications for use

- acne (acne vulgaris)

- hyperpigmentation, incl.

melasma, chloasma (for cream)

- rosacea (for gel).

Contraindications for use

- hypersensitivity to drug components.

Dosage regimen

The dosage regimen and the duration of therapy are set individually.

The drug is prescribed for adults and children over 12 years of age.

Before using the drug, the skin should be cleaned with water or a mild cosmetic cleansing agent, then dried.

The cream or gel is applied to the affected areas of the skin evenly with a thin layer 2 times / day (morning and evening) and rubbed lightly. The drug should be used in sufficient quantity, but not excessively (approximately 2.5 cm is sufficient for the entire surface of the face). The drug should be used regularly throughout the course of treatment, the duration of which depends on the clinical picture of the disease and the severity of symptoms. With acne (acne vulgaris), improvement is usually seen after 4 weeks. For best results, use of the drug should be continued for several months. Additional protection of the skin from UV radiation is not required during acne treatment.

For melasma, the drug is used in the form of a cream.

The minimum duration of therapy is 3 months for best results, Skinoren cream should be used regularly.

During the entire period of melasma therapy, it is imperative to use sunscreen (UVB and UVA) to prevent sun-induced exacerbation of the disease and / or re-pigmentation of the bleached areas.

Overdose

To date, there is no information on overdose.

Side effect

At the beginning of treatment, a small number of patients may experience local irritation, manifested in the form of hyperemia, peeling, erythema, burning, itching.

In most cases, these symptoms are not very pronounced and go away on their own within a few days during treatment.

In very rare cases, allergic skin reactions (rash) are possible.

Drug interactions

The interaction of Skinorens with other drugs has not yet been

Name ENG

SKINOREN

Clinical and pharmacological group

Drug for the treatment of acne and rosacea, Drug with antiproliferative and antibacterial action

ATX code

Azelaic acid

Dosage

15% x 15g

Structure

1 g of gel contains azelaic acid (micronized) - 150 mg

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

Indications

Acne (acne vulgaris)

hyperpigmentation, incl.

melasma, chloasma (for cream)

rosacea (for gel).

INN / Active ingredient

Azelaic acid

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 3 years

Contraindications

hypersensitivity to drug components.

Specifications

Category

Acne

Scope of the medicinal product

Leather

Release form

Gel

Manufacturer country

Italy

Package quantity, pcs

one

Scope of application

Dermatology

Way of introduction

On the skin

Vacation conditions

Without recipe

Brand name

Bayer

The amount of the dosage form in the primary package

15 g

Primary packaging type

Tuba

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Acne rash treatment

Anatomical and therapeutic characteristics

D10AX03 Azelanic acid

Dosage form

Gel for external use

Item weight, g

15

Expiration date in days

1095

The target audience

Adult

Package weight, g

45

Mode of application

:

The dosage regimen and the duration of therapy are set individually.

The gel should be applied to previously thoroughly washed (with water or cleansed with a mild cosmetic cleansing agent) and dried face skin.

The gel is applied in a thin layer to the affected skin 2 times / day (morning and evening) and rubbed lightly.

Approximately 2.5 cm of gel is sufficient for the entire face.

Information on technical characteristics, delivery set, country of manufacture