Azelic^® (Gel) Instructions for Use

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Contact Information

AKRIKHIN JSC (Russia)

ATC Code

D10AX03 (Azelaic acid)

Active Substance

Azelaic acid (Rec.INN registered by WHO)

Dosage Form

Azelic®

Gel for external use 15%: tubes 5 g, 15 g or 30 g

Dosage Form, Packaging, and Composition

Gel for external use white or almost white in color, a slight specific odor is allowed.

Excipients: benzoic acid, methylpyrrolidone, squalane, propylene glycol, disodium edetate, sodium hydroxide, dimethicone 100 cst, macrogol cetostearyl ether, carbomer interpolymer (type A), purified water.

5 g – aluminum tubes (1) – cardboard packs.
15 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Drug for the treatment of acne

Pharmacotherapeutic Group

Acne vulgaris treatment agent

Pharmacological Action

A drug for external use. It has a bacteriostatic activity against Propionibacterium acne and Staphylococcus epidermidis, reduces the production of fatty acids that contribute to the occurrence of acne.

It reduces the formation of comedones. By influencing the process of keratinization of epidermal cells, it suppresses the growth and activity of abnormal melanocytes that cause hyperpigmentation of the melasma type. It has an anti-acne, depigmenting effect.

Pharmacokinetics

Absorption

After application to the skin, it penetrates into the epidermis and dermis, 3.6% of the total dose is absorbed into the systemic bloodstream.

Metabolism and excretion

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

• Acne (acne vulgaris);
• Rosacea.

ICD codes

Dosage Regimen

For external use only.

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

Apply the gel in a thin layer to the affected areas of the skin 2 times a day (in the morning and in the evening) and rub in gently. Approximately 2.5 cm of gel is sufficient for the entire surface of the face.

In patients with acne vulgaris, marked improvement is usually observed after 4 weeks.

To achieve the best results, the use of the drug should be continued for several months.

Adverse Reactions

Skin and subcutaneous tissue disorders: at the beginning of treatment, local irritant effect, skin redness and peeling, burning, erythema, itching are possible, usually subsiding during the course of treatment; skin allergic reactions are possible.

Contraindications

• Hypersensitivity to the components of the drug.

Use with caution during pregnancy and lactation (breastfeeding).

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, it should be used only if the intended benefit of therapy for the mother outweighs the risk to the fetus or breastfed infant.

Special Precautions

In cases of severe skin irritation during the first weeks of treatment, the gel can be applied once a day; a temporary discontinuation of the drug is also possible.

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

Avoid contact of the drug with the eyes, as well as with the mucous membranes of the nose, lips, and mouth; in case of accidental contact, rinse immediately with water.

During treatment, it is necessary to protect the skin from the full spectrum of solar radiation.

Overdose

Currently, no cases of drug overdose have been reported.

Drug Interactions

Can be used in combination with other medicines for the treatment of acne.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F). Do not freeze.

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.