Azelik - instructions for use, dose, side effects, contraindications

active substance: azelaic acid in terms of 100% substance - 15.00 g; Excipients: benzoic acid 0.10 g, methylpyrrolidone 4.00 g, squalane 1.00 g, propylene glycol 8.00 g, disodium edetate 0.10 g, sodium hydroxide 0.25 g, dimethicone 100 cst - 1.00 g, macrogol cetostearyl ether 1.40 g, carbomer interpolymer (type A) 1.40 g, purified water up to 100 g.

Description:The gel is white or almost white, a slight specific odor is allowed.

Pharmacotherapeutic group:Acne rash remedy

ATX: & nbsp

D.10.A.X.03 Azelanic acid

Pharmacodynamics:

Azelaic acid in the treatment of acne normalizes the disturbed processes of keratinization in the follicles of the sebaceous glands, and also reduces the content of free fatty acids in the lipids of the skin. Has antimicrobial activity against Propiombacterium acnes and Staphylococcus epidermidis. The mechanism of action of azelaic acid in rosacea is unknown. It can be assumed,that the anti-inflammatory effect is due to a decrease in neutrophil metabolism and a decrease in the production of free-radical oxygen forms by them. Azelaic acid It has a dose-dependent and over time inhibitory effect on the growth and activity of abnormal melanocytes.

Pharmacokinetics:After application on the skin azelaic acid penetrates the epidermis and dermis, penetration into the damaged skin occurs faster than in the intact. After a single external application of 5 g of gel, 3.6% of the total dose of azelaic acid enters the systemic circulation. Part of the absorbed acid is excreted by the kidneys in an unchanged form, part - in the form of dicarboxylic acids (C7, C5), formed as a result of beta-oxidation.

Indications:

Acne rashes of mild and moderate severity, including those with papules and pustules; rosacea, including the presence of papules and pustules.

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

Carefully:Bronchial asthma.

Pregnancy and lactation:The use of the drug during pregnancy and lactation is possible only after consultation with the doctor.

Adequate and strictly controlled studies with external application azelaic acid in pregnant women were not performed. Study in animals is not has revealed the adverse effect of azelaic acid on pregnancy, intrauterine fetal development, childbirth or postnatal exposure. The potential risk to humans is unknown. In pregnancy, Azelik® is used only if the intended benefit to the mother exceeds the potential risk to the fetus.

It is not known whether azelaic acid in breast milk. Given the low systemic absorption of azelaic acid for external use, during the period of breastfeeding Azelik® is used only if the perceived benefit to the mother exceeds the potential risk for the child. When breastfeeding it is necessary to avoid applying the drug to the area of the mammary glands before feeding; should avoid contact of children with the skin, including the skin of the mammary glands, after applying the drug Azelik®.

Dosing and Administration:Outwardly.Before applying the gel, thoroughly wash the skin with clean water and then dry it, or use a mild cleansing cosmetic. Do not use occlusive dressings. After each application of the gel on the skin, hands should be washed. The gel is applied a thin layer on the affected skin areas 2 times a day (morning and evening), lightly rubbing into the skin (2.5 cm of gel is sufficient for the entire surface of the face).

In children from 12 to 18 years, Azelik® is used in the treatment of acne, dosage adjustment is not required. The efficacy and safety of the drug in children younger than 12 years in the treatment of acne is not established. The efficacy and safety of the drug in children under the age of 18 years in the treatment of rosacea is not established.

It is important that Azelik® is used regularly throughout the treatment period. The duration of treatment is individual and depends on the severity of the disease. Improvement occurs, usually after 4 weeks of treatment, if necessary, the use of Azelik® for several months is possible. 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, then stop Azelik® and consult a doctor.In case of irritation on the skin, the amount of gel should be reduced with each application or the frequency of applying the gel reduced to 1 time per day. Possible a short-term withdrawal of the drug with a subsequent resumption after the disappearance of symptoms of irritation in the recommended dose. Use the drug only according to the method of administration and at the doses indicated in instructions. If necessary, please consult with your doctor before using the medication.

Side effects:Observed in clinical studies and during post-registration observation, the most frequent side effects were: itching, burning and pain at the site of application.

The following side effects are given in accordance with the following grades (WHO World Health Organization): very often (≥ 1/10); often (≥ 1/100, <1/10); infrequently (≥ 1/1 000, <1/100); rarely (≥ 1/10 000, <1/1 000), very rarely (<1/10 000), the frequency is unknown (insufficient data to estimate the frequency of development).

Immune system disorders: frequency unknown - reactions of hypersensitivity (including angioedema, eye swelling, edema of the face, dyspnea), exacerbation of bronchial asthma.

Disturbances from the skin and subcutaneous tissues: infrequently - contact dermatitis, acne ** (acne).

General disorders and disorders in the place of application: very often - in the place of application: itching, burning, pain; often - at the application site: dryness, rash, paresthesia, edema **; rarely in place of application: erythema (redness), desquamation * (epidermal detachment), sensation of heat *, depigmentation (discoloration) of the skin, discomfort **, urticaria **; frequency unknown - irritation on the skin, hives.

* - for acne;

** - for rosacea.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:Overdose phenomena with external application are not established.

Interaction:Clinically significant interactions with the use of Azelik® were not detected.

Special instructions:

For external use only. Avoid contact with the eyes, mouth and other mucous membranes. If you accidentally get the drug on the mucous membranes, including the eyes, mouth, you need to rinse them with plenty of water. If eye irritation persists, consult a physician.After each use, wash your hands. During treatment with Azelik® rosacea, it is recommended that you avoid using cosmetics containing alcohol, alcohol solutions and binders, abrasive or exfoliating agents (for peeling). The Azelik® preparation contains benzoic acid, which can cause skin irritation, eye and mucous membrane irritations, and propylene glycol, which can cause irritation on the skin. During post-registration observation, there was rarely reported exacerbation in patients with bronchial asthma with external use of azelaic acid.

Effect on the ability to drive transp. cf. and fur:

The drug does not affect the ability to drive vehicles or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:Gel for external use 15%.

Packaging:By 5, 15 or 30 g in an aluminum tube. Each tube together with the instruction for use is placed in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001416

Date of registration:11.01.2012 / 13.02.2017

Expiration Date:Unlimited

The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia

Manufacturer: & nbsp

AKRIKHIN HFK, JSC Russia

Information update date: & nbsp11.09.2017

Illustrated instructions

Instructions

Azelik® (Azelic®)