Skinoren gel 15 g 15%

Description

Composition
Active substance:
1 g of gel contains: micronized azelaic acid 0.15 g
Excipients:
0.12 g Propylene glycol, Polysorbate 80 0.015 g, 0.01 g of lecithin, 0.01 g of polyacrylic acid, triglycerides 0.01 g sodium hydroxide 0.002 g disodium edetate 0.001 g Benzoic acid 0.001 g Purified water 0.681 g
Description:
The opaque gel from white to white with a yellowish tinge.
Product form:
Gel for external use 15% 5 g, 30 g or 50 g of an aluminum laminated polyethylene tube with screw cap. Tube with instructions for use placed in a cardboard box.
Contraindications
Hypersensitivity to azelaic acid and other ingredients; Children up to age 12 years (acne), 18 years (rosacea).
Carefully.
Bronchial asthma.
Dosage
150mg / g
Indications
Acne mild rash and moderate severity, including the presence of papules and pustules; rosacea, including the presence of papules and pustules.
Interaction with other drugs
Clinically significant interactions not revealed when using Skinoren® preparation.
Overdose
Overdose phenomena when applied externally installed.
pharmachologic effect
Pharmacological group:
Acne treatment for rashes.
Pharmacodynamics:
Azelaic acid in the treatment of acne normalize the disturbed keratinization processes in the follicles of the sebaceous glands, as well as reducing the content of free fatty acids in the skin lipids. Shows antimicrobial activity against Propionobacterium acnes and Staphyloccocus 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 metabolism of neutrophils and decreased production of free radical forms of oxygen. Azelaic acid has a dose-dependent and time from the inhibitory effect on the growth and viability of abnormal melanocytes.
Pharmacokinetics:
After application to the skin azelaic acid penetrates into the epidermis and dermis, the penetration into the damaged skin is faster than in intact. After a single topical application 5 g of gel 3.6% of the total dose of azelaic acid enters the systemic circulation. Part suck acid excreted by the kidneys in unchanged form part – in the form of dicarboxylic acids (C7, C5) formed as a result of beta-oxidation.
Pregnancy and breast-feeding
Use of the drug during pregnancy and breastfeeding is possible after consultation with the doctor.
Adequate and well-controlled studies with topical azelaic acid have not been conducted in pregnant women. The study on animals showed no adverse effects of azelaic acid with respect to pregnancy, fetal development, birth or postnatal development. The potential risk for humans is unknown. In pregnancy, the drug Skinoren® used only if the expected benefit to the mother outweighs the potential risk to the fetus.
Similarly, it is not known whether azelaic acid into breast milk. Given the low systemic absorption of acid when applied externally, during breastfeeding Skinoren® drug is used only if the expected benefit to the mother outweighs the potential risk to the child. When breastfeeding to avoid application of the drug to the area of ​​the mammary glands before feeding; should avoid contact with the skin of children, including those with breast skin after application Skinoren® drug.
Conditions of supply of pharmacies
Without a prescription.
side effects
Observed in the clinical studies and post-marketing surveillance in the most common side effects were: itching, burning and pain at the site of application.
Violations by the immune system: the frequency is unknown – hypersensitivity reactions (including angioedema, swelling of the eyes, swelling of the face, shortness of breath), exacerbation of asthma.
Violation of the skin and subcutaneous tissue disorders: infrequently – contact dermatitis, acne (acne).
General disorders and application site: very often – at the site of itching, burning, pain; often – the site of application: dry, rash, paresthesia, edema **; rarely – the site of application: erythema (redness), desquamation * (detachment of the epidermis), a feeling of warmth, depigmentation (bleaching) of the skin, discomfort ** * hives; Frequency unknown: skin irritation, urticaria.
If any of these instructions side effects are compounded, or if you notice any other side effects not mentioned in the instructions, tell your doctor.
Footnotes: * – for acne, ** – for rosacea.
special instructions
For external use only. Avoid contact with the gel in the eye, mouth, and other mucous membranes. In case of accidental contact with the drug on the mucous membranes, including the eyes and mouth should be rinsed with plenty of water. If eye irritation persists, consult a doctor. After each application of drug Skinoren® wash hands. During treatment of rosacea Skinoren® advised not to use cosmetics containing alcohol, alcoholic solutions and astringents, abrasives and peeling agents (peeling). Preparation Skinoren® comprises benzoic acid, which can cause irritation to the skin, irritation to the eyes and mucous membranes and propylene glycol, which may cause skin irritation. During post-marketing surveillance has been reported rarely in patients with exacerbation of bronchial asthma with topical azelaic acid. Carefully read the manual before you start using the product. Keep the instructions, it may be necessary again. If you have any questions, contact your doctor.
Medicines that you are being treated meant to you personally, and should not be transferred to other persons as it may harm them even if you have the same symptoms that you have.
Effects on ability to drive vehicles, machinery.
Skinoren® drug does not affect the ability to drive and operate machinery.
Storage conditions
At a temperature of not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Outwardly. Before applying the gel should be washed with water or mild skin cleansing cosmetic product, followed by drying, or use gentle cleansing cosmetic.
Do not use occlusive dressings.
After each application of the gel to the skin wash hands. The gel is applied to a thin layer to the affected areas of the skin 2 times per day (morning and evening), gently rubbing the skin (2.5 cm of gel is sufficient for the entire facial surface).
Children from 12 to 18 years of drug Skinoren® applied in the treatment of acne, dose adjustment is not required.
Efficacy and safety of the drug in children younger than 12 years in the treatment of acne has not been established.
Efficacy and safety of the drug in children younger than 18 years in the treatment of rosacea is not installed.
It is important that Skinoren® used regularly throughout the treatment period.
The duration of treatment depends on the individual and the severity of the disease. The improvement occurs typically after 4 weeks of treatment, when necessary, may use the drug Skinoren® for several months.
If within 1 month of the treatment of acne, and 2 months in the treatment of rosacea no improvement or worsening of the disease occurred, it is necessary to stop the use of Skinoren® and seek medical advice.
In the case of skin irritation should reduce the amount of gel applied for each or reduce the frequency of application of the gel to 1 times per day.
Possible momentary removal of the drug, followed by resumption after the disappearance of symptoms of irritation at the recommended dose.
Use drug only according to the application and in those doses which are specified in the instruction. If necessary, please rokonsultiruytes a physician before using the drug.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist