Skinoren 15% 30g of the gel for the face for problem skin

The instruction for medical use


of Skinoren® medicine

the Trade name
of Skinoren®

the International unlicensed name
Azelaic acid

the Dosage form
Gel of 15%

Structure
One gram of gel contains
active agent - the micronized azelaic acid of 0.15 g
excipients: lecithin, triglycerides, polysorbate 80, propylene glycol, polyacrylic acid, sodium hydroxide, dinatrium edetat, water the purified, benzoic acid.

The description
From white till yellow-white color opaque gel.

Pharmacotherapeutic group
Other drugs for topical treatment of acne rash.
The code of automatic telephone exchange D10AX03

the Pharmacological

Pharmacokinetics Later properties of local putting gel azelaic acid gets into all layers of skin. Penetration happens quicker in the injured skin, than in healthy. After single topical administration of 1 g of azelaic acid about 3.6% of the put dose are soaked up.
A part of the soaked-up acid is removed by kidneys in not changed look. The rest in the form of the dicarboxylic acids from the chain (C7, C5) shortened by length which are formed as a result of beta oxidation is removed also by kidneys.
The pharmacodynamics
Skinorena Active ingredient is azelaic acid which medical effect is connected with influence on the main pathogenetic links of an acne disease - hyper keratinization of a wall of a hair follicle, the strengthened reproduction of microorganisms in a sebaceous gland, development of inflammatory process in a sebaceous gland.
Azelaic acid, having ability to slow down biosynthesis of cellular proteins, renders the moderate cytostatic effect which is shown in normalization of processes of keratinization in a wall of a hair follicle (inhibits proliferation of keratinotsit). Azelaic acid accelerates lysis of comedones, formation of fatty acids normalizes processes (reduces fraction of free fatty acids in superficial lipids of skin). Drug has bacteriostatic activity concerning Propionibacterium acne and Staphylococcus epidermidis, inhibits growth of the acnes of propionic bacteria participating in education, both on the surface of skin, and in sebaceous glands. Besides, drug has anti-inflammatory properties, reducing metabolism of neutrocytes and development of free radical forms of oxygen by them - important factors of maintenance of inflammatory process. Even at prolonged use of Skinoren it is not observed development of resistant forms of microorganisms. Azelaic acid renders the overwhelming impact on growth and viability of abnormal melanocytes depending on a dose and on time. Abnormal melanocytes cause a melazma type hyperpegmentation. The therapeutic effect of Skinoren in a hyperpegmentation (melazma) is caused by inhibition of synthesis of DNA and/or suppression of cellular respiration of abnormal melanocytes (inhibits growth and activity).
Indications
- an acne (acne disease)
- a rozatsea.

Route of administration and doses
Outwardly. Before putting gel it is necessary to wash up carefully skin water or the soft cleaning cosmetic, then to dry up. Gel is applied with a thin layer on affected areas of skin twice a day (in the morning and in the evening) and slightly rubbed. About 2.5 cm of gel are enough for all surface of a face. It is important that Skinoren was used regularly during the entire period of treatment. Use duration Skinorena is individual and depends on disease severity. Improvement occurs, as a rule, in 4 weeks of treatment. However for achievement of the best results it is necessary to use Skinoren gel within several months. Therapy course duration usually is 2-4 months. If necessary treatment can be continued up to 6 months then it is recommended to take a break in 1-2 months.

Side effects
In an initiation of treatment it is in some cases possible:
- local irritative action
- hyperaemia and peeling of skin
- burning
- an erythema
- an itching.
In most cases irritation symptoms insignificant, and they usually stop in the course of treatment.
Seldom or never:
- allergic reactions of skin (for example, rash)
- contact dermatitis
- a folliculitis.

Contraindications
- hypersensitivity to drug components


Medicinal interactions
are not established

Special instructions
in case of irritation of skin it is necessary to impose smaller amount of gel for once or to reduce the frequency of use of Skinoren to once a day, if necessary perhaps temporarily to interrupt treatment for several days.
Not to allow hit of drug in eyes.
At accidental contact – immediately to wash with water.
Pregnancy and the period of a lactation
during pregnancy the use of drug according to indications is possible. The amount of azelaic acid which can get to the baby together with breast milk is insignificant and is not accompanied by any danger (considering extremely hypotoxicity of drug).
Use in pediatrics
Drug is appointed to children 12 years are more senior.
Influence on ability to drive the car or potentially dangerous mechanisms
Use of drug does not affect ability to drive the car or potentially dangerous mechanisms.

The overdose
Overdose is improbable as drug is used outwardly and has no systemic action.

The form of release and packing
place Gel in tubas on 5 and 30 g together with the instruction for use in a cardboard pack.


To Store storage conditions at a temperature not above 25 °C.
To store in places inaccessible for children!


3 years
not to use a period of storage after an expiration date.

Prescription status
Without prescription


the Producer Intendis Manufacturing of SPA, Italy
Intendis Manufacturing SpA,

Italy Via E.Schering, 2120090 Segrate Milano Italy