EFFEZEL GEL FOR EXTERNAL USE 1MG/G + 25MG/G 30G

Gel for external use

Composition

1 g of gel contains: Adapalen - 0.001 g, Benzoyl peroxide - 0.025 g

Packaging

Tuba 30

Mechanism of action

Effezel contains in its composition two active substances with different, however complementary, mechanisms of action.

Adapalen.Adapalen is a chemically stable derivative of naphthoic acid with a retinoid-like effect. Adapalen acts pathogenetically with acne vulgaris: it is a strong modulator of the processes of cell differentiation and keratinization, and also has an anti-inflammatory effect. The mechanism of action of the drug is based on the binding of adapalene to specific nuclear receptors of retinoic acid. Modern data suggest that when applied locally, adapalen regulates the process of differentiation of epithelial cells of the follicles, thus reducing the formation of microcomedo. In vitro adapalen inhibits chemotactic (directed) and chemokinetic (arbitrary) responses of human polymorphonuclear leukocytes, as well as inhibits arachidonic acid metabolism and the formation of inflammatory mediators. According to in vitro studies, adapalen inhibits AP-1 factors, as well as the expression of toll-like receptors-2. Thus, it can be said that the cell-mediated inflammatory component of acne is reduced under the influence of adapalene.

Benzoyl peroxide.Benzoyl peroxide has an antimicrobial effect, in particular, against Propionibacterium acnes, present in the oil-hair follicle with acne. Provides exfoliating and keratolytic action. It has a sebiostatic effect, preventing excessive sebum production that accompanies acne.

Topical treatment of acne with comedones, papules and pustules.

Contraindications

Hypersensitivity or allergic reactions to the active substances or any of the ingredients of the drug.

Pregnancy and Breastfeeding

Pregnancy 
Data on local use of the combination of adapalene and benzoyl peroxide in pregnant women is not enough.However, the few available data collected from patients who received the drug in early pregnancy do not indicate any of its negative effects.
Studies of the combination of adapalene and benzoyl peroxide in animals in which the drug was administered orally to animals showed a toxic effect on the reproductive system during high systemic exposure.
Due to the limited available data, and also due to the possible weak penetration of adapalene through the skin, Effezel should not be used during pregnancy. If pregnancy occurs, treatment should be discontinued.

Lactation
Studies of the penetration of the drug into the milk of animals or humans after dermal application of the gel Effesel were not conducted. Since the systemic effect of Effezel in lactating women is insignificant, no effect on breastfed infants is expected.
Effezel can be applied during breastfeeding. Contact of the newborn with the drug should be avoided, and application of the drug to the breast when used during breastfeeding.

Dosage and administration

Outwardly.
Apply with a thin film with your fingertips to the entire affected surface once a day in the evening on clean and dry skin, avoiding contact with the eyes and lips and mucous membranes.
The therapeutic effect develops after 1-4 weeks of treatment. The duration of treatment should be determined by the doctor based on the clinical condition of the patient.
In the case of signs of skin irritation, the use of non-comedogenic preparations with a moisturizing effect is recommended, the number of applications can be reduced (for example, every other day), treatment can be temporarily suspended until the signs of irritation disappear or are completely stopped.

Adverse reactions

The frequency of side effects is distributed in the following order: often (in 1% - 10% of cases); infrequently (in 0.1% - 1% of cases).

On the part of the skin and subcutaneous fat:
Often: dry skin, irritable contact dermatitis, burning and irritation of the skin.
Infrequently: itch, sunburn.
Frequency unknown (post-marketing data): allergic contact dermatitis.
If skin irritation develops, its intensity is usually mild or moderate, with local symptoms of tolerability (redness, dryness, flaking and burning), which peak during the first week of treatment, and then spontaneously go away.

Special notes

Do not apply Effesel gel on injured skin (cuts or abrasions) or eczematous altered skin.
Avoid contact with eyes, oral cavity, nostrils and other mucous membranes. In case of contact with eyes, rinse immediately with warm water.
The drug contains propylene glycol (E1520), which can cause skin irritation. If you suspect a hypersensitivity to any of the ingredients of the drug use Effezel should be discontinued.
Excessive exposure to sunlight or UV radiation should be avoided.
Contact with any dyed materials (including hair and dyed fabrics) should be avoided, as this may cause discoloration or discoloration.

Drug Interactions

Research interaction with other drugs was not conducted. Based on the experience of using adapalene and benzoyl peroxide, interactions with other drugs have not been identified.
However, one should not simultaneously use other retinoids or benzoyl peroxide, or drugs with a similar mechanism of action. Care should be taken when applying cosmetics with a peeling, irritating or drying effect at the same time due to the possible additional irritating effect.
The absorption of adapalene through the skin is low, so the development of interaction with systemic drugs is unlikely.
Benzoyl peroxide penetration through the skin is low, it is fully metabolized to benzoic acid, which is rapidly excreted from the body. In this regard, the development of the interaction of benzoic acid with systemic drugs is unlikely.

Overdosage

Effesel should be applied only once a day. If accidentally swallowed, appropriate symptomatic therapy should be carried out.

At a temperature not higher than 30 ° С