Effezel gel, 30 g

Topical treatment of acne with comedones, papules and pustules.

Outwardly.
Apply with a thin film using your fingertips to the entire affected surface once a day in the evening on clean and dry skin, avoiding contact with the eyes and mucous membranes of the lips.
The therapeutic effect develops after 1-4 weeks of treatment. The duration of treatment should be determined by the physician based on the patient's clinical condition.

In case of signs of skin irritation, it is recommended to use non-comedogenic agents with a moisturizing effect, the number of applications can be reduced (for example, every other day), treatment can be temporarily suspended until the signs of irritation disappear or completely stopped.

1 g of gel contains:

Active substances:

Adapalene - 0.001 g
Benzoyl peroxide - 0.025 g

Excipients: simulgel 600 PHA (copolymer of acrylamide and acryloyldimethyl taurate 35-40%, isohexadecane 20-25%, polysorbate 80 5-10% sorbitan oleate 2.5%, water up to 100%) - 0.04 g, sodium docusate - 0.0005 g, disodium edetate - 0.001 g, glycerol - 0.04 g, Poloxamer 124 - 0.002 g, propylene glycol - 0.04 g, purified water - up to 1 g.

- Hypersensitivity to active substances or any of the components of the drug;
- Children under 9 years of age (the safety and efficacy of the drug has not been established).

Trade name of the drug:

Effezel

International Non-Proprietary Name (INN) or Generic Name:

adapalene + benzoyl peroxide

Dosage form:

gel for external use

Composition:

1 g of gel contains:

Active substances:

Adapalene - 0.001 g
Benzoyl peroxide - 0.025 g

Excipients: simulgel 600 PHA (copolymer of acrylamide and acryloyldimethyl taurate 35-40%, isohexadecane 20-25%, polysorbate 80 5-10% sorbitan oleate 2.5%, water up to 100%) - 0.04 g, sodium docusate - 0.0005 g, disodium edetate - 0.001 g, glycerol - 0.04 g, Poloxamer 124 - 0.002 g, propylene glycol - 0.04 g, purified water - up to 1 g.

Description:

White or very faintly yellow opaque gel

Pharmacotherapeutic group:

Acne treatment

ATX code: D 10 AD 53

Pharmacological properties:

Pharmacodynamics

Effezel contains two active substances with different, but complementary, mechanisms of action.

• Adapalen.
  Adapalene is a chemically stable derivative of naphthoic acid with retinoid-like action. Adapalene acts pathogenetically for acne vulgaris: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 topically, adapalene normalizes the differentiation of follicular epithelial cells, thus reducing the formation of microcomedones. In vitro, adapalene inhibits chemotactic (targeted) and chemokinetic (voluntary) responses of human polymorphonuclear leukocytes, and also inhibits the metabolism of arachidonic acid and the formation of inflammatory mediators. According to in vitro studies, adapalene inhibits AP-1 factors, as well as the expression of toll-like receptors-2. So it can be saidthat under the influence of adapalene, the cell-mediated inflammatory component of acne is reduced.

• Benzoyl peroxide.
  Benzoyl peroxide has an antimicrobial effect, in particular against Propionibacterium acnes present in the sebaceous hair follicle in acne. It has an exfoliating and keratolytic effect.

Has a sebostatic effect, preventing the excessive production of sebum that accompanies acne.

Pharmacokinetics

The pharmacokinetic properties of Effezel are similar to those of Differin (adapalene) 0.1% gel for external use.
The penetration of benzoyl peroxide through the skin is low. It is completely converted into benzoic acid, which is quickly eliminated from the body.

Indications for use:

Topical treatment of acne with comedones, papules and pustules.

Contraindications

- Hypersensitivity to active substances or any of the components of the drug;
- Children under 9 years of age (the safety and efficacy of the drug has not been established).

Pregnancy and lactation

Pregnancy
There are insufficient data on the topical use of a combination of adapalene and benzoyl peroxide in pregnant women. However, the few available data collected from patients who received the drug in early pregnancy do not indicate any negative effects.

Studies of the combination of adapalene and benzoyl peroxide in animals, in which the drug was fed to animals orally, showed toxic effects on the reproductive system at high systemic exposure.

Due to the limited availability of data, as well as due to the possible weak penetration of adapalene through the skin, Effezel should not be used during pregnancy. In case of pregnancy, treatment should be discontinued.

Lactation
Studies of the penetration of the drug into the milk of animals or humans after the skin application of Effezel gel have not been conducted.
Since systemic exposure to Effezel in lactating women is negligible, no effect on breastfed infants is expected.

Effezel can be used while breastfeeding. Avoid contact of the newborn with the drug, applying the drug to the breast when used during breastfeeding.

Method of administration and dosage:

Outwardly.
Apply with a thin film using your fingertips to the entire affected surface once a day in the evening on clean and dry skin, avoiding contact with the eyes and mucous membranes of the lips.
The therapeutic effect develops after 1-4 weeks of treatment. The duration of treatment should be determined by the physician based on the patient's clinical condition.

In case of signs of skin irritation, it is recommended to use non-comedogenic agents with a moisturizing effect, the number of applications can be reduced (for example, every other day), treatment can be temporarily suspended until the signs of irritation disappear or completely stopped.

Overdose:

Effezel should only be applied once a day.
If accidentally swallowed, appropriate symptomatic therapy should be given.

Interaction with other medicinal products

Interaction studies with other drugs have not been conducted.

Based on the experience of using adapalene and benzoyl peroxide, interactions with other drugs have not been identified.
However, other retinoids or benzoyl peroxide, or drugs with a similar mechanism of action, should not be used concurrently. Caution should be exercised with the simultaneous use of cosmetics with exfoliating, irritating or drying effects due to the possible additional irritant effect.

The absorption of adapalene through the skin is low, therefore, the development of interactions with systemic drugs is unlikely.

The penetration of benzoyl peroxide through the skin is low; it is completely 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.

Special instructions:

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

Release form:

Gel for external use 1mg / g + 25mg / g 2, 15, 30, 45, 60 and 90 g in a tube made of high density polyethylene with a screw cap. 1 tube, together with instructions for use, are placed in a cardboard box.
Gel for external use 1mg / g + 25mg / g 30 g each in a polypropylene bottle with a dispensing device made of high density polyethylene, low density polyethylene and polypropylene.
1 bottle together with instructions for use is placed in a cardboard box.

Storage conditions:

At a temperature not higher than 25 ? C.
Keep out of the reach of children!

Shelf life:

2 years;
after opening the tube / bottle it is stored no more than 6 months.
Do not use after the expiration date.

Terms of dispensing from pharmacies:

On prescription.