Instructions for the medical use of the medicinal product Deriva water gel

active substance:

adapalene;
1 g contains adapalene 1 mg;

excipients:

dinarium edetate, carbomer 940, propylene glycol, methyl parahydroxybenzoate (E 218), poloxamer 407, phenoxyethanol, sodium hydroxide, purified water.

Medical form

Gel.

Main physical and chemical properties:

white homogeneous opaque gel.

Pharmacotherapeutic group:

Drugs for the treatment of acne. Retinoids for topical treatment of acne. PBX code D10А D03.
Adapalene is a derivative of naphthoic acid, a retinoid-like substance that modulates the processes of cell differentiation and keratinization, as well as inflammatory processes in the skin, which are the main pathogenetic links in the development of acne. Adapalene binds to the retinoid receptors of the cell nucleus and thus contributes to the normal differentiation of the epithelial cells of the follicles, which leads to a decrease in the formation of microcomedones and prevents the development of acne, helps to preserve intact skin.

The therapeutic effect of the drug is usually evident within 8-12 weeks from the start of treatment. When using adapalene in the form of a gel, the degree of absorption of the drug through the skin into the blood is extremely low.

Testimony.

Local treatment of common acne (acne vulgaris).

Contraindications.

Hypersensitivity to adapalene or other components of the drug.
Appropriate safety measures during use.

The drug is intended for local use only. You should avoid contact of the gel with the eyes, lips, areas of the wings of the nose and with the skin around the eyes, as well as mucous membranes. If the gel gets on these areas, they should be thoroughly washed with warm water. Do not apply the gel to areas with eczematous skin lesions, sunburns, cuts or other skin lesions. During treatment, excessive exposure to sunlight and ultraviolet light, including lamps, should be avoided due to increased skin sensitivity and increased risk of solar erythema.

Using cosmetic products that dry out the skin (such as abrasive or medicated soaps, skin cleansers, products containing excessive amounts of alcohol, astringents, shaving or aftershave creams or lotions, products, cleansers) during treatment with the drug may cause an irritating effect.
If an allergy occurs during treatment with the drug, the therapy should be stopped and a doctor should be consulted.

Special warnings.

Use during pregnancy or breastfeeding.
Do not use the drug during pregnancy, as adequate clinical trials on the safety of adapalene use in pregnant women have not been conducted. It is not known whether adapalene is secreted into breast milk, so the use of the drug during breastfeeding is not recommended.

The ability to influence the speed of reaction when driving motor vehicles or robotic mechanisms.
Since absorption of the drug through the skin almost does not occur, the influence of the active substance on the speed of reactions is unlikely.

Method of application and dosage.

Deriva water gel should be used for the local treatment of acne in adults and children over 12 years of age.

The gel should be applied in a thin layer on clean, dry skin in places of rashes once a day at night.
During the first weeks of treatment, exacerbation of the acne process is possible due to the effect of the active substance on lesions that were not visible before. In this case, the treatment should not be stopped, the therapeutic effect is observed after 8-12 weeks from the start of the treatment. It is also possible to feel itching and burning of the skin immediately after applying the gel, which passes over time.

Children.

The safety and efficacy of the drug in children under 12 years of age have not been studied, so the drug should not be used in children under 12 years of age.

Overdose.

Symptoms.

When applying a large amount of gel, redness and peeling of the skin is possible. Since absorption of the drug through the skin almost does not occur, any systemic exposure to adapalene is unlikely.

Side effects.

Allergic reactions, photosensitivity reactions, tingling, redness, peeling, dryness, itching and burning of the skin at the site of application, itching and burning of the skin are often observed immediately after applying the gel, as well as exacerbation of the acne process, skin irritation in the first weeks of treatment.

These phenomena are reversible and usually disappear or weaken after 1 month of treatment.
Interaction with other medicinal products and other types of interactions.

Since Deriva water gel can cause a local irritating effect in some patients, the simultaneous use of other potentially irritating local drugs, including cosmetics, increases the risk of unwanted effects on the skin.
It should be prescribed with special care with drugs containing sulfur, resorcinol or salicylic acid.

Expiry date.

3 years.

Storage conditions.

Store at a temperature not higher than 25 °C. Do not freeze. Keep out of the reach of children.

Packaging.

5 g or 15 g of gel in a tube, each tube in a cardboard package.

Category of release.

Without a prescription.

Producer.

Glenmark Pharmaceuticals Ltd. / Glenmark Pharmaceuticals Ltd.

Location of the manufacturer and its address of the place of activity.

Plot No E-37/39, M.I.D.C., Industrial Estate, Satpur, Nasik – 422007, India.

Registration.

Registration certificate: UA/9164/01/01;
Order of the Ministry of Health No. 91 of January 17, 2020;
Validity of the registration certificate: unlimited from 10/22/2018

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