Fenistil Gel for itching and skin irritation, 0.1%, 100g

Composition

Active ingredient: Dimethindenee maleate;1 g of gel contains 1 mg of Dimethindenee maleate. Auxiliary substances: benzalkonium chloride, sodium edetate, carbomer 974 P, sodium hydroxide, propylene glycol, purified water.

Pharmacological action

Histamine H1-receptor blocker. It has an anti-allergic and antipruritic effect. Reduces the increased capillary permeability associated with allergic reactions. When applied to the skin, it reduces itching and irritation caused by allergic skin reactions. The drug also has a pronounced local anesthetic effect. Blocks the action of kinins, has a weak anticholinergic effect. When applied externally, thanks to the gel base, the action with a slight cooling effect begins in a few minutes and reaches a maximum in 1-4 hours.

Clinical pharmacology

When applied externally, it penetrates well into the skin. The systemic bioavailability of the Active ingredient is 10%.

Indications

• Skin pruritus of various origins (except those associated with cholestasis) in: itchy dermatoses; eczema; urticaria; insect bites.
• Sunburn, domestic and industrial burns (mild).

Use during pregnancy and lactation

The use of Fenistil® in the first trimester of pregnancy is possible only after consulting a doctor. In the second and third trimesters of pregnancy and lactation, the drug should not be used on large areas of the skin, especially in the presence of inflammation and bleeding. Nursing mothers should not apply the drug to the nipples of the mammary glands.

Recommendations for use

Externally. The gel is applied to the affected area of the skin 2-4 times a day. In cases of severe itching or common skin lesions, concomitant use of oral forms of antihistamines is recommended.

Contraindications

Angle-closure glaucoma; prostatic hyperplasia; children under 1 month of age (especially premature babies); hypersensitivity to Dimethindenee and other components of the drug. Fenistil® should be prescribed with caution in the first trimester of pregnancy and during lactation (breastfeeding).

Side effects

Determining the frequency of side effects: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10 000 and <1/1000), very rare (From the skin and subcutaneous tissues: infrequently-dry skin, burning sensation of the skin. Allergic reactions: very rare (post-marketing data) – allergic dermatitis, including skin rash, pruritus. If any of the above side effects get worse, or any other side effects occur, the patient should inform the doctor.

Interaction

The drug interaction of Fenistil® is not described.

How to take, course of use and dosage

Apply externally. The drug should be applied to the affected areas of the skin 2-4 times a day. In cases of severe itching or common skin lesions, concomitant use of oral forms is recommended.

Overdose

No overdose cases have been reported.

Description

Gel for external use is homogeneous, colorless, transparent or slightly opalescent, practically odorless.

Special instructions

In case of severe itching or if large areas of the skin are affected, the drug can only be used after consulting a doctor. When using Fenistil® on large areas of the skin, avoid exposure to sunlight. If the severity of the symptoms of the disease does not decrease or increase during the use of Fenistil®, a doctor’s consultation is necessary. The drug is ineffective for itching associated with cholestasis. The drug contains propylene glycol and benzalkonium chloride. The emulsion also contains butylhydroxytoluene. These excipients may cause local allergic reactions (contact dermatitis). Butylhydroxytoluene can also cause eye and mucosal irritation. Use in pediatrics in children aged 1 month to 2 years, the drug should be used only after consulting a doctor. In children and young children, the drug should not be used on large areas of the skin, especially if there are signs of inflammation or bleeding. The ability to drive vehicles is not affected by mechanisms.

Product form

100 g-aluminum tubes (1) – cardboard packs.

Storage conditions

At a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 2 years.

Active ingredient

Dimethindenee

Dosage form

gel for external use

Description

For children older than 1 month, Nursing mothers as prescribed by a doctor, For adults, Pregnant women as prescribed by a doctor

Indications

Eczema, Hives, Dermatitis, Allergies, Insect Bites, Dermatosis