Fenistil emulsion 0.1% 8 ml. Vial

Description

The composition of the drug:

Fenistil emulsion active substance: dimethindene maleate;

1 g of the drug contains dimethindene maleate 1 mg;

Excipients:

benzalkonium chloride, benzyl alcohol, butylhydroxytoluene (E 321), edetate disodium, cocoyl caprylocaprate, mineral oil, polyethylene glycol cetostearyl ether, carbomer, sodium hydroxide 30% solution, propylene glycol.

Fenistil emulsion Dosage form.

The emulsion is cutaneous.

Homogeneous viscous emulsion.

Name and location of the manufacturer.

Novartis Consumer Health SA,

Route de l’Etraz, 1260 Nyon, Switzerland.

Fenistil emulsion Pharmacotherapeutic group.

Antihistamines for topical use. ATC code D04A A13.

Dimethindene maleate is an antagonist of histamine at the level of H1-receptors. It has a high affinity for H1-receptors and reduces capillary hyperpermeability associated with hypersensitivity reactions. The drug also has local anesthetic properties.

Fenistil Emulsion is effective against itching of various origins, it provides rapid relief of itching and other skin irritations. The drug is based on an emulsion that has a cooling, soothing, as well as emollient and moisturizing effect.

Fenistil Emulsion quickly penetrates the skin, the antihistamine effect begins within a few minutes. After topical application of the drug, the systemic penetration of dimethindene maleate in a healthy person is less than 10% of the applied dose.

Preclinical safety, toxicity and genotoxicity studies did not reveal any risk in humans. Studies in rats and rabbits did not reveal a teratogenic effect of the drug. Also in studies on rats, no effect of the drug on the ability to fertilize, as well as on the development of the fetus and newborn when used in doses 250 times higher than the dosage for humans.

Indications for use. Itchy skin, such as insect bites, allergic skin irritations, urticaria, uncomplicated minor skin burns, and mild sun erythema.

Contraindication.

Hypersensitivity to any component of the drug.

Appropriate safety precautions for use. The product contains propylene glycol, which may cause local skin irritation. The drug contains benzalkonium chloride, which has irritating properties and can cause skin reactions. The product contains butylhydroxytoluene, which may cause local skin irritation (eg contact dermatitis), eye and mucous membrane irritation.

Infants and young children should not use the drug on large areas of skin, especially on damaged or inflamed skin.

Prolonged exposure to the sun on the affected areas of the skin should be avoided during treatment with the drug.

Special caveats.

Use during pregnancy or breastfeeding.

The use of the drug during pregnancy in animal studies did not cause either teratogenic or toxic effects on fetal development or further development of the child. However, during pregnancy and breastfeeding, it is not recommended to apply Fenistil Emulsion on large areas of skin, especially on damaged or inflamed skin. The same applies to breastfeeding women. In addition, women who are breastfeeding should not apply the gel to the nipples of the mammary glands.