FENISTAMIN

Fenistamin

Gel, 1 mg/g

One gram of gel contains the active substance dimethindene maleate 1 mg.

Excipients with known effect: propylene glycol 150 mg/g (may cause skin irritation) and benzalkonium chloride 0.05 mg/g (irritant, may cause adverse skin reactions). Other excipients: disodium edetate, sodium hydroxide, carbomer, purified water.

A topical antihistamine for the relief of itching in: dermatoses (skin diseases), urticaria, insect stings and bites, sunburn and superficial burns.

Dimethindene maleate blocks histamine H1 receptors, significantly reducing the increased vascular permeability associated with immediate-type allergic reactions. The gel penetrates the skin quickly and also has a local anaesthetic action. The antipruritic effect begins within a few minutes; the maximum effect is reached after 1–4 hours.

Apply a thin layer to the affected area 2–4 times a day.

For severe itching or large areas, the topical treatment may be supplemented with an oral antihistamine. Avoid prolonged sun exposure on heavily treated areas. In infants and young children, avoid applying to large areas of skin, especially if inflamed or broken.

Do not use this medicine if you are allergic to dimethindene maleate or to any of its excipients.

Important to know

Avoid contact of the gel with the eyes. The medicine contains benzalkonium chloride (irritant, may cause adverse skin reactions) and propylene glycol (may cause skin irritation).

During pregnancy and breast-feeding, do not apply to large areas of skin, especially inflamed or broken skin; during breast-feeding, do not apply to the nipples. Not recommended for newborns. Read the package leaflet carefully before use.

Possible side effects

Frequency not known: dry skin, a burning sensation, allergic dermatitis at the site of application.

If large amounts are accidentally swallowed, symptoms of antihistamine overdose may occur (drowsiness in adults, excitation and anticholinergic effects in children). If a large amount is accidentally swallowed, seek medical help immediately.

If side effects occur, stop using the product and consult a doctor or pharmacist.

Store below 25 °C. Keep out of the reach of children. Shelf life: 24 months.

For questions about the medicine, please consult your doctor or pharmacist. Manufacturer: FARMAPRIM SRL, 5 Crinilor str., Porumbeni village, Criuleni district, Republic of Moldova, MD-4829. Pharmacovigilance: safety@farmaprim.md.

Brief information prepared on the basis of the approved Summary of Product Characteristics. It does not replace consultation with a doctor or pharmacist and does not contain all information about the medicine. Always read the package leaflet.