Fenistil Gel

/ GSK

Adults and children: Apply 2 to 4 times per day on the areas to be treated in a thin layer and massage lightly.

Urticaria, pruritus, dermatoses, burns, insect bites, allergic dermatitis and eczema.

The product should not be used in case of hypersensitivity to dimethindene maleate or to one of the excipients. The product cannot be used as a treatment for known allergies to insect bites (systemic pharmaceutical forms are available for this purpose).
The product should not be used on open or inflamed wounds, seeping dermatitis or mucosa, or close to the eyes, particularly in children and infants

Propylene glycol: can cause local skin irritations.
Benzalkonium chloride: irritant and can cause skin reactions.
Avoid applying over large areas, especially in infants and young children. Avoid
prolonged exposure to the sun of the areas treated.

The most commonly reported adverse effects are transient and mild skin reactions in the area of administration.
See package insert (OTC).

No study of interactions has been conducted.

Pregnancy : Experimental studies conducted with dimethindene on animals revealed no potential teratogenic potential or direct or indirect toxicity with an impact on pregnancy, embryonic development, the development of the fetus, and/or postnatal development.
No clinical data is available concerning use in pregnant women. Therefore, caution is recommended during pregnancy and Fenistil Gel should not be applied to large, burned or inflamed areas of the skin.
Lactation: The precautions are the same as those for pregnancy.
In addition, the gel should not be applied to the nipples when breast-feeding.

Symptoms of intoxication resembling those observed in case of overdose with H1 antihistamines may appear in case of involuntary oral absorption of a large quantity of topical dimethindene maleate. The symptoms are the following: depression of the CNS with dizziness (especially in adults), stimulation of the CNS and an antimuscarinic effect (especially in children) with excitation, ataxia, hallucinations, tonic-clonic seizures, mydriasis, dry mouth, facial redness, urine retention and fever. Hypotension can also occur.
No specific antidote is known. The usual emergency measures should be begun,
including the administration of activated charcoal and osmotic laxatives, as well as stabilisation of the cardiorespiratory system. Do not use a stimulant; vasopressors may be used to normalise hypotension.

Storage: Do not store above 25°C.