Pays: Israël
Langue: anglais
Source: Ministry of Health
DIMETHINDENE MALEATE
GSK CONSUMER HEALTHCARE, ISRAEL LTD
D04AA13
GEL
DIMETHINDENE MALEATE 0.1 %W/W
TOPICAL
Not required
NOVARTIS CONSUMER HEALTH SA, SWITZERLAND
DIMETINDENE
Urticaria, pruritis, dermatoses, burns, insect bites, allergic dermatitis and eczema.
2018-01-04
1 FENISTIL GEL _ _ _COMPOSITION _ _Active substance: _Dimethindene maleate. _Excipients: _ Purified Water, Propylene Glycol, Sodium Hydroxide Solution 30% w/w, Carbomer (Carbopol 974 P), Disodium edetate, Benzalkonium Chloride. _ _ _PHARMACEUTICAL FORM AND QUANTITY OF THE ACTIVE SUBSTANCE PER UNIT _ Dimethindene Maleate 0.1% w/w. The gel is Colourless to slightly yellowish and practically odourless. _ _ _INDICATIONS/POSSIBLE USES _ Urticaria, pruritus, dermatoses, burns, insect bites, allergic dermatitis and eczema. _ _ _POSOLOGY/METHOD OF ADMINISTRATION _ _Adults and children_ Apply 2 to 4 times per day on the areas to be treated in a thin layer and massage lightly. _ _ _CONTRAINDICATIONS _ 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_ _ _ _ _WARNINGS AND PRECAUTIONS _ _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. _ _ _INTERACTIONS _ No study of interactions has been conducted. _ _ _PREGNANCY/LACTATION _ _Pregnancy _ 2 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 (see “Preclinical data”). 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 addit Lire le document complet