FENISTIL GEL

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DIMETHINDENE MALEATE

Available from:

GSK CONSUMER HEALTHCARE, ISRAEL LTD

ATC code:

D04AA13

Pharmaceutical form:

GEL

Composition:

DIMETHINDENE MALEATE 0.1 %W/W

Administration route:

TOPICAL

Prescription type:

Not required

Manufactured by:

NOVARTIS CONSUMER HEALTH SA, SWITZERLAND

Therapeutic area:

DIMETINDENE

Therapeutic indications:

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

Authorization date:

2018-01-04

Summary of Product characteristics

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