FENISTIL GEL

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DIMETINDENE MALEATE

Available from:

GSK CONSUMER HEALTHCARE, ISRAEL LTD

ATC code:

D04AA13

Pharmaceutical form:

GEL

Composition:

DIMETINDENE MALEATE 0.1 %W/W

Administration route:

TOPICAL

Prescription type:

Not required

Manufactured by:

NOVARTIS CONSUMER HEALTH SA, SWITZERLAND

Therapeutic group:

DIMETINDENE

Therapeutic area:

DIMETINDENE

Therapeutic indications:

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

Authorization date:

2020-08-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) –
1986
This medicine is dispensed without a doctor’s prescription
FENISTIL GEL 0.1% W/W
DIMETHINDENE MALEATE 0.1% W/W
Inactive ingredients and allergens in the preparation
–
see section 6 and section 2 under the title “Important
information about some of the ingredients
of the medicine”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have additional questions, refer to the doctor or
the pharmacist.
Use the preparation according to the instructions in the dosage
section of this leaflet. Consult the pharmacist if you
need more information. Refer to the doctor if signs of the ailment
(symptoms) worsen or do not improve after 7 days.
1. WHAT IS THE MEDICINE INTENDED FOR?
Rash, itch, noninflammatory skin diseases, burns, insect bites,
allergic skin inflammation and eczema.
THERAPEUTIC CLASS: anti-histamines
Fenistil Gel neutralizes the effect of histamine, one of the
substances that is released during the allergic reaction.
When in contact with the skin, Fenistil Gel relieves the itchiness
that is caused by the allergic reaction. In addition,
Fenistil Gel has a local anesthetic property. Fenistil Gel is a
water-based gel and it allows the active ingredient to
quickly penetrate well into the skin (within a few minutes) to relieve
irritated and itchy skin.
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE
•
If you are sensitive (allergic) to the active ingredient dimethindene
maleate or to any of the other ingredients the
medicine Fenistil Gel contains, as listed in section 6 of the leaflet.
•
If there is a known allergy to insect bites.
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE
BEFORE TREATMENT WITH FENISTIL GEL, INFORM THE DOCTOR: if you have
another disease, if you are allergic, if you are
already taking or using other oral or topical medicines (even if
self-treating!).
Additional warnings:
•
Avoid applying on extensive areas,

Summary of Product characteristics

1
Fenistil Gel
_Composition _
_Active substance: _Dimethindene maleate.
_Excipients: _ Purified Water, Propylene Glycol, Sodium Hydroxide
Solution 30% w/w,
Carbomer, Disodium edetate, Benzalkonium Chloride solution 50%.
_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.
Maximum duration of use: if no improvement is visible after 7 days,
medical
advice should be sought.
_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).
_Warnings and precautions _
Avoid applying over large areas of skin, especially in case of open
wounds,
injuries or damage affecting large areas of skin. This applies in
particular in
infants and small children.
Avoid prolonged exposure to the sun of the areas treated.
_Fenistil Gel contains: _
_Propylene glycol (E1520 150mg/g): _can cause local skin irritations.
_Benzalkonium chloride(0.05mg/g): _benzalkonium chloride may irritate
the skin. You should
not apply this medicine to the breasts if you are breast-feeding
because the baby may take
it in with your milk. As there is only minimal absorption of
benzalkonium chloride via the
skin, no harmful effects on the mother are expected during pregnancy
and breastfeeding.
Do not use on mucous membranes.
2
_Interactions _
No study of interactions has been conducted.
_Pregnancy/Lactation _
_Pregnancy _
Experimental studies conducted with dimethindene on animals revealed
no potential
teratogenic potential or direct or indirect toxicity with an impact on
preg