Fenistil 0,1% w/w Gel

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DIMETINDENE MALEATE

Available from:

Haleon Hellas Single Member Societe Anonyme, under the distinctive title of Haleon Hellas, 274, Kifissias Ave, 15232 chalandri, Athens, Greece

ATC code:

D04AA13

INN (International Name):

DIMETINDENE MALEATE 1 mg/g

Pharmaceutical form:

GEL

Composition:

DIMETINDENE MALEATE 1 mg/g

Prescription type:

OTC

Therapeutic area:

ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.

Authorization status:

Authorised

Authorization date:

2007-04-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FENISTIL 0,1% GEL,
Dimetindene maleate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use Fenistil gel exactly as described in this leaflet or as
your doctor or pharmacist has
told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
•
You must talk to a doctor if you do not feel better or if you feel
worse after 7 days.
WHAT IS IN THIS LEAFLET:
1.
What Fenistil gel is and what it is used for
2.
What you need to know before you use Fenistil gel
3.
How to use Fenistil gel
4.
Possible side effects
5.
How to store Fenistil gel
6.
Contents of the pack and other information
1.
WHAT FENISTIL GEL
IS AND WHAT IT IS USED FOR
WHAT FENISTIL GEL IS
Fenistil gel contains dimetindene maleate, an active ingredient that
belongs to the group
of medicines called antihistamines, which are used for relief from
skin allergies, as well
as different types of itching.
HOW FENISTIL GEL ACTS
Dimetindene maleate (the active substance of Fenistil gel) stops
itching by blocking the
effect of histamine, which is released into the body through contact
with an allergen and
causes the allergic reaction. As the gel penetrates effectively into
the skin, it provides
immediate relief from itching and irritation in just a few minutes.
Fenistil gel also has local anesthetic action.
WHAT FENISTIL GEL IS USED FOR
Fenistil gel is used in the relief from itching due to limited and
mild symptoms of
urticaria, dermographism and dermatitis from natural causes such as
insect or jellyfish
bites or contact with plants and for the relief of pruritus associated
with sunburn and
superficial burns.
You must talk to a doctor if you do not feel better or if you feel
worse after 7 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fenistil 0,1% w/w Gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 g of gel contains 1 mg of dimetindene maleate.
Excipients with known effect: Each 1 g of gel contains 150 mg
propylene glycol and 0,1
mg benzalkonium chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Odourless and colourless gel.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Relief from itching due to limited and mild symptoms of urticaria,
demographism
and dermatitis from natural causes such as insect or jellyfish bites
or contact with
plants and from pruritus associated with sunburn and superficial
burns.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
Apply small quantity of gel 2-4 times a day to affected area of the
skin.
Maximum duration of use: If no improvement is seen after 7 days of gel
use, the
patient should consult the physician.
Special use instructions
In case of very severe urticaria events or extensive skin lesions,
doctor’s or
pharmacist’s advice should be asked for the topical application
of
Fenistil
to
be supplemented by a systemic therapy with an oral form of
antihistamine.
PAEDIATRIC POPULATION
Fenistil gel should be used on children below 2 years of age only
after doctor’s
advice. Do not use on premature or newborn infants below 4 weeks of
age.
In small children and infants, do not use on extensive areas of the
skin, particularly
on open wounds or inflamed skin (see 4.4 Special warnings and
precautions for
use)
_Μethod of administration _
For dermatological use on intact skin without injuries.
Αpply small quantity on the affected area. Then, gently massage with
your hand to
facilitate penetration of the medicine into the skin. Do not cover
with bandages that
do not allow air to pass through and do not apply on extensive areas
of the skin.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In cas