资料单张
PACKAGE LEAFLET: INFORMATION FOR THE USER
FENISTIL 0.1% GEL
Dimetindene maleate
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use Fenistil gel exactly as described in this leaflet or as your pharmacist has told you.
You should check with your doctor or pharmacist if you are not
sure.
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.
You must talk to a doctor if you do not feel
better or if you feel worse 7 days.
WHAT IS IN THIS LEAFLET
1
What Fenistil is and what it is used
for ................................................................................1
2
What you need to know before you
useFenistil ...................................................................2
3
How to
use Fenistil ..............................................................................................................3
4
Possible side
effects .............................................................................................................3
5
How to
store Fenistil ............................................................................................................3
6
What is in the pack and
further information ........................................................................4
1
WHAT FENISTIL IS AND WHAT IT IS USED FOR
WHAT FENISTIL IS
Fenistil Gel contains an active ingredient that belongs to a group of medicines called
antihistamines.
Fenistil gel is used for the relief of itching associated
with skin reactions like skin rashes,
hives, insect bites, sunburns and mild superficial burns.
HOW FENISTIL WORKS
Fen
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产品特点
1
NAME OF THE MEDICINAL PRODUCT
Fenistil 0.1% Gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of Fenistil gel contains 1 mg of dimethindene maleate.
Excipients with known effect: propylene glycol and 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 of pruritus associated with dermatoses, urticaria, insect bites, sunburn and
superficial burns.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Apply Fenistil Gel 2 to 4 times a day.
_SPECIAL INSTRUCTIONS FOR DOSAGE: _
In case of very severe pruritus or extensive lesions, the local application of Fenistil should
be supplemented by a systemic treatment with an oral form of
Fenistil.
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
Prolonged exposure to the sun of extensively treated areas should
be avoided.
In infants and small children, avoid use on extensive areas of the skin, particularly if
raw or
inflamed.
INFORMATION CONCERNING EXCIPIENTS;
Fenistil gel contains:
PROPYLENE GLYCOL which may cause mild, localized skin
irritation.
BENZALKONIUM CHLORIDE which is irritant, and may cause skin
reactions.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS
OF INTERACTION
No interaction studies have been performed; however since the systemic absorption of
dimetindene maleate from topical application is very low,
interactions are very unlikely.
4.6
FERTILITY, PREGNANCY AND LACTATION
PREGNANCY
Animal studies with dimetindene do not show teratogenic potential nor do the
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