Fenistil Gel

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

dimetindene maleate 1 mg/g

Available from:

Novartis Consumer Health UK Limited

ATC code:

D04AA13

INN (International Name):

dimetindene maleate

Pharmaceutical form:

gel

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 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

Summary of Product characteristics

 
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