NOTICE
ANSM - Last updated: 30/11/2015
Name of the medicinal product
HEXOMEDINE TRANSCUTANEE 1.5 FOR THOUSAND, solution for local application
Hexamidine diisodetionate
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS HEXOMEDINE TRANSCUTANEOUS 1.5 FOR THOUSAND, solution for local application AND WHAT IT IS USED FOR?
2. BEFORE YOU USE HEXOMEDINE TRANSCUTANEOUS 1.5 FOR THOUSAND, solution for local application?
3. HOW TO USE HEXOMEDINE TRANSCUTANEOUS 1.5 FOR THOUSAND, solution for local application?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE HEXOMEDINE TRANSCUTANEOUS 1.5 FOR THOUSAND, solution for local application?
6. ADDITIONAL INFORMATION
1. WHAT IS HEXOMEDINE TRANSCUTANEOUS 1.5 FOR THOUSAND, solution for local application AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
ANTISEPTIC
(D. Dermatology)
Antiseptic of the family of diamidines.
Therapeutic indications
Antiseptics of small superficial wounds and local treatment of a possible superinfection of the skin.
2. BEFORE YOU USE HEXOMEDINE TRANSCUTANEOUS 1.5 FOR THOUSAND, solution for local application?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not use HEXOMEDINE TRANSCUTANEE 1.5 FOR THOUSAND, solution for local application in the following cases:
· antisepsis before sampling (puncture, injection),
· disinfection of medical and surgical equipment,
· in case of allergic reaction to hexamidine or to any of the components of the solution.
· Do not use on open wounds or mucous membranes.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with HEXOMEDINE TRANSCUTANEE 1,5 FOR THOUSAND, solution for local application:
Special warnings
Do not use on a large surface, under occlusive dressing, on a burnt skin, a skin of premature, infant.
This medicine contains propylene glycol and may cause skin irritation.
Precautions for use
As soon as the bottle is opened, microbial contamination is possible.
Take care not to keep too long an antiseptic vial ( see section Dosage ).
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Taking or using other medicines:
Avoid the simultaneous or successive use of different antiseptics with this antiseptic (in particular the previous use of soap must be followed by careful rinsing).
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
This medication should be used with caution during pregnancy and lactation. In general, you should seek advice from your doctor or pharmacist before taking any medication.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Excipient with a known effect: propylene glycol.
3. HOW TO USE HEXOMEDINE TRANSCUTANEOUS 1.5 FOR THOUSAND, solution for local application?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Do not swallow.
Use purely twice a day in whitewash or in local baths.
In the infections of the nail and the periphery of the nail, the solution can be used:
· either as a short wet wound dressing (30 to 45 minutes)
· or in a bath of 1 to 3 minutes (The bottle with large neck is provided for this use).
In this case, the solution should not be used for another antiseptic use, nor should the bottle be used after use.
Rinsing after application is unnecessary.
Close the bottle.
Operating time after opening:
· 15 days if used under hygienic conditions (the product is deposited on a sterile compress before application on the part to be treated).
· 5 days maximum, if the part to be treated is immersed in the bottle (local baths for a nail affection).
Method and route of administration
Dermal.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, HEXOMEDINE TRANSCUTANEE 1.5 FOR THOUSAND, solution for local application is likely to have undesirable effects, although not everyone is subject to it.
· Possible local allergic reactions: redness, irritation, itching, dryness of the skin.
· More severe allergic reactions may occur.
They regress slowly.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE HEXOMEDINE TRANSCUTANEOUS 1.5 FOR THOUSAND, solution for local application?
Keep out of the reach and sight of children.
Expiration date
Do not use HEXOMEDINE TRANSCUTANEE 1.5 FOR THOUSAND, solution for local application after the expiry date stated on the bottle.
Storage conditions
Store at a temperature not exceeding 25 ° C.
After 1 st opening: the product can be kept for up to 15 days (5 days if used in local baths for nail infections).
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What is HEXOMEDINE TRANSCUTANEE 1.5 FOR THOUSAND, solution for local application?
The active substance is:
Hexamidine di-istionate ............................................ .................................................. 0.150 g
For 100 ml of solution for local application.
The other components are:
Propylene glycol, methylal, nonoxynol, 96.5 ° ethyl alcohol, purified water.
Pharmaceutical form and content
What is HEXOMEDINE TRANSCUTANEE 1.5 FOR THOUSAND, solution for local application and contents of the outer packaging?
This medication is in the form of a solution for local application.
Bottle of 45 ml.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
SANOFI-AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
exploiting
SANOFI AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Maker
RPR PHARMA SPECIALTIES
20, AVENUE RAYMOND ARON
92160 ANTONY
or
RPR PROGIPHARM
BP 77
INDUSTRIAL ZONE
45502 GIEN
or
FAMAR HEALTH CARE SERVICES MADRID SAU
AVENIDA LEGANES, 62
28923 ALCORCON MADRID
SPAIN
or
UNITHER LIQUID MANUFACTURING
1-3 ALLEE OF THE NESTE
31770 COLOMIERS
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.