NOTICE
ANSM - Updated on: 03/07/2017
Name of the medicinal product
HEXOMEDINE 1 FOR THOUSAND, solution for local application
Hexamidine di-isetionate
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
What is in this leaflet?
1. What is HEXOMEDINE 1 FOR THOUSAND, solution for local application and in which cases it is used?
2. What should be known before using HEXOMEDINE 1 FOR MILLE, a solution for local application?
3. How to use HEXOMEDINE 1 FOR THOUSAND, solution for local application?
4. What are the possible side effects?
5. How to store HEXOMEDINE 1 FOR THOUSAND, solution for local application?
6. Package contents and other information.
1. WHAT IS HEXOMEDINE 1 FOR THOUSAND, a solution for local application AND WHAT IT IS USED FOR?
Pharmacotherapeutic group - ANTISEPTICS AND DISINFECTANTS, ATC code: D08AC02
(D. Dermatology)
This antiseptic belongs to the family of diamidines.
Antiseptics of small superficial wounds and local treatment of a possible superinfection of the skin.
2. BEFORE YOU USE HEXOMEDINE 1 FOR THOUSAND, solution for local application?
Do not use HEXOMEDINE 1 FOR THOUSAND, solution for local application in the following cases:
· Antiseptic before sampling (puncture, injection).
· Disinfection of medical and surgical equipment.
· Allergy to hexamidine derivatives.
· Do not use on mucous membranes.
Warnings and Precautions
Do not use on a large area, under occlusive dressing, on burned skin, premature or infant skin.
As soon as the bottle is opened, microbial contamination is possible. Be careful not to keep too long an antiseptic vial.
Talk to your doctor or pharmacist before using HEXOMEDINE 1 FOR THOUSAND, a solution for local application .
children
Not applicable.
Other medicines and HEXOMEDINE 1 FOR THOUSAND, solution for local application
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Avoid the simultaneous or successive use of different antiseptics with this antiseptic (especially the previous use of soap must be followed by a careful rinse).
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
HEXOMEDINE 1 FOR THOUSAND, solution for local application with food and beverages
Not applicable.
Pregnancy and breast feeding
This medication should be used with caution during pregnancy and lactation.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor for advice or pharmacist before taking this medication.
Driving and using machines
Not applicable.
HEXOMEDINE 1 FOR THOUSAND, solution for local application contains alcohol, acetic acid and sodium acetate.
3. HOW TO USE HEXOMEDINE 1 FOR THOUSAND, solution for local application?
Do not swallow.
Hexomedine solution should be used purely in local application, wet dressings or local baths at 2-3 times a day.
It can also be used as a spray.
No rinsing is necessary after application.
DERMAL
If you used more HEXOMEDINE 1 FOR THOUSAND, solution for local application you should not have
Not applicable.
If you forget to use HEXOMEDINE 1 FOR THOUSAND, solution for local application
Not applicable.
If you stop using HEXOMEDINE 1 FOR THOUSAND, solution for local application
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· 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.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE HEXOMEDINE 1 FOR THOUSAND, solution for local application?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the package.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What HEXOMEDINE 1 FOR MILLE contains, solution for local application
· The active substance is:
Hexamidine di-isetionate ............................................ .................................................. ...... 0.100 g
For 100 ml of solution for local application.
· The other components are:
Ethanol 96% (v / v), glacial acetic acid, sodium acetate, purified water.
What is HEXOMEDINE 1 FOR MILLE, solution for local application and contents of the pack
This medication is in the form of a solution for local application - 45 ml, 250 ml and 1000 ml flasks and a 60 ml spray bottle.
Marketing Authorization Holder
SANOFI-AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Marketing Authorization Operator
SANOFI-AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Maker
RPR PHARMA SPECIALTIES
20, AVENUE RAYMOND ARON
92160 ANTONY
or
A. NATTERMANN & CIE GMBH
NATTERMANNALLEE 1
50829 KOLN
GERMANY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).