NOTICE
ANSM - Last updated: 30/11/2015
Name of the medicinal product
HEXOMEDINE 0.1 PER CENT, gel 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 0.1 PER CENT, gel for local application AND IN WHAT CASES IS IT USED?
2. BEFORE YOU USE HEXOMEDINE 0.1 PER CENT, gel for local application?
3. HOW TO USE HEXOMEDINE 0.1 PER CENT, gel for local application?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE HEXOMEDINE 0,1 PER CENT, gel for local application?
6. ADDITIONAL INFORMATION
1. WHAT IS HEXOMEDINE 0.1 PER CENT, gel for local application AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
ANTISEPTIC FOR LOCAL APPLICATION
Therapeutic indications
This medication is an antiseptic gel for local application.
This drug is recommended in the antisepsis of small superficial wounds.
Local topical treatment of certain skin disorders.
2. BEFORE YOU USE HEXOMEDINE 0.1 PER CENT, gel for local application?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use HEXOMEDINE 0.1 PER CENT, gel for local application in the following cases:
· Antisepsis before sampling (injection puncture),
· Disinfection of medical and surgical equipment
· In case of allergy to the derivatives of Hexamidine
· On the 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 0.1 PER CENT, gel for local application:
Special warnings
Do not use on a large area, under occlusive dressing, on burned skin, premature or infant skin.
Precautions for use
As soon as the tube is opened, microbial contamination is possible. Be sure to use the gel hygienically.
Replace the tube between two uses, put the gel on clean hands or a compress before applying it to the place to be treated.
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).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription.
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
Not applicable.
3. HOW TO USE HEXOMEDINE 0.1 PER CENT, gel 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
2 to 3 applications per day.
Method and route of administration
Dermal.
IN ALL CASES CONFORM TO THE ORDER OF YOUR DOCTOR STRICTLY.
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 0,1 PER CENT, gel for local application is liable to have undesirable effects, although not everyone is subject to it, including allergic skin reactions such as contact dermatitis.
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 0,1 PER CENT, gel for local application?
Keep out of the reach and sight of children.
Expiration date
Do not use HEXOMEDINE 0,1 PER CENT, gel for local application after the expiry date stated on the outer packaging.
Storage conditions
No special storage conditions.
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 0.1 PER CENT, gel for local application?
The active substance is :
Hexamidine diisodetionate .............................................. .................................................. ................. 0.100 g
For 100 g of gel for local application.
The other components are :
Hydroxyethylcellulose, glacial acetic acid, alcohol, purified water.
Pharmaceutical form and content
What is HEXOMEDINE 0,1 PER CENT, gel for local application and contents of the pack?
This medication is available as a gel for local application - 30 g tube.
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
SANOFI WINTHROP INDUSTRIE
196, RUE DU MARECHAL JUIN
45200 AMILLY
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.