NOTICE
ANSM - Last updated: 30/11/2015
Name of the medicinal product
HEXOMEDINE 1 FOR THOUSAND, solution for spraying skin in pressurized bottle
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, seek medical attention.
· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS HEXOMEDINE 1 FOR THOUSAND, solution for skin sprays in pressurized vial AND WHAT IT IS USED FOR?
2. BEFORE YOU USE HEXOMEDINE 1 FOR THOUSAND, solution for skin spraying in a pressurized vial?
3. HOW TO USE HEXOMEDINE 1 FOR THOUSAND, solution for skin spraying in a pressurized bottle?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE HEXOMEDINE 1 FOR THOUSAND, solution for skin spraying in a pressurized bottle?
6. ADDITIONAL INFORMATION
1. WHAT IS HEXOMEDINE 1 FOR THOUSAND, solution for skin sprays in pressurized vial AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
ANTISEPTICS AND DISINFECTANTS
Therapeutic indications
This medicine is indicated in:
· Antisepsis of small superficial wounds.
· Local supplementation of a possible superinfection of the skin.
2. BEFORE YOU USE HEXOMEDINE 1 FOR THOUSAND, solution for skin spraying in a pressurized vial?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not use HEXOMEDINE 1 FOR THOUSAND, pressurized vial skin spray solution in the following cases :
· Antisepsis before sampling (puncture, injection).
· Disinfection of medical and surgical equipment.
· Allergy to hexamidine derivatives.
· Do not apply to mucous membranes.
In case of doubt do not hesitate to ask the advice of your doctor or pharmacist.
Precautions for use; special warnings
Take special care with HEXOMEDINE 1 FOR THOUSAND, solution for pressurized skin spray
Special warnings
This medicinal product is for external use only.
Do not use on a large surface, under occlusive dressing, on damaged (especially burned) skin, premature skin or infant skin.
Precautions for use
After first use of the drug, microbial contamination is possible. Be careful not to keep too long an antiseptic vial.
If in doubt, do not hesitate to seek the advice 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 - Breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
List of excipients with known effect: alcohol.
3. HOW TO USE HEXOMEDINE 1 FOR THOUSAND, solution for skin spraying in a pressurized bottle?
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.
Spray the solution onto the lesion or lesions to be treated, 2 to 3 times a day, keeping the bottle in a vertical position: head up or head down.
No rinsing is necessary after application.
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 1 FOR THOUSAND, a solution for skin sprays in pressurized bottles, is likely to have undesirable effects, although not everyone is subject to them.
· Possible local allergic reactions: redness, irritation, itching, dryness of the skin.
· More severe allergic reactions may occur. They regress slowly.
Due to the presence of alcohol, frequent applications on the skin can cause irritation and dryness of the skin.
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 1 FOR THOUSAND, solution for skin spraying in a pressurized bottle?
Keep out of the reach and sight of children.
Expiration date
Do not use HEXOMEDINE 1 FOR THOUSAND, a pressurized bottle spray solution after the expiry date stated on the vial.
Storage conditions
Pressure vessel. Protect from sunlight and do not expose to temperatures exceeding 50 ° C.
Do not pierce or burn even after use.
Do not spray on a flame or an incandescent material.
Keep away from sources of ignition or sparks.
No smoking.
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 contains HEXOMEDINE 1 FOR THOUSAND, solution for pressurized skin spray?
The active substance is:
Hexamidine Diisetionate .............................................. .................................................. .................. 0.100 g
For 100 ml of solution.
The other components are:
Alcohol, glacial acetic acid, sodium acetate, purified water.
Propellant gas: nitrogen
Pharmaceutical form and content
What is HEXOMEDINE 1 FOR MILLE, solution for pressurized skin sprays and contents of the pack?
Solution for skin sprays in 60 ml, 75 ml or 100 ml pressurized bottles.
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
CHEMINEAU Laboratories
93, route de Monnaie
BP 16
37210 VOUVRAY
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.