NOTICE
ANSM - Updated on : 11/07/2024
Product name
HEXICID, solution for topical application
Chlorhexidine gluconate / Benzalkonium chloride / Benzyl alcohol
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
You must always use this medicine in strict accordance with the information provided in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any of the side effects listed above, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel better or feel worse after 5 days.
Keep out of the reach of children.
What does this leaflet contain?
1. What is HEXICID, solution for topical application and what is it used for?
2. What do I need to know before using HEXICID, solution for topical application?
3. How do I use HEXICID topical solution?
4. What are the possible side effects?
5. How should HEXICID topical solution be stored?
6. Package contents and other information.
1. WHAT IS HEXICID, solution for topical application AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: Antiseptics and disinfectants - ATC code: D08AC02
Antisepsis of small superficial wounds.
2. WHAT DO I HAVE TO KNOW BEFORE USING HEXICID, solution for topical application?
Never use HEXICID, solution for topical application
- If you are allergic to the active substance or to any of the other ingredients listed in section 6;
- in the ear canal, in the event of tympanic perforation, or in the eyes
- on mucous membranes, particularly genital mucous membranes;
- Do not use to disinfect medical and surgical equipment.
Warnings and precautions
Consult your doctor or pharmacist before using HEXICID, solution for topical application.
Special warnings
Do not use on large surfaces, under occlusive dressings, on deeply burned skin, or on the skin of premature babies or infants, as there is a risk of it entering the general circulation.
This medicine is only a local antiseptic. Its action only reduces the number of micro-organisms.
Use with caution in neonates, particularly premature infants.
HEXICID, solution for topical application may cause chemical burns to the skin.
HEXICID, solution for topical application must not come into contact with the eye, as it may cause visual damage. If it comes into contact with the eyes, rinse immediately and thoroughly with water.
In the event of irritation, redness or pain in the eye, or visual disturbance, seek prompt medical advice.
Serious cases of persistent corneal damage (damage to the surface of the eye), which may require corneal grafting, have been reported when similar products accidentally came into contact with the eye during surgery, in patients under general anaesthesia (sleep without intense pain)Safety precautions
Avoid simultaneous or successive use of other antiseptics.
Handle with care, as microbial contamination may occur as soon as you open an antiseptic preparation.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST.
Children
Not applicable.
Other medicinal products and HEXICID, solution for local application
Tell your doctor or pharmacist if you are using, have recently used or may use any other medicines.
Avoid simultaneous or successive use of different antiseptics with this antiseptic (in particular, prior use of soap should be followed by careful rinsing).
HEXICID, solution for topical application with food and drink
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Sportsmen
Not applicable.
Driving and use of machinery
Not applicable.
HEXICID, solution for topical application contains
Purified water.
3. HOW TO USE HEXICID, solution for topical application
Dosage
1 to 2 applications per day.
It is not necessary to rinse after application.
Method and route of administration
For cutaneous use.
External use
Duration of treatment
Use is limited to 5 days.
If you have used more HEXICID, solution for topical application than you should have
Not applicable.
If you forget to use HEXICID, solution for topical application
Not applicable.
If you stop using HEXICID, solution for topical application
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but these do not always occur in everyone.
- Allergic eczema on contact with the product, particularly in the case of damaged skin, mucous membranes or ulcerations of the lower limbs;
- Rarely, general allergic reactions, including anaphylactic shock;
- chemical burns in neonates (frequency undetermined);
- corneal damage (damage to the surface of the eye) and permanent eye damage, including permanent visual impairment (following accidental ocular exposure during surgical procedures on the head, face and neck) in patients under general anaesthesia (sleep without intense pain).
Reporting side effects
If you experience any side effects, please tell 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: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW DO I USE HEXICID, solution for topical application?
Keep out of sight and reach of children.
Do not use after the expiration date indicated on the bottle. The expiration date refers to the last day of that month.
For the 250 ml bottle: No special storage precautions.
For the 50 ml spray bottle: Store at a temperature not exceeding 25°C.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What HEXICID, solution for topical application, contains
- The active ingredients are :
Chlorhexidine gluconate............................................................................................ 0.250 g
Benzalkonium chloride.............................................................................................. 0.025 g
Benzyl alcohol......................................................................................................... 4.000 ml
Per 100 ml
- The other component is :
Purified water.
What HEXICID, solution for topical application is and what it contains
This medicine is a solution for topical application.
50 ml or 250 ml bottle.
Marketing authorization holder
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Marketing authorization holder
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Manufacturer
DELPHARM HUNINGUE SAS
26 RUE DE LA CHAPELLE
68330 HUNINGUE
Or
VETPROM AD
THE VPHARMA SITE, 26 OTES PAISIY STR
RADOMIR 2400
BULGARIA
Drug names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.