NOTICE
ANSM - Updated on : 16/10/2024
Name of medicinal product
CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL VIATRIS CONSEIL 0.25 g/0.025 g/4 mL per 100 mL, solution for topical application
Chlorhexidine gluconate / Benzalkonium chloride / Benzyl alcohol
Sidebar
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 CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL VIATRIS CONSEIL 0.25 g/0.025 g/4 mL per 100 mL, solution for topical application and what is it used for?
2. What do I need to know before using CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL VIATRIS CONSEIL 0.25 g/0.025 g/4 mL for 100 mL, solution for topical application?
3. How to use CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL VIATRIS CONSEIL 0.25 g/0.025 g/4 mL for 100 mL, solution for topical application?
4. What are the possible side effects?
5. How to store CHLORHEXIDINE/BENZALKONIUM/ALCOHOL BENZYLIQUE VIATRIS CONSEIL 0.25 g/0.025 g/4 mL for 100 mL, solution for topical application?
6. Package contents and other information.
1. WHAT IS CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL VIATRIS CONSEIL 0.25 g/0.025 g/4 mL for 100 mL, 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 CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL VIATRIS CONSEIL 0.25 g/0.025 g/4 mL for 100 mL, solution for topical application?
Never use CHLORHEXIDINE/BENZALKONIUM/ALCOOL BENZYLIQUE VIATRIS CONSEIL 0.25 g/0.025 g/4 mL for 100 mL, solution for topical application.
- if you are allergic (hypersensitive) 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
- Do not use on mucous membranes, particularly genital mucosa;
- not to be used for disinfecting medical-surgical equipment.
Warnings and precautions
Consult your doctor or pharmacist before using CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL VIATRIS CONSEIL 0.25 g/0.025 g/4 mL per 100 mL, 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, due to the risk of passage into the general circulation.
CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL VIATRIS CONSEIL 0.25 g/0.025 g/4 mL per 100 mL, solution for topical application must not come into contact with the eye, as there is a risk of visual damage. If eye contact occurs, rinse immediately and thoroughly with water. In the event of irritation, redness, pain or visual disturbance, seek medical advice immediately.
Serious cases of persistent corneal damage (damage to the surface of the eye) which may require corneal transplantation have been reported when similar products accidentally came into contact with the eye during surgery, in patients under general anaesthesia (sleep without intense pain).
This product is only a local antiseptic. Its action only reduces the number of micro-organisms.
Use with caution in neonates, particularly premature babies. CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL VIATRIS CONSEIL 0.25 g/0.025 g/4 mL per 100 mL, solution for topical application may cause chemical burns to the skin. Precautions for use
Avoid simultaneous or successive use of other antiseptics.
Handle with care, as microbial contamination may occur as soon as you open an antiseptic preparation.
Stop using CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL VIATRIS CONSEIL 0.25 g/0.025 g/4 mL per 100 mL, solution for topical application and consult your doctor immediately if you notice any signs of an allergic reaction. These signs are listed under "Serious adverse reactions" in section 4.IF IN DOUBT, DO NOT HESITATE TO ASK YOUR PHYSICIAN OR DOCTOR FOR ADVICE.
Children and adolescents
KEEP OUT OF THE REACH OF CHILDREN.
Other medicinal products and CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL VIATRIS CONSEIL 0.25 g/0.025 g/4 mL per 100 mL, solution for topical 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 must be followed by careful rinsing).
CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL VIATRIS CONSEIL 0.25 g/0.025 g/4 mL per 100 mL, solution for topical application with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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.
CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL VIATRIS CONSEIL 0.25 g/0.025 g/4 mL per 100 mL, solution for topical application contains
Purified water.
3. HOW TO USE CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL VIATRIS CONSEIL 0.25 g/0.025 g/4 mL for 100 mL, solution for topical application?
Always use this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Injured skin:
1 to 2 applications per day.
Rinsing is not necessary after application.
Method and route of administration
Cutaneous route.
External use
Duration of treatment
Use is limited to 5 days.
If you have used more CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL VIATRIS CONSEIL 0.25 g/0.025 g/4 mL for 100 mL, solution for topical application than you should have, contact your doctor or pharmacist immediately.
Consult your doctor or pharmacist immediately.
If you forget to use CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL VIATRIS CONSEIL 0.25 g/0.025 g/4 mL for 100 mL, solution for topical application
Not applicable.
If you stop using CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL VIATRIS CONSEIL 0.25 g/0.025 g/4 mL for 100 mL, solution for topical application
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone:
Serious side effects
Stop using CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL VIATRIS CONSEIL 0.25 g/0.025 g/4 mL per 100 mL, solution for topical application and consult your doctor immediately if you experience any of the following side effects:
Severe allergic reaction, signs of which may include :
- Difficulty breathing or swallowing
- Low blood pressure, which may lead to dizziness or lightheadedness
- Swelling of the face, lips, tongue or throat
- Severe itching of the skin, accompanied by a red rash or pimples.
Other adverse reactions for which the frequency is unknown:
- Allergic skin conditions such as dermatitis (inflammation of the skin), pruritus (itching), erythema (redness of the skin), eczema, rash, urticaria, skin irritation and blistering.
- chemical burns in neonates
- Eye disorders: 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 contribute to providing more information on drug safety.
5. HOW TO USE CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL VIATRIS CONSEIL 0.25 g/0.025 g/4 mL for 100 mL, solution for topical application?
Keep out of sight and reach of children.
Do not use this medicine 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 are required.
For the 50 ml spray bottle: Store at a temperature not exceeding 25°C.
Do not dispose of any medicine in the sewage system or with 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 CHLORHEXIDINE/BENZALKONIUM/ALCOHOL BENZYLIQUE VIATRIS CONSEIL 0.25 g/0.025 g/4 mL per 100 mL contains, solution for topical application
- The active ingredients are :
chlorhexidine gluconate.............................................................................................. 0.25 g
benzalkonium chloride............................................................................................... 0.025 g
benzyl alcohol............................................................................................................... 4 mL
per 100 ml
- The other component is :
purified water.
What is CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL VIATRIS CONSEIL 0.25 g/0.025 g/4 mL per 100 mL, solution for topical application and what does it contain?
This medicine comes in the form of a solution for topical application.
50 mL or 250 mL bottle.
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Manufacturer
DELPHARM HUNINGUE SAS
26 RUE DE LA CHAPELLE
68330 HUNINGUE
or
VETPROM
THE VPHARMA SITE
26 OTETS PAISIY STR.,
RADOMIR, 2400
BULGARIA
Product 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]
< {MM/YYYY}>< {month/YYYY}.>
Other
Detailed information on this drug is available on the ANSM (France) website.