NOTICE
ANSM - Updated on : 25/07/2024
Name of medicinal product
CHLORHEXIDINE/BENZALKONIUM/BENZYL ALCOHOL BIOGARAN CONSEIL 0.25 g/0.025 g/4 ml for 100 ml, solution for topical application
Chlorhexidine gluconate/Benzalkonium chloride/Benzyl alcohol
Enclosed
Please read this leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as it is described in this leaflet or by your doctor, pharmacist or nurse.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor, pharmacist or nurse. 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.
What does this leaflet contain?
1. What is CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL BIOGARAN 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/ALCOOL BENZYLIQUE BIOGARAN CONSEIL 0.25 g/0.025 g/4 ml for 100 ml, solution for topical application?
3. How to use CHLORHEXIDINE/BENZALKONIUM/ALCOOL BENZYLIQUE BIOGARAN 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/ALCOOL BENZYLIQUE BIOGARAN 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 BIOGARAN 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 BIOGARAN CONSEIL 0.25 g/0.025 g/4 ml for 100 ml, solution for topical application?
Never use CHLORHEXIDINE/BENZALKONIUM/ALCOOL BENZYLIQUE BIOGARAN CONSEIL 0.25 g/0.025 g/4 ml for 100 ml, solution for topical application.
- If you are allergic to chlorhexidine or to the quaternary ammonium family or to any of the other ingredients of this product, as listed in section 6.
- In the ear canal, in case of tympanic perforation.
- In the eyes.
- On mucous membranes, particularly genital mucosa.
- Do not use to disinfect medical and surgical equipment.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using CHLORHEXIDINE/BENZALKONIUM/ALCOOL BENZYLIQUE BIOGARAN CONSEIL 0.25 g/0.025 g/4 ml per 100 ml, solution for topical application.
This medicine is for external use only. Do not swallow.
Avoid contact with eyes, brain, meninges (membranes surrounding the brain and spinal cord) and middle ear.
CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL BIOGARAN CONSEIL 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, 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).
Do not use on large surfaces, under occlusive dressings, on injuredskin (especially burns), 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 carefully, as microbial contamination may occur as soon as you open an antiseptic preparation.
Children and adolescents
Use with caution with newborns, especially premature babies. CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL BIOGARAN CONSEIL 0.25 g/0.025 g/4 ml per 100 ml, solution for topical application may cause chemical burns to the skin.
Other medicinal products and CHLORHEXIDINE/BENZALKONIUM/ALCOOL BENZYLIQUE BIOGARAN CONSEIL 0.25 g/0.025 g/4 ml for 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 (risk of incompatibility or ineffectiveness). Prior use of soap should be followed by thorough rinsing before using this product.
CHLORHEXIDINE/BENZALKONIUM/ALCOOL BENZYLIQUE BIOGARAN CONSEIL 0.25 g/0.025 g/4 ml per 100 ml, solution for topical application with food and drink
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 advicebefore using this product.
Driving and use of machinery
Not applicable.
CHLORHEXIDINE/BENZALKONIUM/ALCOOL BENZYLIQUE BIOGARAN CONSEIL 0.25 g/0.025 g/4 ml for 100 ml, solution for topical application does not contain
Not applicable.
3. HOW TO USE CHLORHEXIDINE/BENZALKONIUM/ALCOOL BENZYLIQUE BIOGARAN 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, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt.
Dosage
1 to 2 applications per day.
Rinsing is not necessary after application.
Method and route of administration
Cutaneous use.
External use.
Duration of treatment
Use is limited to 5 days.
If you have used more CHLORHEXIDINE/BENZALKONIUM/ BENZYLIC ALCOHOL BIOGARAN CONSEIL 0.25 g/0.025 g/4 ml for 100 ml, solution for topical application than you should have done
Consult your doctor or pharmacist immediately.
Excessive use may aggravate undesirable effects. In addition, passage into the bloodstream cannot be ruled out in the event of widespread application or under occlusive dressings.
In the event of massive oral ingestion, perform gastric lavage. The acute per os toxicity of chlorhexidine is low (almost negligible digestive absorption).
Contact a poison control center.
If you forget to use CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL BIOGARAN CONSEIL 0.25 g/0.025 g/4 ml for 100 ml, solution for topical application
Not applicable.
If you stop using CHLORHEXIDINE/BENZALKONIUM/ALCOOL BENZYLIQUE BIOGARAN 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, pharmacist or nurse.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, CHLORHEXID® may cause undesirable effects, but these do not always occur in everyone.
Stop using CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL BIOGARAN CONSEIL 0.25 g/0.025 g/4 ml for 100 ml, solution for topical application and consult your doctor immediately if you experience any of the following adverse reactions:
Severe allergic reaction, signs of which may include :
- Difficulty breathing or swallowing
- Low blood pressure, which may lead to dizziness or lightheadedness
- Swelling ofthe face, lips, tongue or throat
- Severe itching of the skin, accompanied by a red rash or pimples.
Other adverse reactions
- Allergic eczema on contact with the product
- Chemical burns in neonates (frequency unknown).
Other possible adverse reactions, for which the frequency is unknown, are as follows:
- Allergic skin disorders such as dermatitis (inflammation of the skin), pruritus (itching), erythema (redness of the skin), eczema, rash, urticaria, skin irritation and blistering.
- 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 severe pain).
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. 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 TO USE CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL BIOGARAN 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 packaging. The expiration date refers to the last day of that month.
50 ml spray bottle: Store at temperatures 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 CHLORHEXIDINE/BENZALKONIUM/ALCOOL BENZYLIQUE BIOGARAN 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 solution
- The other component is :
Purified water.
What CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL BIOGARAN CONSEIL 0.25 g/0.025 g/4 ml for 100 ml, solution for topical application is and what it contains
This medicine is presented as a solution for topical application.
50 ml spray bottle.
Marketing authorization holder
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Marketing authorization holder
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Manufacturer
DELPHARM HUNINGUE SAS
26 RUE DE LA CHAPELLE
68330 HUNINGUE
VETPROM AD
The vpharma site
26 oteTS paisiy str.
2400 radomir
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].
Other
Detailed information on this drug is available on the ANSM (France) website.