NOTICE
ANSM - Updated on : 17/07/2024
Product name
BISEPTINE, solution for topical application
Benzyl alcohol, chlorhexidine digluconate and benzalkonium chloride
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 advice and information.
- If you experience any of the unwanted effects, 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 any improvement or if you feel less well.
- Keep out of the reach of children.
What does this leaflet contain?
1. What is BISEPTINE, solution for topical application and what is it used for?
2. What do I need to know before using BISEPTINE, solution for topical application?
3. How do I use BISEPTINE topical solution?
4. What are the possible side effects?
5. How should BISEPTINE topical solution be stored?
6. Package contents and other information.
1. WHAT IS BISEPTINE AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: ANTISEPTICS AND DISINFECTANTS (D. Dermatology)
This medicine is indicated for :
Antisepsis of shallow surgical and traumatic wounds.
Local adjunctive treatment of infected skin or skin at risk of infection.
Skin antisepsis prior to surgery.
2. WHAT DO I HAVE TO KNOW BEFORE USING BISEPTINE, solution for topical application?
Never use BISEPTINE, solution for topical application:
- If you are allergic (hypersensitive) to the active substance or to any of the other components of this medicine listed in section 6.
- In the ear canal in the event of tympanic perforation, or in the eyes.
- Do not apply to mucous membranes, particularly genital mucosa.
- Do not use to disinfect medical and surgical equipment.
Warnings and precautions
Talk to your doctor or pharmacist before using BISEPTINE, solution for local application.
Do not apply to the eyes. BISEPTINE, solution for topical application must not come into contact with the eye, as there is a risk of 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) requiring corneal grafting have been reported.s when similar products have accidentally come into contact with the eye during surgery, in patients under general anaesthesia (sleep without intense pain).
Avoid contact with the brain, meninges (membranes surrounding the brain and spinal cord) and middle ear.
Allow to dry before using an electrical instrument, as there is a risk of burns.
Do not use over large areas, 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 newborns, particularly premature infants. BISEPTINE may cause chemical burns to the skin.
Avoid simultaneous or successive use of other antiseptics.
Handle with care, as microbial contamination may occur as soon as an antiseptic preparation is opened.
Stop using BISEPTINE and consult your doctor immediately if you notice any signs suggesting an allergic reaction. These signs are listed under "Serious adverse reactions" in section 4.
Children and adolescents
Keep out of the reach of children.
Other medicinal products and BISEPTINE, 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 thorough rinsing).
BISEPTINE, solution for topical application with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
Tell your doctor or pharmacist if you are using, have recently used or may use any other medicines.
Sportsmen
Not applicable.
Driving and use of machinery
Not applicable.
3. HOW TO USE BISEPTINE, solution for topical application?
Always use this medicine exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist or in case of doubt.
Dosage
Injured skin :
Generally 1 application, 2 times a day.
Preparing healthy skin for surgery :
2 successive applications corresponding respectively to the cleansing/detersion phase and the antisepsis phase.
IN ALL CASES, ADHERE STRICTLY TO MEDICAL PRESCRIPTION.
Method and route of administration
DERMAL ROUTE
IN ALL CASES, ADHERE STRICTLY TO MEDICAL PRESCRIPTION.
Duration of treatment
IN ALL CASES, ADHERE STRICTLY TO MEDICAL PRESCRIPTION.
If you have used more BISEPTINE, solution for topical application than you should have :
Consult your doctor or pharmacist immediately.
If you forget to use BISEPTINE, solution for topical application :
Not applicable.
If you stop using BISEPTINE, 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 taking BISEPTINE 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 with unknown frequency:
- Allergic skin disorders such as dermatitis (inflammation of the skin), pruritus (itching), erythema (redness of the skin), eczema, rash, urticaria, skin irritation and blisters.
- Chemical burns in newborns.
- Corneal damage (damage to the surface of the eye) and permanent eye damage, including permanent visual impairment (following accidental accidental ocular exposure during head, face and neck surgery) in patients under general anaesthesia (pain-free sleep).
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.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW DO I USE BISEPTINE, 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 after EXP. The expiration date refers to the last day of that month.
For polyethylene bottles: No special storage precautions.
For polyethylene spray bottles: Store at a temperature not exceeding 25°C.
Do not dispose of any medicine down the drain 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 BISEPTINE, solution for topical application, contains
- The active ingredients are :
Chlorhexidine digluconate.......................................................................................... 0.250 g
Benzalkonium chloride............................................................................................... 0.025 g
Benzyl alcohol.......................................................................................................... 4,000 ml
Per 100 ml.
- The other component is :
Purified water
What is BISEPTINE, solution for topical application and what does it contain?
This medicine comes in the form of a solution for topical application.
50 or 100 ml spray bottles or 40, 50, 100, 125, 250, 500, 1000 or 2500 ml bottles.
Not all presentations may be marketed.
Marketing authorization holder
BAYER HEALTHCARE
1 RUE CLAUDE BERNARD
59000 LILLE
Marketing authorization holder
BAYER HEALTHCARE
33, RUE DE LINDUSTRIE
74240 GAILLARD
Manufacturer
KVP PHARMA + VETERINAR PRODUKTE GMBH
PROJENSDORFER STRASSE
324 24106 KIEL
GERMANY
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 by the holder]
Other
Detailed information on this drug is available on the ANSM (France) website.