Chlorhexidine/Benzalkonium/Benzyl Alcohol Biogaran 0,25 g / 0,025 g / 4 ml - Antiseptic Solution - Biogaran - 250 ml

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Please read this leaflet carefully before using this medicine as it contains important information for you. You must always use this medicine exactly as instructed 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. - If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. If you do not feel better or feel worse, you should contact your doctor.

1. WHAT IS CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL BIOGARAN 0.25 g/0.025 g/4 ml for 250 ml, solution for topical application AND WHAT IS IT USED FOR?

Pharmacotherapeutic class - ATC code: D08AC02. Antiseptics and disinfectants This medicine is indicated for : - antisepsis of shallow surgical and traumatic wounds. - Local adjunctive treatment of skin conditions that are infected or at risk of infection. - antisepsis of the skin before an operation.

2. WHAT YOU SHOULD KNOW BEFORE USING CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL BIOGARAN 0.25 g/0.025 g/4 ml for 250 ml, solution for local application

Never use CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL BIOGARAN 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 medicine, mentioned in section 6. - in the ear canal in the event of tympanic perforation, or in the eyes. - on mucous membranes, in particular genital mucous membranes. - for the disinfection of medical and surgical equipment. In case of doubt, it is essential to ask your doctor or pharmacist for advice. Warnings and precautions Ask your doctor, pharmacist or nurse before using CHLORHEXIDINE/BENZALKONIUM/BENZYL ALCOHOL BIOGARAN.

Special Warnings

Allow to dry before using an electrical instrument because of the risk of burning. Do not use over a large area, under an occlusive dressing, on deeply burned skin, or on the skin of premature babies or infants, because of the risk of passage into the general circulation. This medicine is only a local antiseptic. Its action only reduces the number of micro-organisms. Use with caution in newborns, especially premature infants. CHLORHEXIDINE/BENZALKONIUM/BENZYL ALCOHOL BIOGARAN may cause chemical skin burns

Precautions for use

Avoid the simultaneous or successive use of other antiseptics. Use cleanly, as microbial contamination is possible as soon as an antiseptic preparation is opened. IN CASE OF DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE. Children and adolescents Never leave within the reach of children. Other medicines and CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL BIOGARAN 0.25 g/0.025 g/4 ml per 100 ml, solution for topical application Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines, including medicines obtained without a prescription. Avoid the simultaneous or successive use of different antiseptics with this antiseptic (in particular, the prior use of soap should be followed by a thorough rinsing). CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL BIOGARAN 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 breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines Not applicable. CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL BIOGARAN 0.25 g/0.025 g/4 ml per 100 ml, solution for topical application contains Not applicable.

3. HOW TO USE CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL BIOGARAN 0.25 g/0.025 g/4 ml for 250 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 you are not sure

Dosage

Injured skin: As a rule, 1 application, twice a day. Preparation of healthy skin for surgery: 2 successive applications corresponding respectively to the cleaning/detersion phase and the antisepsis phase. In all cases, strictly comply with the medical prescription. Method and route of administration Skin application. Do not swallow. In all cases, strictly adhere to the medical prescription. Duration of treatment In all cases, strictly comply with the medical prescription. If you have used more CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL BIOGARAN 0.25 g/0.025 g/4 ml per 100 ml, solution for topical application than you should have: Not applicable. If you forget to use CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL BIOGARAN 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 BIOGARAN 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, ask your doctor or pharmacist for more information.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine may cause side effects, but they do not always occur in everyone. - Allergic eczema on contact with the product, especially in the case of damaged skin, mucous membranes or ulcerations of the lower limbs; - Rarely, a general allergic accident; - Chemical burns in newborns (frequency unknown). 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 Regional Pharmacovigilance Centres - Website: www.ansm.sante.fr. By reporting adverse reactions, you are helping to provide more information about the safety of the medicine.

5. HOW TO USE CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL BIOGARAN 0.25 g/0.025 g/4 ml for 250 ml, solution for topical application

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date indicated on the bottle. The expiry date refers to the last day of that month. For the 250 ml bottle: This medicine does not require any special storage precautions. For the 100 ml spray bottle: Store at a temperature not exceeding 25°C. Do not keep the opened bottle beyond 3 years for the 250 ml bottle and 2 years for the 100 ml spray bottle. Do not dispose of any medicine down the drain or with your household waste. Ask your pharmacist to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What CHLORHEXIDINE/BENZALKONIUM/ BENZYL ALCOHOL BIOGARAN 0.25 g/0.025 g/4 ml per 100 ml solution for topical application contains - The active ingredients are : Chlorhexidine digluconate ...................................................................................................... 0.25 g Benzalkonium chloride .......................................................................................................... 0.025 g Benzyl alcohol ............................................................................................................................. 4 ml For 100 ml. - The other component is: Purified water. What CHLORHEXIDINE/BENZALKONIUM/BENZYL ALCOHOL BIOGARAN 0.25 g/0.025 g/4 ml for 100 ml, solution for topical application is and what it contains This medicinal product is presented as a solution for topical application. Bottle of 250 ml. Spray bottle of 100 ml. Marketing authorisation holder BIOGARAN 15, BOULEVARD CHARLES DE GAULLE 92700 COLOMBES Marketing authorisation holder BIOGARAN 15, BOULEVARD CHARLES DE GAULLE 92700 COLOMBES Manufacturer DELPHARM HUNINGUE SAS 26 RUE DE LA CHAPELLE 68330 HUNINGUE The last date on which this leaflet was revised is: [to be completed subsequently by the holder] Other Detailed information on this medicinal product is available on the ANSM (France) website.