NOTICE
ANSM - Updated on : 17/07/2024
Product name
SEPTIVON 1.5%, solution for cutaneous application
Chlorhexidine digluconate
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 any improvement or if you feel less well.
Keep out of the reach of children.
What does this leaflet contain?
1. What is SEPTIVON 1.5%, solution for cutaneous application and what is it used for?
2. What do I need to know before using SEPTIVON 1.5%, solution for cutaneous application?
3. How do I use SEPTIVON 1.5%, solution for cutaneous application?
4. What are the possible side effects?
5. How do I keep SEPTIVON 1.5%, solution for cutaneous application?
6. Package contents and other information.
1. WHAT IS SEPTIVON 1.5%, solution for cutaneous application AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code: D08AC02
ANTISEPTICS AND DISINFECTANTS
This drug is indicated for the cleansing and adjunctive local treatment of skin conditions which are infected or at risk of infection.
2. WHAT DO I HAVE TO KNOW BEFORE USING SEPTIVON 1.5%, solution for cutaneous application?
Never use SEPTIVON 1.5%, solution for cutaneous application:
- if you are allergic (hypersensitive) to chlorhexidine digluconate or to any of the other ingredients listed in section 6.
- for disinfecting medical and surgical equipment.
Do not use in the eyes or ears if the eardrum has been perforated.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Warnings and precautions
Talk to your doctor or pharmacist before using SEPTIVON 1.5%, solution for cutaneous application.
SEPTIVON 1.5%, solution for cutaneous 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, 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).
Special warnings
If used over a large surface area, under an occlusive dressing, on deeply burned skin, or on the skin of premature babies or infants, there is a risk of the product passing into the general circulation.
Precautions for use
Do not keep opened bottles for a long time, as microbial contamination may occur as soon as they are opened, especially if the bottle volume exceeds 250 ml.
Talk to your doctor or pharmacist before using SEPTIVON 1.5 % solution for cutaneous application.
Children
Use with caution in newborns, particularly premature babies. SEPTIVON 1.5% solution for cutaneous application may cause chemical burns to the skin.
Other drugs and SEPTIVON 1.5%, solution for cutaneous application
This product must not be used in conjunction with other local antiseptics (risk of incompatibility or ineffectiveness). Prior use of soap must be followed by thorough rinsing.
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medication.
SEPTIVON 1.5%, solution for cutaneous application with food and drink
Not applicable.
Pregnancy, breast-feeding and fertility
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.
SEPTIVON 1.5%, solution for cutaneous application does not contain any excipients with a notorious effect.
3. HOW DO I USE SEPTIVON 1.5%, solution for cutaneous application?
Always use SEPTIVON exactly as instructed in this leaflet, or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
For cutaneous use.
For external use only. Do not swallow.
This product can be used pure or diluted.
Pure use :
- Spray on small lesions,
- As a wash.
Diluted use:
- For washing: pour 3 capfuls into 1 liter of water,
- For soaking: pour 3 capfuls into 2 liters of water,
- For vulval cleansing: pour 3 capfuls into 1 liter of water.
Rinse thoroughly after use.
Do not store the mixture for later use.
Close bottle tightly after each use.
If you have used more SEPTIVON 1.5%, solution for cutaneous application than you should have:
Consult your doctor or pharmacist immediately.
If you forget to use SEPTIVON 1.5%, solution for cutaneous application :
Do not use a double dose to make up for the single dose you forgot to use.
If you stop using SEPTIVON 1.5%, solution for cutaneous 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?
As with all medicines, this drug may cause undesirable effects, but they do not occur systematically 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, a general allergic accident leading to anaphylactic shock,
- chemical burns in newborns,
- 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 TO CONSERVE SEPTIVON 1.5%, solution for cutaneous application?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging after EXP. The expiration date refers to the last day of that month.
Before opening: Store at a temperature not exceeding +25°C.
After opening: Do not store for more than 3 months.
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 SEPTIVON 1.5%, solution for cutaneous application, contains
The active substance is :
Chlorhexidine digluconate.................................................................................................... 1.5 g
per 100 ml.
Other components are :
Alcanamidopropylbetaine, decyl glucoside, sodium acetate, polyalkylene glycol 3000, pine fragrance, purified water.
What is SEPTIVON 1.5%, solution for cutaneous application and what does it contain?
This medicine comes in the form of a solution for cutaneous application. Available in 250 ml, 500 ml or 2000 ml bottles.
Marketing authorization holder
LABORATOIRE PERRIGO FRANCE
20, RUE ANDRE GIDE
92320 CHATILLON
Marketing authorization holder
LABORATOIRE PERRIGO FRANCE
20, RUE ANDRE GIDE
92320 CHATILLON
Manufacturer
CHEMINEAU
ROUTE DE LA MONNAIE
37210 VOUVRAY
or
OMEGA PHARMA MANUFACTURING GMBH & CO. KG
BENZSTRASSE 25
71083 HERRENGBERG
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 subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.