NOTICE
ANSM - Updated on : 08/07/2024
Product name
DIASEPTYL 0.5%, 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 advice and information.
- If you experience any undesirable effects, talk to 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 after 7 days.
What does this leaflet contain?
1. What is DIASEPTYL 0.5%, solution for cutaneous application and what is it used for?
2. What do I need to know before using DIASEPTYL 0.5%, solution for cutaneous application?
3. How do I use DIASEPTYL 0.5%, solution for cutaneous application?
4. What are the possible side effects?
5. How should DIASEPTYL 0.5%, solution for cutaneous application, be stored?
6. Package contents and other information.
1. WHAT IS DIASEPTYL 0.5%, solution for cutaneous application AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: ANTISEPTICS AND DISINFECTANTS Biguanides and amidines - ATC code: D08AC02.
This medicine is an antiseptic containing chlorhexidine (antiseptic agents are not sterilizing: they temporarily reduce the number of microbes).
It is indicated for use on premature babies, newborns, infants, children, adolescents and adults for the antisepsis of superficial and small wounds.
2. WHAT DO I HAVE TO KNOW BEFORE USING DIASEPTYL 0.5%, solution for cutaneous application?
Never use DIASEPTYL 0.5%, solution for cutaneous application:
- If you are allergic to chlorhexidine or to any of the other ingredients listed in section 6.
- Do not apply to the eyes, ears (this product must not penetrate the auditory canal in the event of tympanic perforation) or mucous membranes (nose, throat, genital mucosa).
- This product must not come into contact with nervous tissue or the meninges.
This product must not be used for the antisepsis of healthy skin prior to surgery (antisepsis of the operating field, antisepsis of puncture, injection or transfusion areas) or for the disinfection of small surgical equipment.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using DIASEPTYL.
Special warnings
This product is for external use only.
There is a risk of developing an allergy to chlorhexidine. Risk of local allergic reactions (sensitization to chlorhexidine) or severe generalized allergic reactions (such as difficulty in breathing, swelling of the skin, etc.).s breathing, facial swelling or severe rash) and potentially fatal in the absence of immediate medical attention. In the event of an allergic reaction to chlorhexidine, discontinue use immediately and seek medical advice.
DIASEPTYL must not come into contact with the eyes, as there is a risk of visual impairment. 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 have accidentally come into contact with the eyes.
Although the passage of this drug into the general circulation is very low, particular caution is advised, as the risk of passage cannot be ruled out in the event of repeated applications, use over a large skin surface area, under occlusive dressings, etc.Particular caution is required when using on large areas of skin, under occlusive dressings, on injured skin (particularly burns), on mucous membranes, or on the skin of premature babies or infants (due to the surface/weight ratio and the occlusive effect of diapers on the breech area).
Precautions for use
Do not keep opened bottles for long periods, as microbial contamination may occur as soon as they are opened.
Children
Keep out of the reach of children.
Other drugs and DIASEPTYL 0.5%, solution for cutaneous application
Avoid the simultaneous or successive use of different antiseptics with this antiseptic or cleaning agents or certain soaps, particularly those containing anionic agents. There is a risk of incompatibility or ineffectiveness. Prior use of soap should be followed by careful rinsing.
Combination with other antiseptics should be avoided, as their effects may be cancelled.
Do not use in conjunction with ordinary soap.
Tell your doctor, pharmacist or nurse if you are using, have recently used or may use any other medicines.
DIASEPTYL 0.5%, solution for cutaneous application with food and drink
Not applicable.
Pregnancy and breast-feeding
As a precautionary measure, DIASEPTYL should not be used during pregnancy or while 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 use of machinery
Not applicable.
DIASEPTYL 0.5%, solution for cutaneous application contains
Not applicable.
3. HOW DO I USE DIASEPTYL 0.5%, solution for cutaneous application?
Always use this medicine exactly as directed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt.
Dosage
2 cutaneous applications per day directly on the wound.
Duration of treatment: 7 to 10 days.
Method of administration
Cutaneous route. For external use.
The solution is ready-to-use.
Solution for cutaneous application in 125 ml, 250 ml or 500 ml bottles:
Apply directly to wounds.
Solution for cutaneous application in 75 ml or 125 ml spray bottles:
Spray directly onto wounds.
The bottle should not be sealed with a cork.
If you have used more DIASEPTYL 0.5%, solution for cutaneous application than you should have :
Not applicable.
If you forget to use DIASEPTYL 0.5%, solution for cutaneous application :
Not applicable.
If you stop using DIASEPTYL 0.5%, solution for cutaneous application:
When disinfecting a wound or lesion, if you stop treatment too soon, the wound or lesion may become infected.
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, this drug may cause undesirable effects, but they do not occur systematically in everyone.
The following undesirable effects are of undetermined frequency (cannot be estimated on the basis of available data):
- Local or generalized allergy, anaphylactic shock.
- Irritation of the eye in the event of accidental exposure.
- Corneal damage (damage to the surface of the eye), and permanent eye damage including permanent visual impairment following accidental ocular exposure.
- Eczema (contact dermatitis), especially in the case of damaged skin, mucous membranes or ulcerations of the lower limbs.
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 TO CONSERVE DIASEPTYL 0.5%, solution for cutaneous application?
Keep out of sight and reach of children.
There are no special storage precautions.
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.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What DIASEPTYL 0.5%, solution for cutaneous application, contains
- The active substance is :
Chlorhexidine digluconate solution............................................................................ 0.5 g
In the form of 20% Chlorhexidine digluconate solution
per 100 g
- Other components are :
Decylglucoside (ORAMIX NS 150), glycerol, trolamine, purified water.
What DIASEPTYL 0.5%, solution for cutaneous application is and what it contains
This medicine comes as a clear, colorless solution. Available in 125 ml, 250 ml or 500 ml bottles, or in 75 ml or 125 ml spray bottles.
Not all presentations may be marketed.
Marketing authorization holder
PIERRE FABRE MEDICAMENT
LES CAUQUILLOUS
81500 LAVAUR
Marketing authorization holder
PIERRE FABRE MEDICAMENT
PARC INDUSTRIEL DE LA CHARTREUSE
81100 CASTRES
Manufacturer
PIERRE FABRE MEDICAMENT PRODUCTION
SITE PROGIPHARM
RUE DU LYCEE
45500 GIEN
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.