In this manual :
1. WHAT IS DIASEPTYL 0.5%, solution for cutaneous application AND WHAT IS IT USED FOR?
2. WHAT DO YOU 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 DO I USE DIASEPTYL 0.5%, solution for cutaneous application?
6. ADDITIONAL INFORMATION
1. WHAT IS DIASEPTYL 0.5%, solution for cutaneous application AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Not applicable.
This medicine is an antiseptic containing chlorhexidine (antiseptic agents are not sterilising: they temporarily reduce the number of microbes). It is recommended for the antisepsis of superficial and small wounds.
2. WHAT YOU SHOULD KNOW BEFORE USING DIASEPTYL 0.5%, solution for cutaneous application
List of information needed before taking the medicine
Not applicable.
Never use DIASEPTYL 0.5% solution for skin application in the following cases:
- Allergy to chlorhexidine or any of the other components;
- Do not apply to the eyes, ears (this product must not penetrate the ear canal in the event of tympanic perforation), or mucous membranes (nose, throat, genital mucosa).
This drug should not be used for the antisepsis of healthy skin before surgery (antisepsis of the operating field and antisepsis of areas of puncture, injection or transfusion) or for the disinfection of small surgical equipment.
In case of doubt, it is essential to ask your doctor or pharmacist for advice.
Precautions for use; special warnings
Take care with DIASEPTYL 0.5%, solution for cutaneous application:
Special warnings
This medicine is for external use only.
Risk of developing an allergy to chlorhexidine
Although the passage of this medicinal product into the general circulation is very low, particular caution is necessary because the risk of passage cannot be excluded in the event of repeated applications, in the event of use on a large skin surface, under an occlusive dressing, on injured skin (in particular burned skin), on mucous membranes, on the skin of premature babies or infants (because of the surface/weight ratio and the occlusive effect of the layers at the level of the seat).
Do not keep an opened bottle for a long time as microbial contamination is possible as soon as it is opened.
Precautions for use
In case of doubt, do not hesitate to ask your doctor or pharmacist for advice.
Interactions with other medicines
Taking or using other medicines
Avoid simultaneous or successive use of different antiseptics with this antiseptic or cleaning agents (risk of incompatibility or ineffectiveness).
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
Pregnancy and breastfeeding
Do not apply the solution to the breasts while breastfeeding.
Ask your doctor or pharmacist for advice before taking any medication.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
Not applicable.
3. HOW TO USE DIASEPTYL 0.5%, solution for cutaneous application
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
2 skin applications per day, directly on the wound.
Duration of treatment: 7 to 10 days.
Mode of administration
Cutaneous use. External use
The solution is ready to use.
Solution for cutaneous application in 125 ml, 250 ml or 500 ml bottles:
It is to be applied directly to the wounds.
Solution for cutaneous application in spray bottle of 75 ml or 125 ml:
Spray the solution directly onto the wounds.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, DIASEPTYL 0.5%, solution for cutaneous application is likely to have undesirable effects due to the presence of chlorhexidine such as:
- Allergic eczema on contact with the product, especially in the case of damaged skin, mucous membranes or ulcerations of the lower limbs;
- rarely, general allergic accident.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO STORE DIASEPTYL 0.5%, solution for cutaneous application
Keep out of the reach and sight of children.
Do not use DIASEPTYL 0.5%, solution for cutaneous application after the expiry date stated on the bottle.
There are no special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does DIASEPTYL 0.5% solution for skin application contain?
The active substance is:
Chlorhexidine digluconate solution ................................................................................................ 0.5 g
In the form of a 20% chlorhexidine digluconate solution
Per 100 g.
Other components are:
Decylglucoside (ORAMIX NS 150), glycerol, trolamine, purified water.
Pharmaceutical form and content
What is DIASEPTYL 0.5%, solution for cutaneous application and what does it contain?
This medicinal product is in the form of a solution. Bottle of 125 ml, 250 ml, 500 ml or spray bottle of 75 ml or 125 ml.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
LABORATOIRES DERMATOLOGIQUES DUCRAY
45, place Abel Gance
92100 Boulogne
Operator
PIERRE FABRE MEDICAMENT
45, place Abel Gance
92100 BOULOGNE
Manufacturer
PIERRE FABRE MEDICAMENT PRODUCTION
45, place Abel Gance
92100 BOULOGNE
Names of the medicinal product in the member states of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
Not applicable.
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