Diaseptyl 0.5% Disinfectant Spray

Diaseptyl: Chlorhexidine-based antiseptic

Diaseptyl 0.5% solution is a chlorhexidine-based antiseptic (antiseptic agents are not sterilizing; they temporarily reduce the number of microbes), indicated for the antisepsis of superficial and small wounds in premature babies, newborns, infants, children, adolescents, and adults.

What is the composition of Diaseptyl solution for cutaneous application?

The active ingredient composition of Diaseptyl: Chlorhexidine digluconate solution (as 20% chlorhexidine digluconate solution): 0.5 g per 100 g. Its excipients are Decylglucoside (ORAMIX NS 150), glycerol, trolamine, and purified water.

Dosage and Uses of Diaseptyl 0.5% Wound Disinfectant

Diaseptyl is a ready-to-use antiseptic solution.
Diaseptyl can be used topically twice daily, directly on the wound. Treatment should not exceed 7 to 10 days.
This solution is available in a 75 ml or 125 ml spray bottle to be sprayed directly onto wounds.

Contraindications for Diaseptyl Disinfectant Spray

In case of allergy to chlorhexidine or any of the other ingredients, if applied to the eyes, ears (in case of a perforated eardrum), or on mucous membranes (nose, throat, genitals), Diaseptyl 0.5% is contraindicated. It should not come into contact with nervous tissue or the meninges.

Furthermore, Diaseptyl is not indicated for antisepsis of healthy skin before surgery (surgical field antisepsis, antisepsis of puncture, injection, or transfusion areas) or for disinfection of small surgical equipment.

Diaseptyl has a low risk of transcutaneous penetration; however, caution should be exercised when applying it repeatedly, when using it on a large area of ??skin, under an occlusive dressing, on damaged skin (especially burns), on mucous membranes, or on the skin of a premature or infant (due to the surface area-to-weight ratio and the occlusion effect of diapers in the diaper area).

Once opened, the bottle is prone to microbial contamination; avoid storing the bottle of Diaseptyl for too long.

Avoid using other antiseptics or cleansing agents or certain soaps, particularly those containing anionic agents, simultaneously or successively with Diaseptyl due to the risk of incompatibility or ineffectiveness. When using soap before Diaseptyl, rinse the area thoroughly.

Ask your doctor or pharmacist for advice on using the solution.

Diaseptyl and pregnancy or breastfeeding

Diaseptyl during pregnancy and breastfeeding. Do not apply to the breasts while breastfeeding.

Packaging: 75 ml or 125 ml spray bottle

Pierre Fabre also offers Cetavlon antiseptic cream as an adjunctive treatment for minor skin conditions.








LEAFLET

ANSM - Updated on: 07/08/2024

Name of the medicinal product

DIASEPTYL 0.5%, solution for cutaneous application

Chlorhexidine digluconate

Box

Please read this leaflet carefully before using this medicine because it contains important information for you.

You must always use this medicine exactly as 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 or information.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

You must talk to your doctor if you do not feel better or if you feel worse after 7 days.

What is in this leaflet?

1. What is DIASEPTYL 0.5%, solution for cutaneous application and what is it used for?

2. What you need to know before using DIASEPTYL 0.5%, solution for cutaneous application?

3. How to use DIASEPTYL 0.5%, solution for cutaneous application?

4. Possible side effects?

5. How to store DIASEPTYL 0.5%, solution for cutaneous application?

6. Contents of the pack and other information.

1. WHAT IS DIASEPTYL 0.5%, solution for cutaneous application AND WHAT IS IT USED FOR?

Pharmacotherapeutic group: ANTISEPTICS AND DISINFECTANTS – Biguanides and amidines - ATC code: D08AC02.

This medication is an antiseptic containing chlorhexidine (antiseptic agents are not sterilizing: they temporarily reduce the number of microbes).

It is indicated for premature babies, newborns, infants, children, adolescents, and adults for the antisepsis of superficial and small wounds.

2. WHAT YOU NEED 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 any of the other ingredients of this medication, listed in section 6.

· Do not apply to the eyes, ears (this product should not enter the ear canal in case of a perforated eardrum), or to mucous membranes (nose, throat, genital mucous membranes).

This product should not come into contact with nervous tissue or the meninges.

This medication should not be used for antisepsis of healthy skin before surgery (antisepsis of the surgical site, antisepsis of puncture, injection, or transfusion areas) or for disinfection of small surgical equipment.

Warnings and Precautions

Talk to your doctor, pharmacist, or nurse before using DIASEPTYL.

Special Warnings

This medication is for external use only.

There is a risk of developing an allergy to chlorhexidine. There is a risk of local allergic reactions (chlorhexidine sensitization) or severe generalized allergic reactions (such as difficulty breathing, facial swelling, or severe rash) that may be life-threatening if not immediately medically treated. In case of an allergic reaction to chlorhexidine, stop using the medication immediately and consult a doctor.

DIASEPTYL should not come into contact with the eye due to the risk of impaired vision. If it comes into contact with the eyes, rinse immediately and thoroughly with water. If eye irritation, redness, or pain, or visual disturbances occur, seek prompt medical advice.

Serious cases of persistent corneal damage (damage to the surface of the eye) potentially requiring corneal transplantation have been reported when similar products have accidentally come into contact with the eyes.

Although the transfer of this drug into the systemic circulation is very low, special caution is required as the risk of transfer cannot be ruled out in cases of repeated applications, use on a large area of ??skin, under an occlusive dressing, on damaged skin (particularly burns), mucous membranes, or on the skin of a premature baby or infant (due to the surface area/weight ratio and the occlusion effect of diapers in the diaper area).

Precautions for use

Do not store an opened bottle for long periods of time, as microbial contamination is possible upon opening.

Children

Never leave within reach of children.

Other medicines and DIASEPTYL 0.5%, solution for cutaneous application

Avoid the simultaneous or successive use of different antiseptics with this antiseptic, cleaning agents, or certain soaps, particularly those containing anionic agents. There is a risk of incompatibility or ineffectiveness. Prior use of soap must be followed by careful rinsing.

Combination with other antiseptics should be avoided, as their effects may be negated.

Do not use at the same time as ordinary soap.

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medication.

DIASEPTYL 0.5%, solution for cutaneous application with food and drink

Not applicable.

Pregnancy and Breastfeeding

As a precautionary measure, it is best to avoid using DIASEPTYL during pregnancy and breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist before taking this medicine.

Driving and using machines

Not applicable.

DIASEPTYL 0.5% cutaneous solution contains

Not applicable.

3. HOW TO USE DIASEPTYL 0.5% cutaneous solution?

Always use this medicine exactly as your doctor, pharmacist, or nurse has told you. Check with your doctor, pharmacist, or nurse if you are unsure.

Dosage

Twice daily, apply directly to the wound.

Duration of treatment: 7 to 10 days.

Method of administration

Cutaneous route. External use.

The solution is ready to use.

Solution for cutaneous application in 125 ml, 250 ml, or 500 ml bottles:

It should be applied directly to wounds.

Solution for cutaneous application in 75 ml or 125 ml spray bottles:

Spray the solution directly onto wounds.

The bottle should not be closed with a cork.

If you use more DIASEPTYL 0.5% solution for cutaneous application than you should:

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, stopping treatment too soon may cause the wound or lesion to become infected.

If you have any further questions about using this medicine, ask your doctor, pharmacist, or nurse for more information.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects are of unknown frequency (frequency cannot be estimated from the available data):

· Local or generalized allergy, anaphylactic shock.

· Eye irritation in case 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 if it involves damaged skin, mucous membranes, or ulcers of the lower limbs.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: French National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: https://signalement.social-sante.gouv.fr/.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE DIASEPTYL 0.5%, solution for cutaneous application?

Keep this medicine out of the sight and reach of children.

There are no special storage conditions.

Do not use this medicine after the expiry date shown on the bottle after EXP. The expiry date refers to the last day of that month.

Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What DIASEPTYL 0.5%, solution for cutaneous application contains

· The active ingredient is:

Chlorhexidine digluconate solution............................................................................. 0.5 g

As 20% chlorhexidine digluconate solution

Per 100 g

· The other ingredients are:

Decylglucoside (ORAMIX NS 150), glycerol, trolamine, purified water.

What DIASEPTYL 0.5%, solution for cutaneous application looks like and contents of the outer packaging

This medicine is a clear, colorless solution. 125 ml, 250 ml, or 500 ml bottle or 75 ml or 125 ml spray bottle.

Not all pack sizes 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

PROGIPHARM SITE

RUE DU LYCEE

45500 GIEN

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

This leaflet was last revised:

[To be completed later by the holder]

Other

Detailed information on this medicine is available on the ANSM (France) website.