Cyteal Antiseptic Foaming Solution

Cyteal is a medicated foaming solution containing hexamidine and chlorhexidine.
It is a low-level antiseptic solution indicated for the cleansing of skin and mucous membrane conditions that are infected or at risk of infection.

Cyteal's composition: chlorhexidine, chlorocresol, hexamidine

Per 100 ml of solution:
Hexamidine diisethionate ....................................... ...0.10 g
Chlorhexidine gluconate (20% w/v solution) ... 0.50 ml
Chlorocresol ..........................................................................0.30 g

Other ingredients are: cocamidopropyl betaine, coconut fatty acid diethanolamide, edetic acid, coniferol perfume, lactic acid, and purified water.

Using Cyteal Foaming Antiseptic Solution

Dosage should follow your doctor's recommendations.
Cyteal is used like a liquid soap on the skin, either neat or diluted 1/10, followed by thorough rinsing.

Once the diluted solution is used, it must be discarded.

This solution is for external use: do not swallow or inject.

Contraindications for Cyteal Antiseptic Soap

In case of allergy to the active ingredients or any of the other components, administration into the ear (eardrum perforation), into the eyes, for antisepsis before sampling or surgery, or for the detection of medical-surgical equipment, Cyteal solution is contraindicated.

Cyteal should not be used on large areas of skin, on damaged skin (especially burns), or on the skin of premature babies or infants, without medical advice, due to the risk of it entering the systemic circulation.
Microbial contamination is possible upon opening the bottle; avoid keeping it for too long once opened.

Inform your doctor or pharmacist of any medication you are taking, especially if you are combining other antiseptics with Cyteal, as there is a risk that the effects may be reversed.
During pregnancy and breastfeeding, use Cyteal foaming solution with caution. Ask your doctor or pharmacist for advice before taking any medication.

Cytéal, side effects

This medication, like all medications, can have side effects.

It may cause an allergic reaction. If this occurs, stop using the solution immediately and contact a doctor without delay.

Cytéal can cause contact dermatitis. If symptoms are severe, discontinue use and contact a doctor or pharmacist.

Cytéal can cause burning, itching, stinging, redness, and dryness of the skin, especially when the solution is used repeatedly.

If accidentally exposed to the eyes, Cytéal can cause eye irritation and even damage to the cornea and eye.

Sizes to choose from:

250 ml bottle.
500 ml bottle.

After cleansing, you can apply Cicatryl to accelerate skin healing.








LEAFLET
ANSM - Updated on: 07/29/2024
Name of the medicinal product
CYTEAL, foaming solution
Hexamidine diisostemonate, Chlorhexidine digluconate, Chlorocresol
Box
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
You must always use this medicine exactly as described in this leaflet or by your doctor, pharmacist, or nurse.
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, pharmacist, or nurse. 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 several days. What is in this leaflet?
1. What is CYTEAL Foam Solution and what is it used for?
2. What you need to know before you use CYTEAL Foam Solution?
3. How to use CYTEAL Foam Solution?
4. Possible side effects?
5. How to store CYTEAL Foam Solution?
6. Contents of the pack and other information.
1. WHAT IS CYTEAL Foam Solution AND WHAT IS IT USED FOR?
Pharmacotherapeutic group – ATC code: ANTISEPTIC AND DISINFECTANT - Chlorhexidine in combination - ATC code: D08AC52.
This product is a low-level antiseptic containing hexamidine and chlorhexidine in a foam solution. It is indicated for premature babies, newborns, infants, children, adolescents, and adults for cleansing skin and mucous membrane conditions that are infected or at risk of infection.
2. WHAT YOU NEED TO KNOW BEFORE USING CYTEAL, foaming solution?
Never use CYTEAL, foaming solution:
· If you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).
· In the ear canal in case of a perforated eardrum or in the eyes.
· For antisepsis of healthy skin before surgery (antisepsis of the surgical site and antisepsis of puncture, injection, or transfusion areas).
IF IN DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Warnings and Precautions
Talk to your doctor, pharmacist, or nurse before using CYTEAL.
Special Warnings
Do not use this medicine on a large area of ??skin, on damaged skin (especially burns), on the skin of premature babies or infants, without medical advice, due to the risk of entry into the systemic circulation.
Microbial contamination is possible upon opening the packaging of an antiseptic preparation.
Cases of local skin rashes (including allergic dermatitis) have been reported with hexamidine and two excipients contained in the cutaneous solution.
This medicine may cause a severe generalized allergic reaction due to the presence of chlorhexidine, which may occur within minutes of application. CYTEAL 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) that may require a corneal transplant have been reported when similar products have accidentally come into contact with the eyes.
In case of severe symptoms, you should discontinue treatment and consult your doctor, pharmacist, or nurse before using CYTEAL again.
Precautions for use
Follow the use of this product by thoroughly and thoroughly rinsing.
If the bottle is larger than 250 ml: The volume of this bottle, which is greater than 250 ml, poses a risk of contamination of the solution if used for a long time after opening. Other medicines and CYTEAL Foaming Solution
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Avoid using this product with other antiseptics as their effects may cancel each other out.
Do not use with regular soap and do not use a cork stopper.
CYTEAL Foaming Solution with food, drink, and alcohol
Not applicable.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist before using this medicine.
As a precaution, it is best to avoid using CYTEAL if you are pregnant.
CYTEAL can be used during breastfeeding. It is recommended not to apply CYTEAL to the breasts while breastfeeding. Driving and using machines
CYTEAL has no or negligible influence on the ability to drive and use machines.
CYTEAL foaming solution contains
Not applicable.
3. HOW TO USE CYTEAL foaming 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
One or two applications per day for 7 to 10 days.
This product is used like a liquid soap for external use: neat, or diluted 1/10 with water.
Method of administration
Treated areas should always be rinsed thoroughly with water after use.
Undiluted: CYTEAL is used neat as a rub on small lesions. Apply and rinse thoroughly with water.
Diluted: CYTEAL is used diluted in the bath or shower, as a wash or soak, like liquid soap, on infected skin lesions. Then rinse thoroughly with water.
The diluted solution should not be stored but should be used immediately.
FOR USE ON THE SKIN. DO NOT INJECT OR SWALLOW.
In case of accidental ingestion, do not perform gastric lavage (foam product).
General supportive measures should be instituted as deemed necessary by the physician.
If you use more CYTEAL Foam Solution than you should
Not applicable.
If you forget to use CYTEAL Foam Solution
Not applicable.
If you stop using CYTEAL Foam Solution
Not applicable.
If you have any further questions about using this medicine, ask your doctor, pharmacist, or nurse.
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 may occur at an unknown frequency (frequency cannot be estimated from the available data):
· Skin rash and difficulty breathing (general allergic reaction) which can be serious and life-threatening (anaphylactic reaction). An anaphylactic reaction can include difficulty breathing, facial swelling, and a severe rash. In the event of an allergic reaction to chlorhexidine, you must immediately stop using the product and contact your doctor without delay. Ask your doctor or pharmacist for advice before using CYTEAL again. · Localized skin rash or skin irritation (contact dermatitis). Allergic eczema upon contact with the product, particularly when used on broken skin, mucous membranes, or ulcers of the lower limbs. If symptoms are severe, you should discontinue treatment and consult your doctor or pharmacist before using CYTEAL again.
· This medicine contains hexamidine, and the cutaneous solution also contains two excipients that can sometimes cause more severe local allergic reactions. These reactions resolve slowly.
· Minor local effects: stinging, itching, burning sensation, dry skin, and redness, particularly with repeated use.
· 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. Reporting side effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse. 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 CYTEAL, foaming solution?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date shown on the bottle. The expiry date refers to the last day of that month.
Store away from light and at a temperature below 25°C.
Do not dispose of any medicines via wastewater or other 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 CYTEAL Foam Solution contains
· The active ingredients are:
Hexamidine diisocyanate....................................................................................................... 0.10 g
Chlorhexidine digluconate (20% w/v solution)................................................................ 0.50 ml
Chlorocresol.......................................................................................................................... 0.30 g
Per 100 ml of foam solution
· The other ingredients are:
Cocamidopropyl betaine, coconut fatty acid diethanolamide, edetic acid, coniferol perfume, lactic acid, purified water. What CYTEAL foaming solution looks like and contents of the outer packaging
This medicinal product is presented as a foaming solution in 150 ml, 200 ml, 250 ml, 500 ml, or 1000 ml bottles.
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
Not applicable.
Detailed information on this medicine is available on the ANSM (France) website.