NOTICE
ANSM - Last updated: 19/05/2017
Name of the medicinal product
CYTEAL, foaming solution
Hexamidine diisodethionate, Chlorhexidine gluconate, Chlorocresol
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medication exactly as prescribed in this leaflet or by your doctor, pharmacist or nurse.
· Keep this leaflet. You might 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 also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well after several days.
What is in this leaflet?
1. What is CYTEAL, foaming solution and in which cases it is used?
2. What should I know before using CYTEAL, foaming solution?
3. How to use CYTEAL, foaming solution?
4. What are the possible side effects?
5. How to store CYTEAL, foaming solution?
6. Package contents and other information.
1. WHAT IS CYTEAL, foaming solution AND WHAT IT IS USED FOR?
Pharmacotherapeutic group - ATC code: ANTISEPTIC AND DISINFECTANTS - Biguanides and amidines: D08AC.
(D: Dermatology).
This product is a low activity antiseptic containing hexamidine and chlorhexidine in foaming solution.
It is indicated in the cleansing of skin and mucous membranes, infected or at risk of becoming infected.
2. BEFORE YOU USE CYTEAL, foaming solution?
Never use CYTEAL, foaming solution:
· If you are allergic to any of the active ingredients or any of the other ingredients of this medication mentioned in section 6.
· In the ear canal in case of tympanic perforation or in the eyes,
· For antisepsis before sampling or surgical procedure.
· For the disinfection of medical and surgical equipment.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before using Cyteal, a foaming solution.
Special warnings
Do not use this medication on a large area of the skin, on damaged skin (especially burned skin), premature skin or infant skin, without medical advice, because of the risks of passing through the general circulation.
As soon as the packaging of an antiseptic preparation is opened, microbial contamination is possible.
Precaution of use
Follow the use of this product with a careful and abundant rinse.
If the bottle is greater than 250 ml: the volume of this bottle greater than 250 ml exposes the solution to contamination if it is used for a long time after opening.
Other medicines and CYTEAL, foaming solution
Inform your doctor or pharmacist if you are using, have recently used or could use any other medicines.
Combination with other antiseptics should be avoided as their effects may cancel out.
Do not use at the same time as ordinary soap and do not use cork.
CYTEAL, foaming solution with food, drink and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before using this medicine.
As a precaution, it is preferable to avoid the use of CYTEAL during pregnancy and during breastfeeding.
Driving and using machines
CYTEAL has no or negligible effect on the ability to drive and use machines.
CYTEAL, foaming solution contains
Not applicable.
3. HOW TO USE CYTEAL, foaming solution?
Always use this medication exactly as prescribed by your doctor or pharmacist.
Check with your doctor, pharmacist or nurse if you are unsure.
This product is used as a liquid soap: pure, or diluted 1/10, followed by an abundant rinse.
Do not store diluted solution.
DERMAL. DO NOT INJECT DO NOT SWALLOW.
In case of accidental indigestion, do not perform gastric lavage (foaming product).
General support measures should be instituted as deemed necessary by the physician.
If you used more CYTEAL, foaming solution than you should have
Not applicable.
If you forget to use CYTEAL, foaming solution
Not applicable.
If you stop using CYTEAL, foaming solution
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medication may cause side effects, although not everybody gets them.
· Contact dermatitis (rash at the skin that has been in contact with the product and may be accompanied by itching).
· Allergy Risk (body's reaction to the drug) generalized to chlorhexidine, up to anaphylactic shock (severe allergic reaction exacerbated, which puts the game life-threatening , requiring immediate medical care. Anaphylactic shock can s' accompanied by a drop in blood pressure, swelling of the throat, difficulty breathing and loss of consciousness).
· Possibility of local manifestations benign: tingling, itching, burning sensation, dryness of skin, redness, especially in case of repeated use.
· Due to the presence of chlorhexidine, the possibility of allergic eczema in contact with the product, all the more so as it involves injured skin, mucous membranes or ulcerations of the lower limbs.
· Due to the presence of hexamidine more severe local allergic reactions can occur. They regress slowly.
Declaration of side effects
If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly through the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and network of Regional Centers of Pharmacovigilance. Website: www.ansm.sante.fr .
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE CYTEAL, foaming solution?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the vial. The pre-emption date refers to the last day of the month.
Keep away from light and at temperatures below 25 ° C.
Do not throw any medication into drains or other garbage. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What CYTEAL contains, foaming solution
· The active substances are:
Hexamidine diisethionate .............................................. .................................................. ..... 0.10 g
Chlorhexidine digluconate (20% w / v solution) ....................................... ............................ 0.50 ml
Chlorocresol ................................................. .................................................. ....................... 0.30 g
For 100 ml of foaming solution
· The other components are:
Alcanamido (C12-C18) propylbetaine (Amonyl 380 BA), di (hydroxyethylalkanamide) (Comperlan KD), editic acid, perfume coniferol, lactic acid, purified water.
What is CYTEAL, foaming solution and contents of the pack
This medication is in the form of a foaming solution, in a 150 ml, 200 ml, 250 ml, 500 ml or 1000 ml flask.
Not all pack sizes may be marketed.
Marketing Authorization Holder
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92100 BOULOGNE
Marketing Authorization Operator
PIERRE FABRE DERMATOLOGIE
45 PLACE ABEL GANCE
92100 BOULOGNE
Maker
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.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Other
Not applicable.
Detailed information on this medicine is available on the ANSM website (France).