NOTICE
ANSM - Last updated: 04/04/2016
Name of the medicinal product
MERCRYL FOAMING SOLUTION, solution for skin application
Benzalkonium chloride, chlorhexidine digluconate
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 or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor or pharmacist. 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.
Review summary
In this notice :
1. WHAT IS MERCRYL FOAMING SOLUTION, solution for skin application AND IN WHAT CASES IS IT USED?
2. BEFORE YOU USE MERCRYL SOLUTION FOAMING, solution for skin application?
3. HOW TO USE MERCRYL FOAMING SOLUTION, solution for skin application?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE MERCRYL FOAMING SOLUTION, solution for skin application?
6. ADDITIONAL INFORMATION
1. WHAT IS MERCRYL FOAMING SOLUTION, solution for skin application AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
ANTISEPTIC.
(D. Dermatology)
Therapeutic indications
Cleaning and adjunctive treatment of skin and mucous membrane infections, infected or at risk of becoming infected.
2. BEFORE YOU USE MERCRYL SOLUTION FOAMING, solution for skin application?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use MERCRYL SOLUTION FOAMING, solution for skin application, in the following cases:
· If you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6,
· Do not apply in eyes, ears,
· Do not use for disinfection of medical and surgical equipment.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Precautions for use; special warnings
Warnings
This medicinal product is for external use only.
When used on a large area, under occlusive dressing (impermeable to water and air), on a deeply burned skin, a skin of premature or infant, there are risks of passage in the general circulation .
Use with caution in newborns, especially premature infants. MERCRYL, FOAMING SOLUTION, can cause chemical burns to the skin.
Precautions for use
Use cleanly and do not keep an opened bottle for a long time because microbial contamination is possible on opening, especially if the volume of the bottle is more than 250 ml.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Other medicines and MERCRYL FOAMING SOLUTION, solution for skin application
· MERCRYL SOLUTION MOUSSANTE should not be used together with other antiseptics because they may irritate your skin or be less effective.
· If using soap, rinse thoroughly before applying MERCRYL FOAMING SOLUTION.
Inform your doctor or pharmacist if you are taking or have recently taken or may be taking any other medicines.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Do not apply solution to the breasts during breastfeeding.
If you are pregnant or breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO USE MERCRYL FOAMING SOLUTION, solution for skin application?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
The solution is used pure or diluted 1 or 2 times a day.
· Pure use : applied to the skin
· Use diluted 1/10: application on external mucosa. The diluted solution should be prepared immediately before use and should not be stored.
Always rinse thoroughly after application.
In all cases, follow the recommendations of your doctor or pharmacist
Method and route of administration
DERMAL.
Do not swallow.
Duration of treatment
Follow the recommendations of your doctor or pharmacist
Symptoms and Instructions for Overdose
If you have used more MERCRYL SOLUTION FOAMING, solution for skin application you should:
In case of overdose: rinse thoroughly with water.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· sensation of dryness of the skin and mucous membranes which is attenuated by careful rinsing
· skin irritation reactions
· possibility of contact eczema.
Declaration of side effects
If you experience any side effects, talk to 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: 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 MERCRYL FOAMING SOLUTION, solution for skin application?
Keep out of the reach and sight of children.
Expiration date
Do not use this medicine after the expiry date which is stated on the vial.
Storage conditions
Store at a temperature not exceeding 25 ° C.
If necessary, warnings against visible signs of deterioration
Do not throw any medication into the sewer or household waste. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What MERCRYL SOLUTION MOUSSANTE contains , solution for skin application
The active substances are:
Benzalkonium chloride ............................................... .................................................. ............. 0.500 g
As a solution of benzalkonium chloride .......................................... ............................. 0.985 g
Chlorhexidine Digluconate ............................................... .................................................. ......... 0.200 g
In the form of chlorhexidine digluconate solution .......................................... .......................... 1.065 g
For 100 ml.
The other components are:
Cocobetaine, copolymer of ethylene oxide and propylene oxide, hydroxyethylcellulose, citric acid monohydrate, sodium citrate, purified water.
Pharmaceutical form and content
Aspect of MERCRYL FOAM SOLUTION, solution for skin application and contents of the outer packaging
This medication is in the form of a solution for skin application.
Box of 1 bottle of 125, 300 or 1000 ml.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
MENARINI FRANCE
1-7 RUE DU JURA
94633 RUNGIS CEDEX
exploiting
MENARINI FRANCE
1-7, RUE DU JURA
94633 RUNGIS CEDEX
Maker
CHEMINEAU LABORATORIES
93, ROAD OF CURRENCY
37210 VOUVRAY
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 notice was revised is {MM / YYYY}
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Ansm website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.