NOTICE
ANSM - Last updated: 29/10/2013
Name of the medicinal product
AMUKINE 0.06 PERCENT, solution for skin application
Sodium hypochlorite
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS AMUKINE 0.06 PERCENT, solution for skin application AND IN WHAT CASES IS IT USED?
2. BEFORE YOU USE AMUKINE 0.06 PERCENT, solution for skin application?
3. HOW TO USE AMUKINE 0.06 PERCENT, solution for skin application?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE AMUKINE 0.06 PERCENT, solution for skin application?
6. ADDITIONAL INFORMATION
1. WHAT IS AMUKINE 0.06 PERCENT, solution for skin application AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
ANTISEPTICS AND DISINFECTANTS (D. DERMATOLOGY).
ATC Code: D08AX07
Therapeutic indications
This medication is a local antiseptic for external use (it is used for the disinfection of the skin and the mucous membranes).
This medication is recommended in:
· antisepsis of the skin and mucous membranes,
· the antisepsis of the wounds.
2. BEFORE YOU USE AMUKINE 0.06 PERCENT, solution for skin application?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not use AMUKINE 0.06 PERCENT, solution for skin application in the following cases:
· If you are allergic (hypersensitive) to chlorine.
Precautions for use; special warnings
Take special care with AMUKINE 0.06 PERCENT, solution for skin application:
This medicinal product is for external use only.
A transcutaneous passage can not be excluded, therefore the use of AMUKINE must be done with caution in certain situations: on a large surface, under occlusive dressing, on an injured skin (especially burned).
Irritation possible under occlusive dressing.
As soon as the bottle is opened, microbial contamination is possible. Be careful not to keep too long an antiseptic vial.
Avoid the simultaneous or successive use of different antiseptics with this antiseptic (in particular the previous use of soap must be followed by careful rinsing). ( See interactions with other medicines ).
Precautions for use
· Do not swallow
Interaction with other medicines
Use of other medicines
If you are using or have recently used any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist
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
This medication, under normal conditions of use, may be used during pregnancy and lactation.
In general, you should seek advice from your doctor or pharmacist before taking any medication.
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 AMUKINE 0.06 PERCENT, 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
AMUKINE should be used pure:
· in washes (eg wound washes),
· in soaked compresses,
· in wet dressings,
· in baths (eg bath of fingers, feet, seat).
Renew applications as needed.
Symptoms and Instructions for Overdose
Not applicable.
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, AMUKINE 0.06 PERCENT, solution for dermal application is likely to have undesirable effects, although not everyone is subject to it.
· sensations of burning or irritation (in case of major wounds or in gynecological surgery) this is of no consequence and should not cause the treatment to change.
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 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 AMUKINE 0.06 PERCENT, solution for skin application?
Keep this medicine out of the reach and sight of children.
Expiration date
Do not use AMUKINE 0.06 PERCENT, solution for skin application after the expiry date stated on the outer packaging.
Storage conditions
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does AMUKINE contain 0.06 PERCENT, solution for skin application?
The active substance is:
Aqueous solution of sodium hypochlorite and sodium chloride, obtained by electrolysis (sodium chloride) 5,00 ml
Amount corresponding to active chlorine ............................................. .................................................. .... 0.06 g
For 100 ml of solution for skin application.
The other components are:
Purified water
Pharmaceutical form and content
What is AMUKINE 0.06 PERCENT, solution for skin application and contents of the outer packaging?
This medication is in the form of a solution for skin application, 50 ml, 60 ml and 200 ml flask (PVC) and 125 ml, 250 ml, 500 ml and 1000 ml flask (PE).
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
GIFRER BARBEZAT
8 to 10, rue Paul Bert
69150 Décines-CHARPIEU
exploiting
GIFRER BARBEZAT
8-10, rue Paul Bert
69153 Décines CEDEX
Maker
GIFRER BARBEZAT
8-10, rue Paul Bert
69153 Décines CEDEX
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 is {date}.
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.