NOTICE
ANSM - Last updated: 15/03/2017
Name of the medicinal product
DAKIN COOPER STABILIZED, solution for local application in bottle
Concentrated solution of sodium hypochlorite
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 of the 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.
Do not use this medication for children.
What is in this leaflet?
1. What is DAKIN COOPER STABILIZED, solution for local application in a bottle and in which cases is it used?
2. What should be known before using DAKIN COOPER STABILIZE, solution for local application in a vial?
3. How to use DAKIN COOPER STABILIZE, solution for local application in bottle?
4. What are the possible side effects?
5. How to store DAKIN COOPER STABILIZED, a solution for local application in a bottle?
6. Package contents and other information.
1. WHAT DAKIN COOPER IS STABILIZED AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
Not applicable.
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 DAKIN COOPER STABILIZED, solution for local application in a vial?
Do not use DAKIN COOPER STABILIZED, solution for local application in a vial:
· If you are allergic to the active substance or to any of the other ingredients.
· Do not apply in the eye.
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 DAKIN COOPER STABILIZE, a solution for local application in a vial.
Take special care with DAKIN COOPER STABILIZED, solution for local application in vial:
· Do not swallow.
· Do not use at the same time as another antiseptic.
· Possible irritation when applied under occlusive dressing.
· A transcutaneous passage can not be excluded in certain situations (occlusive dressing).
· As soon as the bottle is opened, microbial contamination is possible. Be careful not to keep an opened bottle too long.
Keep out of the reach of children.
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
children
Not applicable.
Other medicines and DAKIN COOPER STABILIZED, solution for local application in bottle:
Inform your doctor or pharmacist if you are using, have recently used or could use any other medicines.
DAKIN COOPER STABILIZED, solution for local application in bottle with food, drinks and alcohol
Not applicable.
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.
Driving and using machines
Not applicable.
DAKIN COOPER STABLISE, solution for local application in bottle contains
Not applicable.
3. HOW TO USE DAKIN COOPER STABILIZED, solution for local application in a bottle?
Dosage
DAKIN COOPER STABILIZED shall be used pure:
· in irrigation ,
· in washes (eg wound washes),
· in soaked compresses,
· in wet dressings,
· in baths (eg baths of fingers, feet, seat).
Renew applications as needed.
Method and route of administration
External use.
If you have used more than DAKIN COOPER STABILIZED, solution for local application in a bottle you should:
Not applicable.
If you forget to use DAKIN COOPER STABILISE, solution for local application in vial:
Not applicable.
If you stop using DAKIN COOPER STABILIZED, solution for local application in a vial:
Not applicable.
If you have any further questions on the use of this medication, ask your doctor, pharmacist or nurse for more information.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Adverse reactions reported during the use of this drug for which the frequency is unknown:
· Sensations of burning or irritation (in case of major wounds or in gynecological surgery). Generally this does not require modification of the treatment.
· Risk of irritation with prolonged occlusion.
· Burn at the application site.
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 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 DAKIN COOPER STABILIZED, solution for local application in bottle?
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 outer packaging.
Store at a temperature below 30 ° C.
Do not throw any medicines into drains or rubbish. 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 DAKIN COOPER STABILIZE contains, solution for local application in a vial
· The active substance is:
Concentrated solution of sodium hypochlorite
Amount corresponding to active chlorine ............................................. .................................. 0.500 g
For 100 ml of solution for local application.
· The other components are:
Potassium permanganate, sodium dihydrogen phosphate dihydrate, purified water.
What is DAKIN COOPER STABILIZED, solution for topical application in bottle and contents of container
This medication is in the form of a solution for local application.
Bottle of 60 ml, 125 ml, 250 ml, 500 ml or 1000 ml.
Marketing Authorization Holder
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Marketing Authorization Operator
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Maker
FRENCH PHARMACEUTICAL COOPERATION
2 RUE DE LA SAUSSAIE
77310 SAINT FARGEAU PONTHIERRY
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).