NOTICE
ANSM - Last updated: 20/09/2010
Name of the medicinal product
OXYGEN WATER 10 VOLUMES COOPER, solution for skin application
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 your doctor.
· 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 OXYGENATED WATER 10 VOLUMES COOPER, solution for skin application AND WHAT IT IS USED FOR?
2. BEFORE YOU USE OXYGEN WATER 10 VOLUMES COOPER, solution for skin application?
3. HOW TO USE OXYGEN WATER 10 VOLUMES COOPER, solution for skin application?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE OXYGEN WATER 10 VOLUMES COOPER, solution for skin application?
6. ADDITIONAL INFORMATION
1. WHAT IS OXYGENATED WATER 10 VOLUMES COOPER, solution for skin application AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
This medication is a local antiseptic for external use (for the skin).
Therapeutic indications
This medication is recommended:
· for antiseptic cleaning of eroded skin and small wounds.
· for bleeding from small superficial wounds.
2. BEFORE YOU USE OXYGEN WATER 10 VOLUMES COOPER, solution for skin application?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use OXYGEN WATER 10 VOLUMES COOPER, solution for skin application:
This medication MUST NOT be in contact with the eyes.
Precautions for use; special warnings
Take special care with OXYGEN WATER 10 VOLUMES COOPER, solution for skin application:
Special warnings
· The solution should be used immediately after opening the package.
· Do not use to irrigate closed or semi-closed cavities, or on highly vascularized wounds or under occlusive dressing. This product must be used in strict compliance with its instructions.
· Do not use to disinfect medical and surgical equipment.
Precautions for use
Do not swallow.
Do not use hydrogen peroxide together with any other antiseptic solution.
Interaction with other medicines
Taking or using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription.
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
Ask your doctor or pharmacist for advice before taking any 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 OXYGEN WATER 10 VOLUMES COOPER, 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
· Use pure 10% oxygenated water for cleansing injured skin and small wounds.
· Apply 10 pure volumes of oxygenated water to small superficial wound hemorrhages.
IN ALL CASES CONFORM TO THE ORDER OF YOUR DOCTOR STRICTLY.
Symptoms and Instructions for Overdose
If you used more WATER OXYGENATE 10 VOLUMES COOPER, solution for skin application you should:
Immediately consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to use WATER OXYGENATE 10 VOLUMES COOPER, solution for skin application:
Do not take a double dose to compensate for the single dose that you have forgotten to use.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, OXYGENEOUS WATER 10 VOLUMES COOPER, solution for skin application is likely to have undesirable effects, although not everyone is subject to it.
It is possible that tingling sensations occur on the wounds, this is of no consequence and should not cause the treatment to change.
Cases of gas embolism (formation and diffusion of air bubbles in the blood vessels) of sometimes fatal evolution have been reported.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE OXYGEN WATER 10 VOLUMES COOPER, solution for skin application?
Keep out of the reach and sight of children.
Expiration date
Do not use OXYGEN WATER 10 VOLUMES COOPER, solution for skin application after the expiry date which is stated on the vial.
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 EAU OXYGENEE 10 VOLUMES COOPER contain, solution for skin application?
The active substance is:
3% Hydrogen Peroxide Solution cent (w / w) corresponding to 10 volumes of active oxygen ... 100 ml
For 100 ml.
Pharmaceutical form and content
What is EAU OXYGENEE 10 VOLUMES COOPER, solution for skin application and contents of the pack?
This medication is in the form of a solution for skin application. Bottle of 125 ml or 250 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
Cooperation Pharmaceutique Francaise
Place Lucien-Auvert
77020 Melun Cedex
exploiting
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Maker
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN 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 Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.