NOTICE
ANSM - Last updated: 13/01/2015
Name of the medicinal product
WATER OXYGENE GIFRER 10 VOLUMES, solution for skin application
Hydrogen peroxide
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 your 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 OXYGENE WATER GIFRER 10 VOLUMES, solution for skin application AND WHAT IS IT USED FOR?
2. BEFORE YOU USE WATER OXYGENE GIFRER 10 VOLUMES, solution for skin application?
3. HOW TO USE OXYGENE WATER GIFRER 10 VOLUMES, solution for skin application?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE OXYGENE WATER GIFRER 10 VOLUMES, solution for skin application?
6. ADDITIONAL INFORMATION
1. WHAT IS OXYGENE WATER GIFRER 10 VOLUMES, solution for skin application AND WHAT IS IT USED FOR?
Pharmacotherapeutic group
OTHER ANTISEPTICS AND DISINFECTANTS
(D08AX01)
Therapeutic indications
This medication is a local antiseptic for external use (for skin)
2. BEFORE YOU USE WATER OXYGENE GIFRER 10 VOLUMES, solution for skin application?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use OXYGENE GIFRER 10 VOLUMES, solution for skin application in the following cases:
· If you are allergic to hydrogen peroxide or any of the other ingredients of this medication mentioned in section 6.
· In application on the eyes.
· To clean the skin before taking (puncture), injecting or performing surgery.
· To disinfect medical and surgical equipment
Precautions for use; special warnings
Talk to your doctor, or pharmacist, before using EAU OXYGENEE GIFRER.
Take special care with OXYGENE WATER GIFRER 10 volumes solution for skin application:
You should not swallow this medication nor inject it.
You must not use OXYGENE WATER GIFRER 10 volumes:
· On a large surface of the skin, on injured skin or on burned skin,
· On the mucous membranes (inside the mouth, inside the nose and especially in the genital area),
· On the skin of premature or infant baby,
· Under an occlusive dressing (impermeable to water and air),
· To disinfect surgical equipment,
· At certain cavities of the body (closed or semi-closed cavities), or on highly vascularized wounds.
As soon as the bottle is opened, microbial contamination is possible. Be careful not to take too long a preparation of skin antiseptic.
Interaction with other medicines
This medication should not be used along with other local antiseptics or cleansers as there is a risk that the combination of several antiseptics may be incompatible or render them ineffective.
Inform your doctor or pharmacist if you are using, have recently used or could use any other medicines.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Not applicable.
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 OXYGENE WATER GIFRER 10 VOLUMES, 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
Always use this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage:
You must apply the pure solution for
· Clean injured skin and small wounds,
· Stop slight bleeding of superficial wounds.
Administration mode :
Dermal
Do not swallow, do not inject
OXYGENE WATER GIFRER applies pure on the wound, burn or skin that bleeds.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
The following side effects may occur:
Tingling sensations on the wounds may occur. This is of no consequence and you should not alter your treatment.
Cases of gas embolism (formation of air bubbles in the blood vessels) of sometimes fatal evolution have been reported.
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 OXYGENE WATER GIFRER 10 VOLUMES, solution for skin application?
Keep this medicine out of the reach and sight of children.
Expiration date
Do not use this medicine after the expiry date which is stated on the carton or on the single dose container after {EXP}. The expiry date refers to the last day of that month.
Storage conditions
Low density polyethylene bottle: Keep away from light.
If necessary, warnings against visible signs of deterioration
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. ADDITIONAL INFORMATION
Full list of active substances and excipients
What OXYGENE GIFRER 10 VOLUMES contains, solution for skin application
• The active substance is: 3 per cent hydrogen peroxide solution (m / m).
1 volume of 3% hydrogen peroxide solution is about 10 times its oxygen volume.
• The other components are: Phosphoric acid, sodium pyrophosphate, sodium salicylate, sodium stannate, purified water.
Pharmaceutical form and content
Aspect of WATER OXYGENEE GIFRER 10 VOLUMES, solution for skin application and contents of the pack
This medication is in the form of a solution for skin application.
This medicine is available in 45 ml, 100 ml, 125 ml, 250 ml or 500 ml flasks or a 125 ml spray bottle.
Not all pack sizes may be marketed.
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 A 10 RUE PAUL BERT
69150 DECINES-CHARPIEU
exploiting
GIFRER BARBEZAT
8-10, RUE PAUL BERT
69153 DECINES CEDEX
Maker
GIFRER BARBEZAT
8-10, RUE PAUL BERT
69153 DECINES 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 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.