NOTICE
ANSM - Last updated: 15/10/2015
Name of the medicinal product
EOSINE COOPER 2 PER CENT, solution for skin application in single-dose containers
Eosin disodium
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
· This medication is a specialty of AUTOMEDIZATION which can be used without consultation or prescription from a doctor.
· The persistence of the symptoms, the aggravation or the appearance of new disorders, require to take a medical opinion.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
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 EOSINE COOPER 2 PER CENT, solution for skin application in single-dose containers AND WHAT CASES IS IT USED FOR?
2. BEFORE YOU USE EOSINE COOPER 2 PER CENT, solution for skin application in single dose containers?
3. HOW TO USE EOSINE COOPER 2 PER CENT, solution for skin application in single dose containers?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE EOSINE COOPER 2 PER CENT, solution for skin application in single dose containers?
6. ADDITIONAL INFORMATION
1. WHAT IS EOSINE COOPER 2 PER CENT, solution for skin application in single-dose containers AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group
Other antiseptics and disinfectants.
Therapeutic indications
This medicine is indicated for skin irritation, especially in the case of diaper rash (red buttocks) of the infant.
2. BEFORE YOU USE EOSINE COOPER 2 PER CENT, solution for skin application in single dose containers?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use EOSINE COOPER 2 PERCENT solution for single-dose skin application in the following cases:
· If you are allergic (hypersensitive) to eosin.
If in doubt, you should seek the advice of your doctor or pharmacist.
Precautions for use; special warnings
Take special care with EOSINE COOPER 2 PER CENT, solution for skin application in single-dose containers:
· Do not swallow it.
· Any opened single dose vials should be used within 48 hours to avoid microbial contamination.
Skin irritation : If symptoms persist for more than 5 days, consult a physician or seek advice from the pharmacist.
Red buttocks of the infant : in case the diaper rash of the infant persists beyond 3 days consult a doctor or seek advice from the pharmacist.
If in doubt, you should seek the advice of your doctor or pharmacist.
Interaction with other medicines
Taking or using other medicines:
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist. In particular, avoid using aqueous eosin together with another solution for local application.
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 should be used with caution 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 EOSINE COOPER 2 PER CENT, solution for skin application in single dose containers?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage, Mode and Route of Administration
Dermal.
Apply locally with a sterile compress 1 to 2 times a day, or pour directly on the place to be treated .
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, EOSINE COOPER 2 PERCENT, solution for single-dose skin application is likely to have undesirable effects, although not everyone is subject to it.
Tell your doctor if you notice the following:
· localized skin rashes,
· photosensitization (skin reaction when exposed to sunlight or UV) of the surfaces treated with this drug.
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 EOSINE COOPER 2 PER CENT, solution for skin application in single dose containers?
Keep out of the reach and sight of children.
Expiration date
Do not use EOSINE COOPER 2 PER CENT, single dose solution for skin application after the expiry date stated on the outer packaging. The expiry date refers to the last day of the month.
Storage conditions
This medication should be stored at a temperature below 25 ° C.
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 EOSINE COOPER 2 PERCENT contain, one-pot solution for skin application?
The active substance is :
Eosin disodium ................................................ .................................................. ............................. 2.00 g
For 100 ml of solution.
The other component is :
Purified water.
Pharmaceutical form and content
What is EOSINE COOPER 2 PER CENT, solution for single-dose skin application and contents of the pack?
This medicinal product is in the form of a solution for topical application in a single-dose container.
Box of 15 single-dose containers of 1 ml.
Box of 10 single-dose containers of 2 ml.
Box of 48 single-dose containers of 5 ml.
Box of 96 single-dose containers of 5 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
FRENCH PHARMACEUTICAL COOPERATION
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
COUNCIL / HEALTH EDUCATION
In order to limit the risk of infant rash, it is necessary to:
· change the baby frequently, at least 6 times a day,
· at each change, clean the baby's buttocks with soap surgras, insisting at the folds and then rinse thoroughly with water,
· do not layer on wet buttocks. If necessary, dry thoroughly with a clean absorbent towel without rubbing to avoid irritation.
In case of diaper rash of the infant, it is also recommended to leave the baby's buttocks in the air more often and for as long as possible.