NOTICE
ANSM - Last updated: 27/03/2014
Name of the medicinal product
ECONAZOLE TEVA 1 PER CENT, solution for skin application
Econazole Nitrate
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 ECONAZOLE TEVA 1 PER CENT, solution for skin application AND WHAT USE IS IT USED FOR?
2. WHAT TO DO ABOUT BEFORE USING ECONAZOLE TEVA 1 PER CENT, solution for skin application?
3. HOW TO USE ECONAZOLE TEVA 1 PER CENT, solution for skin application?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE ECONAZOLE TEVA 1 PER CENT, solution for skin application?
6. ADDITIONAL INFORMATION
1. WHAT IS ECONAZOLE TEVA 1 PER CENT, solution for skin application AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
ANTIFONGIC of the imidazole family.
(D. Dermatology)
Therapeutic indications
This medication is recommended for the treatment or adjunctive treatment of certain cutaneous diseases caused by fungi (mycoses).
2. WHAT TO DO ABOUT BEFORE USING ECONAZOLE TEVA 1 PER CENT, solution for skin application?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not use ECONAZOLE TEVA 1 PER CENT, solution for skin application in case of hypersensitivity to any of the components.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with ECONAZOLE TEVA 1 PER CENT, solution for skin application:
Precautions for use
· Avoid spraying near the eyes and on the genital mucous membranes.
· Do not spray within 10 cm of the genital mucosa.
· In case of application in children, on a large surface or on injured skin, it is imperative that you observe the recommendations and the dosage indicated by your doctor because of the greater penetration of the product in these circumstances.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
NEVER LEAVE TO CHILDREN.
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.
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
List of excipients with a well-known effect: propylene glycol.
3. HOW TO USE ECONAZOLE TEVA 1 PER CENT, 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
Dosage
After the bottle has been stirred, spray more than 10 cm of the affected areas and their periphery twice a day after washing and drying the skin. Follow the application of a gentle and regular massage until complete penetration.
It is essential not to insist on prolonged spraying, but to sweep all affected areas. The duration of the treatment is 2 to 4 weeks depending on the mycosis, it may be longer for some localizations. Regular use of the product throughout the course of treatment is critical to successful treatment.
Method and route of administration
DERMAL.
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, ECONAZOLE TEVA 1 PER CENT, solution for skin application is likely to have undesirable effects, although not everyone is subject to it:
· Itching, irritation, burning sensation, redness: IT MUST BE TESTED BY YOUR DOCTOR.
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 ECONAZOLE TEVA 1 PER CENT, solution for skin application?
Keep out of the reach and sight of children.
Expiration date
Do not use ECONAZOLE TEVA 1 PER CENT, solution for skin application after the expiry date stated on the outer packaging.
Storage conditions
Pressure vessel.
Do not expose to excessive heat.
Do not drill.
Do not throw into the fire even empty.
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 contains ECONAZOLE TEVA 1 PER CENT, solution for skin application?
The active substance is:
Econazole Nitrate .............................................. .................................................. ................................. 1 g
For 100 g.
The other components are:
Propylene glycol, alcohol, perfume.
Pharmaceutical form and content
What is ECONAZOLE TEVA 1 PER CENT, solution for skin application and contents of the outer packaging?
This medication is in the form of a solution for skin application. Pressurized bottle of 30 g.
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
TEVA HEALTH
100-110 Esplanade of the General de Gaulle
92931 PARIS LA DEFENSE CEDEX
exploiting
TEVA HEALTH
100-110 Esplanade of the General de Gaulle
92931 PARIS LA DEFENSE CEDEX
Maker
TEVA HEALTH
Street Bellocier
89107 SENS CEDEX
or
THEPENIER PHARMA INDUSTRIE
Route of Alencon
Saint Langis the Mortagne
61400 MORTAGNE
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.