NOTICE
ANSM - Updated on: 01/09/2009
Name of the medicinal product
ECONAZOLE BIOGARAN LP 150 mg, extended release egg
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 BIOGARAN LP 150 mg, prolonged-release egg AND WHAT IT IS USED FOR?
2. BEFORE YOU USE ECONAZOLE BIOGARAN LP 150 mg, prolonged-release egg?
3. HOW TO USE ECONAZOLE BIOGARAN LP 150 mg, prolonged-release egg?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE ECONAZOLE BIOGARAN LP 150 mg, prolonged-release ovule?
6. ADDITIONAL INFORMATION
1. WHAT IS ECONAZOLE BIOGARAN LP 150 mg, prolonged-release egg AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
This medicine contains econazole nitrate: an antifungal and antibacterial.
Therapeutic indications
It is indicated in the local treatment of mycoses (affections due to microscopic fungi) of the vulva and the vagina sometimes overinfected.
2. BEFORE YOU USE ECONAZOLE BIOGARAN LP 150 mg, prolonged-release egg?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not use ECONAZOLE BIOGARAN LP 150 mg, sustained-release egg in the following cases:
· ( see ECONAZOLE BIOGARAN LP 150 mg, sustained release ovule? ) or a related substance (belonging to the imidazole group),
· use with a latex diaphragm.
If in doubt, it is essential to seek the advice of your doctor or pharmacist.
Precautions for use; special warnings
Take special care with ECONAZOLE BIOGARAN LP 150 mg, extended release egg:
Local treatment of mycosis is only part of the overall treatment. To avoid relapses, the search for factors favoring your doctor is essential.
Do not use acid soap for local hygiene, acidity promoting fungal growth ( see Method of administration ).
This treatment can cause local burning sensations and increased itching. Generally, these phenomena yield spontaneously to the continuation of the treatment. If symptoms persist beyond 24 to 48 hours, discontinue treatment and see your doctor.
If in doubt, it is essential to seek the advice of your doctor or pharmacist.
Interaction with other medicines
Taking or using other medicines
Do not use with spermicidal products (risk of inactivation) or with a latex diaphragm (risk of rupture of the diaphragm).
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
This medication will only be used during pregnancy on the advice of your doctor. If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.
Breast-feeding is possible when treated with this medication.
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 ECONAZOLE BIOGARAN LP 150 mg, prolonged-release egg?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
In the majority of cases, 1 ovule preferably in the evening at bedtime, in single administration.
In some cases, your doctor may prescribe an egg in the evening and an egg the next morning.
In all cases, follow the recommendations of your doctor or pharmacist.
If you feel that the effect of ECONAZOLE BIOGARAN LP 150 mg, prolonged release ovule is too strong or too weak, talk to your doctor or pharmacist.
Administration mode
Vaginal pathway.
Introduce the egg deeply into the vagina, preferably in the extended position. The easiest way to do this is to lie down on your back with your knees folded away.
Practical advice:
· toilet with neutral or alkaline pH soap,
· so as not to contaminate your surroundings, use your own towels (glove, towel),
· your doctor will:
o also treat your sexual partner, to avoid that it recontamine you,
o prescribe an antifungal to apply locally,
· wear cotton underwear,
· avoid vaginal douches,
· do not interrupt treatment during menstruation,
· avoid wearing internal pads during treatment.
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 BIOGARAN LP 150 mg, a prolonged-release egg is likely to have side effects, although not everyone is subject to it.
· reactions at the application site such as burning sensations, irritations, itching and erythema (redness of the skin),
· contact dermatitis (inflammation of the skin) and urticaria.
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 BIOGARAN LP 150 mg, prolonged-release ovule?
Keep out of the reach and sight of children.
Expiration date
Do not use ECONAZOLE BIOGARAN LP 150 mg prolonged-release egg after the expiry date which is stated on the carton.
Storage conditions
Store at a temperature not exceeding 30 ° 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 ECONAZOLE BIOGARAN LP 150 mg, Prolonged-Release Ovule contain?
The active substance is:
Econazole Nitrate .............................................. .................................................. 150 mg
For a sustained release ovule.
The other components are:
Galactomannan, anhydrous colloidal silica, solid hemisynthetic glycerides, stearyl enantate.
Pharmaceutical form and content
What is ECONAZOLE BIOGARAN LP 150 mg, sustained release ovule and contents of the pack?
This medication is in the form of a sustained release ovule. Box of 1 ovule.
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
ADS PHARMA
7, ALLEE D'ORLEANS
92200 NEUILLY SUR SEINE
exploiting
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Maker
UNITHER INDUSTRIES
INDUSTRIAL AREA LE MALCOURLET
03800 GANNAT
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.