NOTICE
ANSM - Updated on: 20/07/2017
Name of the medicinal product
MYLEUGYNE LP 150 mg, extended release egg
Econazole Nitrate
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 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.
Do not use this medication for children.
What is in this leaflet?
1. What is MYLEUGYNE LP 150 mg, sustained release ovule and in which cases is it used?
2. What should I know before using MYLEUGYNE LP 150 mg, a sustained release ovule?
3. How to use MYLEUGYNE LP 150 mg, extended release egg?
4. What are the possible side effects?
5. How to store MYLEUGYNE LP 150 mg, extended release egg?
6. Package contents and other information.
1. WHAT IS MYLEUGYNE LP 150 mg, sustained-release ovule AND WHAT IT IS USED FOR?
Pharmacotherapeutic group - ATC code:
This medicine contains econazole nitrate: an antifungal and antibacterial.
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 MYLEUGYNE LP 150 mg, prolonged-release ovule?
Do not use MYLEUGYNE LP 150 mg, extended release egg:
· if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medication mentioned in section 6 or to a related substance (belonging to the imidazole group),
· if you are using a latex diaphragm.
If in doubt, it is essential to seek the advice of your doctor or pharmacist.
Warnings and Precautions
Take special care with MYLEUGYNE 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.
Talk to your doctor or pharmacist before using MYLEUGYNE LP 150 mg prolonged-release egg .
Children and Youth
Not applicable.
Other medications and MYLEUGYNE LP 150 mg, prolonged-release ovule
Do not use with spermicidal products (risk of inactivation) or with a latex diaphragm (risk of rupture of the diaphragm).
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
MYLEUGYNE LP 150 mg, extended release egg with food and beverages
Not applicable.
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.
Driving and using machines
Not applicable.
MYLEUGYNE LP 150 mg, extended release ovule contains galactomannan, anhydrous colloidal silica, solid hemisynthetic glycerides, stearyl enantate.
3. HOW TO USE MYLEUGYNE LP 150 mg, prolonged-release ovule?
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
In the majority of cases, 1 ovule preferably in the evening at bedtime, in single administration.
In some cases, your doctor may prescribe 1 egg in the evening and 1 egg the next morning.
In all cases, follow the recommendations of your doctor or pharmacist.
If you feel that the effect of MYLEUGYNE LP 150 mg, a 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.
If you take more than MYLEUGYNE LP 150 mg, prolonged-release egg you should:
Not applicable.
If you forget to take MYLEUGYNE LP 150 mg, prolonged-release egg:
Do not take a double dose to make up for the single dose that you have forgotten to take.
If you stop taking MYLEUGYNE LP 150 mg, prolonged-release egg:
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· reactions to the site of applications such as burning sensations, irritations, itching and erythema (redness of the skin),
· contact dermatitis (inflammation of the skin) and urticaria.
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 via 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 MYLEUGYNE LP 150 mg, prolonged-release egg?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Store at a temperature not exceeding + 30 ° C.
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. PACKAGE CONTENTS AND OTHER INFORMATION
What MYLEUGYNE LP 150 mg contains, prolonged-release ovule
· 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.
What is MYLEUGYNE 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 or 2 ova.
Marketing Authorization Holder
IPRAD PHARMA LABORATORIES
174 quai de Jemmapes
75010 PARIS
Marketing Authorization Operator
IPRAD PHARMA LABORATORIES
174 quai de Jemmapes
75010 PARIS
Maker
LAPHAL INDUSTRIES
AVENUE DE PROVENCE
13190 ALLAUCH
or
LAPHAL INDUSTRIES - ROUSSET
248 AVENUE OF THE VICTORY
13106 ROUSSET
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
<{MM / YYYY}> <{YYYY month}.>
Other
Not applicable.
Detailed information on this medicine is available on the ANSM website (France).
