NOTICE
ANSM - Last updated: 06/06/2016
Name of the medicinal product
MONAZOL, ovule
Sertaconazole 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 a physician.
· 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 MONAZOL, Ovum AND WHAT IT IS USED FOR?
2. BEFORE YOU USE MONAZOL, Ovule?
3. HOW TO USE MONAZOL, Ovule?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE MONAZOL, Ovule?
6. ADDITIONAL INFORMATION
1. WHAT IS MONAZOL, Ovum AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
LOCAL ANTIFUNG.
(G: genitourinary system and sex hormones)
Therapeutic indications
This medication is indicated for the local treatment of candidiasis (diseases due to microscopic fungi) of the vagina.
2. BEFORE YOU USE MONAZOL, Ovule?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use MONAZOL, ovule in the following cases:
· in the event of an allergy to any component of the product or to a related substance,
· when used with male condoms and latex diaphragms.
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 MONAZOL, ovule:
Special warnings
Local treatment of mycosis is only one element of treatment. To avoid relapses, the search for factors favoring your doctor is essential.
Precautions for use
· Do not use acid soap for local hygiene (acidity promoting fungal growth) ( see How to use MONAZOL, ovule ).
· 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, consult your doctor.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Do not use with spermicidal products (risk of inactivation).
TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, IT MUST BE INFORMED SYSTEMATICALLY OF ANY OTHER TREATMENT IN PROGRESS AT YOUR DOCTOR OR YOUR 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.
In general, during pregnancy and breast-feeding you should always seek advice from your doctor or pharmacist 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 MONAZOL, Ovule?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
An ovule in single administration, in the evening at bedtime.
Method and route of administration
Vaginal pathway. Introduce an egg deep into the vagina, preferably in the lying position. The easiest way is to lie on your back with your knees bent back and forth.
Practical advice
· toilet with soap at neutral or alkaline pH,
· so as not to contaminate your surroundings, use your own towels (gloves, towels),
· your doctor will:
o also treat your sexual partner, to avoid that it recontamine you,
o prescribe an antifungal for local application.
· wearing cotton underwear,
· avoid wearing internal buffers during treatment,
· avoid vaginal douches,
· possible treatment during menstruation.
Frequency of Administration
The egg should preferably be administered at bedtime.
Duration of treatment
The duration of the treatment is theoretically 1 day.
However, if the clinical signs persist, your doctor may prescribe a second ovule at 7 days intervals.
Symptoms and Instructions for Overdose
If you used more MONAZOL, ovule than you should:
Excessive use may lead to worsening of adverse effects. If you take more MONAZOL, ovulate than you should, and you feel any side effects not mentioned in this leaflet, please consult your doctor.
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, MONAZOL, an ovule is likely to have side effects, although not everyone is subject to it.
· local burning sensations, itchy itching and possibility of allergy.
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 MONAZOL, Ovule?
Keep out of the reach and sight of children.
Expiration date
Do not use MONAZOL, an ovum after the expiry date which is stated on the outer packaging.
Storage conditions
No special storage conditions.
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 MONAZOL contain, egg?
The active substances are:
Sertaconazole Nitrate ............................................... .................................................. .................. 0.300 g
For an egg.
The other components are:
Solid hemi-synthetic glycerides (WITEPSOL H19), solid hemi-synthetic glycerides (SUPPOCIRE NAI50), anhydrous colloidal silica
Pharmaceutical form and content
What is MONAZOL, ovule and contents of the pack?
This medication is in the form of an ovule. Box of 1 or 2 ova.
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
FERRER INTERNACIONAL, SA
GRAN VIA CARLOS III, 94
08028 BARCELONA
SPAIN
exploiting
TEVA HEALTH
100-110 Esplanade of the General de Gaulle
92931 PARIS LA DEFENSE CEDEX
Maker
LABORATOIRE THERAMEX
6, AVENUE ALBERT II
98000 MONACO
MONACO
or
TROMMSDORFF GMBH & CO. KG
TROMMSDORFFSTR
2-6, 52477 ALSDORF
GERMANY
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 Ansm website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.