NOTICE
ANSM - Updated on: 30/06/2015
Description of the Medicine
MONAZOL 2 PER CENT, cream
Sertaconazole Nitrate
© framed
Please read this leaflet carefully before using this medication. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist for more information.
AT· Keep this leaflet, you may need to read it again.
AT· If you need more information and advice, ask your pharmacist.
AT· If symptoms worsen or persist, consult a physician.
AT· If you notice any side effects not listed in this leaflet, or if you notice any of the side effects listed as severe, please inform your doctor or pharmacist.
Summary sheet
In this notice :
1. WHAT IS MONAZOL 2 PER CENT, cream AND WHAT USE IS IT USED FOR?
2. WHAT TO DO ABOUT BEFORE USING MONAZOL 2 PER CENT, cream?
3. HOW TO USE MONAZOL 2 PER CENT, cream?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE MONAZOL 2 PER CENT, cream?
6. ADDITIONAL INFORMATION
1. WHAT IS MONAZOL 2 PER CENT, cream AND WHAT USE IS IT USED FOR?
Pharmacotherapeutic group
Antifungal of the class of imidazoles.
Therapeutic Indications
This medication is an antifungal, from the family of imidazoles, prescribed in the treatment of cutaneous-mucous fungal infections with Candida and dermatophytes.
2. WHAT TO DO ABOUT BEFORE USING MONAZOL 2 PER CENT, cream?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use MONAZOL 2 PERCENT, cream:
This medication MUST NOT BE USED in cases of known hypersensitivity to an antimycotic agent of the imidazole group or any of the excipients.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Employment precautions; special warnings
Take special care with MONAZOL 2 PER CENT, cream:
Employment Precautions
This medication contains methyl parahydroxybenzoate and may cause allergic reactions.
IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Interactions with other medicines
Taking or using other medicines
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 phytotherapeutic products 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.
GENERALLY, DURING PREGNANCY OR BREASTFEEDING, ALWAYS REQUEST THE OPINION OF YOUR DOCTOR OR PHARMACIST BEFORE USING A MEDICINE.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Important information about some of the ingredients of MONAZOL 2 PER CENT, cream
List of excipients with known effect: methyl parahydroxybenzoate.
3. HOW TO USE MONAZOL 2 PER CENT, cream?
Instructions for proper use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Administration Frequency and Duration of Treatment
Dosage
One application per day
Method and route of administration
After washing and drying the lesions, apply the cream to the lesion and peripheral to 1 cm.
Hygiene Tips
Perform your toilet with a pH neutral or alkaline soap, an acid pH soap favoring the multiplication of Candida .
If possible, wear cotton underwear and avoid all factors that promote the proliferation of fungi.
Duration of treatment
In all cases, comply strictly with the medical prescription.
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 undesirable effects
Like all medicines MONAZOL 2 PERCENT, cream is likely to have undesirable effects, although not everyone is subject to it.
Local manifestations of intolerance, such as discomfort or the onset of redness have been reported in rare cases.
The absence of sertaconazole in the general circulation during the application of the cream on healthy or harsh skin and on the vaginal mucosa renders unlikely the occurrence of undesirable effects. More important.
If you notice any side effects not listed in this leaflet, or if certain undesirable effects become serious, please inform your doctor or pharmacist.
5. HOW TO STORE MONAZOL 2 PER CENT, cream?
Keep out of the reach and sight of children.
Date of filing
Do not use MONAZOL 2 PERCENT, cream after the expiration date stated on the outer packaging.
Storage conditions
No special precautions for storage.
If necessary, warnings against some visible signs of deterioration
Medicines should not be thrown away at the sewer or with household garbage. Ask your pharmacist what to do with unused medications. These measures will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does MONAZOL 2 PERCENT, cream contain?
The active substance is:
Sertaconazole Nitrate ............................................... .................................................. .................... 2.00 g
For 100 g of cream.
The other components are:
Polyethylene glycol ether glycol etherate (TEFOSE 63), lauric macrogolglycerides (LAM 2130 CS / LABRAFIL M 2130 CS), glycerol isosterate (ISOSTEARIC PECEOL), liquid paraffin Sorbic acid, methylated parahydroxybenzoate, purified water.
Pharmaceutical form and content
What is MONAZOL 2 PERCENT, cream and contents of the outer packaging?
This medication is in the form of a cream. Tube of 15 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
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
Names of medicines in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last day this notice was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicinal product can be found on the website of AFssaps (France).
Information for health professionals
Not applicable.
Other
Not applicable.