Fazol Creme Mycose 2% (30-gram tube) is recommended for the treatment or adjunctive treatment of certain fungal infections (mycoses) of the skin or mucous membranes.
For warnings, precautions, and contraindications, please refer to the package insert.
Skin fungal infections are very common skin conditions caused by microscopic fungi. They can affect the skin’s surface, the nails, and the scalp. Symptoms vary depending on the part of the body affected.
This medication is recommended for the treatment or adjunctive treatment of certain fungalinfections (mycoses)of the skin or mucous membranes.
For the treatment of itchy skin, explore our selection ofover-the-counter cortisone-based creams, which includes Bayer’s Bepanthensensicalm Anti-Itch Eczema Cream, available online.
Fungal infections are a widespread condition and can be highly debilitating. They are caused by fungi or yeasts that colonize the skin, nails, or internal or external mucous membranes. Fungal infections can take several forms depending on their location: while some appear in highly visible areas, others are hidden, sometimes even in our private parts. It’s a minor condition, but one that can be contagious. Let’s go on a hunt for fungal infections!
Per 100 g
The active ingredient is :
Isoconazole nitrate ............................................................2 g
The other ingredients are : A mixture of mono- and di-stearic esters of ethylene glycol and polyoxyethylene glycols, glycero-polyethylene glycol glycerides, fluid paraffin oil, butylhydroxyanisole, benzoic acid, purified water.
Do not use Fazol Cream 30 g Tube if you are allergic to imidazole derivatives or to any of the product’s ingredients.
If you are taking or have recently taken any other medication, including over-the-counter medications, tell your doctor or pharmacist.
Fazol 2% Antifungal Cream is available in a 30 g tube.
Warning: This medication is not like other products. Read the package insert carefully before ordering. Keep medications out of the reach of children. If symptoms persist, consult your doctor or pharmacist. Be aware of potential interactions with other medications you are currently taking.
Skin fungal infections are superficial skin infections caused by fungi (fungal infections); they are not serious but require appropriate treatment to heal. They cause significant discomfort and are a common reason for seeking medical care.
Fazol creamis an antifungal treatment in the imidazole class. It treats nail infections, mucosal infections, and various skin fungal infections: dermatophytosis, pityriasis versicolor, candidiasis, and infections in various locations (ringworm, feet, skin, vulva, anus, mouth). Fazol is used to treat localized fungal infections.
To prevent the growth of fungi, wear socks made of natural fibers (linen, cotton). Let your shoes air out after wearing them, and avoid wearing the same pair two days in a row. Wear loose-fitting clothing to avoid friction and dry thoroughly between your toes, as moisture there can promote the development of fungal infections.
Pharmacovigilance Report an adverse drug reaction(s)
NOTICE
ANSM - Updated on: 03/10/2016
Name of the medicinal product
FAZOL cream
Isoconazole 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 FAZOL, cream and in what cases is it used?
2. What should I know before using FAZOL, cream?
3. How to use FAZOL, cream?
4. What are the possible side effects?
5. How to store FAZOL, cream?
6. Package contents and other information.
1. WHAT FAZOL, cream AND WHAT IT IS USED FOR?
LOCAL ANTIFUNGIC - ATC code: D01AC05
This medication is recommended in the treatment or supplementation of certain skin conditions or mucous membranes due to fungi (mycoses).
2. WHAT TO DO ABOUT BEFORE USING FAZOL, cream?
Do not use FAZOL, cream:
· if you are allergic (hypersensitive) to imidazol derivatives or to any of the other ingredients of this medication mentioned in section 6.
Warnings and Precautions
Talk to your doctor or pharmacist before using FAZOL, cream .
· Precautions for use
o Avoid application near the eyes.
o It is recommended not to use an acid soap (the acidity favoring the multiplication of certain fungi).
o Discontinue treatment if you are allergic or intolerant.
children
· In case of application in children, on a large surface or on injured skin, it is imperative to observe the recommendations and the dosage indicated by your doctor due to the greater penetration of the product in these circumstances.
Other medicines and FAZOL, cream
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
FAZOL, cream with food and beverages
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Sport
Not applicable.
Driving and using machines
Not applicable.
FAZOL, cream contains butylhydroxyanisole (E320) and benzoic acid.
3. HOW TO USE FAZOL, cream?
Always use this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Apply to the affected areas and their periphery 2 times a day, after toilet and drying of the skin. Follow the application of a gentle and regular massage until complete penetration.
Dermal.
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.
If you used more FAZOL, cream than you should:
Not applicable.
If you forget to use FAZOL, cream:
Not applicable.
If you stop using FAZOL, cream:
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Cases of itching, irritation, burning sensation, exceptional general allergic manifestations (angioedema, urticaria) and contact dermatitis (linked to the presence of butylhydroxyanisole and benzoic acid) have been reported.
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
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE FAZOL, cream?
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 package.
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 FAZOL contains, cream
· The active substance is:
Isoconazole Nitrate .............................................. .................................................. .............. 2 g
For 100 g.
· The other ingredients are: a mixture of mono and distearic esters of ethylene glycol and polyoxyethylene glycols, polyoxyethylene glycolysed glycerides, liquid petroleum jelly, butylhydroxyanisole, benzoic acid, purified water.
What is FAZOL, cream and contents of the pack
This medication is in the form of a cream in 30 g tube.
Marketing Authorization Holder
ALLIANCE PHARMA FRANCE SAS
35 RUE D'ARTOIS
75008 PARIS
Marketing Authorization Operator
ALLIANCE PHARMA FRANCE SAS
35 RUE D'ARTOIS
75008 PARIS
Maker
FARMACLAIR
440 AVENUE OF THE GENERAL DE GAULLE
14200 HEROUVILLE SAINT-CLAIR
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]
Other
Detailed information on this medicine is available on the ANSM website (France).
Local antifungal
isoconazole
. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
FAZOL 2%: cream; 30 g tube.
Refunded at 30%. - price: 3,52 euro (s).
FAZOL 2%: fluid emulsion for local application; 30 g bottle.
Refunded at 30%. - price: 3,33 euro (s).
FAZOL 2%: powder for local application; powder bottle of 30 g.
Refunded at 30%. - price: 3,70 euro (s).
Laboratory Sinclair Pharma France
| p 100 g | |
| Isoconazole nitrate | 2 g |
Usual dosage:
2 applications per day.
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