MycoSédermyl 1% Cream Tube 30g

MycoSédermyl 1% Cream Tube 30g View larger

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MycoSédermyl 1% Cream 30g Tube is a drug indicated for adjunctive treatment of certain skin diseases caused by fungi (mycoses).

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MYCOSEDERMYL 1% CREAM 30G TUBE

For warnings, precautions for use and cons-indications, see the instructions for use.


Description MycoSédermyl 1% Cream Tube 30g

MycoSédermyl 1% Cream 30g Tube is recommended in the treatment or supportive treatment of certain skin diseases caused by fungi (mycoses).

Council MycoSédermyl use 1% Cream Tube 30g

Apply to affected areas and their periphery 2 times a day, after dressing and drying of the skin. Forward applying a gentle and regular massage until completely absorbed.
  • Method and route of administration

Dermal.

  • Frequency of administration

2 times per day.

  • Duration of treatment

The treatment time is 2 to 4 weeks depending on the fungus, it may be longer for some locations. Regular use of the product during the duration of treatment is critical to successful treatment.

Composition MycoSédermyl 1% Cream Tube 30g

  • Active substances

Econazole nitrate 1g per 100g cream

  • Excipients

Ethylene glycol palmitostearate and polyoxyethyleneglycols (Tefose 63) macrogolglycerides oleic (Labrafil M 1944 CS), light liquid paraffin, benzoic acid, butylhydroxyanisole (E320), fragrance (essential oils of lavender, orange, mandarin, linalyl acetate , citronellol, butylhydroxytoluene (E321), dipropyleneglycol), purified water.

Introducing MycoSédermyl 1% Cream Tube 30g

30g cream tube

Warnings on drugs

Warning, the drug is not a product like any other. Read the package leaflet before ordering. Do not leave medicines within reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

Please tell your online pharmacist of current treatments to identify any incompatibilities. The order confirmation form contains a custom message field provided for this purpose.

Click here to find the manual of this drug on the website of the National Agency of Drug Safety and health products.

Pharmacovigilance Reporting an or effect (s) Adverse (s) bound (s) use of a medicament

VIDAL OF THE FAMILY

MYCOSÉDERMYL

Local antifungal

econazole

. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

MYCOSEDERMYL: cream; 30 g tube.
-

French Pharmaceutical Cooperation Laboratory

COMPOSITION (summary)
p 100 g
Econazole nitrate 1 g

INDICATIONS (summary)
This drug of local action contains an antifungal agent of the imidazole family.
It is used in the treatment of certain diseases of the skin due to microscopic fungi ( mycoses ): candidiasis , dermatophyties ...
CONTRAINDICATIONS (summary)
This medication should not be used if you are allergic to antifungal agents in the imidazole family.
WARNING (Contents)
Avoid using this medication, especially in children, for prolonged periods of time and on extensive or deeply injured surfaces without the advice of your pharmacist or doctor.
Rinse thoroughly in case of accidental contact with eyes.
PREGNANCY AND BREAST-FEEDING (summary)
The effect of this medication during pregnancy or lactation is not well known. The assessment of the possible risk associated with its use is individual: ask your pharmacist or doctor for advice.
DIRECTIONS FOR USE AND DOSAGE (summary)
The medication should be applied after thorough washing and drying of the area to be treated.
Apply the cream directly to the lesions and massage to penetrate. In the folds of the skin, the cream should be applied in small amounts to limit the risk of maceration.

Usual dosage:

1 application, 2 times a day.
The duration of treatment varies between 1 to 3 weeks depending on the case. It may be longer in some locations.
TIPS (summary)
In case of candidiasis , avoid using acid soaps: they promote the multiplication of fungi.
Excessive sweating contributes to the development of lesions due to fungi. The wearing of natural fiber socks (cotton, wool) is recommended. The same pair of shoes should not be worn two days in a row.
POSSIBLE ADVERSE EFFECTS (summary)
Rarely: burning sensation, itching, redness of the skin.
Very rarely: contact eczema .


GLOSSARY (summary)


allergy
Skin reaction (itching, pimples, swelling) or general discomfort occurring after contact with a particular substance, use of a medication, or ingestion of food. The main forms of allergy are eczema, urticaria, asthma, angioedema and allergic shock (anaphylactic shock). Food allergy can also result in digestive disorders.


antifungal
Medication that destroys fungi and microscopic yeasts. These can be present on the skin or the mucous membranes (digestive tract or genital organs). The most common yeast is Candida albicans.


candida
Abnormal multiplication of a microscopic yeast, Candida albicans most often. This is a frequent and benign complication of antibiotic treatments. The main symptoms are digestive disorders, a brown or black color of the tongue, white spots on the palate or tongue (thrush), itching or burning of the vulva or glans.


dermatophytes
Infection of the skin or nails by a microscopic fungus (dermatophyte).


eczema
Skin disease manifested by pimples and itching. Eczema may be due to contact with an allergic substance (contact eczema) or be linked to a genetic predisposition (atopic eczema).


imidazole
A family of medicines that includes antifungals, antibiotics and antiparasitics.


mycoses
Affection due to microscopic fungi, favored by the taking of antibiotics.

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Last updated: 07/07/2014

Name of the medicinal product

MYCOSEDERMYL 1 PER CENT, cream

Econazole 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 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 MYCOSEDERMYL 1 PER CENT, cream AND WHAT CASES IS IT USED FOR?

2. BEFORE YOU USE MYCOSEDERMYL 1 PER CENT, cream?

3. HOW TO USE MYCOSEDERMYL 1 PER CENT, cream?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE MYCOSEDERMYL 1 PER CENT, cream?

6. ADDITIONAL INFORMATION

1. WHAT IS MYCOSEDERMYL 1 PER CENT, cream AND WHAT CASES IS IT USED FOR?

Pharmacotherapeutic group

This medicinal product contains an antifungal for dermatological use in the imidazole family.

Therapeutic indications

This medication is recommended for the treatment or adjunctive treatment of certain cutaneous diseases caused by fungi (mycoses).

2. BEFORE YOU USE MYCOSEDERMYL 1 PER CENT, cream?

List of information needed before taking the medication

Not applicable.

Cons-indications

Never use MYCOSEDERMYL 1 PER CENT, cream if you are allergic to any of the ingredients.

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 MYCOSEDERMYL 1 PER CENT, cream:

Precautions for use

· Avoid application near eyes.

· It is recommended not to use an acid soap (acidity favoring the multiplication of candida).

· In case of application in children, on a large surface or on injured skin, it is imperative that you observe the recommendations and the dosage indicated by your doctor because of the greater penetration of the product in these circumstances.

· Due to the presence of benzoic acid, this medicinal product may cause irritation to the skin, eyes and mucous membranes.

· This medicinal product contains butylhydroxyanisole (E320) and butylhydroxytoluene (E321) and may cause local skin reactions (eczema) or irritation of the eyes and mucous membranes.

IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.

Interaction with other medicines

Taking or using other medicines

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

Not applicable.

Sport

Not applicable.

Effects on ability to drive or use machines

Not applicable.

List of excipients with known effect

This medicine contains benzoic acid, butylhydroxyanisole (E320) and butylhydroxytoluene (E321).

3. HOW TO USE MYCOSEDERMYL 1 PER CENT, cream?

Instructions for proper use

Not applicable.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Dosage

Apply to the affected areas and their periphery 2 times a day, after washing and drying the skin. Follow the application of a gentle and regular massage until complete penetration.

Administration mode

DERMAL

Duration of the treatment

The duration of 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.

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, MYCOSEDERMYL 1 PER CENT, cream is likely to have unwanted effects, although not everyone is subject to it:

Itching, irritation, burning sensation, redness and in very rare cases, allergic reactions with eczema type have been observed: IT MUST BE TESTED BY YOUR DOCTOR.

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 MYCOSEDERMYL 1 PER CENT, cream?

Keep out of the reach and sight of children.

Expiration date

Do not use MYCOSEDERMYL 1 PERCENT, cream after the expiry date stated on the carton.

Storage conditions

Store at a temperature not exceeding 25 ° 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 contains MYCOSEDERMYL 1 PER CENT, cream?

The active substance is:

Econazole Nitrate .............................................. .................................................. ................................. 1 g

For 100 g of cream.

The other components are:


Palmitostearate of ethylene glycol and polyoxyethylene glycols (Tefose 63), oleic macrogolglycerides (Labrafil M 1944 CS), light liquid paraffin, benzoic acid, butylhydroxyanisole (E320), perfume (essential oils of lavandin, orange, mandarin, linalyl acetate , citronellol, butylhydroxytoluene (E321), dipropylene glycol), purified water.

Pharmaceutical form and content

What is MYCOSEDERMYL 1 PERCENT, cream and contents of the pack?

This medication is in the form of a cream. Tube of 30 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

French Pharmaceutical Co-operation

Place Lucien AUVERT

77020 MELUN Cedex

exploiting

French Pharmaceutical Co-operation

Place Lucien AUVERT

77020 MELUN Cedex

Maker

CHEMINEAU LABORATORIES

93 ROAD OF CURRENCY

37210 VOUVRAY

OR

THEPENIER PHARMA INDUSTRIE

ALENÇON ROUTE

ST LANGIS-LES-MORTAGNE

61400 MORTAGNE

OR

French Pharmaceutical Co-operation

Place Lucien AUVERT

77020 MELUN Cedex

OR

French pharmaceutical cooperation

2 rue de la saussaie

77310 saint fargeau ponthierry

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.

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