MYCOAPAISYL 1% FLUID EMULSION 30G

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Apaisyl Apaisyl

MYCOAPAISYL 1% FLUID EMULSION 30G: This medicine is a fluid emulsion for topical application containing an antifungal imidazole family of this drug is recommended in the treatment or adjunctive treatment of certain skin diseases caused by fungi (mycoses).

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MYCOAPAISYL 1% EMULSION FLUID ANTI FUNGUS 30G

Warning: This is a drug. Before use, read the instructions carefully. If in doubt, do not hesitate to contact your pharmacist.

Description MYCOAPAISYL 1% EMULSION FLUID ANTI FUNGUS 30G

This drug is a fluid emulsion for topical application containing an antifungal agent of the imidazole family.
This drug is recommended in the treatment or adjunctive treatment of certain skin diseases caused by fungi (mycoses).

Application advice and opinions on MYCOAPAISYL 1% EMULSION FLUID ANTI FUNGUS 30G

Topical medication:
· Apply to the affected areas and their periphery 2 times a day, after visiting the toilet and drying of the skin. Forward application of a gentle and regular massage until completely absorbed.

Composition MYCOAPAISYL 1% EMULSION FLUID ANTI FUNGUS 30G

The active substance is:
Econazole nitrate .1 g per 100 g.
The other ingredients are:
Palmitostearate ethylene glycol and polyoxyethylene glycols (TEFOSE 63), unsaturated glycerides polyglycolized (LABRAFIL M 1944 CS), light liquid paraffin, benzoic acid, butylated hydroxyanisole, colloidal anhydrous silica (Aerosil 200), fragrance (essential oils of lavender, orange and tangerine, linalyl acetate, citronellol, butylated, dipropylene glycol), purified water.

Precaution for use with MYCOAPAISYL 1% EMULSION FLUID ANTI FUNGUS 30G

Special warnings
· Avoid applications near the eyes.
· In case of application in children over a large area, or on broken skin, always observe the recommendations and the dose recommended by your doctor because of the greater penetration of the product in these circumstances.
· Avoid applications in situations where the phenomenon of local occlusion can reproduce (eg elderly, bedsores, intertrigo under the breast).
IF IN DOUBT DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST.
NEVER KEEP OUT OF REACH OF CHILDREN.

Cons-indications


Never use MYCOAPAISYL 1 PERCENT, fluid emulsion for topical application in the following cases:
· Hypersensitivity to any component.

Interactions with other drugs


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are medicines obtained without a prescription, especially if you are taking oral anticoagulants.

Pregnancy and lactation


Ask your doctor or pharmacist before taking any medicine.

Possible side effects


Like all medicines, MYCOAPAISYL 1 PERCENT, fluid emulsion for topical application may cause side effects, although not everybody there is not about:
Itching, irritation, burning, redness: you must tell your doctor.
If you notice any side effects not listed in this leaflet, or if the side effects gets serious, please tell your doctor or pharmacist.

Introducing MYCOAPAISYL 1% EMULSION FLUID ANTI FUNGUS 30G

Box of 1 bottle as fluid emulsion for skin application.

Warnings on drugs

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

Tell your pharmacist online treatments underway to identify possible incompatibilities. The checkout form contains a custom message field provided for this purpose.

Click here to find record of the drug at the site of the National Security Agency of Medicines and Health Products.

Pharmacovigilance : Report or a related adverse event (s) (s) (s) the use of a drug

VIDAL OF THE FAMILY

MYCOAPAISYL

Local antifungal

econazole

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

PRESENTATIONS (summary)

MYCOAPAISYL: cream; 30 g tube.
-

MYCOAPAISYL: emulsion for local application; 30 g bottle.
-

MYCOAPAISYL: powder for local application; powder bottle of 20 g.
-

Merck Family Medication 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, nails and mucous membranes , due to microscopic fungi ( fungus ): candidiasis , pityriasis versicolor , 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 form used (cream, emulsion, powder) and the duration of the treatment vary according to the case. Follow your doctor's prescription or advice from your pharmacist.
In all cases, the medicinal product must be applied after thorough washing and drying of the area to be treated.
The powder can be used in shoes, a frequent source of recontamination in case of foot mycosis .

Usual dosage:

1 application, 2 times a day.
TIPS (summary)
In case of candidiasis , avoid using acid soaps: they promote the multiplication of fungi.
If the nails of the toes are damaged, prior grinding by a pedicure facilitates the action of the medication. 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)
Skin irritation.


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).


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


mucous
Tissue (membrane) that lines the cavities and ducts of the body communicating with the outside (digestive tract, respiratory tract, urinary tract, etc.).


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


pityriasis versicolor
Infection of the skin due to a microscopic fungus. It manifests itself in spots that appear brown on a white skin and white on a bronzed skin. After treatment, only exposure to the sun makes it possible to remove the spots.

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: 17/08/2017

Name of the medicinal product

MYCOAPAISYL 1 PER CENT, fluid emulsion for skin application

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 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.

What is in this leaflet?

1. What is MYCOAPAISYL 1 PER CENT, a fluid emulsion for skin application and in which cases it is used?

2. What should I know before using MYCOAPAISYL 1 PER CENT, fluid emulsion for skin application?

3. How to use MYCOAPAISYL 1 PER CENT, fluid emulsion for skin application?

4. What are the possible side effects?

5. How to store MYCOAPAISYL 1 PER CENT, fluid emulsion for skin application?

6. Package contents and other information.

1. WHAT IS MYCOAPAISYL 1 PER CENT, fluid emulsion for dermal application AND WHAT IT IS USED FOR?

Pharmacotherapeutic group: ANTIFUNGALS FOR TOPICAL USE, ATC code: D01AC03.

This medication is a cream for topical application containing an antifungal agent of the imidazole family.

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

2. BEFORE YOU USE MYCOAPAISYL 1 PER CENT, fluid emulsion for skin application?

Never use MYCOAPAISYL 1 PERCENT, fluid emulsion for skin application:

· if you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

Warnings and Precautions

· Avoid applications near the eyes.

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

· Avoid applications in situations where the phenomenon of local occlusion can reproduce (eg elderly subjects, pressure sores, intertrigo under breast).

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

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

· This medicine contains dipropylene glycol and may cause skin irritation.

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

children

NEVER LEAVE TO CHILDREN.

Other medicines and MYCOAPAISYL 1 PER CENT, fluid emulsion for dermal application

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including over-the-counter medications, including oral anticoagulants.

MYCOAPAISYL 1 PER CENT, fluid emulsion for skin application with food and beverages

Not applicable.

Pregnancy and breast feeding

Ask your doctor or pharmacist for advice before taking any medicine .

Driving and using machines

Not applicable.

MYCOAPAISYL 1 PER CENT, fluid emulsion for dermal application contains benzoic acid, butylhydroxyanisole, butylhydroxytoluene, dipropylene glycol

3. HOW TO USE MYCOAPAISYL 1 PER CENT, fluid emulsion for skin application?

Always use this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

Posology and method of administration

Medicinal products for local use:

· 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.

Duration of the treatment

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.

IN ALL CASES CONFORM TO THE ORDER OF YOUR DOCTOR STRICTLY.

If you used more MYCOAPAISYL 1 PER CENT, fluid emulsion for skin application than you should have

Not applicable.

If you forget to use MYCOAPAISYL 1 PER CENT, fluid emulsion for skin application

Not applicable.

If you stop using MYCOAPAISYL 1 PER CENT, fluid emulsion for skin application

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine may cause side effects, although not everybody gets them.

· itching, irritation, burning, redness: tell 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.

Declaration of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. 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 MYCOAPAISYL 1 PER CENT, fluid emulsion for skin application?

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.

No special storage conditions.

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 MYCOAPAISYL contains 1 PERCENT, fluid emulsion for skin application

· The active substance is:

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

For 100 g.

· The other components are:

(LABRAFIL M 1944 CS), light liquid paraffin, benzoic acid, butylhydroxyanisole, perfume (essential oils of lavandin, orange and mandarin, linalyl acetate, lithium acetate), polyoxyethylene glycol palmitostearate (TEFOSE 63), polyglycolysedes citronellol, butylhydroxytoluene, dipropylene glycol), purified water

What is MYCOAPAISYL 1 PER CENT, fluid emulsion for skin application and contents of the outer packaging

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

Marketing Authorization Holder

MERCK MEDICATION FAMILIALE SAS

37, RUE SAINT-ROMAIN

69379 LYON CEDEX 08

Marketing Authorization Operator

MERCK MEDICATION FAMILIALE

18C, BOULEVARD WINSTON CHURCHILL

21000 DIJON

Maker

MERCK SANTE SAS

LACASSAGNE PRODUCTION CENTER

115, AVENUE LACASSAGNE

69003 LYON

Or

CHEMINEAU LABORATORIES

93, ROAD OF CURRENCY

37120 VOUVRAY

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.

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