PACKAGE LEAFLET: INFORMATION FOR THE USER

MICETAL Dermal Cream

Flutrimazole

Read all of this leaflet carefully before you start using this medicine.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What MICETAL Dermal Cream is and what it is used for

2.    Before you use MICETAL Dermal Cream

3.    How to use MICETAL Dermal Cream

4.    Possible side effects

5.    How to store MICETAL Dermal Cream

6.    Further information

1.    WHAT MICETAL Dermal Cream IS AND WHAT IT IS USED FOR

MICETAL Dermal Cream is used to treat fungal skin infections such as ringworm, athlete's foot and fungal infections of the breast fold and groin (intertrigo). It may be used for the treatment of a skin rash (pityriasis versicolor) which is caused by a yeast, as well as rashes caused by Candida yeasts.

2.    BEFORE YOU USE MICETAL Dermal Cream Do not use MICETAL Dermal Cream:

-    if you are allergic (hypersensitive) to flutrimazole or antifungals of the imidazole type or any of the other ingredients of MICETAL Dermal Cream. See section 6 of this leaflet for list of ingredients.

-    in children under the age of 10 years old

-    on your genital organs unless isntructed by your doctor.

Take special care with MICETAL Dermal Cream:

-    when you use MICETAL Dermal Cream, you should wash your hands before and after its application

-    when you use MICETAL Dermal Cream, apply the cream ONLY to the areas your doctor has told you

-    when you apply MICETAL Dermal Cream, it is important to avoid using the cream anywhere near the eye or near the mouth

-    if skin folds are infected, i.e. between your toes, under the breasts or in the groin, pay particular attention to wash and dry the area thoroughly before applying a small amount of cream.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Using MICETAL Dermal Cream with food and drink

There is no evidence that food and drink affect the use of MICETAL Dermal Cream.

Pregnancy and breast-feeding

If you are pregnant, planning a family or breast feeding, tell your doctor or pharmacist before using MICETAL Dermal Cream. If you have informed your doctor or pharmacist already, follow their instructions carefully. Do not apply MICETAL Dermal Cream on the breasts during breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

The use of MICETAL Dermal Cream is unlikely to have any affect on your ability to drive a car or to operate machinery.

Important information about some of the ingredients of MICETAL Dermal Cream

MICETAL Dermal Cream contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

3. HOW TO USE MICETAL Dermal Cream

Always use MICETAL Dermal Cream exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is once or twice daily in both adults and children over 10 years of age.

MICETAL Dermal Cream should be applied to the skin in an amount sufficient to cover the lesion and surrounding areas. MICETAL Dermal Cream should be applied sparingly and rubbed in gently. Before and after the application of the cream you should wash your hands.

If skin folds are infected, i.e. between your toes, under the breasts or in the groin, pay particular attention to wash and dry the area thoroughly before applying a small amount of cream.

The symptoms of your skin infection, such as itching or soreness, should improve within a few days of treatment although signs such as redness and scaling may take longer to disappear.

You can help the treatment work if you follow these simple self-help tips:

-    Although the infected area may be itchy, do not scratch. Scratching will damage the surface of the skin and cause the infection to spread further.

-    Keep the affected areas of the skin clean.

-    Pay particular attention to drying the skin but avoid excessive rubbing.

It is important that you avoid application of MICETAL Dermal Cream to some areas (see section 2. BEFORE YOU USE MICETAL Dermal Cream) and that the cream is spread only on the affected area and around the rim. Do not spread the cream on unaffected skin.

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Your MICETAL Dermal Cream is for application to skin only and should not be put in the mouth or swallowed. If it is swallowed accidentally, seek medical advice immediately.

The recommended duration of the treatment is four weeks, with the exception of pityriasis (skin rash caused by a yeast) for which 1-3 weeks may be enough. DO NOT APPLY THE CREAM FOR MORE THAN THIS TIME UNLESS INSTRUCTED BY YOUR DOCTOR.

Do not use any remaining contents of the tube for any other skin rash or for a rash which recurs and looks similar to the original rash without instructions from the doctor.

If symptoms persist or worsen on treatment consult your doctor.

If you use more MICETAL Dermal Cream than you should

It is unlikely that you will overdose with Micetal Dermal Cream. However, if MICETAL Dermal Cream is swallowed accidentally, contact your doctor or pharmacist immediately.

If you forget to use MICETAL Dermal Cream

Apply the cream as soon as possible and then continue the rest of your treatment as usual.

Do not apply a second application to make up for a forgotten one.

If you stop using MICETAL Dermal Cream

Please talk to your doctor before you stop using MICETAL Dermal Cream. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, MICETAL Dermal Cream can cause side effects, although not everybody gets them.

If, upon first use of MICETAL Dermal Cream, you experience a rash and itching, tell your doctor immediately as you may be allergic to MICETAL Dermal Cream.

Frequencies are defined as: very common (affecting more than 1 in 10 patients); common (affecting less than 1 in 10 patients); uncommon (affecting less than 1 in 100 patients); rare (affecting less than 1 in 1,000 patients); very rare (affecting less than 1 in 10,000 patients).

General disorders and administration site conditions Common:    Slight burning.

Uncommon:    Irritation, itching, erythema (redness and/or swelling).

If you find this unbearable, stop treatment and tell your doctor.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOW TO STORE MICETAL Dermal Cream

Keep out of the reach and sight of children.

Do not use MICETAL Dermal Cream after the expiry date which is stated on the carton after «expir.».

The expiry date refers to the last day of that month.

MICETAL Dermal Cream should be stored in the original package in order to protect from light and moisture. Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What MICETAL Dermal Cream contains

-    The active substance is flutrimazole (1%)

-    The other ingredients are benzyl alcohol 1%, macrogol cetostearyl ether, cetostearyl alcohol, glyceryl monostearate 40-50, diisopropyl adipate, anhydrous disodium hydrogen phosphate, sodium dihydrogen phosphate dihydrate, macrogol 400 and purified water.

What MICETAL Dermal Cream looks like and contents of the pack

MICETAL Dermal Cream is a white cream and is available in tubes of 30 g.

Marketing Authorisation Holder and Manufacturer

J. Uriach & Cla, S.A.

Av. Cam! Reial 51-57

08184 Palau-solita i Plegamans (Barcelona), Spain

Distributed by

Dee Pharmaceuticals Ltd.

Office 3K6 Redwither Tower Redwither Business Park Wrexham LL13 9XT, United Kingdom

This leaflet was last approved in 07/1997 (Version June 2009).

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