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INFORMATION FOR CONSUMERS

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Consumer Medicine Information

MICREME H

Miconazole nitrate 2% w/w, Hydrocortisone 1% w/w Topical Cream

What is in this leaflet

This leaflet answers some common questions about MICREME H. It does not contain all the information available on this medicine. It does not take the place of talking to your pharmacist or doctor. All medicines have risks and benefits. Your pharmacist or doctor has weighed the risks of using MICREME H against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your pharmacist or doctor.

Keep this leaflet. You may want to read it again.

What MICREME H is used for and how it works

MICREME H contains two active ingredients: miconazole nitrate and hydrocortisone. It is a broad-spectrum anti-fungal and anti-inflammatory cream. Miconazole nitrate acts against fungal organisms and certain bacteria to help treat infections, while hydrocortisone reduces the irritation and redness of inflamed skin.

MICREME H is used on the skin to treat inflamed skin conditions such as tinea, athlete's foot, ringworm and thrush infections of the skin.

Your doctor, however, may prescribe MICREME H for another purpose. Ask your doctor if you have any questions about why MICREME H has been prescribed for you.

MICREME H is available over the counter at a pharmacy or on a prescription from your doctor.

Before you use MICREME H

When you must not use it

Do not use MICREME H if you are allergic to miconazole nitrate, hydrocortisone, or any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include unusual reddening of the face, rash, itching or hives on the skin; shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body.

Do not use MICREME H if you have any of the following skin conditions:

Talk to your pharmacist or doctor if you are not sure whether you should use this medicine.

Do not use MICREME H on children under 2 years unless your doctor or pharmacist tells you to.

Do not use MICREME H after the expiry date (EXP) printed on the pack.

Do not use MICREME H if the packaging is torn or shows signs of tampering.

Before you use it

Tell your pharmacist or doctor if you:

If you have not told your pharmacist or doctor about any of the above, tell them before you use MICREME H.

Taking other medicines

If you are taking any other medicines, including any you get without a prescription from a pharmacy, supermarket or health food shop, tell your pharmacist or doctor.

How to use MICREME H

Instructions for use

Each tube of MICREME H is sealed. Use the cap to pierce the seal.

Before applying the cream

Wash the infected skin and dry it well each time you use the cream. As many skin conditions are infectious, you should keep a towel and a flannel for your own use so that you do not infect anyone else.

After applying the cream

Unless the infected skin is on your hands, wash your hands carefully to avoid spreading the infection to other parts of the body or to other people. Similarly, clothing which comes into contact with the infected areas should be washed and changed frequently.

How much to use

Your pharmacist or doctor will tell you when to use and how often to apply MICREME H. It is important that you apply MICREME H exactly as directed by your pharmacist or doctor. Do not use more than the recommended dose.

Unless your pharmacist or doctor tells you otherwise, MICREME H should be applied sparingly once or twice daily to the affected areas of your body and rubbed gently with a finger into the skin.

How long to use it

Regular application of MICREME H is essential for successful treatment. If you use it less often than you should, it may not work as well and your skin problem may not improve. Using it more often than you should may not improve your skin problems any faster and may cause or increase side effects.

Once the inflammation has subsided continue treatment with an anti-fungal agent without hydrocortisone, such as MICREME. Continue treatment with MICREME until the symptoms completely disappear.

Do not use MICREME H for longer than 14 days, unless your pharmacist or doctor tells you to.

If your condition does not improve after 7 days of treatment with MICREME H, consult with your doctor.

If you miss a dose

If you miss one or more doses of MICREME H, apply a single dose of the cream again as soon as you remember and continue using until the course of treatment is completed. Do not apply two doses at once to make up for a missed dose.

If you have trouble remembering to use your medicine, ask your pharmacist for some hints.

While you are using MICREME H

Things you must do

Tell all doctors, dentists and pharmacists who are treating you that you are using MICREME H.

Tell your doctor or pharmacist if you become pregnant while using MICREME H.

If you are going to have surgery, tell the surgeon or anaesthetist that you are using MICREME H.

If you are going to have any blood tests, tell your doctor that you are using MICREME H.

MICREME H should only be used on the skin. It should not be eaten or swallowed.

Keep away from eyes and mouth. If you get any of the cream into your eyes rinse immediately with large amounts of cool tap water with your eyes open.

Areas such as the armpits and the feet, especially between the toes, should be dried thoroughly after washing.

Things you must not do

Do not use MICREME H in or near the eyes.

Do not use MICREME H for acne.

Do not use MICREME H on your face, unless your doctor or pharmacist tells you to.

Do not use MICREME H to treat any other condition unless your doctor tells you to.

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Things to be careful of

Do not use MICREME H under dressings (including waterproof bandages) or under a baby's nappy, unless your doctor or pharmacist tells you to.

Do not use MICREME H on large areas of skin, unless your doctor or pharmacist tells you to.

MICREME H can damage certain synthetic materials. Therefore, it is recommended that cotton underwear be worn where clothing contacts the affected area.

Side effects

Most people find that if they use MICREME H correctly they will not experience any side effects. All medicines can however, have some unwanted effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

MICREME H is generally well tolerated after local application.

Occasionally, irritation or a burning sensation of the skin may occur. If irritation occurs, stop using the cream and talk to your pharmacist or doctor.

If your skin condition gets worse during treatment, stop applying MICREME H and tell your pharmacist or doctor as soon as possible.

The list of side effects mentioned above is not complete. If you should suffer from any of these side effects or any other undesired effect please tell your pharmacist or doctor.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

In case of swallowing

You should only use MICREME H as directed by your pharmacist or doctor. MICREME H must not be eaten or swallowed.

Immediately contact your doctor or the National Poisons Information Centre (0800 POISON or 0800 764 766) or go to the Emergency department at your nearest hospital, if you have eaten or swallowed MICREME H, or if you think anyone else may have eaten or swallowed MICREME H by mistake. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Take the pack of MICREME H with you if you can.

Keep telephone numbers for these places handy.

Storage conditions

Keep your MICREME H in the container until it is time to use it.

Store below 25°C. Keep out of reach of children. Avoid exposure to heat, moisture and light.

Do not use this medicine if the cream does not appear white in colour or has liquefied.

Disposal

If you do not use MICREME H, it has passed the expiry date, or your pharmacist or doctor tells you to stop using this medicine, ask your pharmacist what to do with the remaining medicine.

List of other ingredients

Your medicine is in the form of a smooth white cream supplied in an aluminium tube. Each tube of MICREME H contains 15g of cream.

MICREME H contains the active ingredients: miconazole nitrate and hydrocortisone.

MICREME H also contains octyldodecanol, cetostearyl alcohol, cetyl esters wax, sorbitan monostearate, polysorbate 60, benzyl alcohol and purified water.

If you want to know more

Should you have any questions regarding this product, please contact your pharmacist or doctor.

Who supplies this medicine

Distributed in New Zealand by:

Mylan New Zealand Ltd,
P O Box 11183,
Ellerslie,
Auckland.

Freephone: 0800 168 169

Date of information

2 February 2009 (Based on datasheet 2 February 2009)