ZIMYCAN 2.5mg/g Cutaneous Paste

miconazole nitrate

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 your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child’s.

-    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 ZIMYCAN is and what it is used for

2.    Before you use ZIMYCAN

3.    How to use ZIMYCAN

4.    Possible side effects

5.    How to store ZIMYCAN

6.    Further information

1.    What Is ZIMYCAN and what it is used for?

Zimycan is used to treat infants and toddlers with local skin rashes caused by a long exposure to urine and faeces (wee and poo) in the nappy area (nappy rash), where an additional infection with a yeast, Candida spp., is an aggravating factor.

Zimycan should not to be used in older children and adults.

Zimycan contains active substance miconazole nitrate that is active against most fungi and yeasts.

2.    What you should know before you use ZIMYCAN?

Zimycan is for external use on the skin.

Only use if it is confirmed that your child has a yeast infection.

Do not use Zimycan if your child is younger than 2 months.

Do not use if you or your child are allergic to miconazole nitrate or any of the other ingredients of Zimycan.

Do not use Zimycan on open wounds or the genitals (mucous membranes).

Contact your doctor or pharmacist when in doubt, especially in case of repeated use, to make sure that your child does have a yeast infection.

Take special care with Zimycan

•    Avoid contact with the eyes. If Zimycan comes into contact with the eyes, rinse well with lots of water.

•    Wash your hands thoroughly after applying Zimycan.

•    Discontinue at the first appearance of any signs of local or general hypersensitivity of the condition.

•    Expose the nappy area to air whenever possible.

Using Zimycan in combination with food and drinks

Not applicable.

Pregnancy

Not applicable.

Breast-feeding

Not applicable.

Driving and using machines Not applicable.

Important information about some ingredients of Zimycan

Not applicable.

Using Zimycan in combination with other medicines

Do not mix with other creams or.medicines.

Zimycan is applied to the skin and will have limited availability to other parts of the body.

It is unlikely that Zimycan will cause problems with other medicines that have been swallowed.

Please inform your doctor or pharmacist if you or your infant is taking or have recently been given any other medicines, even those not prescribed by your doctor.

It is particulary important to inform your doctor in case of taking, e.g. anticoagulants (warfarin), phenytoin, methylprednisolone.

3. HOW TO USE ZIMYCAN 2.5mg/g CUTANEOUS PASTE?

Always use Zimycan exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Apply Zimycan carefully at every nappy change on the entire infected area after it has been cleaned with lukewarm water and dried carefully.

The paste should be applied gently with the fingertips (do not rub).

The infected area should not be cleaned with scented soap, shampoos, lotions or wet wipes.

Do not stop general preventive measures like regularly changing nappies, especially when your baby has had previous episodes of nappy rash.

The usual treatment period is 7 days even if symptoms have improved earlier. If, after 3 days, the symptoms worsen or do not improve, you should contact your doctor.

If you use Zimycan more than your doctor advised.

Local overdose may cause irritation or skin sensitisation. These symptoms disappear if the treatment is stopped. If young children accidentally swallow Zimycan paste immediately contact your doctor or local hospital. Possible side effects might be vomiting, nausea and diarrhoea.

4.    POSSIBLE SIDE EFFECTS.

Like all medicines, Zimycan may cause side effects, although not everybody gets them. The topical application of Zimycan causes only in rare cases irritation of the skin. As with any substance that is applied to the skin, an allergic reaction to one of the ingredients may occur.

If you notice any side effects not mentioned on this leaflet, please inform your doctor or pharmacist.

5.    STORING ZIMYCAN 2.5mg/g CUTANEOUS PASTE.

Keep out of the reach and the sight of children.

Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of that month.

The first two digits after ‘EXP.’ indicate the month, the last two the year.

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 Zimycan 2.5mg/g cutaneous paste contains.

•    The active substance is miconazole nitrate 2.5mg/g.

•    The other ingredients are white soft paraffin, zinc oxide, trihydroxystearin and lilac perfume.

What Zimycan looks like and contents of the pack

Available as a tube of 5g, 15g, 30g, 60g or 90g.

Zimycan is a white cutaneous paste for use on the skin.

Marketing Authorisation Holder

Barrier Therapeutics nv Cipalstraat 3 B-2440 Geel Belgium

Manufacturer

Cardinal Health UK 417 Ltd.

Sedge Close, Headway, Great Oakley,

Corby, Northamptonshire NN 18 8HS United Kingdom

Marketing authorisation number: PL 20990/0003

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation holder.

Supply

Subject to medical prescription.

This leaflet was last reviewed on 04/2007 Date of approval of this leaflet is 04/2007