Package leaflet: Information for the user

Daktarin® cream

Miconazole nitrate

Daktarin is a registered trademark

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 you get side effects and they become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

In this leaflet

1    What Daktarin cream is and what it is used for

2    Before you use Daktarin cream

3    How to use Daktarin cream

4    Possible side effects

5    How to store Daktarin cream

6    Further i nformation

1 What Daktarin cream is and what it is used for

Daktarin cream is used for infections of the skin or nails caused by fungi including yeasts, and some bacteria. Infections may appear on the:

•    Trunk

•    Hands or feet

•    Scalp or outer ear

•    Groin

Daktarin cream works by destroying the fungus and associated bacteria which may be present.

2 Before you use Daktarin cream

Do not use Daktarin cream:

•    If you are allergic to miconazole, any of the other ingredients of this medicine (listed in section 6) or to other similar antifungal medicines

Do not use this medicine if the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Daktarin cream.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.

In particular tell your doctor if you are taking:

•    Medicines to thin the blood (anticoagulants) such as warfarin.

Your doctor may check that the anticoagulant is working properly

Pregnancy and breast-feeding

Please tell your doctor before using Daktarin cream if you are pregnant, think you may be pregnant or might become pregnant.

You may still be able to use Daktarin cream if your doctor thinks you need to.

Talk to your doctor before using this medicine if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

Daktarin cream is not likely to affect you being able to drive or use any tools or machines.

Important information about some of the ingredients of Daktarin cream

•    Daktarin cream contains benzoic acid (E210). This can irritate your eyes, eyelids, mouth and nostrils if it comes into contact with them

•    Daktarin cream also contains butylated hydroxyanisole (E320). This can cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes

3 How to use Daktarin cream

Always use Daktarin cream exactly as your

doctor has told you. You should check with

your doctor or pharmacist if you are not sure.

Using the cream

•    Each tube of Daktarin cream is sealed. You will need to use the cap to pierce the seal

•    Rub the cream gently into the affected area and surrounding skin with clean fingers

•    Do not put Daktarin cream into or near the eyes - it is for use on the skin and nails only

•    Do not swallow the cream

For skin infections

•    Use the cream twice a day - once in the morning and again at night. Keep using the cream for at least 7 days after all signs of infection have gone away.

This will stop the infection from coming back.

For nail infections

•    Use the cream once or twice a day.

Your doctor will tell you which one. Keep using the cream for 10 days after all signs of infection have gone away. This will stop the infection from coming back.

Personal hygiene

•    Unless the affected skin is on your hands, wash your hands with soap and water after using the cream

•    Washing your hands after using the cream will stop you spreading the infection to other parts of your body or to other people

•    Do not allow other people to use your flannel or towel. This will stop them from getting your infection

•    Clothing that touches infected skin should be washed and changed often. Daktarin cream is non-greasy and should not stain clothes

If you swallow Daktarin cream

If you swallow any cream, talk to a doctor or go to the nearest hospital casualty department straight away.

If you forget a dose

•    Do not apply the missed dose of cream

•    Apply the next dose of cream as usual and keep using the cream as your doctor has told you

•    Do not use a double dose of cream to make up for a missed dose

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4 Possible side effects

Like all medicines, Daktarin cream can cause side effects, although not everybody gets them.

Stop using Daktarin cream and tell your doctor straight away if you notice the following. You may need medical treatment.

Very rare (affects less than 1 in

10.000    people)

•    Sudden swelling of the face or throat. Hives (also known as nettle rash or urticaria), difficulty breathing, severe irritation, reddening or blistering of your skin. These may be signs of a severe allergic reaction

Tell your doctor or pharmacist if you notice any of the following side effects: Very rare (affects less than 1 in

10.000    people)

•    Burning sensation, itching, redness, or rash on the skin

Rare side effects (affects less than 1 in

1,000 people)

• Local irritation of the treated area. This is much milder than an allergic reaction

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Daktarin cream

Keep out of the reach and sight of children. Store the cream in its original packaging. Do not store above 25°C.

Do not use Daktarin cream after the expiry date which is stated on the packaging.

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

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 protect the environment.

6 Further information

The active substance in Daktarin cream is miconazole nitrate. Each gram (g) of Daktarin cream contains 20 milligrams (mg) of miconazole nitrate (2 % w/w).

The other ingredients are water, PEG-6, PEG-32 and glycol stearate, oleoyl macroglycerides, liquid paraffin, benzoic acid (E210) and butylated hydroxyanisole (E320).

What Daktarin cream looks like and contents of the pack

Daktarin cream comes in a tube containing 30 g of a white cream.

The product licence is held by:

JANSSEN-CILAG LTD, 50-100 Holmers Farm Way, High Wycombe,

Buckinghamshire, HP12 4EG, UK

Daktarin cream is made by:

Janssen Pharmaceutica NV,

Turnhoutseweg 30, B-2340 Beerse,

Belgium

OR

McGregor Cory Ltd, Middleton Close, Banbury, OX16 4RS, UK

For information in large print, tape, CD or Braille, telephone 0800 7318450.

This leaflet was last revised in Novcm2er2014