The name of this medicine is Daktarin 2% w/w cream. Daktarin cream contains a medicine called miconazole. This belongs to a group of medicines called ‘antifungals’. 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.

It is important that you read and fully understand the Patient Information Leaflet before purchasing this item.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. 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.

Ingredients

The active substance 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).

Precautions

Do not use Daktarin cream:

• If you are allergic to miconazole, any of the other ingredients of this medicine (listed above) 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.

Warnings and precautions

Keep this medicine away from your eyes. If you get any cream in your eyes, rinse with water straight away. Keep your eyes open when you rinse.

Other medicines and Daktarin Cream

Tell your doctor or pharmacist if you are taking, have recently taken, or might take 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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. You may still be able to use Daktarin cream if your doctor thinks you need to.

Driving and using machines

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

Daktarin cream contains

• Benzoic acid (E210). This can irritate your eyes, eyelids, mouth and nostrils if it comes into contact with them
• Butylated hydroxyanisole (E320). This can cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes

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

Side effects when using

Like all medicines, this medicine 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)

• Swelling of the face, tongue or throat, difficulty swallowing or difficulty breathing.
• Hives (also known as nettle rash or urticaria), 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 (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, pharmacist or nurse. This includes any possible side

effects not listed here 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 product.

 Other Information

If you need more advice consult your doctor or pharmacist.

Keep all medicines out of the sight and reach of children.

Daktarin Cream SPC