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Nizoral'

Dandruff Shampoo

ketoconazole

■    This product is used to treat and prevent dandruff and dry or greasy scaling of the scalp (seborrhoeic dermatitis).

■    The shampoo is for use by adults and adolescents over 12 years.

■    Do not use this product:

i If you have ever had a bad reaction to any of the ingredients. For the list of ingredients see section 6 ►

■    Follow the usage instructions carefully. These are shown in the dosage table. See section 3 ►

Now read this whole leaflet carefully before you use this product. Keep the leaflet: you might need it again.

1 What the product is for

Nizoral Dandruff Shampoo is used to treat and prevent dandruff and dry or greasy scaling of the scalp (seborrhoeic dermatitis), which is a more severe kind of dandruff.

The shampoo contains ketoconazole, which is an antifungal that targets an increased number of yeasts on the skin called Malassezia. These yeasts occur naturally on everyone's skin, however, people with dandruff and seborrhoeic dermatitis seem to have more Malassezia. The shampoo also treats the inflammation associated with dandruff, relieving scalp redness and itching.

This product is for use in adults and adolescents over 12 years.

2 Before using this product

This product is suitable for most people, but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.

□ Do not use this product...

■    If you have ever had a bad reaction to any of the ingredients.

If this applies to you, get advice from a doctor or pharmacist without using Nizoral Dandruff Shampoo.

^k If you are pregnant or breast-feeding

■    You can use Nizoral Dandruff Shampoo if you are pregnant, think you might be pregnant or are breast-feeding.

^k Special warnings about this product

■    As with most shampoos, if any gets into your eyes bathe them gently with water.

■    If you have been regularly using a lotion or cream, which contains a steroid (such as betamethasone or hydrocortisone) to control your dandruff or seborrhoeic dermatitis, gradually use it less over

2 - 3 weeks as you start to use Nizoral Dandruff Shampoo. This will stop your condition flaring up while Nizoral Dandruff Shampoo starts to work.

If you have any questions about stopping your steroid lotion or cream, speak to your doctor or pharmacist.

3 How to use this product

Check the table below to see how much

product to use.

■    For external use only.

■    Do not use more often than directed in the table. If you need to use a shampoo to wash your hair more often, use your usual shampoo. If your hair is very thick, you can wash with your usual shampoo and then use Nizoral Dandruff Shampoo.

O Adults and adolescents over 12 years

Age	How to apply
Adults and	■ Wet hair thoroughly.
adolescents over	■ Apply a small amount of Nizoral
12 years	Dandruff Shampoo to your scalp and massage into a lather.
	■    Leave the lather on your scalp for 3 - 5 minutes. ■    Rinse thoroughly.

■    Use every 3 or 4 days for 2 - 4 weeks.

■    If your scalp has not cleared within 4 weeks, speak to your doctor or pharmacist.

■    To keep your scalp clear and to prevent dandruff returning, use Nizoral Dandruff Shampoo once every 1 - 2 weeks. If you stop using Nizoral Dandruff Shampoo altogether, your symptoms may become

a problem again.

■    Not for children aged under 12.

^k If anyone accidentally swallows this product

If anyone accidentally swallows Nizoral Dandruff Shampoo, contact a doctor or your nearest Accident & Emergency department (Casualty) taking this leaflet and pack with you.

turn over ►

If you forget an application

If you forget to use Nizoral Dandruff Shampoo use as per the directions next time you wash your hair.

4 Possible side-effects

Nizoral Dandruff Shampoo can have side-effects like all medicines, although these don't affect everyone and are usually mild.

If you experience any of the following, stop using the medicine and talk to your doctor:

■ Severe allergic reactions, including swelling of the face, lips, tongue or throat

Other side effects which occur but it is unknown how often:

■ Hair discolouration and hives, which is known as nettle rash or urticaria

If you experience any side-effect not included in this leaflet or are unsure of anything, talk to your doctor or pharmacist. Also you can help to make sure medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.mhra.gov.uk/vellowcard: alternatively you can call Freephone 0808 100 3352 (available between 10am - 2pm Monday to Friday) or fill in the paper form available from your local pharmacy.

What the product looks like

Nizoral Dandruff Shampoo is a pink liquid shampoo. It is available in bottles of 100 ml.

Product Licence holder:

McNeil Products Ltd, Maidenhead, Berkshire,

SL6 3UG, UK.

Manufacturer:

Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.

This leaflet was revised April 2013.

Nizoral is a registered trade mark.