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NIZORAL DANDRUFF SHAMPOO

Active substance: KETOCONAZOLE

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®

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:
■ 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

3 How to use 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.

Check the table below to see how much
product to use.

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.

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.

■ For

external use only.
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.

■ Do

Adults and adolescents over 12 years
Age

How to apply

Adults and
adolescents over
12 years



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.

Wet hair thoroughly.
Apply a small amount of Nizoral
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.



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

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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
Uncommon side-effects (less than 1 in 100 people)
which may occur include:
■ Application site reactions including itching, irritation,
blistering, red, dry or tender skin or a skin burning
sensation
■ Inflamed hair follicles, hair loss or changes in hair
texture
■ Increased tear production
■ Skin rash and dry skin
Rare side-effects (less than 1 in 1000 people) which
may occur include:
■ A change in the way some things taste
■ Eye irritation
■ Acne
■ Skin inflammation (dermatitis)
■ Flaking skin
■ Application site reactions including blistering and
over-sensitivity (allergic) reactions
■ General allergic reaction (over-sensitivity)

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Other side effects which occur but it is unknown how
often:
■ Hair discolouration and hives, which is known as
nettle rash or urticaria

What the product looks like

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/yellowcard; 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.

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.

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

5 Storing this product
Keep the product out of the reach and sight of children.
Do not store above 25ºC.
Do not use this product after the expiry date shown
on the packaging.
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’s in this product?
The active ingredient in 1 g of Nizoral Dandruff
Shampoo is ketoconazole 20 mg.
Other ingredients are: Sodium lauryl ether sulphate,
disodium monolauryl ether sulphosuccinate, coconut
fatty acid diethanolamide, laurdimonium hydrolysed
animal collagen, macrogol 120 methyl glucose dioleate,
sodium chloride, concentrated hydrochloric acid,
imidurea, sodium hydroxide, erythrosine sodium (E127),
purified water.

10/0395
GB - AW_85918

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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