NIZORAL 2% SHAMPOO

Active substance: KETOCONAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

GB - AW_85697
© J-C 2013

2% shampoo
Ketoconazole
Nizoral 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 Nizoral shampoo is and what
it is used for
2 Before you use Nizoral shampoo
3 How to use Nizoral shampoo
4 Possible side effects
5 How to store Nizoral shampoo
6 Further information

1 What Nizoral shampoo is and what it is used for
The name of your medicine is Nizoral 2%
shampoo. It is called ‘Nizoral Shampoo’
or just ‘shampoo’ in this leaflet.
Nizoral shampoo contains a medicine
called ketoconazole. This belongs to
a group of medicines called ‘antifungals’.
Like other shampoos, it also contains
ingredients to clean your hair.

These conditions can be itchy. They are
caused by a fungus (yeast) called
‘Malassezia’. This fungus is found
on everyone’s skin, but sometimes it can
overgrow and cause problems. Nizoral
shampoo works by killing the fungus and
stopping it from coming back.

Nizoral shampoo is used for fungal
infections on the scalp and body such as:
• Dandruff
• Dry or greasy scaling of the scalp and
other parts of the body called
‘seborrhoeic dermatitis’
• White to brown patches on the body that
sometimes appear after being in the sun
called ‘tinea versicolor’ or ‘pityriasis
versicolor’

2 Before you use Nizoral shampoo
Do not use Nizoral shampoo if:

Taking other medicines

Take special care with Nizoral
shampoo

Pregnancy and breast-feeding

• You are allergic to anything in Nizoral
shampoo (listed in section 6 below)
Do not use this medicine if the above
applies to you. If you are not sure,
talk to your doctor or pharmacist before
using Nizoral shampoo.

Check with your doctor or pharmacist
before using this medicine if:
• You use a lotion or cream on your hair
that contains a steroid, such as
betamethasone or hydrocortisone:
- You should use less and less of the
lotion or cream during the first 2 to
3 weeks of Nizoral shampoo treatment
- This will stop your condition flaring
up while Nizoral shampoo starts
to work
If you have any questions about stopping
your steroid lotion or cream, ask your
doctor or pharmacist.

Nizoral shampoo does not normally react
with other medicines. However, 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.
Nizoral shampoo can be used if you are
pregnant or breast-feeding.
But ask your doctor or pharmacist for
advice before taking any medicine if you
are pregnant or breast-feeding.

Driving and using machines

Nizoral shampoo is not likely to affect you
being able to drive or use any tools or
machines.

3 How to use Nizoral shampoo
Always use Nizoral shampoo exactly as
your doctor has told you. Nizoral Shampoo
is not recommended for use in infants and
children. Nizoral shampoo is for use on
your hair or skin only. You should check
with your doctor or pharmacist if you are
not sure.

How often you should use Nizoral
shampoo
For dandruff or dry or greasy scaling
of the skin
• Start by using the shampoo twice a week
• You should use it every 3 or 4 days for
2 to 4 weeks
• You should then use the shampoo once
every 1 to 2 weeks to stop the symptoms
coming back
• Do not use the shampoo more often than
your doctor has told you

For white to brown patches on the skin
• You should use the shampoo on the
white to brown patches of skin once
a day for up to 5 days
• If the white to brown patches become
more noticeable when you have been
in the sun:
- You should use the shampoo once
a day for 3 days before you next expose
your skin to the sun
• Do not use the shampoo more often than
your doctor has told you

AW_85697.pdf - Page 1 of 3 - July 24, 2013 - 06:52:58

Using Nizoral shampoo

• Wash your hair or infected part of skin
with the shampoo
• Leave it on for 3 to 5 minutes
• Rinse thoroughly

If Nizoral shampoo gets in your
eyes
Gently bathe your eyes in cold water.

Using your normal shampoo

• If you need to wash your hair between
treatments, use a normal shampoo
• If your hair is very thick or long, you can
wash it with your usual shampoo and
then use Nizoral shampoo

If you swallow Nizoral shampoo
If you swallow any shampoo, tell your
doctor straight away.

If you forget to use Nizoral
shampoo

• If you miss a treatment with Nizoral
shampoo, you should use it as soon
as you remember
• Do not use the shampoo twice to make
up for a missed treatment
If you have any further questions on the
use of this product, ask your doctor
or pharmacist.

© J-C 2013

GB - AW_85697

4 Possible side effects
Like all medicines, Nizoral shampoo can
cause side effects, although not everybody
gets them.

Tell your doctor or pharmacist if you
notice or suspect any of the following
side effects:

Stop using Nizoral shampoo and tell
your doctor straight away if you notice
or suspect any of the following. You
may need urgent medical treatment.
• Allergic reaction, swelling of the face,
lips, mouth, tongue or throat which may
cause difficulty in swallowing or
breathing. This can affect fewer than
1 in 1000 people
• Severe irritation or reddening of the skin
where the shampoo has been used,
or other signs of allergy during the first
few days of treatment. This can affect
fewer than 1 in 100 people
Peeling or blistering of the skin. This can
affect fewer than 1 in 1000 people

Uncommon side effects (affects fewer
than 1 in 100 people)
• Infection of the hair roots
• Increase in production of tears
• Unusual hair loss or thinning
• Dry skin, rash, burning feeling
• Changes in how your hair feels
Rare side effects (affects fewer than
1 in 1000 people)
• Taste impairment
• Irritation of the eyes
• Acne
• Flaking skin
The following side effects have been
reported, however the precise frequency
cannot be identified and therefore how
often they occur is classed as unknown
• Hives (also known as nettle rash or
urticaria)
• Hair colour changes
If you get any of these side effects, or other
side effects not listed in this leaflet, tell your
doctor or pharmacist straight away.

5 How to store Nizoral shampoo
Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use Nizoral shampoo after the
expiry date which is stated on the label.
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 Nizoral shampoo
is ketoconazole. Each gram (g) of Nizoral
shampoo contains 20 milligrams (mg)
of ketoconazole (2 % w/w).

Nizoral shampoo is made by:
Janssen Pharmaceutica NV,
Turnhoutseweg 30, B-2340 Beerse,
Belgium

The 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, sodium
hydroxide, imidurea, hydrochloric acid,
erythrosine (E127) and purified water.

OR

What Nizoral shampoo looks like
and contents of the pack
Nizoral shampoo comes in a white bottle
containing 120 ml of pink shampoo.

The product licence is held by:
Janssen-Cilag Ltd, 50-100 Holmers Farm
Way, High Wycombe, Buckinghamshire,
HP12 4EG, UK

AW_85697.pdf - Page 2 of 3 - July 24, 2013 - 06:52:58

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

For information in large
print, tape, CD or Braille,
telephone 0800 7318450.
This leaflet was last revised in July 2013

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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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