NIZORAL 2% SHAMPOO

Active substance: KETOCONAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

GB - AW_90562
© J-C 2014

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 only. Do not pass it on to others.
It may harm them, even if their signs of
illness are the same as yours
• If you get side effects, talk to your doctor
or pharmacist. This includes any possible
side effects not listed in this leaflet.
See section 4.

In this leaflet
1 What Nizoral shampoo is and what
it is used for
2 What you need to know before you
use Nizoral shampoo
3 How to use Nizoral shampoo
4 Possible side effects
5 How to store Nizoral shampoo
6 Contents of the pack and other
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 What you need to know before you use Nizoral
shampoo
Do not use Nizoral shampoo if:
• 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.

Warnings and precautions

Talk to 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.

Children and adolescents

Nizoral Shampoo is not recommended for
use in infants and children.

Other medicines and Nizoral
Shampoo

Nizoral shampoo does not normally react
with other medicines. However, 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.

Pregnancy and breast-feeding

Nizoral shampoo can be used if you are
pregnant or breast-feeding.
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 this medicine exactly as your
doctor has told you. Nizoral shampoo is for
use on your hair or skin only. Check with
your doctor or pharmacist if you are not
sure.

Using Nizoral shampoo

How often you should use Nizoral
shampoo

If Nizoral shampoo gets in your
eyes

The recommended dose is:
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_90562.pdf - Page 1 of 3 - February 10, 2014 - 05:38:14

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

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 2014

GB - AW_90562

4 Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
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
Tell your doctor or pharmacist if you
notice or suspect any of the following
side effects:
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
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 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 Nizoral shampoo
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry
date which is stated on the label. The expiry
date refers to the last day of that month.

Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.

6 Contents of the pack and other information
What Nizoral Shampoo contains
The active substance is ketoconazole.
Each gram (g) of shampoo contains
20 milligrams (mg) of ketoconazole
(2 % w/w).

The other ingredients are sodium lauryl
ether sulfate, 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.

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

Marketing Authorisation Holder:
Janssen-Cilag Ltd, 50-100 Holmers Farm
Way, High Wycombe, Buckinghamshire,
HP12 4EG, UK

AW_90562.pdf - Page 2 of 3 - February 10, 2014 - 05:38:14

Manufacturer:
Janssen Pharmaceutica NV,
Turnhoutseweg 30, B-2340 Beerse,
Belgium
OR
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 February 2014

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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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