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NIZORAL 2% CREAM

Active substance(s): KETOCONAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

GB - 995616
© J-C 2014

2% cream
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 cream is and what it
is used for
2 What you need to know before you
use Nizoral cream
3 How to use Nizoral cream
4 Possible side effects
5 How to store Nizoral cream
6 Contents of the pack and other
information

1 What Nizoral cream is and what it is used for
The name of your medicine is Nizoral
2% cream.
It is called ‘Nizoral cream’ or just ‘cream’
in this leaflet.
Nizoral cream contains a medicine called
ketoconazole. This belongs to a group
of medicines called ‘antifungals’.

Nizoral cream is used for fungal and
yeast infections of the skin in adults.
Infections may appear on the:
• Trunk, chest or back
• Hands or feet
• Scalp or face
• Groin or genitals
Nizoral cream works by killing the fungus
that causes the infection.

2 What you need to know before you use Nizoral cream
Do not use Nizoral cream:

• If you are allergic to anything in Nizoral
cream (listed in section 6 below)
• For eye infections
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 cream.

Warnings and precautions

Talk to your doctor or pharmacist before
using this medicine:
• If you have recently used a cream,
ointment or lotion on your skin infection
that contains a steroid:
- You should continue to apply a mild
steroid (such as hydrocortisone)
cream, ointment or lotion in the
morning whilst applying Nizoral cream
in the evening. The mild steroid
treatment can then be gradually
stopped over a period of 2-3 weeks.
If you have any questions about stopping
your steroid cream, ointment or lotion,
ask your doctor or pharmacist.

Children and adolescents

Nizoral Cream is not recommended for
use in children under 18 years of age.

Other medicines and Nizoral
Cream

Nizoral cream 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 cream 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 cream is not likely to affect you
being able to drive or use any tools or
machines.
Nizoral cream contains propylene
glycol
This may cause skin irritation
Nizoral cream contains cetyl alcohol
and stearyl alcohol
These may cause skin reactions such
as contact dermatitis

3 How to use Nizoral cream
Always use this medicine exactly as your
doctor has told you. Check with your
doctor or pharmacist if you are not sure.

How often you should use Nizoral
cream
This will depend on the type of infection
and how serious it is. Your doctor will tell
you how often to use Nizoral cream and
for how long.

The recommended dose is:
• Once or twice each day for 1 to 6 weeks
Do not use the cream more often than
your doctor has told you.

Preparing your skin

• Wash the infected skin and dry it well

Using Nizoral cream

• Each tube of Nizoral 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 Nizoral cream in the eyes

Personal hygiene

• Unless the affected skin is on your
hands, wash your hands with soap
and water after using the cream
• Washing your hands after using the
cream will stop you spreading the
infection to other parts of your body
or to other people
• Do not allow other people to use your
flannel or towel. This will stop them
from getting your infection
• Clothing that touches infected skin
should be washed and changed often.
Nizoral cream is non-greasy and
should not stain clothes

If you stop using Nizoral cream

Keep using the cream for several days
after all the symptoms have gone away.
This will stop the symptoms from coming
back.
If your symptoms do not improve after
4 weeks, talk to your doctor.

If you swallow Nizoral cream

If you swallow any cream, tell your doctor
straight away.
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

© J-C 2014

GB - 995616

4 Possible side effects
Like all medicines, this medicine can
cause side effects, although not
everybody gets them.
Stop using Nizoral cream and tell
your doctor straight away if you notice
or suspect any of the following.
You may need urgent medical
treatment.
• Severe irritation or reddening of the
skin where the cream has been used,
or other signs of allergy during the first
few days of treatment. This can affect
fewer than 1 in 10 people
• Peeling or blistering of the skin. This can
affect fewer than 1 in 100 people
Tell your doctor or pharmacist if you
notice or suspect any of the following
side effects:
Common side effects (affects fewer
than 1 in 10 people)
• Burning sensation

Uncommon side effects (affects
fewer than 1 in 100 people)
• Problems where the cream has been
used such as:
- Bleeding
- Discomfort
- Dryness
- Inflammation (contact dermatitis)
- Tingling
• Rash, hives (also known as nettle rash
or urticaria)
• Sticky skin
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 cream
Keep out of the sight and reach of children.
Store the cream in its original packaging.
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 Cream contains

The active substance is ketoconazole.
Each gram (g) of cream contains
20 milligrams (mg) of ketoconazole
(2 % w/w).

Manufacturer:
Janssen Pharmaceutica NV,
Turnhoutseweg 30, B-2340 Beerse,
Belgium
OR
McGregor Cory Ltd, Exel, Middleton
Close, Banbury, OX16 4RS, UK

The other ingredients are purified water,
propylene glycol, cetyl alcohol, stearyl
alcohol, sorbitan stearate, polysorbate 60,
polysorbate 80, sodium sulphite (E221)
and isopropyl myristate.
See section 2 ‘Nizoral Cream contains’
for further information.

For information in large
print, tape, CD or Braille,
telephone 0800 7318450.

What Nizoral cream looks like and
contents of the pack

This leaflet was last revised in
January 2014.

Nizoral cream comes in a tube
containing 30 g of white cream.

Marketing Authorisation Holder:
JANSSEN-CILAG LTD, 50-100 Holmers
Farm Way, High Wycombe,
Buckinghamshire, HP12 4EG, UK

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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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