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NIZORAL 2% CREAM

Active substance: KETOCONAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

© J-C 2013

GB - AW_85698

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.
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 cream is and what it is used
for
2 Before you use Nizoral cream
3 How to use Nizoral cream
4 Possible side effects
5 How to store Nizoral cream
6 Further 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. 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 Before you use Nizoral cream
Do not use Nizoral cream:

Taking other medicines

Take special care with Nizoral cream

Pregnancy and breast-feeding

• 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.
Check with 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.

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

Important information about some of
the ingredients of Nizoral cream
• Nizoral cream contains propylene glycol.
This may cause skin irritation
• Nizoral cream also contains cetyl alcohol
and stearyl alcohol. These may cause skin
reactions such as contact dermatitis

3 How to use Nizoral cream
Always use Nizoral cream exactly as your doctor
has told you. Nizoral Cream is not recommended
for use in infants and children. You should 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 cream is normally used:
• 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

When to 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.

4 Possible side effects
Like all medicines, Nizoral cream 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

5 How to store Nizoral cream
Keep out of the reach and sight of children.
Store the cream in its original packaging. Do not
store above 25°C.
Do not use Nizoral cream after the expiry date
which is stated on the packaging. 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 cream is
ketoconazole. Each gram (g) of Nizoral cream
contains 20 milligrams (mg) of ketoconazole
(2 % w/w).
The other ingredients are purified water,
propylene glycol, cetyl alcohol, stearyl alcohol,
sorbitan stearate, polysorbate 60, polysorbate 80,
sodium sulphite (E221) and isopropyl myristate.

What Nizoral cream looks like and
contents of the pack

Nizoral cream comes in a tube containing 30 g
of white cream.
The product licence is held by:
JANSSEN-CILAG LTD, 50-100 Holmers Farm
Way, High Wycombe, Buckinghamshire
HP12 4EG, UK

AW_85698.pdf - Page 1 of 3 - April 26, 2013 - 08:47:59

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

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