Skip to Content

KETOCONAZOLE 2% CREAM

Active substance(s): KETOCONAZOLE / KETOCONAZOLE / KETOCONAZOLE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nizoral 2% Cream
(ketoconazole)
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.
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.
• 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.
• If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
• 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 in Nizoral cream is ketoconazole.
Each gram (g) of Nizoral Cream contains 20 milligrams (mg) of
ketoconzole (2 % w/w).
The other ingredients are:
Propylene glycol, Stearyl alcohol, Cetyl alcohol, Sorbitan monostearate,
Polysorbate 60, Polysorbate 80, Isopropyl myristate, Sodium sulphite
(E-221) and Purified water.
What Nizoral Cream looks like and contents of the pack
Nizoral Cream comes in a tube containing 30g of white cream.
Manufactured by JANSSEN PHARMACEUTICA, N.V., Turnhoutseweg,
30, 2340 Beerse, Belgium.
It is procured from within the EU by PL Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER
Repackaged by MPT Pharma Ltd.
PL: 33532/0465

POM

Nizoral 2% Cream

Leaflet date: 09 March 2014
Leaflet code: xxxxxxxxxxxxxxx
®

Nizoral is a registered trade mark of XXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXX.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ketoconazole 2% Cream
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 Ketoconazole Cream is and what it is used for
2) What you need to know before you use Ketoconazole Cream
3) How to use Ketoconazole Cream
4) Possible side effects
5) How to store Ketoconazole Cream
6) Contents of the pack and other information
1) WHAT KETOCONAZOLE CREAM IS AND WHAT IT IS
USED FOR
The name of your medicine is Ketoconazole 2% cream.
It is called ‘Ketoconazole Cream or just ‘cream’ in this leaflet.
Ketoconazole Cream contains a medicine called ketoconazole. This
belongs to a group of medicines called ‘antifungals’.
Ketoconazole 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
Ketoconazole Cream works by killing the fungus that causes the
infection.
2) WHAT YOU NEED TO KNOW BEFORE YOU USE
KETOCONAZOLE CREAM
Do not use Ketoconazole Cream:
• If you are allergic to anything in Ketoconazole 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 Ketoconazole 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
Ketoconazole 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
Ketoconazole Cream is not recommended for use in children under 18
years of age.
Other medicines and Ketoconazole Cream
Ketoconazole 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
Ketoconazole 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
Ketoconazole Cream is not likely to affect you being able to drive or use
any tools or machines.

Ketoconazole Cream contains propylene glycol.
This may cause skin irritation
Ketoconazole Cream contains cetyl alcohol and stearyl alcohol.
These may cause skin reactions such as contact dermatitis
3) HOW TO USE KETOCONAZOLE 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 Ketoconazole Cream
This will depend on the type of infection and how serious it is. Your
doctor will tell you how often to use Ketoconazole 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 Ketoconazole Cream
• Each tube of Ketoconazole 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 Ketoconazole 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. Ketoconazole Cream is non-greasy and should not stain clothes
If you stop using Ketoconazole 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 Ketoconazole 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, this medicine can cause side effects, although not
everybody gets them.
Stop using Ketoconazole 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 KETOCONAZOLE CREAM
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Do not use Ketoconazole Cream after the expiry date which is stated
on the packaging. The expiry date refers to the last day of that month.
• If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
• 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 Ketoconazole Cream contains
The active substance in Ketoconazole cream is ketoconazole.
Each gram (g) of Ketoconazole Cream contains 20 milligrams (mg) of
ketoconzole (2 % w/w).
The other ingredients are:
Propylene glycol, Stearyl alcohol, Cetyl alcohol, Sorbitan monostearate,
Polysorbate 60, Polysorbate 80, Isopropyl myristate, Sodium sulphite
(E-221) and Purified water.
What Ketoconazole Cream looks like and contents of the pack
Ketoconazole Cream comes in a tube containing 30g of white cream.
Manufactured by JANSSEN PHARMACEUTICA, N.V., Turnhoutseweg,
30, 2340 Beerse, Belgium.
It is procured from within the EU by PL Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER
Repackaged by MPT Pharma Ltd.
PL: 33532/0465

Ketoconazole 2% Cream

Leaflet date: 09 March 2014
Leaflet code: xxxxxxxxxxxxxxx

POM

Expand Transcript

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.

Hide