Nizoral 2% Cream
Ref: 1379/121114/1 /F
Nizoral® 2% cream
(ketoconazole)
Patient Information Leaflet
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.
Your medicine is called Nizoral 2% cream but will be referred to as Nizoral cream throughout this leaflet.
In this leaflet:
0 What Nizoral cream is and what it is used for 0 What you need to know before you use Nizoral cream 0 How to use Nizoral cream 0 Possible side effects 0 How to store Nizoral cream 0 Contents of the pack and other information
0 What Nizoral cream is and what it is used for
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.
0 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
0 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
(ketoconazole)
Patient Information Leaflet (continued)
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.
0 How to store Nizoral cream
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
Do not use this medicine after the expiry date shown on the tube or carton label. The expiry date refers to the last day of that month. If your doctor tells you to stop taking the medicine, take any remaining medicine back to the pharmacist for safe disposal. Only keep this medicine if your doctor tells you to. If your medicine becomes discoloured or show any other signs of deterioration, ask your pharmacist who will advise you what to do.
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 to protect the environment.
Q 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.
0 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 ketoconazole (2 % w/w).
The other ingredients are propylene glycol, stearyl alcohol, cetyl alcohol, sorbitan monostearate, polysorbate 60, polysorbate 80, isopropyl myristate, sodium sulphite (E221) and purified water.
What Nizoral cream looks like and contents of the pack Nizoral cream comes in a tube containing white cream.
Each tube contains 30g of cream.
Manufacturer and Licence Holder
This medicine is manufactured by Janssen Pharmaceutica, N.V., Turnhoutseweg, 30, 2340 Beerse, Belgium and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
POM PL 15184/1379 Nizoral 2% cream
Nizoral is a registered trademark of Janssen-Cilag Ltd Revision date: 12/11/14