NIZORAL 200MG TABLETS

Active substance: KETOCONAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

© J-C 2010

200 mg tablets
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 tablets are and what they
are used for
2 Before you take Nizoral tablets
3 How to take Nizoral tablets
4 Possible side effects
5 How to store Nizoral tablets
6 Further information

1 What Nizoral tablets are and what they are used for
The name of your medicine is Nizoral 200 mg
tablets. They are called ‘Nizoral tablets’ in this
leaflet.
Nizoral tablets contain a medicine called
ketoconazole. This belongs to a group of
medicines called ‘antifungals’.

Nizoral tablets are used to treat a range of
conditions which can't be treated with other
antifungal medicines, including some fungal
infections affecting the skin, mouth and throat.
Nizoral tablets work by killing the fungus that
causes the infection.

2 Before you take Nizoral tablets
Do not take Nizoral tablets:

• If you are allergic to anything in Nizoral
tablets (listed in section 6 below)
• If you are allergic to ‘antifungal’ medicines
called ‘imidazoles’
• If you have ever had liver problems.
You must inform your doctor of any previous
liver disease
• In children weighing less than 15 kg
Do not take this medicine if any of the above
apply to you or your child. If you are not sure,
talk to your doctor or pharmacist before using
Nizoral tablets.

Liver problems

Liver problems can sometimes happen, even
with a short course of Nizoral tablets.
If after taking this medicine you:
• Have long-lasting severe headache or
blurred vision
• Have a severe lack of appetite
• Lose a large amount of weight (anorexia)
• Feel sick (nausea) or are sick (vomiting)
• Feel unusually tired or feverish
• Get stomach pain
• Have muscle weakness
• Get yellowing of the skin or whites of the eyes
• Pass unusually dark urine or pale stools
Stop taking Nizoral tablets and tell your doctor
straight away.

Blood tests

Before you are given Nizoral tablets your doctor
will check your liver by testing your blood. Your
doctor will then re-test your blood at weeks 2
and 4 of your treatment. If your treatment
continues longer than this, your doctor will
continue to re-test your blood every 4 weeks.

Adrenal gland problems

The adrenal glands are involved in the
response to stress. Tell your doctor if:
• You have Addison’s disease (adrenal glands
not working properly)
• You are under periods of stress, such as
facing major surgery
Your doctor may need to check how your
adrenal glands are working.

Taking other medicines

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.
Do not take Nizoral tablets and tell your
doctor if you are taking any of the
following medicines:
• Terfenadine, astemizole or mizolastine for
hay fever or allergy
• halofantrine, a medicine used to treat malaria
• levacetylmethadol (levomethadyl), a medicine
for severe pain or to manage addiction
• Lovastatin or simvastatin to lower cholesterol
• Quinidine, disopyramide or dofetilide for an
irregular heart beat
• Midazolam (by mouth) or triazolam for
anxiety or to help you sleep
• Cisapride for digestive problems
• Pimozide or sertindole for conditions
affecting thoughts, feelings and behaviour
• Nisoldipine and bepridil for angina (crushing
chest pain) and high blood pressure
• Eplerenone for heart failure

• Ergot alkaloids:
• Ergometrine (ergonovine) or
methylergometrine (methylergonovine)
after childbirth
• Ergotamine for migraine
• Irinotecan, an anti-cancer drug
• Everolimus, usually given after an organ
transplant and sirolimus (also known as
rapamycin)
Do not start taking Nizoral tablets and tell your
doctor if you are taking any of the above.
You must talk to your doctor before taking
Nizoral tablets if you take:
• Domperidone, a medicine used to avoid
feeling sick
Your doctor may need to alter the dose of
Nizoral tablets or certain other medicines
if you take them together
Tell your doctor if you are taking:
• Medicines to thin the blood such as warfarin
• Medicines that are usually given after an
organ transplant called ciclosporin,
busulphan and tacrolimus
• Medicines for inflammation (given by mouth,
injection or inhaled) called methylprednisolone,
budesonide, fluticasone or dexamethasone
• Medicines that act on the heart and blood
vessels called digoxin, or ‘calcium-channel
blockers’ such as dihydropyridines or
verapamil
• Medicines for pain called alfentanil or fentanyl
• Medicines used in the treatment of cancer
such as docetaxel and a group of medicines
known as ‘vinca alkaloids’
• Medicines for HIV infection such as:
• Indinavir and saquinivir (antiviral protease
inhibitors)
• Nevirapine (a non-nucleoside reverse
transcriptase inhibitor)
• Ritonavir. Your doctor may have to lower
your dose of Nizoral tablets if you are
taking this medicine
• Medicines for anxiety or to help you sleep
(tranquillisers) such as buspirone,
alprazolam or brotizolam
• Medicines used in the treatment of cancer
including erlotinib and imatinib
• Midazolam to help you relax or sleep when
given into a vein
• Sildenafil for impotence (erectile dysfunction)
• A medicine called trimetrexate used for a
certain type of pneumonia
• Ebastine for allergy
• Medicines for epilepsy called phenytoin or
carbamazepine
• Rifampicin for serious bacterial infections
• Medicines for tuberculosis called isoniazid or
rifabutin
• Atorvastatin to lower cholesterol
• Reboxetine for depression
• Cilostazol to help circulation
• Repaglinide for diabetes
• Eletriptan for migraine headaches
• Quetiapine, used to treat conditions affecting
thoughts, feelings or behaviours
• Medicines called tolterodine and solifenacin
used to help control the need to urinate too
often
Talk to your doctor before taking Nizoral tablets
if you are taking any of these medicines.

Taking Nizoral tablets with food

Always take Nizoral tablets with food as this
helps your body to use the medicine.

Nizoral tablets and alcohol

• Drinking alcohol with Nizoral tablets may cause
a headache, a rash or make you feel sick
• You are advised not to drink alcohol whilst
taking this medicine
Talk to your doctor if you are an alcoholic or
have been treated for alcoholism. Your doctor
will decide if you can have Nizoral tablets.

Pregnancy and breast-feeding

Talk to your doctor before taking Nizoral
tablets if you are pregnant, think you may be
pregnant or might become pregnant.

© J-C 2010

You may still be able to take Nizoral tablets if
your doctor thinks you need to.
Do not take this medicine if you are breastfeeding. This is because small amounts may
pass into the mother’s milk.
Ask your doctor or pharmacist for advice
before taking any medicine if you are pregnant
or breast-feeding.

Driving and using machines

Nizoral tablets are not likely to affect you being
able to drive or use any tools or machines.

Important information about some
of the ingredients of Nizoral tablets

Nizoral tablets contain lactose. If your doctor has
told you that you are intolerant of some sugars,
contact them before taking this medicine.

3 How to take Nizoral tablets
Always take Nizoral tablets exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.

Taking Nizoral tablets

• Always take Nizoral tablets with food as this
helps your body to use the medicine
• Swallow the tablets whole with some liquid
• There must be enough acid in your stomach
to make sure that your body can use the
medicine. Medicines for indigestion, stomach
ulcers or heartburn can affect the stomach
producing acid. For this reason you should
wait two hours after taking Nizoral tablets
before taking any of these other medicines

How much to take

The dose of Nizoral tablets is based on:
• Where the infection is
• What type of fungus is causing it
• Your, or your child’s, body weight in kilograms
Your doctor will tell you how many Nizoral
tablets to take and for how long.
Adults and children weighing more than
30 kilograms
• The usual dose is one tablet taken once
each day
• Your doctor may increase the dose and tell
you to take two tablets each day

Children weighing between 15 and
30 kilograms
• One-half tablet taken once each day with
a meal

If you take more Nizoral tablets
than you should

If you take more Nizoral tablets than you were
told to, talk to your doctor or go to the nearest
hospital casualty department straight away.

If you forget to take Nizoral tablets

• If you forget to take a dose, take it as soon
as you remember. Then keep taking the
medicine as your doctor has told you
• Do not take a double dose to make up for the
missed dose

When to stop taking Nizoral tablets

Keep taking Nizoral tablets for as long as your
doctor has told you.
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 tablets can cause
side effects, although not everybody gets them.
Tell your doctor straight away if you notice
or suspect any of the following. You may
need urgent medical treatment.
• Sudden swelling of the face or throat. Hives
(also known as nettle rash or urticaria),
severe irritation, reddening or blistering of
your skin. These may be signs of a severe
allergic reaction
• Yellowing of the skin or whites of your eyes
(jaundice), unusually dark urine, pale stools,
abnormal tiredness or fever. These may be
signs of liver problems
Tell your doctor or pharmacist if you notice or
suspect any of the following side effects:
Common (affects less than 1 in 10 people)
• Stomach pain, feeling sick (nausea) or being
sick (vomiting)
• Itching (pruritus)
Uncommon (affects less than 1 in
100 people)
• Headache
• Diarrhoea

• Skin rash or reddening
• Sleepiness
• Dizziness
The following side effects have been reported,
however the precise frequency cannot be
identified and therefore how often they occur
is classed as unknown:
• lower number of blood platelets that can cause
abnormal bleeding
• Insufficiency of the adrenal gland (a small
gland close to the kidney) has occurred.
• Increased pressure in the brain (in infants,
the fontanelle may bulge)
• Tingling sensation in the hands or feet
• Increased sensitivity to strong sunlight
• Hair loss
• Heartburn
• Impotence
• Menstrual disorders may be experienced in
women, and in men a short-term decrease in
testosterone levels can also be experienced
and, at higher doses, lower sperm count
Men may get swelling of the breasts.
If you get any of these side effects, or other
side effects not listed in this leaflet, tell your
doctor or pharmacist straight away.

5 How to store Nizoral tablets
Keep out of the reach and sight of children.
Do not store above 30°C. Store in the original
package to protect from moisture.
Do not take Nizoral tablets after the expiry
date which is stated on the label. 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 tablets is
ketoconazole. Each Nizoral tablet contains
200 mg of ketoconazole.
The other ingredients are maize starch, lactose,
polyvidone, microcrystalline cellulose, colloidal
anhydrous silica and magnesium stearate.

What Nizoral tablets look like and
contents of the pack

Nizoral tablets are white, circular, flat tablets,
marked “JANSSEN” on one side and “K/200”
on the other. They come in blister packs of
30 tablets.

Nizoral tablets are made by:
Janssen-Cilag SpA (Latina), Via C Janssen,
04010 Borgo San Michele, Latina, Italy

For information in large
print, tape, CD or Braille,
telephone 0800 7318450.
This leaflet was last approved in
04/2010.


The product licence is held by:
Janssen-Cilag Ltd, 50-100 Holmers Farm Way,
High Wycombe, Bucks HP12 4EG, UK
GB - AW_54102

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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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