NIZORAL 200 MG TABLETS

Active substance: KETOCONAZOLE

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Patient Information Leaflet

Nizoral® 200 mg tablets
(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. 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

The name of your medicine is Nizoral 200 mg tablets. They are called
‘Nizoral tablets’ in this leaflet.

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)

Nizoral tablets contain a medicine called ketoconazole. This belongs to a
group of medicines called ‘antifungals’.

Do not start taking Nizoral tablets and tell your doctor if you are taking
any of the above.

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.

You must talk to your doctor before taking Nizoral tablets if you
take:
 Domperidone, a medicine used to avoid feeling sick

Nizoral tablets work by killing the fungus that causes the infection.

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

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

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

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.

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.

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.
You may still be able to take Nizoral tablets if your doctor thinks you need
to.
Do not take this medicine if you are breast-feeding. 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.

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
 Do not store above 30°C. Store in the original package to protect from
moisture.
 Keep out of the sight and reach of children.
 If your doctor stops your treatment, take any leftover tablets back to
the pharmacy.
 If your tablets become discoloured or show any sign of deterioration,
return them to your pharmacist.
 Do not take your tablets after the expiry date on the container. 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 that are no
longer required. These measures will help to protect the environment.
6) FURTHER INFORMATION
What Nizoral tablets contain:
The active substance in Nizoral tablets is ketoconazole. Each Nizoral
tablet contains 200 mg of ketoconazole.
The other ingredients are colloidal anhydrous silica, magnesium
stearate, microcrystalline cellulose, povidone, lactose monohydrate,
maize starch.
What Nizoral tablets look like and contents of the pack:
Nizoral tablets are white, circular, flat bevelled-edge, half scored tablet
marked 'JANSSEN' on one side and 'K’ over ‘200' on the other side.
Nizoral 200 mg tablets are available as blister packs of 10 and 30 tablets.
Manufacturer:
Nizoral 200 mg tablets are manufactured by
Janssen-Cilag S.p.A., Latina, Italy

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

They are procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER
Repackaged by XXXXXXXXXXXXXXXXXXXXXXXXXXXX
PL: 33532/0385

POM

Leaflet coded: xxxxxxxxxxxx
Leaflet dated: 12th March 2013
Nizoral® is a registered trademark of xxxxxxxxxxxxxxxxxxxx.

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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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