Consumer Medicine Information
NIZORAL™
ketoconazole
200 mg tablets
What is in this leaflet
This leaflet answers some of the common questions about NIZORAL tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking NIZORAL tablets against the benefits this medicine is expected to have for you.
If you have any concerns about using NIZORAL tablets ask your doctor or pharmacist.
Keep this leaflet with your medicine. You may need to read it again.
What NIZORAL tablets are used for
NIZORAL tablets are used to treat:
- fungal infections of the skin, hair and mucous membrane that cannot be treated by applying a medicine directly to the infected area
- persistent fungal infections of the vagina
- fungal infections of the mouth, throat and stomach, intestines or other internal organs.
NIZORAL contains ketoconazole, which belongs to a group of medicines called antifungals. It works by killing or stopping the growth of certain types of fungi or yeasts that cause the infection.
Your doctor may have prescribed NIZORAL tablets for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Before you take NIZORAL tablets
When you must not take it
Do not take NIZORAL tablets if:
- you have an allergy to NIZORAL or any of the ingredients. See Product Description at the end of this leaflet for a list of ingredients.
- you have liver diseases or are recovering from hepatitis.
- you are pregnant
Do not use NIZORAL tablets with any of the following:
- certain medicines for allergy or hayfever (terfenadine, mizolastine or astemizole)
- cisapride or domperidone (used to treat certain digestive problems)
- certain medicines used to produce calmness or to help you sleep (midazolam or triazolam)
- certain HMG-Co A reductase inhibitors, such as simvastatin or lovastatin (used to lower your cholesterol)
- pimozide or sertindole (used to treat mental disorders)
- halofantrine (used to treat malaria)
- levacetylmethodyl (levomethadyl) used for severe pain or to manage addiction
- certain medicines used to treat angina (crushing chest pain) and high blood pressure such as bepridil, epleronone and nisoldipine
- medicines called ergot alkaloids such as ergotamine, dihydroergotamine, ergometrine (ergonovine), methylergometrine (methylergonovine)
- quinidine, disopyramide and dofetilide (used to treat irregular heat beats)
- irinotecan (used to treat cancer)
- everolimus (used to reduce the activity of the body's natural defences).
Do not use NIZORAL tablets if the packaging is torn or shows signs of tampering. Do not use NIZORAL tablets beyond the expiry date (month and year) printed on the pack.
Before you start to take it
You must tell your doctor if:
- you are pregnant or planning to become pregnant.
- you are breast feeding or wish to breastfeed.
- you know you have a liver problem. You should not receive NIZORAL tablets if you have acute or chronic liver disease. Liver disorders, sometimes serious, can occur during treatment with NIZORAL tablets. The chances of this happening are greater if you use NIZORAL tablets for long periods of time, if you know you have liver disorders or if you are allergic to medicines. Before you start taking NIZORAL tablets, your doctor will have some laboratory tests done to be sure your liver is working properly. As the treatment continues, your doctor will tell you to have a regular blood test because liver disorders can be discovered early in the blood. See also Side Effects.
- you have recently taken griseofulvin (an antifungal)
- you have an allergy to penicillin (an antibiotic)
If you have to take NIZORAL tablets, your doctor will need to carry out regular blood tests to rule out any liver disorders and to make sure you can continue taking your medicine.
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking or are given NIZORAL tablets.
Your doctor will advise you whether or not to take NIZORAL tablets or if you need to adjust the dose or adapt your treatment.
Taking other medicines:
Tell your doctor or pharmacist if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.
In particular, NIZORAL tablets must not be taken with some medicines. Examples are:
- certain medicines for allergy or hayfever (terfenadine, mizolastine or astemizole)
- halofantrine (used to treat malaria)
- levacetylmethodyl (levomethadyl) used for severe pain or to manage addiction
- cisapride or domperidone (used to treat certain digestive problems)
- certain medicines used to produce calmness or to help you sleep (midazolam or triazolam)
- certain HMG-Co A reductase inhibitors, such as simvastatin, atrovastatin or lovastatin (used to lower your cholesterol)
- pimozide (used to treat mental disorders)
- certain medicines used to treat angina (crushing chest pain) or high blood pressure, such as bepridil, epleronone and nisoldipine
- medicines called ergot alkaloids such as ergotamine, dihydroergotamine, ergometrine (ergonovine), methylergometrine (methylergonovine)
- quinidine, disopyramide and dofetilide (used to treat irregular heat beats)
- irinotecan (used to treat cancer)
- everolimus (used to reduce the activity of the body's natural defences).
Certain medicines may be affected by NIZORAL tablets or may affect how well NIZORAL tablets work. Your doctor may need to adjust the dose or adapt your treatment. Examples of these medicines are:
- cyclosporine, tacrolimus and sirolimus (used to help prevent organ transplant rejection or to treat certain problems with the immune system)
- methylprednisolone, budesonide and dexamethasone (medicines given by mouth, injection or inhalation for inflammation within the body, asthma and allergies)
- certain medicines used to treat AIDS such as indinavir, saquinavir and ritonavir
- phenytoin or carbamazepine (used to treat fits)
- busulphan, vinca alkaloids, docetaxel, erlotinib and imatinib (used to treat some cancers)
- medicines taken for diabetes such as repaglinide
- certain calcium channel blockers such as verapamil (used to treat heart or blood vessel problems)
- digoxin (used to treat heart failure)
- ergot alkaloids (ergotamine and dihydroergotamine)-used to treat migraine
- anticoagulants (used to slow blood clotting)
- medicines used to regulate fat and body metabolism such as fluticasone
- buspirone and alprazolam (used to treat anxiety)
- alfentanil and fentanyl (used in surgery for pain relief and to help anaesthesia)
- sildenafil (used to treat erectile dysfunction)
- trimetrexate (used to treat a certain type of pneumonia)
- tolterodine and solifenacin (used to help control the need to urinate too frequently)
- rifampicin, rifabutin or isoniazid (used to treat tuberculosis)
- medicines which neutralise stomach acid or suppress the production of stomach acid (such as antacids, cimetidine, ranitidine, omeprazole)
- quetiapine (used to treat chemical imbalances in the brain which causes mental illness).
Effect of alcohol
- Some people may feel sick if they drink alcohol during treatment with NIZORAL tablets. You are advised not to drink alcohol when taking NIZORAL tablets.
Taking NIZORAL tablets
How much to take
Adults
The usual dose for adults is 1 tablet once daily. Sometimes your doctor may increase this dose to 2 tablets daily.
The period of treatment may vary between 5 days to 12 months. Follow your doctor's directions.
How to take it
NIZORAL tablets should be taken during meals or with food. This will make sure that they are fully absorbed by the body.
Do not take medicines that neutralise stomach acid within 2 hours of taking NIZORAL. This is because sufficient stomach acid is required to ensure that NIZORAL tablet is properly absorbed by the body. If you take medicines that suppress the production of stomach acid, you should take your NIZORAL with an acidic drink, such as a cola beverage.
If you do not understand the instructions provided with this medicine, ask your doctor or pharmacist for help.
If you forget to take it
- Take the dose you missed as soon as you remember, and then continue to take it as you would normally.
- If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
- Do not take a double dose to make up for the one you missed.
If you have missed more than one dose, or are not sure what to do, check with your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you have taken too much (overdose)
Immediately telephone your doctor, or the Poisons Information Centre for advice, or go to the Accident and Emergency Department at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
You can contact the Poisons Information Centre by dialling 0800 POISON or 0800 764 766. This is a 24-hour a day service. Keep this number handy.
While you are taking NIZORAL tablets
Things you must do
- Always follow your doctor's instructions carefully.
If you are taking NIZORAL tablets for longer than 2 weeks, you are advised to have a regular blood test (about once a month). This is to detect liver problems that may occur during long term treatment with NIZORAL tablets. Liver problems can be recognised by the following symptoms: unusual tiredness, nausea and vomiting, yellowing of the skin or eyes (jaundice), dark urine or pale stools, lack of appetite, abdominal pain and fever. Stop the treatment and tell your doctor if you notice any of these symptoms.
- Tell your doctor if you become pregnant while taking NIZORAL tablets.
- If you are about to start taking a new medicine, tell your doctor and pharmacist that you are taking NIZORAL tablets
Things you must not do
- Do not use NIZORAL tablets to treat any other complaint unless your doctor says so.
- Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Side Effects
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some side effects. Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you experience any of the following:
- upset stomach, stomach cramps, nausea and vomiting, diarrhoea or constipation
- a change in menstrual pattern, inability to get or maintain an erection
- headache, dizziness, sensitivity to light or sunlamps, tingling sensations, decreased number of platelets, swelling of the breast
- unusual hair loss or thinning.
Tell your doctor immediately if you notice any of the following as you may need urgent medical care:
- bleeding or bruising more easily than normal
- fever or chills
- numb feeling in your fingers or toes
- skin rash or itching
- symptoms of sunburn (such as redness, itching, swelling, blistering) which may occur more quickly than normal
- blurred vision.
STOP taking NIZORAL tablets immediately and tell your doctor or go to Accident and Emergency at your nearest hospital straightaway if any of the following happen:
- abnormal tiredness, dark urine, pale stools, yellowing of the skin or eyes, nausea, vomiting, lack of appetite, abdominal pain and/or fever. These can be symptoms of liver toxicity.
- sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing.
Men who take NIZORAL tablets for a long time may get swelling of the breasts or a decrease in their level of sperm. These effects will reverse on stopping treatment.
Other side effects not listed above may also occur in some people. Tell your doctor if you experience any other effects.
After taking NIZORAL tablets
Storage
- Keep NIZORAL tablets in the pack until it is time to take them.
- Keep NIZORAL tablets in a cool dry place where the temperature is below 25°C.
- Keep your medicines where children cannot reach them. A locked cupboard at least one-and-a-half metres (1.5 m) above the ground is a good place to store medicines.
- Do not store NIZORAL tablets, or any other medicine in the bathroom or near a sink. Do not leave medicines in the car or on window sills. Heat and dampness can destroy some medicines.
Disposal
If your doctor tells you to stop taking NIZORAL tablets, or your medicine has passed its expiry date, ask your pharmacist what to do with any which may be left over.
Product Description
What it looks like
NIZORAL 200 mg tablets are white, round, scored tablets. Each tablet is marked "K/200" on one side and "JANSSEN" on the reverse. They are available in blisters in cartons of 30 tablets.
Ingredients
Each NIZORAL tablets contains:
- 200 milligrams of ketoconazole as the active ingredient
- lactose, povidone, maize starch, microcrystalline cellulose, colloidal anhydrous silica and magnesium stearate.
Sponsor
Johnson & Johnson (New Zealand) Ltd,
Ground Floor, Ericsson House
105 Carlton Gore Road, Newmarket
Auckland, NEW ZEALAND
Distributed by
Janssen-Cilag Pty Ltd, PO Box 9222, Newmarket, Auckland, New Zealand
Tel: (09) 524 5012
Fax: (09) 523 1646
This leaflet was prepared in May 2008.