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Voriconazole Sandoz

Voriconazole Tablets
Consumer Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Voriconazole Sandoz. It does not contain all the information that is known about Voriconazole Sandoz. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What VORICONAZOLE SANDOZ is used for

This medicine is used to treat fungal and yeast infections such as:
invasive aspergillosis, a fungal infection caused by a fungus called Aspergillus, which usually begins in the respiratory tract (in the nose, sinuses or lungs). Aspergillus is harmless in most healthy people; however, in people with poor immune systems (such as people who have had organ transplants and people with cancer or HIV/AIDS) invasive aspergillosis can be serious and spread to other tissues and organs.
serious Candida infections, including Candida infections of the oesophagus (food pipe or gullet) and those that have spread into the blood stream or to other parts of the body.
serious fungal infections caused by Scedosporium species and Fusarium species.
other serious fungal infections in patients who do not respond to, or cannot tolerate, other antifungal medicines.
Voriconazole Sandoz is also used to prevent invasive fungal infections in patients who are at risk of developing such infections.
It contains the active ingredient voriconazole. Voriconazole belongs to a group of medicines called triazole antifungals.
It works by preventing the growth of fungal and yeast organisms causing your infection.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
This medicine is available only with a doctor's prescription.

Before you take VORICONAZOLE SANDOZ

When you must not use it

Do not take VORICONAZOLE SANDOZ if you have an allergy to:
voriconazole, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description
any other similar medicines such as itraconazole (Sporanox), fluconazole (Diflucan), posaconazole (Noxafil) or ketoconazole (Nizoral) (not all brands given).
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not take VORICONAZOLE SANDOZ if you are taking any of the following medicines:
pimozide (e.g. Orap), a medicine used to treat mental illness
quinidine (e.g. Kinidin Durules), a medicine used to treat irregular heartbeat
rifampicin (e.g. Rifadin, Rimycin), a medicine used to treat tuberculosis and other infections
carbamazepine (e.g. Tegretol, Teril), a medicine used to treat seizures
long-acting barbiturates such as phenobarbitone, medicines used to treat severe insomnia and seizures
rifabutin (e.g. Mycobutin) an antibiotic
ergotamine (e.g. Cafergot) or dihydroergotamine (e.g. Dihydergot), medicines used to treat migraine
sirolimus (e.g. Rapamune), a medicine used in transplant patients
efavirenz (e.g. Stocrin) (a medicine used to treat HIV infection) in doses of 400mg or more once a day
ritonavir (e.g. Norvir, Kaletra) (a medicine used to treat HIV infection) in doses of 400mg or more twice a day
St John's Wort (a herbal medicine).
VORICONAZOLE SANDOZ should not be given to a child under the age of 2 years.
Safety and effectiveness in children younger than 2 years has not been established.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor first.

Before you start to take it

Tell your doctor if you have allergies to any foods, preservatives or dyes or any other medicines, especially antifungal medicines such as itraconazole (Sporanox), fluconazole (Diflucan), posaconazole (Noxafil) or ketoconazole (Nizoral) (not all brands given).
Tell your doctor if you have or have had any of the following medical conditions:
heart problems
any problems affecting your kidneys
any problems affecting your liver. If you have liver disease your doctor may prescribe a lower dose
recent chemotherapy or stem cell transplant.
Tell your doctor if you are pregnant or plan to become pregnant.
VORICONAZOLE SANDOZ should not be taken during pregnancy, unless indicated by your doctor. Effective contraception should be used in women of childbearing potential. Your doctor can discuss with you the risks and benefits involved.
Tell your doctor if you are breast - feeding.
VORICONAZOLE SANDOZ should not be taken whilst breastfeeding, unless indicated by your doctor. It is not known if the active ingredient voriconazole passes into breast milk. Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell him/her before you start taking VORICONAZOLE SANDOZ.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from a pharmacy, supermarket or health food shop.
Some medicines should not be taken with VORICONAZOLE SANDOZ. These include (not all brands given):
pimozide (e.g. Orap), a medicine used to treat mental illness
quinidine (e.g. Kinidin Durules), a medicine for irregular heartbeat
rifampicin (e.g. Rifadin, Rimycin), a medicine used to treat tuberculosis and other infections
carbamazepine (e.g. Tegretol, Teril), a medicine used to treat seizures
long-acting barbiturates such as phenobarbitone, medicines used to treat severe insomnia and seizures
rifabutin (e.g. Mycobutin) an antibiotic
ergotamine (e.g. Cafergot) or dihydroergotamine (e.g. Dihydergot), medicines used to treat migraine
sirolimus (e.g. Rapamune) a medicine used in transplant patients
efavirenz (Stocrin) (a medicine used to treat HIV infection) in doses of 400mg or more once a day
ritonavir (e.g. Norvir, Kaletra) (a medicine used to treat HIV infection) in doses of 400mg or more twice a day
St John's Wort, (a herbal medicine).
Some medicines and VORICONAZOLE SANDOZ may interfere with each other. These include (not all brands given):
efavirenz (Stocrin) (a medicine used to treat HIV infection) in doses below 400mg once a day
ritonavir (Norvir, Kaletra) (a medicine used to treat HIV infection) in doses of 100mg twice a day
warfarin (e.g. Marevan, Coumadin), a medicine used to stop blood clots
everolimus (e.g. Afinitor, Certican), a medicine used to treat cancer
fluconazole (e.g. Diflucan), a medicine used to treat fungal infections
phenytoin (e.g. Dilantin), a medicine used to treat epilepsy
cyclosporin (e.g. Sandimmun, Neoral), a medicine used to prevent organ transplant rejection or to treat certain problems with the immune system
sulphonylureas, medicines used to treat diabetes such as glibenclamide, gliclazide and glipizide (e.g. Daonil, Diamicron, Minidiab)
some antihistamines, medicines used to treat hayfever, allergic skin reactions, itching
theophylline (e.g. Nuelin), a medicine used to treat asthma
benzodiazepines (e.g. Valium), medicines used to treat insomnia or anxiety
statins (e.g. Zocor, Lipitor, Crestor), medicines used for lowering cholesterol
tacrolimus (e.g. Prograf), a medicine used in patients who have had a liver or kidney transplant
indinavir (e.g. Crixivan) and some other medicines used to treat HIV infection
omeprazole (e.g. Losec), a medicine used to treat indigestion, reflux and stomach or duodenal ulcers
methadone (used to treat heroin addiction)
oral contraceptives (the Pill)
vincristine, vinblastine or vinorelbine, medicines used in treating cancer (e.g.Vepesid)
strong pain killers such as alfentanil (e.g. Rapifen), fentanyl (e.g. Durogesic, Actiq, Sublimaze) and oxycodone (e.g. Endone, Proladone)
non-steroidal anti-inflammatory drugs, medicines used to treat pain and inflammation such as ibuprofen and diclofenac (e.g. Nurofen, Advil, Voltaren).
These medicines may be affected by VORICONAZOLE SANDOZ or may affect how well it works. You may need different amounts of your medicines or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take VORICONAZOLE SANDOZ

Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.

How much to take

Your doctor will tell you how much to take depending on your weight.
Adults
Treatment of invasive fungal infections
The usual dose of VORICONAZOLE SANDOZ tablets in adults weighing 40kg and greater is 400mg (two 200mg tablets twice a day) for the first day and then 200mg to 300mg twice a day thereafter.
In adults weighing less than 40kg the dose of VORICONAZOLE SANDOZ tablets is halved.
Prevention of invasive fungal infections
The usual dose is 6mg/kg every 12 hours for the first day, given by injection*. The dose is then adjusted to 4mg/kg every 12 hours by injection* or, in adults weighing 40kg and greater, one 200mg tablet twice a day.
In adults weighing less than 40kg the dose of VORICONAZOLE SANDOZ tablets is halved.
Children
VORICONAZOLE SANDOZ should not be given to a child under the age of 2 years.
Your doctor will determine the dose of VORICONAZOLE SANDOZ required for your child.
Depending on how serious the infection is and how your child reacts to the medicine, your doctor may increase or decrease the dose.
Adolescents (12-16 years of age)
Adolescents aged 12-16 years of age are usually given the same dose as adults.

How to take it

VORICONAZOLE SANDOZ needs to be taken regularly to be effective.
Take VORICONAZOLE SANDOZ tablets at least one
hour before or one hour after a meal.
Swallow the tablets whole with a full glass of water.

When to take it

Take your medicine regularly at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

How long to take it

The length of time you take VORICONAZOLE SANDOZ will depend on the type of infection you have.
If you have a weakened immune system or a difficult infection, you may need long-term treatment to prevent the infection from returning.
Continue taking VORICONAZOLE SANDOZ for as long as your doctor tells you. Do not stop taking VORICONAZOLE SANDOZ because you are feeling better.
If you do not complete the full course prescribed by your doctor, the infection may not clear completely or your symptoms may return.

If you forget to take it

If you forget to take one 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 dose that you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764 766) for advice, or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too much VORICONAZOLE SANDOZ. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Symptoms of an overdose may include upset stomach, diarrhoea, headache and sensitivity to light.

While you are using VORICONAZOLE SANDOZ

Things you must do

Tell your doctor immediately if you develop a rash or blisters while taking VORICONAZOLE SANDOZ.
If this rash worsens, VORICONAZOLE SANDOZ may need to be stopped.
Avoid going out in the sun for long periods of time while you are taking VORICONAZOLE SANDOZ.
VORICONAZOLE SANDOZ can cause sensitivity to light.
Tell your doctor if you notice any changes to your skin while you are taking Voriconazole Sandoz.
If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.
Make sure you follow your doctor's instructions and keep all appointments, including blood tests.
Your doctor should monitor the function of your liver and kidneys using blood tests. If you have liver disease, your doctor might lower your dose of VORICONAZOLE SANDOZ or stop your VORICONAZOLE SANDOZ treatment. Your doctor might also monitor the function of your pancreas.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking VORICONAZOLE SANDOZ.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.
If you are a woman of child-bearing age, you should avoid becoming pregnant while taking VORICONAZOLE SANDOZ. If you become pregnant while taking VORICONAZOLE SANDOZ, tell your doctor immediately.
If you are about to have any blood tests, tell your doctor that you are taking this medicine.
It may interfere with the results of some tests.

Things you must not do

Do not take VORICONAZOLE SANDOZ to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else even if they have the same condition as you.
Do not stop taking your medicine or lower the dosage without checking with your doctor.
If you do not complete the full course prescribed by your doctor, the infection may not clear completely or your symptoms may return.

Things to be careful of

Be careful driving or operating machinery until you know how VORICONAZOLE SANDOZ affects you.
You may experience changes to your vision, such as blurriness, colour changes or uncomfortable sensitivity to light.
If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous. Do not drive at night.
Children should be careful when riding bicycles or climbing.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking VORICONAZOLE SANDOZ.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists 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 or pharmacist if you notice any of the following and they worry you:
changes to your vision, such as blurred vision, colour changes or sensitivity to light
irregular heartbeat
nausea or feeling sick, vomiting
headache
stomach pain, indigestion, diarrhoea
back pain in middle or upper back
swelling of the arms or legs
soreness at the injection site.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
asthma, wheezing, shortness of breath
sudden or severe itching, skin rash, hives or blisters
fainting, seizures or fits
flaking of the skin
yellowing of the skin or eyes, also called jaundice
signs of frequent or worsening infections such as fever, severe chills, sore throat or mouth ulcers
blood in urine
signs of kidney failure such as tiredness, lack of appetite and reduced or greatly increased amount of urine
convulsions, fits.
These may be signs of a serious allergic reaction or side effect. You may need urgent medical attention or hospitalisation. These side effects are rare.
Tell your doctor if you notice any other side effects.
Other side effects not listed above may also occur in some people.

After using VORICONAZOLE SANDOZ

Storage

Keep your medicine in the original container.
If you take it out of the original container it may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 30°C.
Do not store VORICONAZOLE SANDOZ or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

VORICONAZOLE SANDOZ comes in two types of tablets:
VORICONAZOLE SANDOZ 50mg - White to off-white, round, biconvex, film coated tablets with '50' debossed on one side and plain on other side.
VORICONAZOLE SANDOZ 200mg - White to off-white, biconvex, capsule shaped film coated tablets with '200' debossed on one side and plain on other side.
Available in blister packs and bottles of 30, 56, 100 tablets.
All strengths and presentations may not be marketed.

Ingredients

Active Ingredients:
VORICONAZOLE SANDOZ 50mg - 50mg voriconazole
VORICONAZOLE SANDOZ 200mg - 200mg voriconazole
Inactive Ingredients:
lactose
maize starch (pregelatinised)
croscarmellose sodium
povidone
magnesium stearate
hypromellose
titanium dioxide
glycerol triacetate

Supplier

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Australia
Tel: 1800 634 500
Novartis New Zealand Ltd
PO Box 99102
Newmarket, Auckland 1149
New Zealand
Tel: 0800 354 335
This leaflet was prepared in May 2015.
Australian Registration Numbers
VORICONAZOLE SANDOZ 50mg tablets: AUST R 207786 (blisters)
VORICONAZOLE SANDOZ 200mg tablets: AUST R 207785 (blisters)
*Available from other brand (s).