VORICONAZOLE SANDOZ^®

Active ingredient(s): voriconazole (vori-con-a-zole)

This leaflet provides important information about using Voriconazole Sandoz. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Voriconazole Sandoz.

Where to find information in this leaflet:

1. Why am I using Voriconazole Sandoz?
2. What should I know before I use Voriconazole Sandoz?
3. What if I am taking other medicines?
4. How do I use Voriconazole Sandoz?
5. What should I know while using Voriconazole Sandoz?
6. Are there any side effects?
7. Product details

Voriconazole Sandoz contains the active ingredient voriconazole. Voriconazole Sandoz is belongs to a group of medicines called triazole antifungals.

This medicine works by preventing the growth of fungal and yeast organisms causing your infection.

Voriconazole Sandoz is used to treat fungal and yeast infections such as:

• invasive aspergillosis (as-pur-ji-losis), a fungal infection caused by a fungus called Aspergillus (as-pur-jilus), 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 (can-did-da) 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 (skidoe-spore-rium) species and Fusarium (few-saa-rium) 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.

Warnings

Do not use Voriconazole Sandoz if:

• you are allergic to voriconazole, or any similar medicines, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
  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; skin rash, itching or hives.

Do not use Voriconazole Sandoz if you are taking any of the following medicines:

• Medicines to treat mental illness:
  - pimozide, a medicine used to treat mental illness.
  - St John's Wort (a herbal medicine).
  - lurasidone, a medicine to treat schizophrenia and bipolar disorder.
• Medicines used to manage heart health
  - Quinidine, a medicine used to treat irregular heartbeat.
  - ivabradine, a medicine used to treat heart problems.
• Medicines used to treat infections
  - rifampicin, a medicine used to treat tuberculosis and other infections.
  - rifabutin, an antibiotic.
  - efavirenz (a medicine used to treat HIV infection), in doses of 400mg or more once a day.
  - ritonavir (a medicine used to treat HIV infection) in doses of 400mg or more twice a day.
• Medicines used for seizures, insomnia or migraines
  - carbamazepine, a medicine used to treat seizures.
  - long-acting barbiturates such as phenobarbitone, medicines used to treat severe insomnia and seizures.
  - ergotamine or dihydroergotamine, medicines used to treat migraine.
• Other medicines:
  - sirolimus, a medicine used in transplant patients.
  - naloxegol, a medicine used to treat constipation caused by opioids (narcotic pain medicines).
  - tolvaptan used to treat low levels of sodium in your blood or for kidney problems).
  - venetoclax, a medicine used to treat blood cancers.
  - lemborexant, a medicine used to help manage insomnia

Do not use 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.

Check with your doctor if you:

• have any other medical conditions, including:
  - 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.
• take any medicines for any other condition
• have allergies to foods, preservatives or dyes or any other medicines, especially antifungal medicines such as itraconazole, fluconazole, posaconazole or ketoconazole.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Voriconazole Sandoz should not be used 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.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Voriconazole Sandoz should not be used 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.

Use in Children

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.

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines should NOT be taken with Voriconazole Sandoz. Please see Section 2 above for a list of those medicines.

Some medicines may interfere with Voriconazole Sandoz and affect how it works. These include:

• Medicines used to treat infections:
  - fluconazole, a medicine used to treat fungal infections.
  - indinavir and some other medicines used to treat HIV infection
• Medicines used for cancer treatment:
  - everolimus, a medicine used to treat cancer
  - other cancer drugs such as glasdegib, axitinib, bosutinib, cabozantinib, ceritinib, cobimetinib, dabrafenib, dasatinib, nilotinib, sunitinib, ibrutinib, ribociclib, dasatinib, sunitinib.
  - tretinoin, a medicine used for the treatment of acne and acute promyelocytic leukemia.
  - vincristine, vinblastine or vinorelbine, medicines used in treating cancer.
• Medicines used in management of organ transplant:
  - ciclosporin, a medicine used to prevent organ transplant rejection or to treat certain problems with the immune system.
  - tacrolimus, a medicine used in patients who have had a liver or kidney transplant.
  - letermovir used to prevent viral infections after bone marrow transplant).
• Medicines for management of diabetes and other heart-related conditions:
  - warfarin, a medicine used to stop blood clots.
  - sulphonylureas, medicines used to treat diabetes such as glibenclamide, gliclazide and glipizide.
  - statins, medicines used for lowering cholesterol.
• Medicines for management of mental health:
  - benzodiazepines, medicines used to treat insomnia or anxiety.
  - eszopiclone, a medicine used to treat insomnia.
• Medicines used for pain management:
  - strong pain killers such as alfentanil, fentanyl and oxycodone.
  - non-steroidal anti-inflammatory drugs, medicines used to treat pain and inflammation such as ibuprofen and diclofenac.
• Other medicines:
  - ivacaftor, a medicine used to treat cystic fibrosis.
  - phenytoin, a medicine used to treat epilepsy.
  - some antihistamines, medicines used to treat hayfever, allergic skin reactions, itching.
  - theophylline, a medicine used to treat asthma.
  - omeprazole, a medicine used to treat indigestion,
  - reflux and stomach or duodenal ulcers.
  - methadone (used to treat heroin addiction).
  - oral contraceptives (the Pill).
  - methotrexate, a medicine used to treat arthritis and cancers.

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.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Voriconazole Sandoz.

How much to take / use

• Your doctor will tell you how much to use depending on your weight.

Treatment of invasive fungal infections
Adults

• The usual dose of Voriconazole Sandoz Tablets in adults weighing 40 kg and greater is 400 mg (two
  200 mg tablets twice a day) for the first day and then 200 to 300 mg twice a day thereafter.
• In adults weighing less than 40 kg the dose of Voriconazole Sandoz Tablets is halved.
• The usual dose is 6 mg/kg every 12 hours for the first day, given by injection*. The dose is then adjusted to 4 mg/kg every 12 hours by injection* or, in adults weighing 40 kg and greater, one 200 mg tablet twice a day.

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.

When to take Voriconazole Sandoz

• Take your medicine 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.
• Take your medicine 1 hour before food after a meal

How to take Voriconazole Sandoz

• Swallow the tablets whole with a full glass of water.

How to long to take Voriconazole Sandoz

• 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 or pharmacist recommends. 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 use Voriconazole Sandoz

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 dose 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 take too much Voriconazole Sandoz

If you think that you have take too much Voriconazole Sandoz, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

Symptoms of an overdose may include upset stomach, diarrhoea, headache and sensitivity to light.

Things you should do

• 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.
• Avoid going out in the sun for long periods of time while you are taking Voriconazole Sandoz. Voriconazole Sandoz can cause sensitivity to sunlight.
• 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 have any blood tests, tell your doctor that you are taking this medicine.
  It may interfere with the results of some tests.

Call your doctor straight away if you:

• notice any changes to your skin while you are taking Voriconazole Sandoz.
• develop a rash or blisters while taking Voriconazole Sandoz. If this rash worsens, Voriconazole Sandoz may need to be stopped.
• suffer from chronic, or long-lasting fatigue, muscle weakness, loss of appetite, weight loss or abdominal pain while on Voriconazole Sandoz.
• notice the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.
• become pregnant while taking Voriconazole Sandoz, tell your doctor immediately. If you are a woman of child-bearing age, you should avoid becoming pregnant while taking Voriconazole Sandoz.

Remind any doctor, dentist or pharmacist you visit that you are using Voriconazole Sandoz.

Things you should not do

• 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.
• Do not use 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 or if their symptoms seem similar to yours.

Driving or using machines

Be careful before you drive or use any machines or tools 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.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

Keep your tablets in the pack until it is time to take them.

If you take the tablets our of the blister pack, they may not keep well.

Store it in a cool dry place below 30°C away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

This medicine is only available with a doctor's prescription.

What Voriconazole Sandoz contains

Do not take this medicine if you are allergic to any of these ingredients.

What Voriconazole Sandoz looks like

Voriconazole Sandoz 50 mg tablets – White to off-white, round, biconvex, film coated tablets with '50' debossed on one side and plain on other side (AUST R 207786).

Voriconazole Sandoz 200 mg tablets – White to off-white, biconvex, capsule shaped film coated tablets with '200' debossed on one side and plain on other side
(AUST R 207785).

Available in blister packs of 56 tablets.

Not all strengths or presentations may be marketed.

Who distributes Voriconazole Sandoz

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Tel: 1800 726 369

This leaflet was revised in June 2023.

*Available from other brand (s).

Published by MIMS August 2023