What are Ortrex® voriconazole 200mg tablets?

Ortrex® Voriconazole tablets are a prescription medicine used to treat certain serious fungal infections in your blood and body. These infections are called “aspergillosis,” “esophageal candidiasis,” “Scedosporium,” “Fusarium” and “candidemia”.
It is not known if voriconazole tablets are safe and effective in children younger than 12 years old.

Do not take voriconazole tablets if you:

are allergic to voriconazole or any of the ingredients in voriconazole tablets: See the end of this leaflet for a     complete list of ingredients in voriconazole tablets.
are taking any of the following medicines:

• cisapride
• pimozide
• quinidine
• sirolimus
• rifampin
• carbamazepine
• long-acting barbiturates like phenobarbital
• ritonavir
• rifabutin
• ergotamine, dihydroergotamine (ergot alkaloids)
• St. John’s Wort (herbal supplement)

    Ask your healthcare provider or pharmacist if you are not sure if you are taking any of the medicines listed above.
    Do not start taking a new medicine without talking to your healthcare provider or pharmacist.

What should I tell my healthcare provider before taking voriconazole tablets?

Before you take voriconazole tablets, tell your healthcare provider if you:
have or ever had an abnormal heart rate or rhythm. Your healthcare provider may order a test to check your heart     (EKG) before starting voriconazole tablets.
have liver or kidney problems. Your healthcare provider may do blood tests to make sure you can take voriconazole     tablets.
have trouble digesting dairy products, lactose (milk sugar). Voriconazole tablets contain lactose.
are pregnant or plan to become pregnant. Voriconazole tablets can harm your unborn baby. Talk to your healthcare     provider if you are pregnant or plan to become pregnant. Women who can become pregnant should use effective birth     control while taking voriconazole tablets.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Voriconazole tablets may affect the way other medicines work and other medicines may affect how voriconazole works.

Know what medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I take voriconazole tablets?

Take voriconazole tablets exactly as your healthcare provider tells you to.
Take voriconazole tablets at least one hour before or at least one hour after meals.
If you take too much voriconazole, call your healthcare provider or go to the nearest hospital emergency room.

What should I avoid while taking voriconazole tablets?

You should not drive at night while taking voriconazole tablets. Voriconazole tablets can cause changes in your vision     such as blurring or sensitivity to light.
Do not drive or operate machinery, or do other dangerous activities until you know how voriconazole tablets affect you.
Avoid direct sunlight. Voriconazole tablets can make your skin sensitive to the sun and the light from sunlamps and     tanning beds. You could get a severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin if you     have to be in sunlight. Talk to your healthcare provider if you get sunburn.

What are possible side effects of voriconazole tablets?

Voriconazole tablets may cause serious side effects including:

• liver problems. Symptoms of liver problems may include:
  • itchy skin
  • yellowing of your eyes
  • feeling very tired
  • flu-like symptoms
  • nausea or vomiting
• vision changes.Symptoms of vision changes may include:
  • blurred vision
  • changes in the way you see colors
  • sensitivity to light (photophobia)
• serious heart problems.Voriconazole tablets may cause changes in your heart rate or rhythm, including your heart stopping (cardiac arrest).
• allergic reactions.Symptoms of an allergic reaction may include:
  • fever
  • sweating
  • feels like your heart is beating fast (tachycardia)
  • chest tightness
  • trouble breathing
  • feel faint
  • nausea
  • itching
  • skin rash
• kidney problems. Voriconazole tablets may cause new or worse problems with kidney function, including kidney failure. Your healthcare provider should check your kidney function while you are taking voriconazole tablets. Your healthcare provider will decide if you can keep taking voriconazole tablets.
• serious skin reactions. Symptoms of serious skin reactions may include:
  • rash or hives
  • mouth sores
  • blistering or peeling of your skin
  • trouble swallowing or breathing

Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above.

The most common side effects of voriconazole tablets include:

• vision changes
• rash
• vomiting
• nausea
• headache
• fast heart beat (tachycardia)
• hallucinations (seeing or hearing things that are not there)
• abnormal liver function tests

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of voriconazole tablets. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store voriconazole tablets?

• Store voriconazole tablets at room temperature, 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not refrigerate or freeze.
• Keep voriconazole tablets in a tightly closed container.
• Safely throw away medicine that is out of date or no longer needed.
• Keep voriconazole tablets, as well as all other medicines, out of the reach of children.

Medicines are sometimes prescribed for purposs other than those listed in a Patient Information leaflet. Do not use voriconazole tablets for a condition for which it was not prescribed. Do not give voriconazole tablets to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information Leaflet summarizes the most important information about voriconazole tablets. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about voriconazole tablets that is written for health professionals.

What are the ingredients of voriconazole tablets?

Active ingredient: voriconazole
Inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, titanium dioxide and triacetin.

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