Uses of Posaconazole Oral Suspension:

• It is used to treat fungal infections.
• It is used to prevent fungal infections.

What do I need to tell my doctor BEFORE I take Posaconazole Oral Suspension?

• If you have an allergy to posaconazole or any other part of posaconazole oral suspension.
• If you are allergic to posaconazole oral suspension; any part of posaconazole oral suspension; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have kidney disease.
• If you have any of these health problems: Low calcium levels, low magnesium levels, or low potassium levels.
• If you are taking any of these drugs: Atorvastatin, dihydroergotamine, ergonovine, ergotamine, lovastatin, methylergonovine, phenytoin, pimozide, quinidine, rifabutin, simvastatin, or sirolimus.
• If you are taking any of these drugs: Cimetidine or esomeprazole.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with posaconazole oral suspension.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take posaconazole oral suspension with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Posaconazole Oral Suspension?

• Tell all of your health care providers that you take posaconazole oral suspension. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Do not use longer than you have been told. A second infection may happen.
• This medicine interacts with many other drugs. The chance of side effects may be raised or how well posaconazole oral suspension works may be lowered. Check with your doctor and pharmacist to make sure that it is safe for you to take posaconazole oral suspension with all of your other drugs (prescription or OTC, natural products, vitamins).
• If you are taking vinblastine, vincristine, or vinorelbine, talk with your doctor. Very bad nerve problems like seizures; burning, numbness, and tingling; and a type of bowel block have happened when posaconazole oral suspension was used with vincristine.
• If you are throwing up or have diarrhea, posaconazole oral suspension may not work as well. Talk with your doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking posaconazole oral suspension, call your doctor right away.

How is this medicine (Posaconazole Oral Suspension) best taken?

Use posaconazole oral suspension as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take posaconazole oral suspension with a full meal.
• If you are not able to eat a full meal, take posaconazole oral suspension with a liquid nutrition supplement or an acidic carbonated drink like ginger ale. If you are not able to drink these drinks, talk with your doctor.
• Shake well before use.
• Measure liquid doses carefully. Use the measuring device that comes with posaconazole oral suspension.
• Keep taking posaconazole oral suspension as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Shortness of breath.
• Swelling in the arms or legs.
• Fever or chills.
• Sore throat.
• Nosebleed.
• Any unexplained bruising or bleeding.
• Vaginal bleeding that is not normal.
• Feeling very tired or weak.
• Mouth irritation or mouth sores.
• A type of abnormal heartbeat (prolonged QT interval) has happened with posaconazole oral suspension. Sometimes, this has led to another type of unsafe abnormal heartbeat (torsades de pointes). Call your doctor right away if you have a fast or abnormal heartbeat, or if you pass out.
• Very bad and sometimes deadly liver problems have happened with posaconazole oral suspension. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

What are some other side effects of Posaconazole Oral Suspension?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Feeling tired or weak.
• Stomach pain or diarrhea.
• Constipation.
• Upset stomach or throwing up.
• Cough.
• Not hungry.
• Dizziness.
• Joint pain.
• Back pain.
• Trouble sleeping.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Posaconazole Oral Suspension?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Do not freeze.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about posaconazole oral suspension, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.