Posaconazole Gastro-resistant tablet

What is this medicine?

POSACONAZOLE (POE sa KON a zole) is an antifungal medicine. It is used to prevent certain kinds of fungal or yeast infections.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease

• history of irregular heartbeat

• history of low levels of calcium, magnesium, or potassium in the blood

• kidney disease

• liver disease

• an unusual or allergic reaction to posaconazole, antifungals, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Do not cut, crush or chew this medicine. Follow the directions on the prescription label. Take with a full meal or liquid nutritional supplement. Take your medicine at regular intervals. Do not take your medicine more often than directed. Take all of your medicine as directed even if you think you are better. Do not skip doses or stop your medicine early.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 13 years old for selected conditions, precautions do apply.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 12 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• certain medicines for cholesterol like atorvastatin, lomitapide, lovastatin, simvastatin

• certain medicines for irregular heart beat like dofetilide, dronedarone, quinidine

• cisapride

• ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine

• ibrutinib

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• pimozide

• sirolimus

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• antiviral medicines for HIV or AIDS

• certain medicines for anxiety or sleep like alprazolam, midazolam, triazolam

• certain medicines for blood pressure like diltiazem, nifedipine, nicardipine, verapamil

• certain medicines for cancer like vinblastine, vincristine

• certain medicines for diabetes like glipizide

• certain medicines for seizures like phenytoin

• digoxin

• medicines that lower your chance of fighting infection like cyclosporine, tacrolimus

• metoclopramide

• other medicines for fungal infections

• rifabutin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for regular check ups. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. Some fungal infections can take many weeks or months of treatment to cure.

If you get severe diarrhea or vomiting tell your doctor right away. You may not get your full dose of medicine if you are sick.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• dark urine

• diarrhea and/or vomiting

• fever

• irregular heartbeat, chest pain

• pale stools

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• swelling in feet, ankles, legs

• tingling hands, feet

• unusual bruising or bleeding

• unusually weak or tired

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• dizziness

• headache

• loss of appetite

• nausea

• stomach upset, bloating

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Posaconazole Oral suspension

What is this medicine?

POSACONAZOLE (POE sa KON a zole) is an antifungal medicine. It is used to treat or prevent certain kinds of fungal or yeast infections.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease

• history of irregular heartbeat

• history of low levels of calcium, magnesium, or potassium in the blood

• kidney disease

• liver disease

• an unusual or allergic reaction to posaconazole, antifungals, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Shake well before using. Take with a full meal or liquid nutritional supplement. Use a specially marked spoon or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Take your medicine at regular intervals. Do not take your medicine more often than directed. Take all of your medicine as directed even if you think you are better. Do not skip doses or stop your medicine early.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 13 years old for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• certain medicines for cholesterol like atorvastatin, lomitapide, lovastatin, simvastatin

• certain medicines for irregular heart beat like dofetilide, dronedarone, quinidine

• cisapride

• ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine

• ibrutinib

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• pimozide

• sirolimus

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• antiviral medicines for HIV or AIDS

• certain medicines for anxiety or sleep like alprazolam, midazolam, triazolam

• certain medicines for blood pressure like diltiazem, nifedipine, nicardipine, verapamil

• certain medicines for cancer like vinblastine, vincristine

• certain medicines for diabetes like glipizide

• certain medicines for seizures like phenytoin

• certain medicines for stomach problems like cimetidine

• digoxin

• medicines that lower your chance of fighting infection like cyclosporine, tacrolimus

• metoclopramide

• other medicines for fungal infections

• rifabutin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for regular check ups. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. Some fungal infections can take many weeks or months of treatment to cure.

If you get severe diarrhea or vomiting tell your doctor right away. You may not get your full dose of medicine if you are sick.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• dark urine

• diarrhea and/or vomiting

• fever

• irregular heartbeat, chest pain

• pale stools

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• swelling in feet, ankles, legs

• tingling hands, feet

• unusual bruising or bleeding

• unusually weak or tired

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• dizziness

• headache

• loss of appetite

• nausea

• stomach upset, bloating

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Throw away any unused medicine after the expiration date.

Posaconazole Solution for injection

What is this medicine?

POSACONAZOLE (POE sa KON a zole) is an antifungal medicine. It is used to prevent certain kinds of fungal or yeast infections.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease

• history of irregular heartbeat

• history of low levels of calcium, magnesium, or potassium in the blood

• kidney disease

• liver disease

• an unusual or allergic reaction to posaconazole, antifungals, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• certain medicines for cholesterol like atorvastatin, lovastatin, simvastatin, lomitapide

• certain medicines for irregular heart beat like dofetilide, dronedarone, quinidine

• cisapride

• ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine

• ibrutinib

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• pimozide

• sirolimus

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• antiviral medicines for HIV or AIDS

• certain medicines for anxiety or sleep like alprazolam, midazolam, triazolam

• certain medicines for blood pressure like diltiazem, nifedipine, nicardipine, verapamil

• certain medicines for cancer like vinblastine, vincristine

• certain medicines for diabetes like glipizide

• certain medicines for seizures like phenytoin

• digoxin

• medicines that lower your chance of fighting infection like cyclosporine, tacrolimus

• metoclopramide

• other medicines for fungal infections

• rifabutin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• dark urine

• diarrhea and/or vomiting

• fever

• irregular heartbeat, chest pain

• pale stools

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• swelling in feet, ankles, legs

• tingling hands, feet

• unusual bruising or bleeding

• unusually weak or tired

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• dizziness

• headache

• loss of appetite

• nausea

• stomach upset, bloating

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

This drug is usually given in a hospital or clinic and will not be stored at home.

In rare cases, this medicine may be given at home. If you are using this medicine at home, you will be instructed on how to store this medicine. Throw away any unused medicine after the expiration date on the label.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.