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:

• kidney disease
• liver disease
• take an ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine
• take astemizole, cisapride, halofantrine, pimozide, quinidine, or terfenadine
• 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:

• cisapride
• ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine
• pimozide
• quinidine
• red yeast rice
• sirolimus

This medicine may also interact with the following medications:

• atazanavir
• cimetidine
• cyclosporine
• digoxin
• efavirenz
• medicines for blood pressure like amlodipine, diltiazem, verapamil
• midazolam
• phenytoin, fosphenytoin
• rifabutin
• ritonavir-some medicines for anxiety or sleep like alprazolam, clorazepate, flurazepam, midazolam, triazolam
• some medicines for cancer like vinblastine, vincristine
• some medicines for cholesterol like atorvastatin, cerivastatin, lovastatin, simvastatin
• tacrolimus

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
• 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.

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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.