longation). Certain medicines used to treat fungus called azoles, including posaconazole, the active ingredient in Noxafil, may cause heart rhythm problems. People who have certain heart problems or who take certain medicines have a higher chance for this problem. Tell your healthcare provider right away if your heartbeat becomes fast or irregular.
• liver problems. Some people who also have other serious medical problems may have severe liver problems that may lead to death, especially if you take certain doses of Noxafil. Your healthcare provider should do blood tests to check your liver while you are taking Noxafil. Call your healthcare provider right away if you have any of the following symptoms of liver problems:◦itchy skin
◦nausea or vomiting
◦yellowing of your eyes
◦feeling very tired
◦flu-like symptoms
• increased amounts of midazolam in your blood. If you take Noxafil with midazolam, Noxafil increases the amount of midazolam in your blood. This can make your sleepiness last longer. Your healthcare provider should check you closely for side effects if you take midazolam with Noxafil.
The most common side effects of Noxafil Delayed-Release Tablets include:
•diarrhea
•fever
•nausea
The most common side effects of Noxafil Oral Suspension include:
•diarrhea
•nausea
•headache
•vomiting
•fever
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 Noxafil. 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 Noxafil?
•Store Noxafil at room temperature between 68°F to 77°F (20°C to 25°C).
•Keep Noxafil delayed-release tablets in a tightly closed container.
• Do not freeze Noxafil oral suspension.
•Safely throw away medicine that is out of date or no longer needed.
Keep Noxafil and all medicines out of the reach of children.
General information about the safe and effective use of Noxafil.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Noxafil for a condition for which it was not prescribed. Do not give Noxafil 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 Noxafil. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about Noxafil that is written for health care professionals.
For more information, go to www.noxafil.com or call 1-800-672-6372.
What are the ingredients in Noxafil?
Active ingredient: posaconazole
• Noxafil Delayed-Release Tablets:
Inactive ingredients: hypromellose acetate succinate, microcrystalline cellulose, hydroxypropylcellulose, silicon dioxide, croscarmellose sodium, magnesium stearate, and Opadry® II Yellow (consists of the following ingredients: polyvinyl alcohol partially hydrolyzed, Macrogol/PEG 3350, titanium dioxide, talc, and iron oxide |
