Istradefylline oral tablets

What is this medication?

ISTRADEFYLLINE (iz TRA de FYE leen) is used in combination with levodopa; carbidopa therapy to treat Parkinson's disease.

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

COMMON BRAND NAME(S): NOURIANZ

What should I tell my care team before I take this medication?

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

• cigarette smoker
• liver disease
• mental illness
• an unusual or allergic reaction to istradefylline, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

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

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 medication?

• certain antibiotics like clarithromycin
• certain medicines for cholesterol like atorvastatin, lovastatin, and simvastatin
• certain medicines for fungal infections like ketoconazole, itraconazole, or posaconazole
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• digoxin
• rifampin
• St. John's wort

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 medication?

Visit your health care professional for regular checks on your progress. Tell your health care professional if your symptoms do not start to get better or if they get worse. Do not stop taking except on your health care professional's advice. You may develop a severe reaction. Your health care professional will tell you how much medicine to take.

There have been reports of increased sexual urges or other strong urges such as gambling while taking this medicine. If you experience any of these while taking this medicine, you should report this to your health care professional as soon as possible.

If you smoke, tell your health care professional if you notice this medicine is not working well for you. Talk to your health care professional if you decide to stop smoking.

Do not become pregnant while taking this medicine. Women should inform their health care professional if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects and harm to an unborn child. Talk to your health care professional for more information.

What side effects may I notice from receiving this medication?

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
• changes in emotions or moods
• hallucinations
• new or increased gambling urges, sexual urges, uncontrollable spending, binge or compulsive eating, or other urges
• uncontrollable movements of the arms, face, head, mouth, neck, or upper body

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

• constipation
• dizziness
• nausea
• trouble sleeping

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 medication?

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.