Uses of Fanapt Titration Pack:

• It is used to treat schizophrenia.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Fanapt Titration Pack?

• If you have an allergy to iloperidone or any other part of Fanapt Titration Pack (iloperidone).
• If you are allergic to Fanapt Titration Pack (iloperidone); any part of Fanapt Titration Pack (iloperidone); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have ever had a long QT on ECG or other heartbeat that is not normal.
• If you have had a recent heart attack.
• If you have heart failure (weak heart).
• If you have liver disease.
• If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
• If you are breast-feeding. Do not breast-feed while you take Fanapt Titration Pack (iloperidone).

This is not a list of all drugs or health problems that interact with Fanapt Titration Pack (iloperidone).

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 Fanapt Titration Pack (iloperidone) 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 Fanapt Titration Pack?

• Tell all of your health care providers that you take Fanapt Titration Pack (iloperidone). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Fanapt Titration Pack (iloperidone) affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• It may take several weeks to see the full effects.
• High blood sugar or diabetes, high cholesterol, and weight gain have happened with drugs like this one. These may raise the chance of heart and brain blood vessel disease.
• Check your blood sugar as you have been told by your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Avoid drinking alcohol while taking Fanapt Titration Pack (iloperidone).
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• Dizziness, sleepiness, and feeling less stable may happen with Fanapt Titration Pack (iloperidone). These may lead to falling, which can cause broken bones or other health problems.
• This medicine may cause a very bad and sometimes deadly heartbeat that is not normal (long QT on ECG, torsades de pointes). Sometimes, this has happened in people who are not at risk for these health problems. Talk with the doctor.
• Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of infection. Rarely, infections have been deadly. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.
• A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.
• If you are 65 or older, use Fanapt Titration Pack (iloperidone) with care. You could have more side effects.
• Older adults with dementia taking drugs like this one have had a higher number of strokes. Sometimes these have been deadly. This medicine is not approved to treat mental problems caused by dementia.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Fanapt Titration Pack (iloperidone) while you are pregnant.
• Taking Fanapt Titration Pack (iloperidone) in the third trimester of pregnancy may lead to uncontrolled muscle movements and withdrawal in the newborn.

How is this medicine (Fanapt Titration Pack) best taken?

Use Fanapt Titration Pack (iloperidone) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Keep taking Fanapt Titration Pack (iloperidone) as you have been told by your doctor or other health care provider, even if you feel well.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.

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.
• If you miss 3 days of Fanapt Titration Pack (iloperidone), call your doctor to find out what to do.

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 high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• If you are planning to harm yourself or the want to harm yourself gets worse.
• Dizziness or passing out.
• A heartbeat that does not feel normal.
• A fast heartbeat.
• Change in how you act.
• Mood changes.
• Shakiness, trouble moving around, or stiffness.
• Not able to pass urine or change in how much urine is passed.
• Trouble swallowing.
• Seizures.
• Shortness of breath.
• Enlarged breasts.
• Not able to get or keep an erection.
• Nipple discharge.
• For women, no period.
• Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.
• Some people may get a severe muscle problem called tardive dyskinesia. This problem may lessen or go away after stopping Fanapt Titration Pack (iloperidone), but it may not go away. The risk is greater with diabetes and in older adults, especially older women. The risk is greater with longer use or higher doses, but it may also occur after short-term use with low doses. Call your doctor right away if you have trouble controlling body movements or problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.

What are some other side effects of Fanapt Titration Pack?

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:

• Upset stomach.
• Weight gain.
• Dry mouth.
• Feeling sleepy.
• Feeling tired or weak.
• Stuffy nose.
• Diarrhea.

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 Fanapt Titration Pack?

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• 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 Fanapt Titration Pack (iloperidone), 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.