Paliperidone Oral tablet, extended-release

What is this medicine?

PALIPERIDONE (pal ee PER i done) is used to treat schizophrenia and schizoaffective disorder.

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:

• chronic constipation or diarrhea

• dementia

• diabetes or family history of diabetes

• history of stroke

• irregular heartbeat or low blood pressure

• kidney disease

• liver disease

• stomach problems like adhesions, bowel disease, short gut, trouble swallowing

• an unusual or allergic reaction to paliperidone, risperidone, 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 with a glass of water. Follow the directions on the prescription label. Do not chew, crush, or cut the tablets. You can take this medicine with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your prescriber's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 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:

• bepridil

• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole

• cisapride

• dofetilide

• dronedarone

• droperidol

• grepafloxacin

• halofantrine

• levomethadyl

• phenothiazines like chlorpromazine, mesoridazine, thioridazine

• pimozide

• sertindole

• sparfloxacin

• ziprasidone

This medicine may also interact with the following medications:

• abarelix

• alcohol

• alfuzosin

• certain antibiotics like clarithromycin, erythromycin, gemifloxacin, levofloxacin, pentamidine, rifampin

• certain medicines for anxiety, depression, or psychotic disturbances

• certain medicines for blood pressure

• certain medicines for cancer like daunorubicin, doxorubicin, vorinostat

• certain medicines for irregular heart beat

• certain medications for Parkinson's disease like levodopa

• certain medicines for seizures like carbamazepine

• certain medicines for sleep

• chloroquine

• cyclobenzaprine

• dolasetron

• lithium

• local anesthetics

• narcotic pain medicines

• octreotide

• ondansetron

• other medicines for schizophrenia

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

• St. John's Wort

• tramadol

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 or health care professional for regular checks on your progress. It may be several weeks before you see the full effects. Do not suddenly stop taking this medicine. You may need to gradually reduce the dose. Only stop taking this medicine on the advice of your doctor or health care professional.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

This medicine can reduce the response of your body to heat or cold. Dress warm in cold weather and stay hydrated in hot weather. If possible, avoid extreme temperatures like saunas, hot tubs, very hot or cold showers, or activities that can cause dehydration such as vigorous exercise.

The tablet shell for some brands of this medicine does not dissolve. This is normal. The tablet shell may appear whole in the stool. This is not a cause for concern.

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

• change in blood sugar

• changes in vision

• confusion

• dark urine

• fast or irregular heartbeat

• feeling faint or lightheaded, falls

• fever or chills, sore throat

• increased thirst or hunger

• inner restlessness, unable to keep still

• men: prolonged or painful erection

• muscle pain, stiffness

• trouble passing urine or change in the amount of urine

• unusual movements, spasms, tremor

• unusual decrease in sweating

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

• change in sex drive or performance

• cough

• drowsiness

• dry mouth

• headache

• menstrual irregularity

• more or less saliva than normal

• nausea

• stomach upset

• weight gain

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). Protect from moisture. Throw away any unused medicine after the expiration date.

Paliperidone palmitate Suspension for injection

What is this medicine?

PALIPERIDONE (pal ee PER i done) injection is either given as a once-monthly injection (Invega Sustenna) for the treatment of schizophrenia and schizoaffective disorder or as an injection every 3 months (Invega Trinza) for the treatment of schizophrenia.

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:

• chronic constipation or diarrhea

• dementia

• diabetes or family history of diabetes

• history of stroke

• irregular heartbeat or low blood pressure

• kidney disease

• liver disease

• stomach problems like adhesions, bowel disease, short gut, trouble swallowing

• an unusual or allergic reaction to paliperidone, risperidone, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection into a muscle. 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?

Try to keep all appointments for your injections. This medicine is given either once every 4 weeks or once every 3 months depending on which type of injection your doctor has prescribed for you. Contact your health care provider for instructions if you miss an appointment.

What may interact with this medicine?

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

• bepridil

• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole

• cisapride

• dofetilide

• dronedarone

• droperidol

• grepafloxacin

• halofantrine

• levomethadyl

• phenothiazines like chlorpromazine, mesoridazine, thioridazine

• pimozide

• sertindole

• sparfloxacin

• ziprasidone

This medicine may also interact with the following medications:

• abarelix

• alcohol

• alfuzosin

• certain antibiotics like clarithromycin, erythromycin, gemifloxacin, levofloxacin, pentamidine, rifampin

• certain medicines for anxiety, depression, or psychotic disturbances

• certain medicines for blood pressure

• certain medicines for cancer like daunorubicin, doxorubicin, vorinostat

• certain medicines for irregular heart beat

• certain medications for Parkinson's disease like levodopa

• certain medicines for seizures like carbamazepine

• certain medicines for sleep

• chloroquine

• cyclobenzaprine

• dolasetron

• lithium

• local anesthetics

• narcotic pain medicines

• octreotide

• ondansetron

• other medicines for schizophrenia

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

• St. John's Wort

• tramadol

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. It may be several weeks before you see the full effects. Do not stop this medicine except on the advice of your doctor or health care professional.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

This medicine can reduce the response of your body to heat or cold. Dress warm in cold weather and stay hydrated in hot weather. If possible, avoid extreme temperatures like saunas, hot tubs, very hot or cold showers, or activities that can cause dehydration such as vigorous exercise.

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

• change in blood sugar

• changes in vision

• confusion

• dark urine

• fast or irregular heartbeat

• feeling faint or lightheaded, falls

• fever or chills, sore throat

• increased thirst or hunger

• inner restlessness, unable to keep still

• men: prolonged or painful erection

• muscle pain, stiffness

• redness or swelling at the injection site

• trouble passing urine or change in the amount of urine

• unusual decrease in sweating

• unusual movements, spasms, tremor

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

• change in sex drive or performance

• cough

• drowsiness

• dry mouth

• headache

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?

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