Paliperidone palmitate Suspension for injection

What is this medicine?

PALIPERIDONE (pal ee PER i done) injection is used to treat 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. Usually, this medicine is given every 4 weeks. 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
• cisapride
• droperidol
• grepafloxacin
• halofantrine
• levomethadyl
• pimozide
• sertindole
• some phenothiazines like chlorpromazine, mesoridazine, thioridazine
• sparfloxacin

This medicine may also interact with the following medications:

• abarelix
• alcohol
• alfuzosin
• antibiotics like clarithromycin, erythromycin, gemifloxacin, levofloxacin
• chloroquine
• cyclobenzaprine
• daunorubicin, doxorubicin
• dolasetron
• levodopa and other medications for Parkinson's disease
• lithium
• local anesthetics
• medicines for anxiety, depression or psychotic disturbances
• medicines for blood pressure
• medicines for irregular heartbeat
• medicines for sleep
• medicines for treating seizures
• octreotide
• ondansetron
• other medicines for schizophrenia
• pentamidine
• prescription pain medications
• tramadol
• vorinostat

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.

Avoid extreme heat. This medicine can cause you to sweat less than normal. Your body temperature could increase to dangerous levels, which may lead to heat stroke.

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
• 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.

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.