Paliperidone Oral tablet,...

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
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
carbamazepine
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
rifampin
St. John's Wort
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?

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.

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.