Haloperidol Decanoate Suspension for injection

What is this medicine?

HALOPERIDOL (ha loe PER i dole) helps to treat schizophrenia. It can help you to keep in touch with reality and reduce your mental problems.

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:

• dementia
• head injury
• heart disease
• irregular heartbeat
• low or high levels of electrolytes in the blood
• lung disease
• Parkinson's disease
• thyroid disease
• an unusual or allergic reaction to haloperidol, tartrazine, 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 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?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

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

• arsenic trioxide
• certain antibiotics like grepafloxacin and sparfloxacin
• cisapride
• droperidol
• levomethadyl
• medicines for malaria like chloroquine and halofantrine
• medicines to control heart rate
• methadone
• pentamidine
• pimozide
• ranolazine
• risperidone
• ziprasidone

This medicine may also interact with the following medications:

• alcohol
• atropine
• benztropine
• cabergoline
• dicyclomine
• levodopa or other medicines for Parkinson's disease
• lithium
• medicines for hay fever and other allergies
• prescription pain medicines
• warfarin

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 a few weeks before you see the full effects of this medicine.

You may get dizzy or drowsy or have blurred vision. 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 can increase dizziness and drowsiness. Avoid alcoholic drinks.

Do not treat yourself for colds, diarrhea or allergies. Ask your doctor or health care professional for advice, some nonprescription medicines may increase possible side effects.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

Avoid extreme heat or cold. This medicine can stop you sweating and increase your body temperature. It can also make your body unable to stand extreme cold. Avoid hot baths and saunas. Be careful about exercising especially in hot weather. Dress warmly in cold weather and do not stay out long in the cold.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

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
• breast pain or swelling or unusual production of breast milk
• breathing problems
• chest pain
• confusion
• fast, irregular, pounding heartbeat
• feeling faint or lightheaded, falls
• fever, chills, or sore throat
• hot, dry skin or lack of sweating
• problems with balance, talking, walking
• seizures
• stiffness, spasms, trembling
• trouble passing urine or change in the amount of urine
• uncontrollable head, mouth, neck, arm, or leg movements
• unusually weak or tired

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

• anxiety or agitation
• change in sex drive or performance
• constipation or diarrhea
• menstrual changes
• nausea or vomiting
• 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?

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.