When This Medicine Should Not Be Used:
You should not receive this medicine if you have had an allergic reaction to fluphenazine or a phenothiazine (such as Compazine®, Phenergan®, Thorazine®,or Serentil®). You should not receive this medicine if you have liver disease or a blood disorder, or if you are using large doses of medicines that make you sleepy. This medicine should not be given to a child younger than 12 years old.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin or into a muscle.
• A nurse or other health provider will give you this medicine.
• A single shot of this medicine may last as long as 4 weeks. Make sure you keep all doctor's appointments.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using atropine, or pain or arthritis medicine (such as aspirin, ibuprofen, Advil®, Aleve®, Motrin®, Orudis®).
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have liver disease, kidney disease or pheochromocytoma (tumor of the adrenal gland). Tell your doctor if you have a history of seizures.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• Make sure your doctor knows if you are exposed to extreme heat or insecticides.
• Make sure any doctor who treats you knows that you are using this medicine. This medicine may affect the results of pregnancy tests.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision or headache.
• Change in how much or how often you urinate.
• Dark-colored urine or pale stools.
• Fast heartbeat.
• Fever, sweating, confusion, uneven heartbeat, muscle stiffness.
• Light-headedness or fainting.
• Nausea, vomiting, loss of appetite, pain in your upper stomach.
• Problems with balance, walking, or speech.
• Swelling in your hands, ankles, or feet.
• Twitching or muscle movements you cannot control (often in your eyes, tongue, arems, legs, jaw, neck or upper body).
• Unusual bleeding, bruising, or weakness.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Constipation.
• Dry mouth.
• Excessive salivation.
• Loss of appetite or change in your weight.
• Menstrual pain or irregularity.
• Mild skin rash or discoloration.
• Muscle cramps.
• Runny or stuffy nose.
• Trouble having sex (in men).

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088