Paliperidone Palmitate Prefilled Syringe 312 mg/mL (3.5 mL) (PALIPERIDONE 3 MONTH - INTRAMUSCULAR INJECTION)

Instructions

This medicine is given as an injection into a muscle.

This medicine should be given by a trained health care provider.

Tell your doctor if you have severe or persistent sweating, diarrhea or vomiting. These can increase your risk of a serious side effect.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you miss a dose, contact your doctor for instructions.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

This medicine may cause higher blood sugar levels or diabetes. Please follow your doctor's instructions and check your blood sugar level regularly while on this medicine.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this medicine.

This medicine may cause dizziness or fainting. Do not stand or sit up quickly.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

If possible, avoid using with alcohol, marijuana, or other medicines that can cause dizziness or drowsiness. These include allergy/cold products, muscle relaxers, sleep aids, and pain relievers.

Avoid becoming overheated during exercise or other activities. Try to stay cool in hot weather.

Call the doctor if there are any signs of confusion or unusual changes in behavior.

This medicine passes into breast milk. Ask your doctor before breastfeeding.

If you have a painful erection or an erection for more than 4 hours, seek medical care right away.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• dizziness or drowsiness
• lack of energy and tiredness
• high blood sugar
• pain, redness, swelling near injection
• restlessness
• weight gain

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• breast pain or swelling
• breathing interruption during sleep
• confusion
• fainting
• high fever
• swelling in the neck or throat
• fast, irregular, or slow heartbeat
• uncontrollable movement of face, tongue, arms or legs
• muscle aches, spasms or abnormal movements
• muscle pain or weakness
• seizures
• problems with sexual functions or desire
• shakiness
• shortness of breath
• difficulty swallowing
• sweating
• persistent or unusual thirst
• unusual or unexplained tiredness or weakness
• increased urinary frequency
• dark urine

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.