When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to asenapine.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Dry your hands before you handle the tablet.
• Do not open the blister pack that contains the tablet until you are ready to take the medicine. Peel back the foil, then remove the tablet. Do not push the tablet through the foil.
• Place the tablet under your tongue and let it melt. Do not split, crush, chew, or swallow the tablet.
• Do not eat or drink anything for at least 10 minutes after you take this medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

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

• Some medicines can affect how asenapine works. Tell your doctor if you are using any of the following:
  
  • Chlorpromazine, fluvoxamine, gatifloxacin, moxifloxacin, paroxetine, thioridazine, ziprasidone
  • Blood pressure medicine
  • Heart rhythm medicine (including amiodarone, procainamide, quinidine, sotalol)
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, diabetes, high cholesterol, trouble swallowing, or a history of seizures. Tell your doctor if you have a blood vessel or heart problem, including low blood pressure, heart failure, heart rhythm problems, or a history of heart attack or stroke.
• This medicine may cause the following problems:
  
  • Neuroleptic malignant syndrome (NMS), which can be life-threatening
  • Tardive dyskinesia (a movement disorder) that may not go away after you stop using this medicine
  • Heart rhythm changes, such as QT prolongation
  • Increased risk for infections
• This medicine may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you. Stand up slowly. You may feel lightheaded if you get up suddenly from a lying or sitting position.
• You might get overheated while you are taking this medicine. Drink more water during hot weather, and while you exercise.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Fast, slow, pounding, or uneven heartbeat
• Fever, sweating, confusion, muscle stiffness
• Fever, chills, cough, sore throat, and body aches
• Increased hunger or thirst, frequent urination, tiredness, blurred vision
• Jerky muscle movement you cannot control (often in your face, tongue, or jaw), problems with balance or walking
• Lightheadedness, dizziness, drowsiness, or fainting
• Mood or behavior changes, or thoughts of hurting yourself or others
• Numbness or tingling in your mouth or throat, sores or blisters in your mouth
• Seizures, tremors, or twitching

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

• Headache
• Nipple discharge, breast swelling (even in men)
• Weight gain

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