Asenapine is an antipsychotic medicine that is used to treat schizophrenia in adults, and bipolar I disorder in adults and children who are at least 10 years old.

Asenapine may also be used for purposes not listed in this medication guide.

Asenapine is not approved for use in older adults with dementia-related psychosis.

Asenapine is usually taken 2 times per day. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Keep the tablet in its blister pack until you are ready to take the medicine. Using dry hands, gently remove the tablet and place it under your tongue.

Do not swallow the sublingual tablet. Allow it to dissolve under your tongue without chewing.

Do not eat or drink anything for 10 minutes after the tablet has dissolved.

Asenapine may cause you to have high blood sugar (hyperglycemia). Symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, and blurred vision. If you are diabetic, check your blood sugar levels on a regular basis while you are taking asenapine.

Your doctor will need to check your progress while you are using asenapine.

Store at room temperature away from moisture and heat.

You should not use asenapine if you are allergic to it, or if you have:

• severe liver disease.

Asenapine may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Tell your doctor if you have ever had:

• heart problems;

• high blood pressure;

• a heart attack or stroke;

• diabetes (asenapine may raise your blood sugar);

• a seizure;

• liver disease;

• breast cancer;

• trouble swallowing;

• Parkinson's disease;

• low white blood cell (WBC) counts; or

• long QT syndrome (in you or a family member).

Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. If you get pregnant, tell your doctor right away. Do not stop taking asenapine without your doctor's advice.

It may not be safe to breastfeed while using asenapine. Ask your doctor about any risk.

Asenapine should not be given to a child younger than 10 years old. Asenapine is not approved for schizophrenia in anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking asenapine.

Avoid driving or hazardous activity until you know how asenapine will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Get emergency medical help if you have signs of an allergic reaction: hives; fast heartbeats, feeling light-headed; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

High doses or long-term use of asenapine can cause a serious movement disorder that may not be reversible. The longer you use asenapine, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Asenapine may cause serious side effects. Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

• ulcers, blisters, swelling, o peeling in your mouth;

• a light-headed feeling, like you might pass out;

• breast pain or swelling, nipple discharge;

• low white blood cell counts--fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing; or

• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common side effects of asenapine may include:

• dizziness, drowsiness, tiredness;

• feeling restless or agitated;

• numbness or tingling in or around your mouth;

• muscle stiffness, jerky muscle movements;

• nausea, altered sense of taste; or

• increased appetite, weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Taking asenapine with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may affect asenapine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.