Uses of Asenapine Sublingual Tablets:

• It is used to treat schizophrenia.
• It is used to treat bipolar problems.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Asenapine Sublingual Tablets?

• If you have an allergy to asenapine or any other part of this medicine (asenapine sublingual tablets).
• If you are allergic to this medicine (asenapine sublingual tablets); any part of this medicine (asenapine sublingual tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Liver problems, low magnesium levels, low potassium levels, or slow heartbeat.
• If you have ever had a long QT on ECG or other heartbeat that is not normal.
• If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.

This is not a list of all drugs or health problems that interact with this medicine (asenapine sublingual tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (asenapine sublingual tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Asenapine Sublingual Tablets?

• Tell all of your health care providers that you take this medicine (asenapine sublingual tablets). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (asenapine sublingual tablets) affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of infection. Rarely, infections have been deadly. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• High blood sugar or diabetes, high cholesterol, and weight gain have happened with drugs like this one. These may raise the chance of heart and brain blood vessel disease.
• Check your blood sugar as you have been told by your doctor.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• Dizziness, sleepiness, and feeling less stable may happen with this medicine (asenapine sublingual tablets). These may lead to falling, which can cause broken bones or other health problems.
• Older adults with dementia taking drugs like this one have had a higher number of strokes. Sometimes these have been deadly. This medicine is not approved to treat mental problems caused by dementia.
• If you are 65 or older, use this medicine (asenapine sublingual tablets) with care. You could have more side effects.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
• Taking this medicine (asenapine sublingual tablets) in the third trimester of pregnancy may lead to uncontrolled muscle movements and withdrawal in the newborn.

How is this medicine (Asenapine Sublingual Tablets) best taken?

Use this medicine (asenapine sublingual tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Wash and dry your hands before you take this medicine (asenapine sublingual tablets). Do not touch the tablet with wet or damp hands.
• Do not take this medicine (asenapine sublingual tablets) out of the blister pack until you are ready to take it. Take this medicine (asenapine sublingual tablets) right away after opening the blister pack. Do not store the removed drug for future use.
• Place tablet under the tongue and let dissolve.
• Do not swallow whole. Do not chew, break, or crush.
• Do not eat or drink for at least 10 minutes after taking this medicine (asenapine sublingual tablets).
• Keep taking this medicine (asenapine sublingual tablets) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Fast, slow, or abnormal heartbeat.
• Shortness of breath.
• Very bad dizziness or passing out.
• Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
• Mouth irritation or mouth sores.
• Seizures.
• Enlarged breasts, nipple discharge, not able to get or keep an erection (in males), or period (menstrual) changes (in females).
• A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.
• Some people may get a severe muscle problem called tardive dyskinesia. This problem may lessen or go away after stopping this medicine (asenapine sublingual tablets), but it may not go away. The risk is greater with diabetes and in older adults, especially older women. The risk is greater with longer use or higher doses, but it may also occur after short-term use with low doses. Call your doctor right away if you have trouble controlling body movements or problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.

What are some other side effects of Asenapine Sublingual Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling dizzy, sleepy, tired, or weak.
• Headache.
• Restlessness.
• Upset stomach or throwing up.
• More hungry.
• Weight gain.
• Trouble sleeping.
• Constipation.
• Numbness or tingling in the mouth.
• Change in taste.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Asenapine Sublingual Tablets?

• Store at room temperature in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (asenapine sublingual tablets), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.