Asenapine Sublingual tablet

What is this medicine?

ASENAPINE (a SEN a peen) is used to treat schizophrenia and bipolar disorder.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• dementia

• diabetes or a family history of diabetes

• heart disease

• history of breast cancer

• irregular heartbeat or low blood pressure

• liver disease

• low blood counts, like low white cell, platelet, or red cell counts

• Parkinson's disease

• seizures

• suicidal thoughts, plans, or attempt by you or a family member

• an unusual or allergic reaction to asenapine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Leave the tablet in the package until you are ready to take it. Do not push the tablet through the tablet pack. Peel back the colored tab with dry hands, gently remove the tablet, and place the tablet under your tongue. The tablet will dissolve quickly and be swallowed in your saliva. Do not chew, crush, or swallow the tablet. Do not eat or drink for 10 minutes after taking a dose. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 10 years for selected conditions, precautions do apply.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• certain antibiotics like gatifloxacin, moxifloxacin

• certain medicines for irregular heartbeat like amiodarone, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, quinidine, sotalol

• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole

• chlorpromazine

• cisapride

• pimozide

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• alcohol

• carbamazepine

• certain medicines for anxiety or sleep

• certain medicines for blood pressure

• certain medicines for Parkinson's disease like levodopa

• cimetidine

• fluvoxamine

• imipramine or other tricyclic antidepressants

• other medicines for schizophrenia

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• paroxetine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. It may be several weeks before you see the full effects of this medicine. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. Tell your doctor or healthcare professional if you feel out of control, very discouraged or think you might harm yourself or others.

Do not suddenly stop taking this medicine. You may need to gradually reduce the dose. Ask your doctor or health care professional for advice.

You may get dizzy or drowsy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can increase dizziness and drowsiness. Avoid alcoholic drinks.

This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water will help.

This medicine can reduce the response of your body to heat or cold. Dress warm in cold weather and stay hydrated in hot weather. If possible, avoid extreme temperatures like saunas, hot tubs, very hot or cold showers, or activities that can cause dehydration such as vigorous exercise.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• confusion

• fainting spells

• fast or irregular heartbeat

• fever or chills, sore throat

• inability to control muscle movements in the face, mouth, hands, arms, or legs

• increased hunger or thirst

• increased urination

• restlessness or need to keep moving

• seizures

• stiffness, spasms, trembling

• ulcers, blisters, peeling/sloughing, or swelling in the mouth

• unusually weak or tired

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• constipation

• drowsiness or dizziness

• dry mouth

• nausea, vomiting

• weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.