Asenapine sublingual tablets

What is this medicine?

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

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Leave the tablet in the sealed blister pack until you are ready to take it. With dry hands, open the blister and gently remove the tablet. If the tablet breaks or crumbles, throw it away and take a new tablet out of the blister pack. Place the tablet in the mouth under the tongue and allow it to dissolve, and then swallow. The tablet will dissolve quickly. Do not cut, crush, or chew this medicine. 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.

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.

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

• fast, irregular heartbeat

• fever or chills, sore throat

• inability to keep still

• mouth sores, blisters, peeling or swelling inside the mouth

• problems with balance, talking, walking

• seizures

• signs and symptoms of high blood sugar such as being more thirsty or hungry or having to urinate more than normal. You may also feel very tired or have blurry vision

• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired

• signs and symptoms of neuroleptic malignant syndrome like confusion; fast or irregular heartbeat; high fever; increased sweating; stiff muscles

• sudden numbness or weakness of the face, arm, or leg

• trouble swallowing

• uncontrollable movements of the arms, face, head, mouth, neck, or upper body

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

• changes in taste

• constipation

• diarrhea

• drowsiness

• dry mouth

• tingling, numbness in the mouth

• upset stomach

• weight gain

What may interact with this medicine?

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

• cisapride

• dronedarone

• metoclopramide

• pimozide

• thioridazine

This medicine may also interact with the following medications:

• alcohol

• antihistamines for allergy, cough, and cold

• certain medicines for sleep or anxiety

• certain medicines for blood pressure, heart disease, irregular heart beat

• certain medicines for depression like amitriptyline, imipramine, fluoxetine, sertraline

• certain medicines for Parkinson's disease like levodopa

• certain medicines for seizures like carbamazepine, phenobarbital, primidone

• ciprofloxacin

• enoxacin

• fluvoxamine

• general anesthetics like halothane, isoflurane, methoxyflurane, propofol

• medicines that relax muscles for surgery

• narcotic medicines for pain

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

• paroxetine

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine

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.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medicine in the original container. Throw away any unused medicine after the expiration date.

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

• difficulty swallowing

• heart disease

• history of irregular heartbeat

• history of stroke

• low blood pressure

• liver disease

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

• Parkinson's disease

• seizures

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

• pregnant or trying to get pregnant

• breast-feeding

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 increase blood sugar. Ask your healthcare provider if changes in diet or medicines are needed if you have diabetes.

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.