Pronunciation: a SEN a peen

Brand: Saphris, Saphris Black Cherry

Saphris 10 mg

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Saphris 5 mg

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What is the most important information I should know about asenapine?

You should not use asenapine if you are allergic to it, or if you have severe liver disease.

Asenapine can cause serious neurologic problems. Stop taking this medicine and call your doctor at once if you have: very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling light-headed, tremors, twitching, or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs.

Asenapine is not approved for use in psychotic conditions related to dementia. Asenapine may increase the risk of death in older adults with dementia-related conditions.

What is asenapine?

Asenapine is an antipsychotic medication. It works by changing the actions of chemicals in the brain.

Asenapine 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.

What should I discuss with my healthcare provider before taking asenapine?

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

  • severe liver disease; or
  • a history of severe allergic reaction to asenapine.

Asenapine is not approved for use in psychotic conditions related to dementia. Asenapine may increase the risk of death in older adults with dementia-related conditions.

To make sure asenapine is safe for you, tell your doctor if you have:

  • liver disease;
  • heart disease, high blood pressure, heart rhythm problems;
  • a history of heart attack or stroke;
  • a history of breast cancer;
  • seizures or epilepsy;
  • diabetes (asenapine may raise your blood sugar);
  • trouble swallowing;
  • Parkinson's disease;
  • a history of low white blood cell (WBC) counts; or
  • a personal or family history of Long QT syndrome.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking asenapine, do not stop taking it without your doctor's advice.

It is not known whether asenapine passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

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.

How should I take asenapine?

Asenapine is usually taken 2 times per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

To take asenapine sublingual (under the tongue) tablets:

  • Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the colored tab from the tablet blister. Do not push a tablet through the blister or you may damage the tablet.
  • Using dry hands, gently remove the tablet and place it under your tongue. Do not crush or break the tablet. It will begin to dissolve right away.
  • Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
  • Swallow several times as the tablet dissolves. 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.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking asenapine?

While you are taking asenapine, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. 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.

Asenapine may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

Avoid drinking alcohol. Dangerous side effects could occur.

What are the possible side effects of asenapine?

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.

Asenapine can cause serious neurologic problems. Stop taking this medicine and call your doctor at once if you have: very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling light-headed, tremors, twitching, or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs.

High doses or long-term use of asenapine can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you take asenapine, the more likely you are to develop a serious movement disorder. The risk of this side effect is higher in women and older adults.

Call your doctor at once if you have:

  • slow heartbeats, a light-headed feeling (like you might pass out);
  • uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
  • sudden weakness or ill feeling, fever, chills, sore throat, swollen gums, painful mouth sores, skin sores, cold or flu symptoms, cough;
  • breast pain or swelling, nipple discharge;
  • trouble swallowing; or
  • sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Common side effects may include:

  • dizziness, drowsiness, feeling tired;
  • feeling restless or being unable to sit still;
  • numbness or tingling inside or around your mouth;
  • ulcers, blisters, swelling, or peeling of your gums;
  • 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.

What other drugs will affect asenapine?

Taking asenapine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • an antibiotic;
  • an antidepressant;
  • anti-malaria medication;
  • cancer medicine;
  • heart or blood pressure medicine; or
  • other antipsychotic medications.

This list is not complete. Other drugs may interact with asenapine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about asenapine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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