Saphris Black Cherry

Name: Saphris Black Cherry

What is Saphris Black Cherry (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 is the most important information I should know about Saphris Black Cherry (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.

How should I take Saphris Black Cherry (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.

Saphris Black Cherry (asenapine) side effects

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 Saphris Black Cherry (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.

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