Saphris (Asenapine) belongs to class of medications called atypical antipsychotics. Asenapine is used to treat schizophrenia in adults. It is also used alone or together with lithium or valproate to treat symptoms of psychotic (mental) disorders, such as mania or bipolar disorder. This medication works by helping to restore the balance of certain natural substances in the brain (neurotransmitters).

Doctor's prescription is required to use this medicine.

Always take Saphris (Asenapine) as directed by your physician. Follow all directions on your prescription label and read all medication guides or instruction sheets. Asenapine comes as a sublingual tablet to dissolve under the tongue. It is usually taken twice a day. Take asenapine at around the same times every day. Do not swallow, split, chew, or crush the tablet. Do not eat or drink anything for 10 minutes after the tablet dissolves.

Do not take more or less of it or take it more often than prescribed by your doctor.

Asenapine may help to control your symptoms but will not cure your condition.

Continue to take asenapine even if you feel well. Do not stop taking asenapine without talking to your doctor.

Before taking asenapine, tell your doctor or pharmacist if you are allergic to it or any other medications. Tell your doctor or pharmacist about your medical history especially of liver problems, heart problems (such as past heart attack, angina, abnormal heart rhythm), stroke, diabetes (including family history), obesity, low blood pressure, seizures, low white blood cell count, loss of too much body water (dehydration), breast cancer, drug/alcohol/substance abuse, Alzheimer's disease, dementia, trouble swallowing, breathing trouble during sleep (sleep apnea).

Tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breastfeeding. If you become pregnant while taking asenapine, call your doctor. Asenapine may cause problems in newborns following delivery if it is taken during the last months of pregnancy. Asenapine may make you drowsy.

Do not drive a car or operate machinery until you know how this medication affects you. Ask your doctor about the safe use of alcoholic beverages while you are taking asenapine. Alcohol can make the side effects of asenapine worse.

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

Asenapine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

•  dry mouth
•  stomach pain
•  constipation
•  vomiting
•  heartburn
•  increased appetite
•  increase in amount of saliva in the mouth
•  change in taste
•  toothache
•  weight gain
•  loss of feeling in the lips or mouth
•  dizziness, feeling unsteady, or having trouble keeping your balance
•  excessive tiredness
•  restlessness or constant urge to keep moving
•  irritability
•  anxiety
•  depression
•  difficulty falling asleep or staying asleep
•  pain in the joints, arms, or legs

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• hives
• rash
• itching
• difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• wheezing
• fever
• muscle stiffness or pain
• spasm or tightening of the neck muscles
• confusion
• fast or irregular heartbeat
• sweating
• uncontrollable movements of the arms, legs, face, mouth, tongue, jaw, lips or cheeks
• falling
• seizures
• sore throat, chills, cough, and other signs of infection
• red or brown colored urine

Asenapine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

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?

In case of overdose, call the poison control helpline. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. Symptoms of overdose may include: severe drowsiness/deep sleep, agitation, confusion, fainting.

Where should I keep my medicine?

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use.

What other drugs will affect Saphris?

Taking Saphris 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
• 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.