Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Saphris (Asenapine).

Alcohol and other medications that cause drowsiness: Do not combine Saphris (Asenapine) with alcohol or other medications (e.g., antidepressants, sleeping pills, anxiety medications) that cause drowsiness since additive drowsiness can occur and be dangerous.

Allergy: Some people taking Saphris (Asenapine) have experienced severe allergic reactions. Get medical attention as soon as possible if you experience symptoms of a Anaphylaxis (severe allergic reaction) or anaphylactic reaction, such as:

• difficulty breathing
• itching
• swelling of the face, tongue, or throat
• feeling lightheaded or dizzy

Blood Clots: Saphris (Asenapine) may increase the chance of blood clot formation, causing reduced blood flow to the organs or extremities. If you have a history of clotting or if you have risk factors for developing blood clots (e.g., family history, age over 65, Obesity, recent major surgery, smoking, taking birth control pills), you may be at increased risk of experiencing blood-clot-related problems such as Heart Attack, Stroke, or clots in the deep veins of your leg. Discuss with your doctor how Saphris (Asenapine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Saphris (Asenapine), and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, contact your doctor immediately.

Body temperature: Saphris (Asenapine), like other antipsychotic medications, may disrupt the body's ability to control body temperature. If you exercise vigorously, are exposed to extreme heat, are dehydrated, or are taking anticholinergic medications (e.g., Benztropine, Oxybutynin), you are more at risk. Contact your doctor as soon as possible if you feel very hot and are unable to cool down while taking Saphris (Asenapine).

Drowsiness/reduced alertness: Saphris (Asenapine) may impair the mental and physical abilities required for driving a car or operating machinery. Do not drive, operate machinery, or perform other hazardous tasks until you have determined how Saphris (Asenapine) affects you. Avoid drinking alcohol while taking Saphris (Asenapine), as it may produce extreme drowsiness.

Heart rhythm: Saphris (Asenapine) can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., if you have heart failure, Angina, or low potassium or magnesium levels, or if you take other medications that can affect heart rhythm), discuss with your doctor how Saphris (Asenapine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Saphris (Asenapine), and whether any special monitoring is needed.

High blood sugar: Saphris (Asenapine) may cause an increase in blood sugar levels. Your doctor may monitor your blood sugar levels while you are taking Saphris (Asenapine). If you have Diabetes or are at an increased risk of developing diabetes, discuss with your doctor how Saphris (Asenapine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Saphris (Asenapine), and whether any special monitoring is needed.

If you experience weakness, increased thirst, increased urination, and increased appetite while taking Saphris (Asenapine), contact your doctor as soon as possible, as these are signs that your blood glucose level may be high.

Infection: Saphris (Asenapine) can reduce the number of cells that fight infection in the body (white blood cells). Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe Diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Liver disease: Liver disease or reduced liver function may cause Saphris (Asenapine) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Saphris (Asenapine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Saphris (Asenapine), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Saphris (Asenapine). Saphris (Asenapine) should not be used by people with severely reduced liver function.

Low blood pressure: Saphris (Asenapine) may cause low blood pressure, especially when moving from a lying or sitting position to a standing position. Low pressure may cause dizziness, lightheadedness, or even fainting for some people. If you have heart disease, cerebrovascular disease, or conditions that increase the risk of developing low blood pressure (e.g., dehydration, treatment with blood pressure medications) you should be monitored by your doctor.

Neuroleptic malignant syndrome (NMS): Saphris (Asenapine), like other antipsychotic medications, may cause a potentially fatal syndrome known as neuroleptic malignant syndrome (NMS). If you notice the symptoms of NMS such as high fever, confusion or loss of consciousness, racing or irregular heartbeat, muscle stiffness, or sweating, get immediate medical attention.

Medical conditions: Like other similar medications, Saphris (Asenapine) can increase the levels of the hormone prolactin in your body. If you have a medical condition called hyperprolactinemia (increased blood levels of the hormone prolactin), Saphris (Asenapine) may make the symptoms worse. Discuss with your doctor how Saphris (Asenapine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Saphris (Asenapine), and whether any special monitoring is needed.

Mouth numbness: Saphris (Asenapine) can cause a sensation of numbness in the mouth immediately after letting a tablet dissolve in your mouth. This usually goes away within an hour of taking the medication. Avoid eating or drinking anything for at least 10 minutes after taking the medication.

Prolonged erection: In rare cases, use of Saphris (Asenapine) by some men may cause them to develop priapism (a prolonged and painful erection). If you have an erection that lasts for more than 4 hours, seek immediate medical attention.

Seizures: Saphris (Asenapine) may increase the risk of seizures, especially if you have had seizures in the past. If you are at risk of seizures or have a history of seizures, discuss with your doctor how Saphris (Asenapine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Saphris (Asenapine), and whether any special monitoring is needed.

Suicide/Self-harm: People with schizophrenia or bipolar disorder are at risk of suicide and self-harm. If you feel like harming yourself or if you notice this behaviour in a friend or family member, seek immediate medical attention. You should be closely monitored by your doctor for emotional and behaviour changes while taking Saphris (Asenapine).

Tardive dyskinesia (TD): People who take certain antipsychotic medications, including Saphris (Asenapine), may develop TD, a syndrome consisting of potentially irreversible, involuntary, repetitive movements of the muscles. Although TD appears most commonly in seniors, especially women, it is impossible to predict who will develop TD. The risk of developing TD increases with higher doses and long-term treatment. If you experience muscle twitching or abnormal movements of the muscles in the face, tongue, or extremities, contact your doctor as soon as possible.

Weight gain: People who take Saphris (Asenapine) as a long-term treatment have experienced weight gain.

Pregnancy: Saphris (Asenapine) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Saphris (Asenapine), contact your doctor immediately.

Breast-feeding: It is not known if Saphris (Asenapine) passes into breast milk. If you are breast-feeding and are taking Saphris (Asenapine), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Saphris (Asenapine) have not been established for children under the age of 18.

Seniors: There may be a higher risk of death associated with the use of Saphris (Asenapine) by seniors with Dementia. Deaths have usually been related to cardiovascular causes or infection. Seek medical attention immediately if you notice the signs and symptoms of a stroke (e.g., sudden weakness or numbness, speech problems, vision problems, dizziness, confusion, sudden severe headache), heart attack (e.g., discomfort or pain in the chest, back, neck, jaw, arms; sweating; shortness of breath; nausea; lightheadedness), or infection (e.g., pneumonia). Saphris (Asenapine) should not be used by seniors with dementia.