The brand name of the medication is Saphris. The active ingredient is asenapine maleate, which is an atypical antipsychotic from the dibenzo-oxepino pyrroles class. It is available as sublingual tablets in dosage strengths of 2.5 mg, 5 mg, and 10 mg, intended for sublingual administration. Key inactive ingredients include aspartame, colloidal silicon dioxide, and microcrystalline cellulose.

How should I use this medication?

Take this medication 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 medication. Do not eat or drink for 10 minutes after taking a dose. Take your medication at regular intervals. Do not take it more often than directed. Do not stop taking except on your care team's advice. Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 10 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

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 medication?

Keep out of the reach of children and pets. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. Get rid of any unused medication after the expiration date. To get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing -High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision -High fever, stiff muscles, increased sweating, fast or irregular heartbeat, and confusion, which may be signs of neuroleptic malignant syndrome -High prolactin level—unexpected breast tissue growth, discharge from the nipple, change in sex drive or performance, irregular menstrual cycle -Infection—fever, chills, cough, or sore throat -Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision -Pain or trouble swallowing -Seizures -Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision -Uncontrolled and repetitive body movements, muscle stiffness or spasms, tremors or shaking, loss of balance or coordination, restlessness, shuffling walk, which may be signs of extrapyramidal symptoms (EPS) Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Change in taste -Dizziness -Drowsiness -Burning or tingling of the tongue, mouth, throat, or face -Weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Dementia -Diabetes -Have trouble controlling your muscles -Heart disease -High cholesterol -History of breast cancer -History of irregular heartbeat or rhythm -History of stroke -Liver disease -Low blood cell levels (white cells, red cells, and platelets) -Low blood pressure -Parkinson disease -Seizures -Trouble swallowing -An unusual or allergic reaction to asenapine, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following: -Cisapride -Dronedarone -Metoclopramide -Pimozide -Thioridazine This medication may also interact with the following: -Alcohol -Antihistamines for allergy, cough, and cold -Certain antibiotics, such as gatifloxacin, moxifloxacin -Certain medications for fungal infections, such as fluconazole, itraconazole, ketoconazole, posaconazole -Certain medications for irregular heartbeat, such as amiodarone, dofetilide, procainamide, quinidine, sotalol -Certain medications for sleep or anxiety -Certain medications for depression, such as amitriptyline, fluoxetine, paroxetine, sertraline -Fluvoxamine -General anesthetics, such as halothane, isoflurane, methoxyflurane, propofol -Levodopa or other medications for Parkinson disease -Medications for blood pressure -Medications for seizures -Medications that relax muscles for surgery -Opioid medications for pain -Other medications that cause heart rhythm changes -Phenothiazines, such as chlorpromazine, prochlorperazine -Ziprasidone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. Do not stop taking except on your care team's advice. You may develop a severe reaction. Your care team will tell you how much medication to take. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects. This medication may increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team what you can do to lower your risk of diabetes while taking this medication. Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe. This medication can cause problems with controlling your body temperature. It can lower the response of your body to cold temperatures. If possible, stay indoors during cold weather. If you must go outdoors, wear warm clothes. It can also lower the response of your body to heat. Do not overheat. Do not over-exercise. Stay out of the sun when possible. If you must be in the sun, wear cool clothing. Drink plenty of water. If you have trouble controlling your body temperature, call your care team right away.

What are the most serious risks of this medication?

This medication should not be used to treat mood and behavior changes caused by dementia. It may increase the risk of death in older adults with dementia.