Elderly people with dementia-related psychosis (a severe mental health problem) taking atypical antipsychotic drugs, including SAPHRIS, are at an increased risk for death compared with those taking placebo (sugar tablet). SAPHRIS is not approved for the treatment of people with dementia-related psychosis (see Boxed Warning). An increased risk for stroke and ministroke has been reported in elderly people with dementia-related psychosis.

Serious allergic reaction: Do not take SAPHRIS if you are allergic to any of its ingredients. Seek immediate emergency assistance if you have symptoms of a serious allergic reaction, such as difficulty breathing; itching; swelling of the face, tongue, or throat; or light-headedness.

Neuroleptic malignant syndrome (NMS): Tell your healthcare provider right away if you have high fever; stiff muscles; confusion; changes in pulse, heart rate, or blood pressure; sweating; or muscle pain and weakness. These can be signs of a rare and potentially fatal side effect (NMS) that has been reported with SAPHRIS and similar medicines. Treatment should be stopped if you have NMS.

Tardive dyskinesia (TD): Tell your healthcare provider if you experience uncontrollable movements of the face, tongue, or other parts of the body. These could be signs of a serious and sometimes permanent side effect (TD). The risk for developing TD and the chance that it will become permanent is thought to increase the longer a person takes the medicine and the more medicine a person takes over time. TD can develop after a person has been taking the medicine for a short time at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if the person stops taking the medicine.

High blood sugar: If you have diabetes or risk factors for diabetes, such as being overweight or a family history of diabetes, your blood sugar should be tested at the beginning of and throughout treatment with SAPHRIS. Complications of diabetes can be serious and even life threatening. Tell your healthcare provider if you have blood sugar problems or signs of diabetes, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry.

Weight gain: Some patients may gain weight while taking SAPHRIS. Your healthcare provider should check your weight regularly.

Also tell your healthcare provider if:

• You have or had low white blood cell counts, because low white blood cell counts and related conditions have been reported with SAPHRIS and similar medicines
• You have certain heart conditions such as irregular heartbeats, or take certain medicines that can cause irregular heartbeats, because SAPHRIS should be avoided in these circumstances
• You have a seizure disorder, have had seizures, or have conditions that increase your risk for seizures
• You are taking or plan to take prescription and over-the-counter medicines, because there is a risk for drug interactions with SAPHRIS
• You have thoughts of suicide or of hurting yourself or others. Symptoms of bipolar I disorder or schizophrenia may include these thoughts. If you have these thoughts at any time, tell your healthcare provider or go to an emergency room right away
• You have or have had swallowing problems, because SAPHRIS and medicines like it have been associated with swallowing problems
• You experience a lack of menstrual periods, leaking or enlarged breasts, or impotence, because SAPHRIS and medicines like it may raise the levels of prolactin. The levels may continue to be high when SAPHRIS is used over time
• You are pregnant or planning to get pregnant while taking SAPHRIS

Other important information to remember:

• Get up slowly after sitting or lying down to avoid getting dizzy, especially at the start of treatment, or when your dose is increased. Light-headedness or faintness caused by a sudden change in heart rate and blood pressure when rising quickly from a sitting position has been reported with SAPHRIS
• Do NOT drive or use dangerous machines until you know how SAPHRIS affects you, because SAPHRIS and medicines like it can affect your judgment, thinking, and motor skills
• Be careful when exercising or when doing things likely to cause dehydration or make you warm, because SAPHRIS may make you more sensitive to heat. You may have trouble cooling off
• Do NOT drink alcohol
• Breastfeeding is NOT recommended
• The most common side effects that occurred with SAPHRIS were sleepiness, dizziness, uncontrolled movements of the body and face, muscle stiffness, weight gain, numbing of the mouth, and restlessness

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please click here for full Prescribing Information, including the Boxed Warning about increased risk of death in elderly people with dementia-related psychosis (a severe mental health problem), and discuss it with your
healthcare provider.

* Savings apply on up to 12 qualifying prescriptions for SAPHRIS prior to the expiration date. Not all patients are eligible. Please see Terms & Conditions.

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SAPHRIS is a registered trademark of N.V. Organon, a subsidiary of Merck & Co., Inc.