Do not chew or swallow the tablet. Do not eat or drink for 10 minutes.
STEP 5. Slide the tablet pack back into case until it clicks.
n
Increased blood cholesterol or triglycerides: Your healthcare provider may decide to check your cholesterol and triglyceride levels during your treatment with SAPHRIS
n
Weight gain: You and your healthcare provider should check your weight regularly
What should I avoid while taking SAPHRIS? • Do NOT drive, operate machinery, or do other dangerous activities until you know how SAPHRIS affects you. SAPHRIS may make you drowsy
• Avoid getting over-heated or dehydrated: Do not over-exercise; in hot weather, stay inside in a cool place if possible; stay out of the sun; do not wear too much or heavy clothing; drink plenty of water
What are possible side effects of SAPHRIS? SAPHRIS can cause serious side effects, including:
• See “What is the most important information I should know about SAPHRIS?”
• Stroke that can lead to death can happen in elderly people with dementia who take medicines like SAPHRIS
• Neuroleptic malignant syndrome (NMS): Stop taking SAPHRIS and call your healthcare provider right away if you have high fever; stiff muscles; confusion; changes in pulse, heart rate, or blood pressure; or sweating. These can be symptoms of a rare but potentially fatal side effect called NMS
• Tardive dyskinesia (TD): Tell your healthcare provider if you cannot control the movements of your face, tongue, or other body parts. These could be signs of a serious and sometimes permanent side effect called TD. TD may not go away, even if you stop taking SAPHRIS. TD may also start after you stop taking SAPHRIS
• Problems with your metabolism, which may increase
your risk for heart disease or stroke, such as: n
High blood sugar (hyperglycemia) and diabetes: Extremely high blood sugar can lead to coma or death. 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 before you start SAPHRIS and regularly during treatment. Call your healthcare provider if you have symptoms of high blood sugar while taking SAPHRIS, such as feeling very thirsty or very hungry, urinating more than usual, or feeling weak
• Serious allergic reaction: Do not take SAPHRIS if you are allergic to any of its ingredients. Get emergency medical help if you think you are having an allergic reaction. Symptoms may include difficulty breathing; itching, swelling of the face, tongue, or throat; or light-headedness
• Decreased blood pressure (orthostatic hypotension), including light-headedness or fainting caused by a sudden change in heart rate and blood pressure when rising too quickly from a sitting or lying position
• Low white blood cell count. This may increase your risk of infection
• Increases in prolactin levels: You may experience a lack of menstrual periods, leaking or enlarged breasts, or impotence, because medicines like SAPHRIS may raise prolactin levels. Your healthcare provider may do blood tests to check your prolactin levels
• Seizures
• Impaired judgment, thinking, and motor skills: Do NOT drive or use dangerous machinery until you know how SAPHRIS affects you
• Increased body temperature: SAPHRIS may make you more sensitive to heat. You may have trouble cooling off
• Thoughts of suicide or of hurting yourself or others: If you have any of these thoughts at any time, tell your healthcare provider or go to an emergency room right away
• Difficulty swallowing Common side effects with SAPHRIS include the following:
• In adults: sleepiness, dizziness, uncontrolled movements of the body and face, muscle stiffness, weight gain, numbing of the mouth, and restlessness
• In children (ages 10- 17): sleepiness, dizziness, strange sense of taste, numbing of the mouth, nausea, increased appetite, feeling tired, and weight gain
In addition, patients taking SAPHRIS have reported reactions under the tongue (where you place SAPHRIS), such as sores, blisters, peeling/sloughing or inflammation. Choking has also been reported.
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