IMPORTANT RISK INFORMATION (CONTINUED)


SAPHRIS can cause problems with your metabolism, which may increase your risk for heart disease or stroke, such as: • High blood sugar and diabetes: 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. Complications of diabetes can be serious and even life threatening. Tell your healthcare provider if you have symptoms of high blood sugar or diabetes, such as feeling very thirsty or very hungry, urinating more than usual, or feeling weak.


• Increased blood cholesterol or triglycerides: Your healthcare provider may decide to check your cholesterol and triglyceride levels during your treatment with SAPHRIS.


• Weight gain: 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 any reactions under your tongue (where you place SAPHRIS), such as sores, blisters, peeling/sloughing or infl ammation, because these reactions have been reported with SAPHRIS. SAPHRIS may also cause numbness or tingling of the mouth or throat


• 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 or 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. 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 and choking


THE ONE UNDER THE


Actavis™, its design, and The One Under the Tongue™ are trademarks of Actavis, Inc. or its affi liates. The trademarks SAPHRIS, SAPHRIS & Star Design, and Star Design are used by Actavis, Inc. or its affi liates under license from Merck Sharp & Dohme B.V. ©Actavis 2015. All rights reserved.


SPH30517 5/15


• 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


• The most common side effects that occurred with SAPHRIS in children (ages 10-17) were sleepiness, dizziness, strange sense of taste, numbing of the mouth, nausea, increased appetite, feeling tired, and weight gain


This is not a complete summary of safety information. Please discuss the full Prescribing Information, including Boxed Warning, for SAPHRIS with your doctor.


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 see additional Important Risk Information on the reverse side and Brief Summary of full Product Information on the following pages.


TONGUE


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