IMPORTANT RISK INFORMATION (CONTINUED)
What is the most important information I should know about SAPHRIS? (continued) Saphris may cause serious side effects, including:
• Decreased blood pressure: You may feel lightheaded or faint when you rise too quickly from a sitting or lying position. Ask your healthcare provider about ways to reduce feeling dizzy or lightheaded upon standing, such as sitting on the edge of the bed for several minutes before getting up in the morning or slowly rising after sitting
• Low white blood cell count: Low white blood cell counts have been reported with antipsychotic drugs, including SAPHRIS. This may increase your risk of infection. Very low white blood cell counts, which can be fatal, have been reported with other antipsychotics
• Increases in prolactin levels: Tell your healthcare provider if you experience a lack of menstrual periods, leaking or enlarged breasts, or impotence, because SAPHRIS may raise the levels of prolactin. The levels may continue to be high when SAPHRIS is used over time
• Seizures
• Impaired judgment, thinking, and motor skills: Do NOT drive or use dangerous machinery until you know how SAPHRIS affects you. SAPHRIS may make you drowsy
• Increased body temperature: SAPHRIS may make you more sensitive to heat. You may have trouble cooling off. Be careful when exercising or when doing things likely to cause dehydration or make you warm
• Suicide: Tell your healthcare provider right away or go to an emergency room if you have thoughts of suicide or of hurting yourself or others. People with schizophrenia and bipolar disorder may have these thoughts
• Diffi culty swallowing: SAPHRIS and medicines like it have been associated with diffi culty swallowing
Who should not take SAPHRIS?
Do not take SAPHRIS if you have certain liver problems, or if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (eg, diffi culty breathing; itching; swelling of the face, tongue, or throat; or light-headedness).
What should I tell my healthcare provider before taking SAPHRIS?
Tell your healthcare provider about any medical conditions and if you have or have had:
• Diabetes or high blood sugar in you or your family
Learn more:
www.SAPHRIS.com
© 2016 Merck Sharp & Dohme B. V.; used by Allergan under license. ©2016 Allergan. All rights reserved. Allergan®
, its design, and The One Under the TongueTM 02/16 are trademarks of Allergan, Inc.
The trademarks SAPHRIS, SAPHRIS & Star Design, and Star Design are used by Allergan under license from Merck Sharp & Dohme B.V. SPH42342
• High levels of total cholesterol, triglycerides, or LDL-cholesterol; or low levels of HDL-cholesterol
• Seizures or conditions that increase your risk for seizures
• Low or high blood pressure • Low white blood cell count
• Certain heart problems such as irregular heartbeats or are at risk for these problems, or if you take medicines that can cause irregular heartbeats, because SAPHRIS should be avoided in these circumstances
Tell your healthcare provider if you are pregnant, or if you plan to become pregnant. SAPHRIS may cause harm to your unborn baby. A special program (National Pregnancy Registry for Atypical Antipsychotics) collects information on the safety of antipsychotic drugs, including SAPHRIS, during pregnancy. For information, contact the program at 1-866-961-2388 or http://www.
womensmentalhealth.org/clinical-and-research- programs/pregnancyregistry/.
Tell your healthcare provider about all medicines that you take or have recently taken, including prescriptions, over-the-counter medicines, and supplements. SAPHRIS may affect the way other medicines work, and other medicines may affect how SAPHRIS works.
What are possible side effects of SAPHRIS?
• The most common side effects in children (ages 10-17): sleepiness, dizziness, strange sense of taste, numbing of the mouth, nausea, increased appetite, feeling tired, and weight gain
• Since FDA approval, patients taking SAPHRIS have reported reactions under the tongue (where you place SAPHRIS), such as sores, oral blisters, peeling/sloughing, or infl ammation. Choking has also been reported
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all possible side effects of SAPHRIS.
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.
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