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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). Continued below
How to take SAPHRIS
Be sure to read these instructions carefully and talk with your healthcare provider if you have questions about taking SAPHRIS sublingual tablets.SAPHRIS is a type of medicine called an atypical antipsychotic. It is approved for the acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults.
Your healthcare provider may have prescribed SAPHRIS without flavoring or SAPHRIS with black cherry flavor. The medicine in each is the same.
Your healthcare provider will decide how long you should take SAPHRIS tablets. Talk with your healthcare provider if you have questions about how or when to take SAPHRIS.
Before taking SAPHRIS
SAPHRIS is taken in a way that is different from how you may take other medicines. Before taking SAPHRIS:- Make sure your hands are dry
- Do NOT touch the tablet with wet or damp hands. This may cause the tablet to dissolve
- Do NOT remove the tablet from the tablet pack until you are ready to take it
- Do NOT eat or drink anything for 10 minutes after taking SAPHRIS
Directions for taking SAPHRIS
Read these directions carefully. SAPHRIS is taken in a way that is different from how you may take other medicines.
Step 1
Firmly press and hold thumb button, then pull out tablet pack.
- Do not push tablet through tablet pack
- Do not cut or tear tablet pack
Step 2
Peel back colored tab.
Step 3
Gently remove tablet.
- Do not crush tablet
Step 4
Place tablet under tongue and allow it to dissolve completely.
- Do not chew or swallow tablet
- Do not eat or drink for 10 minutes
Step 5
Slide tablet pack into case until it clicks.
After taking SAPHRIS:
- Your tongue may feel numb for a little while after taking SAPHRIS. You may notice a bitter taste. Talk with your healthcare provider if you have questions
- Do NOT eat or drink anything for 10 minutes after taking SAPHRIS. Eating or drinking during this time may affect how well SAPHRIS works
SAPHRIS is a type of medicine called an atypical antipsychotic. It is approved for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
It may be taken alone or with a mood stabilizer (lithium or valproate).
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.
Important Safety Information
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.
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 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.
This site is intended only for residents of the United States, its territories, and Puerto Rico.
SAPHRIS is a registered trademark of N.V. Organon, a subsidiary of Merck & Co., Inc.
Copyright © 2013 MSD Oss B.V., a subsidiary of Merck & Co., Inc. All rights reserved.
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NEUR-1065684-0000 03/13