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Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking antipsychotic drugs, including SAPHRIS, are at an increased risk for death. SAPHRIS is not approved for treating people with dementia-related psychosis. Continued below

Living with schizophrenia

Schizophrenia is a serious mental illness that does not go away. But there is good news. The symptoms of schizophrenia can be managed. People with the illness can feel better. You can find ways to live your life with schizophrenia. Medicine, counseling, and support may help make a difference.


Medicine is one important part of treatment for schizophrenia.

  • Medicine does not cure schizophrenia
  • Medicine can help manage certain symptoms of schizophrenia
  • Medicines may work differently for different people. Work closely with your healthcare provider to find the right medicine for you
  • You need to take your medicine exactly as your healthcare provider prescribes and for as long as your healthcare provider advises

Counseling can help people with schizophrenia to:

  • Take a more active role in managing their illness
  • Stick with their treatment and learn more about staying on treatment
  • Learn how to deal with problems at work, at school, or with other people
  • Have a plan for getting help
  • Improve communication skills
  • Manage daily routines

Support can make a difference to people with schizophrenia.

People with schizophrenia may find it helpful to go to:
  • Family education programs, which allow family members to learn about schizophrenia and ways they can help
  • Self-help groups, which provide a place for people with schizophrenia to meet to help and support one another. Find organizations that have support groups
When talking with
your healthcare provider
You may want to ask:
  • Do I need medicine to help manage symptoms of schizophrenia?
  • What medicine do you think is right for me?
  • Can you help me find a counselor and support group?
 
For family and friends
Knowing what you can do

Going to appointments

It may help to go to healthcare provider appointments with your family member or friend. You can ask questions and hear information directly. That can be reassuring to your family member or friend.

You may want to attend family education programs or support groups. There are a number of support organizations to help you.


SAPHRIS is a prescription medicine approved for the treatment of schizophrenia in adults.

IMPORTANT RISK INFORMATION

What is the most important information I should know about SAPHRIS?
Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking antipsychotic drugs are at an increased risk for death. SAPHRIS is not approved for treating people with dementia-related psychosis.

SAPHRIS may cause serious side effects, including:

  • Stroke (which can be fatal) in elderly people with dementia
  • Neuroleptic malignant syndrome (NMS): 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. SAPHRIS should be stopped if you have 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. Risk of developing TD and the chance that it will become permanent are thought to increase the longer a person takes the medicine and the more medicine a person takes over time. TD can develop even after a person has been taking the medicine for a short time at low doses. 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:
    • High blood sugar and diabetes: If you have diabetes or risk factors for diabetes (eg, being overweight or 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 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 treatment
    • Weight gain: Weight gain has been reported with SAPHRIS. Your healthcare provider should check your weight regularly
  • 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
  • Difficulty swallowing: SAPHRIS and medicines like it have been associated with difficulty 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, difficulty 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
  • 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 adults were sleepiness, dizziness, uncontrolled movements of the body and face, muscle stiffness, weight gain, numbing of the mouth, and restlessness
  • Since FDA approval, patients taking SAPHRIS have reported reactions under the tongue (where you place SAPHRIS), such as sores, oral blisters, peeling/sloughing, or inflammation. 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.

Please see the full Prescribing Information, including Boxed Warning.

The product information provided in this site is intended only for residents of the United States. The products discussed on this site may have different product labeling outside of the United States.
The health information described on this site is provided for educational purposes only and is not intended to substitute for discussions with a healthcare provider.
The trademarks SAPHRIS, SAPHRIS & Star Design, and Star Design are used by Actavis, Inc. or its affiliates under license from Merck Sharp & Dohme B.V.
© 2011, 2013 Merck Sharp & Dohme B.V.; used by Actavis, Inc. or its affiliates under license.
© Actavis 2015. All rights reserved.
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