Frequently Asked Questions about Schizophrenia

1. What is schizophrenia?

2. What are some symptoms of schizophrenia?

3. What causes schizophrenia?

4. What is RISPERDAL® (risperidone)?

5. What are the available doses of RISPERDAL?

6. What is RISPERDAL® M-TAB® (risperidone)?

7. How does RISPERDAL® work?

8. When can I expect to feel better with RISPERDAL®?

9. What side effects might I encounter with RISPERDAL®?

10. Should RISPERDAL® be taken with or without food?

11. How should RISPERDAL® be stored?

12. Can RISPERDAL® Oral Solution be taken with all beverages?

13. Does RISPERDAL® contain latex?

14. Does RISPERDAL® contain gluten?

15. Are RISPERDAL® Tablets kosher?

16. Does RISPERDAL® contain aspartame?

17. Does RISPERDAL® contain phenylalanine?

18. Is there a patient assistance program for RISPERDAL®?

1. What is schizophrenia?

   Schizophrenia is a chronic mental illness that impairs a person's thinking, judgment, interpretation of the world around them and ability to function in society. As a result of their inability to correctly interpret the world around them, people with schizophrenia may react inappropriately. They can feel frightened, nervous and confused.

   For more information on schizophrenia, please visit the National Institute of Mental Health Web site.

   

2. What are some symptoms of schizophrenia?

   People with schizophrenia may experience different types of symptoms - and not everyone experiences the same symptoms. Some people may have only a few symptoms, while others may have many. Generally, these symptoms fall into two different categories: "positive" symptoms and "negative" symptoms. A person with positive symptoms exhibits signs of "added" experiences or behaviors. When a person demonstrates a "lack of" or "reduction" of experiences or behaviors, he or she may have negative symptoms.

   Positive symptoms may include:

   • Delusions - belief in ideas that are obviously false

   • Hallucinations - seeing or hearing things that do not exist

   • Agitation - nervousness

   • Paranoia - suspiciousness or unrealistic fears

   • Impulsiveness - taking action without really thinking about what one is doing

   • Disorganized thinking - unclear or confused thoughts

   Negative symptoms may include:

   • Lack of drive or initiative - daily activities cannot be accomplished (e.g., bathing)

   • Social withdrawal - isolate oneself from friends, family, and the public

   • Apathy - lack of feeling or emotion

   • Emotional unresponsiveness - having no feeling towards anything, the person would not cry if sad, show anger if mad, or smile/laugh when happy

   • Anhedonia - diminished ability to experience pleasure

   You may have heard the term "psychotic" used in association with schizophrenia. A psychotic episode is a state of mental impairment, during which a person experiences hallucinations and/or delusions, or has disorganized thinking.

   

3. What causes schizophrenia?

   Although schizophrenia has been extensively researched, no single cause has been identified. Schizophrenia is a complex illness. Scientists have found that some people with schizophrenia have abnormalities in the structure of their brain, while others have an imbalance (too many or too few) of the chemicals that transmit messages in the brain. These chemicals are thought to affect emotions, motivation, movement, mood, sleep, and appetite. While schizophrenia is not caused by stress, psychological conflicts or drug use can trigger an episode in a person prone to schizophrenia.

   Like high blood pressure and heart disease, schizophrenia can run in families. A person who has a relative with schizophrenia is more likely to develop the illness than someone who does not.

   

4. What is RISPERDAL^® (risperidone)?

   RISPERDAL^® is a prescription medication that has been proven effective in treating the symptoms of schizophrenia. RISPERDAL^® can help many people manage the symptoms that are part of schizophrenia.

   Medications known as conventional antipsychotics were introduced in the 1950s and are still in use today. RISPERDAL^® is a newer medication, called an atypical antipsychotic.

   For people who have trouble swallowing pills, RISPERDAL^® is also available in an oral liquid and as a rapidly disintegrating tablet (called RISPERDAL^® M-TAB^®*).

   * RISPERDAL^® M-TAB^® contains phenylalanine. It should not be taken by people who have been diagnosed with PKU (phenylketonuria).

   

5. What are the available doses of RISPERDAL^®?

   RISPERDAL^® (risperidone) is available in a variety of formulations and strengths. This allows your doctor to prescribe the formulation and dose that's most appropriate and convenient for you.

   RISPERDAL^® is available as:

   • Rapidly disintegrating tablets, known as RISPERDAL^® M-TAB^®* - 5 strengths
     

   • Oral tablets - 6 strengths
     

   • Oral liquid
     

     * RISPERDAL^® M-TAB^® contains phenylalanine. It should not be taken by people who have been diagnosed with PKU (phenylketonuria).

   

6. What is RISPERDAL^® M-TAB^® (risperidone)?

   RISPERDAL^® M-TAB^®* is a rapidly disintegrating tablet formulation of RISPERDAL^® with added convenience:

   • Disintegrates in the mouth within seconds
   • Easy to swallow (does not require a beverage to be taken)
   • Mint flavored

   * RISPERDAL^® M-TAB^® contains phenylalanine. It should not be taken by people who have been diagnosed with PKU (phenylketonuria).

   

7. How does RISPERDAL^® work?

   The symptoms of schizophrenia are thought to be caused by chemical imbalances in the brain. Although it is unclear exactly how RISPERDAL^® works, it seems to help balance the chemicals in the brain. While it is not a cure, RISPERDAL^® can help many people manage the symptoms of schizophrenia.

   

8. When can I expect to feel better with RISPERDAL^®?

   For some people, RISPERDAL^® can start working soon after initiating therapy. However, it may take several weeks to get the full benefit of the medication.

   

9. What side effects might I encounter with RISPERDAL^®?

   RISPERDAL^® (risperidone) has some possible side effects that you should know about.

   If you have any side effects with RISPERDAL^®, or feel you're not getting better, please talk to your healthcare professional.

   Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL^® (risperidone) is not approved for the treatment of patients with dementia-related psychosis.

   The most common adverse reactions observed in all clinical trials with RISPERDAL^® occurring at a rate of at least 10% were somnolence, increased appetite, fatigue, rhinitis, upper respiratory tract infection, vomiting, coughing, urinary incontinence, increased saliva, constipation, fever, tremors, muscle stiffness, abdominal pain, anxiety, nausea, dizziness, dry mouth, rash, restlessness, and indigestion.

   Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with RISPERDAL^® and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.

   Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with RISPERDAL^® and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy 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 therapy is stopped.

   RISPERDAL^® and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection. The connection between prolactin levels and side effects is unknown.

   High blood sugar and diabetes have been reported with RISPERDAL^® and similar medications. If the person being treated has diabetes or risk factors such as being overweight or a family history of diabetes, blood sugar testing should be performed at the beginning and throughout treatment. Complications of diabetes can be serious and even life threatening. If signs of high blood sugar or diabetes develop, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry, contact your doctor.

   RISPERDAL^® should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.

   Some people taking RISPERDAL^® may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional's dosing instructions, this side effect may be reduced or it may go away over time.

   Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you observe any of these symptoms, talk to your healthcare professional.

   Some medications interact with RISPERDAL^®. Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while taking RISPERDAL^®.

   Inform your healthcare professional if you are pregnant or if you are planning to get pregnant while taking RISPERDAL^®. Do not breast-feed if you are taking RISPERDAL^®.

   RISPERDAL^® may affect your driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional.

   RISPERDAL^® may affect alertness and motor skills; use caution until the effect of RISPERDAL^® is known.

   

10. Should RISPERDAL^® be taken with or without food?

    RISPERDAL^® may be taken conveniently with or without food.

    

11. How should RISPERDAL^® be stored?

    RISPERDAL^® M-TAB^®, RISPERDAL^® Tablets, and RISPERDAL^® Oral Solution should be stored at controlled room temperature (59-77°F/15-25°C), away from children, and should be protected from light and moisture. RISPERDAL^® Oral Solution should be protected from light and freezing temperatures.

    

12. Can RISPERDAL^® Oral Solution be taken with all beverages?

    No. RISPERDAL^® is compatible with water, orange juice, coffee, and low-fat milk. RISPERDAL^® Oral Solution should not be taken with tea or cola because these beverages will make the medication less effective. Avoid alcohol while taking RISPERDAL^®.

    

13. Does RISPERDAL^® contain latex?

    No. RISPERDAL^® Oral Solution, Tablets and M-TAB^® do not contain latex. Janssen^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. cannot, however, discount any inadvertent exposure of our products (for example, contact with latex gloves) during manufacturing or processing operations.

    

14. Does RISPERDAL^® contain gluten?

    Patients who must adhere to a gluten-free diet must avoid products that contain wheat, rye, oats, or barley. RISPERDAL^® Tablets and RISPERDAL^® Oral Solution contain none of these ingredients. However, gluten may be a component of the protein present in cornstarch (which is approximately 0.3% protein), which is contained in RISPERDAL^® Tablets. RISPERDAL^® M-TAB^® does contain bovine - animal source gelatin, plus two synthetic carbohydrates but these components do not have gluten content such as what is contained in wheat-based ingredients.

    

15. Are RISPERDAL^® Tablets kosher?

    RISPERDAL^® Tablets contain no alcohol but do contain animal products in the form of lactose (from cow's milk). They also contain cornstarch. RISPERDAL^® M-TAB^® contains gelatin that is bovine-sourced (i.e. from cattle) and is certified to be BSE-free.

    

16. Does RISPERDAL^® contain aspartame?

    Only RISPERDAL^® M-TAB^® contains aspartame.

    

17. Does RISPERDAL^® contain phenylalanine?

    Only RISPERDAL^® M-TAB^® contains phenylalanine.

    

18. Is there a patient assistance program for RISPERDAL^®?

    Yes, Janssen^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. provides assistance with RISPERDAL^® to patients who, because of financial burden and lack of prescription drug coverage, may have difficulty paying for their treatment.

    The Patient Assistance Program is designed to make our products available free of charge to persons who have a medical need and meet specific financial criteria. It is important to note that our patient assistance programs provide assistance when no source of prescription drug coverage is available.

    Please visit access2wellness.com.