Frequently Asked Questions about Bipolar Mania

1. What is bipolar mania?

2. What is bipolar I disorder?

3. What are some symptoms of bipolar mania?

4. What causes bipolar mania or bipolar I disorder?

5. What is a manic episode?

6. What is RISPERDAL?

7. What are the available doses of RISPERDAL?

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

9. How does RISPERDAL work?

10. When can I expect to feel better with RISPERDAL?

11. What side effects might I encounter with RISPERDAL?

12. Should RISPERDAL be taken with or without food?

13. How should RISPERDAL be stored?

14. Can RISPERDAL Oral Solution be taken with all beverages?

15. Does RISPERDAL contain latex?

16. Does RISPERDAL contain gluten?

17. Are RISPERDAL Tablets kosher?

18. Does RISPERDAL contain aspartame?

19. Does RISPERDAL contain phenylalanine?

20. Is there a patient assistance program for RISPERDAL?

1. What is bipolar mania?

   Bipolar mania is a mental illness. It is part of a mental illness called bipolar I disorder.

2. What is bipolar I disorder?

   Bipolar I disorder is a mood disorder. It is characterized by dramatic swings in mood and energy levels. People with bipolar I disorder alternate between phases or episodes of mania (intense “highs”) and depression (dramatic “lows”). Sometimes, people may experience a “ mixed” episode, a combination of manic and depressive symptoms. The moods associated with bipolar I disorder are much more exaggerated than the simple “ups and downs” most people experience, and if left untreated, may seriously affect your ability to function effectively.

   Bipolar I disorder can sometimes disrupt your life and your relationships with both family and friends. While there is no cure for the illness, there is much hope. Symptoms of bipolar I disorder can be successfully treated in many cases. With medication, psychosocial counseling and strong support systems, people with bipolar I disorder may stabilize their moods and lead full, productive lives. However, it is important to remember that this illness is chronic and may require lifelong treatment and management.

   For more information on bipolar disorder, please visit the National Institute on Mental Health Web site

   

3. What are some symptoms of bipolar mania?

   People who have bipolar I disorder may experience episodes of mania or mixed episode.

   Manic Episode

   A manic episode is defined as a period during which people are in a highly elevated, expansive, irritable, or angry mood, which lasts at least 1 week.

   Symptoms of mania may include:

   • Unrealistic beliefs in one’s ability – exaggerated confidence

   • Excessive energy, activity, restlessness

   • Decreased need for sleep

   • Racing thoughts, rapid talking

   • Uncharacteristically poor judgment – reckless driving, spending sprees, foolish business ventures

   In severe cases of mania, people may also experience hallucinations (hearing voices and seeing things that are not there) and delusions (beliefs in ideas that are obviously false).

   Mixed Episode

   Patients may also experience a mixed episode, which is characterized by the manic symptoms described above in addition to depressive symptoms listed below.

   Symptoms of depression may include:

   • Feeling sad, anxious, empty, guilty, hopeless, or worthless

   • Sleeping or eating too much or too little

   • Loss of interest or pleasure in activities, including sex

   • Difficulty concentrating, remembering, or making decisions

   • Fatigue or loss of energy

   • Physical symptoms that don’t respond to treatment (eg, chronic pain or digestive disorders)

   

4. What causes bipolar mania or bipolar I disorder?

   No one knows for sure what causes bipolar I disorder or bipolar mania. It is believed that the illness is caused by chemical imbalances in the brain. These chemicals carry messages between your brain cells. Scientists believe an imbalance of these chemicals may cause mood swings. These chemicals may include dopamine and serotonin .

   While stress may trigger an episode of mania or depression, it is not a cause of the illness. People with bipolar I disorder may be more susceptible to physical and emotional factors such as changes in sleep.

   Like high cholesterol and other medical conditions, bipolar I disorder tends to run in families. People who have a relative with bipolar I disorder are more likely to develop the illness than those who do not. People with a family history of mental illness have a greater chance of developing it, which means there may be a genetic link to at least some cases of bipolar I disorder.

   Whatever the cause, it is important to understand that you did not bring the illness on yourself. It's equally important to remember that with proper treatment people can learn to live with bipolar I disorder and have a full and rewarding life.

   

5. What is a manic episode?

   A manic episode (return of symptoms) can be triggered anytime. People with bipolar I disorder can sometimes experience mood swings/changes even if they have been taking their medication as prescribed.

   The major reason people experience an episode is because they stop taking their medication. Other reasons include:

   • Their dosage may not be high enough to prevent the return of symptoms

   • They are using street drugs or drinking alcohol

   • They have experienced severe mental stress, such as the death of a loved one

   • They are physically exhausted

   • They lack support at home, work or in the community

   It is important that you learn to watch for the early warning signs of an episode. These include:

   • Feeling so good or so hyper that other people think you are not your normal self or you are so hyper that you got into trouble

   • You are so irritable that you shout at people or start fights or arguments

   • You feel much more self-confident than usual

   • You get much less sleep than usual and find that you don’t really miss it

   • You are much more talkative or speak much faster than usual

   • Thoughts race through your head or you can’t slow your mind down

   • You are so easily distracted by things around you that you have trouble concentrating or staying on track

   • You have much more energy than usual

   • You are much more active or do many more things than usual

   • You are much more social or outgoing than usual; for example, you telephone friends in the middle of the night

   • You are much more interested in sex than usual

   • You do things that are unusual for you or that other people might think are excessive, foolish, or risky

   • You spend so much money that it gets you or your family into trouble

   If you notice changes in your mood, you should report them immediately to your healthcare professional so that you can be treated before a full-blown mania episode occurs.

   

6. What is RISPERDAL?

   RISPERDAL^® (risperidone) is a prescription medication that has been approved by the Food and Drug Administration (FDA) for the treatment of bipolar I disorder or to treat acute to manic or mixed episodes associated with bipolar I disorder. It has been proven effective for use as therapy alone or in combination with drugs called mood stabilizers, (lithium or valproate).

   In clinical trials, RISPERDAL either alone or combined with a mood stabilizer (valproic acid or lithium) was highly effective in improving manic symptoms compared to placebo (sugar pill) and a mood stabilizer. Your results may vary.

   In addition to the effective control of your mania symptoms, RISPERDAL provides a convenient solution to people who dislike swallowing pills. RISPERDAL is available in a variety of formulations and strengths, including rapidly disintegrating tablets (called RISPERDAL M-TAB) and an oral liquid.

   Remember, RISPERDAL may not be right for all people with bipolar mania. Be sure to talk with your healthcare professional.

   

7. What are the available doses of RISPERDAL?

   RISPERDAL has convenient, flexible dosing allowing it to be prescribed in different formulations to best meet your preferences and in different strengths to best manage your symptoms. Your healthcare professional will determine which formulation and strength is right for you.

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

   • Oral tablets - 6 strengths
     

   • Oral liquid
     

   

8. 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

   • Flexible dosing options

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

   

9. How does RISPERDAL work?

   The symptoms of bipolar mania are thought to be caused by chemical imbalances in the brain (either too high or too low). These chemicals are called dopamine and serotonin. Although it is unclear as to exactly how RISPERDAL works, it seems to help balance the balance of dopamine and serotonin. While it's not a cure, RISPERDAL may help you to manage your symptoms.

   

10. When can I expect to feel better with RISPERDAL?

    For some people, RISPERDAL can start working soon after initiating therapy. However, it may take the full course of therapy to get the full benefit of your medication. So please be patient and give RISPERDAL a chance to take effect. If you are still experiencing symptoms or have questions call your healthcare professional.

    

11. What side effects might I encounter with RISPERDAL?

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

    With any medication, some people have side effects and some don't. If you have any side effects with RISPERDAL, or feel you're not getting better, please talk to your healthcare professional. Your healthcare professional may adjust the dose to help reduce or minimize your side effects.

    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 side effects that may occur with RISPERDAL are: 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.

    Studies suggest an increased risk of elevated blood sugar-related side effects, and sometimes potentially fatal, in patients treated with this class of medications, including RISPERDAL. Some people may need regular blood sugar testing.

    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.

    You may have heard the term "extrapyramidal symptoms (EPS)." These are usually reversible movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. Some people taking RISPERDAL have these side effects. If you have these symptoms, talk to your healthcare professional.

    You may have heard the term "tardive dyskinesia." These are potentially irreversible, uncontrollable, slow or jerky facial or body movements that can be caused by all medications of this type (antipsychotics). If you have these symptoms, talk to your healthcare professional. Only your healthcare professional should adjust your dose or stop your medication.

    There are some medications that interact with RISPERDAL. Please inform your healthcare professional of all medications or supplements that you are taking.

    

12. Should RISPERDAL be taken with or without food?

    RISPERDAL may be taken conveniently with or without food.

    

13. 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.

    

14. 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.

    

15. 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.

    

16. 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 ingredient.

    

17. 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.

    

18. Does RISPERDAL contain aspartame?

    Only RISPERDAL M-TAB contains aspartame.

    

19. Does RISPERDAL contain phenylalanine?

    Only RISPERDAL M-TAB contains phenylalanine.

    

20. 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.