What is the most important information I should know about Risperdal?

• Contact your doctor immediately if you experience fever, sweating, severe muscle stiffness (rigidity), confusion, fast or irregular heart beat. These could be symptoms of a potentially fatal side effect called Neuroleptic Malignant Syndrome (NMS).
• Use caution when driving, operating machinery, or performing other hazardous activities. Risperdal may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.
• Dizziness may be more likely to occur when rising from a sitting or lying position. Rise slowly to prevent dizziness and a possible fall.
• Avoid alcohol or use it with caution. Alcohol may increase drowsiness and dizziness while taking Risperdal.
• Avoid becoming overheated in hot weather and during exercise. Risperdal may increase the risk of heat stroke.
• Elderly patients with dementia-related psychosis treated with Risperdal are at an increased risk of death compared to placebo. Risperdal is not approved for the treatment of patients with Dementia-Related Psychosis. Talk to your doctor if you have any questions regarding the use of Risperdal.
• Do not mix the liquid form of Risperdal with cola or tea.

What is Risperdal?

• Risperdal is an antipsychotic medication. It works by changing the effects of chemicals in the brain.
• Risperdal is used for the treatment of schizophrenia and mania associated with bipolar disorder.
• Risperdal may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Risperdal?

• Before taking this medication, tell your doctor if you have
  • had a heart attack, low blood pressure, an irregular heart-beat, or any other type of heart disease;
  • epilepsy or another seizure disorder (or a history of this);
  • diabetes;
  • ever been diagnosed with breast cancer;
  • liver disease; or
  • kidney disease.
• You may not be able to take Risperdal, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• Elderly patients with dementia-related psychosis treated with Risperdal are at an increased risk of death compared to placebo. Risperdal is not approved for the treatment of patients with Dementia-Related Psychosis. Talk to your doctor if you have any questions regarding the use of Risperdal.
• Hyperglycemia (increased blood sugar) has been reported in patients treated with atypical antipsychotics including Risperdal. Talk to your doctor if you experience any signs of hyperglycemia including excessive thirst, frequent urination, excessive hunger or weakness.
• The Risperdal (Risperdal) orally-disintegrating tablets contain phenylalanine. The 0.5 mg tablets contain 0.14 mg phenylalanine, the 1 mg tablets contain 0.28 mg phenylalanine, and the 2 mg tablets contain 0.5 mg phenylalanine. Individuals with phenylketonuria may need to monitor their intake of this additive.
• Risperdal is in the FDA pregnancy category C. This means that it is not known whether Risperdal will be harmful to an unborn baby. Do not take Risperdal without first talking to your doctor if you are pregnant or could become pregnant during treatment.
• It is not known whether Risperdal passes into breast milk. Do not take Risperdal without first talking to your doctor if you are breast-feeding a baby.
• If you are over the age of 65, you may be more likely to experience side effects from Risperdal. An increased risk of stroke and transient ischemic attack (TIA, “mini-stroke”) has been associated with the use of Risperdal in elderly patients with dementia-related psychosis. Your doctor may prescribe a lower dose of the medication or special monitoring during treatment.

How should I take Risperdal?

• Take Risperdal exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• The injectable form of Risperdal (Risperdal Consta) will be administered by a healthcare professional. If you are administering injectable Risperdal at home, your healthcare provider will give you detailed instructions regarding preparation, administration, and storage of the medication.
• Take the regular oral tablets with a full glass of water.
• The Risperdal orally-disintegrating tablets (Risperdal M-Tabs) can be taken without water. Using dry hands, peel back the foil on blister. Do not push tablet through the foil as this may damage the tablet. Immediately upon opening the blister, remove the tablet and place it on the tongue. The tablet must be taken immediately after opening the blister and not saved for later use. The tablet will disintegrate rapidly in the mouth and can be easily swallowed with or without liquid. Do not chew or split the tablets.
• Measure the liquid form of Risperdal carefully and mix it with water, coffee, orange juice, or low-fat milk and drink it immediately.
• Do not mix the liquid form of Risperdal with cola or tea.
• Risperdal can be taken with or without food or milk.
• It is important to take Risperdal regularly to get the most benefit.
• Do not stop taking Risperdal without first talking to your doctor. It may be several weeks before you begin to feel better, and you may require continuous treatment for quite some time. Talk to your doctor before you stop taking this medication.
• Your doctor may want you to have blood tests or other medical evaluations during treatment with Risperdal to monitor progress and side effects.
• Store Risperdal at room temperature away from moisture, light, and heat. Do not allow the liquid form of Risperdal to freeze.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication.

What happens if I overdose?

• Seek emergency medical treatment if an overdose is suspected.
• Symptoms of a Risperdal overdose include dizziness; drowsiness; increased heart rate; fainting; fever; sweating; muscle spasms; and uncontrollable movements of the arms, hands, tongue, face, or other body parts.

What should I avoid while taking Risperdal?

• Use caution when driving, operating machinery, or performing other hazardous activities. Risperdal may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.
• Dizziness may be more likely to occur when rising from a sitting or lying position. Rise slowly to prevent dizziness and a possible fall.
• Avoid alcohol or use it with caution. Alcohol may increase drowsiness and dizziness while taking Risperdal.
• Avoid becoming overheated in hot weather and during exercise. Risperdal may increase the risk of heat stroke.

What are the possible side effects of Risperdal?

• Contact your doctor immediately if you experience fever, sweating, severe muscle stiffness (rigidity), confusion, fast or irregular heart beat. These could be symptoms of a potentially fatal side effect called Neuroleptic Malignant Syndrome (NMS).
• If you experience any of the following serious side effects, stop taking Risperdal and seek emergency medical treatment or contact your doctor immediately:
  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • uncontrollable movements of the tongue, face, lips, arms, or legs;
  • muscle spasms of the face or neck;
  • severe restlessness or tremor;
  • severe drowsiness or fainting; or
  • irregular or very fast heartbeat.
• Other, less serious side effects may be more likely to occur. Continue to take Risperdal and talk to your doctor if you experience
  • mild restlessness, drowsiness, or tremor;
  • insomnia;
  • blurred vision;
  • dizziness or headache;
  • nausea; or
  • weight gain.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Risperdal?

• Before taking this medication, tell your doctor if you are taking any of the following medicines:
  • carbamazepine (Tegretol);
  • clozapine (Clozaril);
  • medicines used to treat Parkinson's Disease such as levodopa (Dopar, Larodopa, Sinemet, Atamet, others), bromocriptine (Parlodel, others), pergolide (Permax), pramipexole (Mirapex), or ropinirole (Requip), or;
  • any medicine used to lower blood pressure.
• You may not be able to take Risperdal, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.
• Risperdal may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor.
• Drugs other than those listed here may also interact with Risperdal. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.