Risperdal M-TAB is a prescription medication used to treat schizophrenia. It is also used to treat manic or mixed episodes associated with Bipolar I Disorder. Risperdal M-TAB also is used to treat behavioral symptoms associated with autism. Risperdal M-TAB belongs to a group of drugs called atypical antipsychotics. It is not fully known how it works, but it is believed to work by changing the activity of natural substances in the brain.

Risperdal M-TAB comes as an orally disintegrating tablet. It is usually taken once or twice a day with or without food. 

Risperdal M-TAB is placed under the tongue. Risperdal M-TAB can be swallowed with or without liquid.

Common side effects of Risperdal M-TAB are headache, increased appetite, and tremors.

Risperdal M-TAB can cause dizziness. Do not drive or operate heavy machinery until you know how Risperdal M-TAB affects you.

Risperdal M-TAB is a prescription medication used to treat schizophrenia. It is also used to treat manic or mixed episodes associated with Bipolar I Disorder. Risperdal M-TAB also is used to treat behavioral symptoms associated with autism.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Janssen Pharmaceuticals, Inc.

Common side effects of Risperdal M-TAB include the following:

• drowsiness
• dizziness
• nausea
• vomiting
• diarrhea
• constipation
• heartburn
• dry mouth
• increased saliva
• increased appetite
• weight gain
• stomach pain
• anxiety
• agitation
• restlessness
• dreaming more than usual
• difficulty falling asleep or staying asleep
• decreased sexual interest or ability
• breastmilk production
• vision problems
• muscle or joint pain
• dry or discolored skin
• difficulty urinating

Tell your doctor about the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take: 

• antidepressants
• carbamazepine (Tegretol)
• cimetidine (Tagamet)
• clozapine (Clozaril)
• dopamine agonists such as bromocriptine (Parlodel), cabergoline (Dostinex), levodopa (Dopar, Larodopa), pergolide (Permax), and ropinirole (Requip)
• medications for anxiety, high blood pressure, or seizures
• other medications for mental illness
• paroxetine (Paxil)
• phenobarbital (Luminal, Solfoton)
• phenytoin (Dilantin)
• quinidine (Quinaglute, Quinidex)
• ranitidine (Zantac)
• rifampin (Rifadin, Rimactane)
• sedatives
• sleeping pills
• tranquilizers
• valproic acid (Depakote, Depakene)

This is not a complete list of Risperdal M-TAB drug interactions. Ask your doctor or pharmacist for more information.

• Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as Risperdal M-TAB have an increased risk of death during treatment. Older adults with dementia may also have a greater chance of having a stroke or mini-stroke during treatment. Tell your doctor and pharmacist if you are taking furosemide (Lasix).
• Risperdal M-TAB is not approved by the Food and Drug Administration (FDA) for the treatment of behavior problems in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking Risperdal M-TAB.
• Other serious side effects that require medical attention include the following:
  • fever
  • muscle stiffness
  • confusion
  • fast or irregular pulse
  • sweating
  • unusual movements of your face or body that you cannot control
  • faintness
  • seizures
  • slow movements or shuffling walk
  • rash
  • hives
  • itching
  • difficulty breathing or swallowing
  • painful erection of the penis that lasts for hours

Risperdal M-TAB may cause children to gain more weight than expected and for boys and male teenagers to have an increase in the size of their breasts. Talk to your doctor about the risks of giving this medication to your child.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Risperdal M-TAB there are no specific foods that you must exclude from your diet when receiving Risperdal M-TAB.

Before receiving Risperdal M-TAB, tell your doctor about all of your medical conditions including if you have:

• Parkinson's Disease
• breast cancer
• heart disease (angina, irregular heartbeat, heart failure, heart attack, stroke)
• high blood pressure
• low blood pressure
• a history of seizures
• kidney disease
• liver disease
• diabetes

Tell your doctor if you are allergic to any ingredient in Risperdal M-TAB.

Be sure to tell your doctor if you are pregnant or breastfeeding.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. Risperdal M-TAB can cross into human breast milk. It may harm your baby.

• Risperdal M-TAB comes as an orally disintegrating tablet (tablet that dissolves quickly in the mouth) to take by mouth.
• It is usually taken once or twice a day with or without food. Take Risperdal M-TAB at around the same time(s) every day.
• Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
• Take Risperdal M-TAB exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Using dry hands, remove the tablet from the blister unit and immediately place the entire Risperdal M-TAB Orally Disintegrating Tablet on the tongue. The Risperdal M-TAB Orally Disintegrating Tablet should be consumed immediately, as the tablet cannot be stored once removed from the blister unit. Risperdal M-TAB Orally Disintegrating Tablets disintegrate in the mouth within seconds and can be swallowed subsequently with or without liquid. Patients should not attempt to split or to chew the tablet.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Schizophrenia in Adults - The recommended dose range is 2 to 16 mg. 

Schizophrenia in Adolescents - The recommended dose range is 0.5 to 6 mg. 

Bipolar Mania in Adults - The recommended dose range is 2 to 6 mg. 

Bipolar Mania in Children and Adolescents - The recommended dose range is 0.5 to 6 mg.

Irritability associated with autistic disorder - The recommended dose range is 0.25 to 3 mg (if you weigh less than 20 kg) OR 0.5 to 3 mg (if you weight 20 kg or greater).

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Risperdal M-TAB Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F).
• Keep out of reach of children.

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Risperdal M-TAB is not approved for the treatment of patients with dementia-related psychosis.