Risperdal

What you should know before using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatrics

Appropriate studies have not been performed on the relationship of age to the effects of risperidone in children less than 13 years of age with schizophrenia. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of risperidone in children less than 10 years of age with bipolar disorder. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of risperidone in children less than 5 years of age with autistic disorder. Safety and efficacy have not been established.

Geriatric

Elderly people may be especially sensitive to the effects of risperidone. This may increase the chance of having side effects during treatment. This medicine should not be used for behavioral problems in older adults with dementia.

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of risperidone in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment of dosage in patients receiving risperidone.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Cisapride
• Levomethadyl
• Mesoridazine
• Pimozide
• Terfenadine
• Thioridazine
• Ziprasidone

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Aspiration pneumonia, risk or history of or
• Blood circulation problems or
• Dehydration or
• Dementia, such as decreasing mental ability or
• Difficulty swallowing—These conditions may increase the chance of serious side effects from the medicine.

• Breast cancer or
• Heart or blood vessel problems, including stroke and unusual heartbeats or
• Parkinson's disease—Risperidone may make these conditions worse.

• Diabetes or family history of diabetes—May make condition worse and cause serious side effects.

• Drug abuse problems in the past—These patients should be observed for any signs of abuse of this medicine.

• Epilepsy or other seizure disorders—Risperidone may increase the risk of having seizures.

• Kidney disease or
• Liver disease—Higher blood levels of risperidone may occur, increasing the chance of side effects.

• Other medical problems causing vomiting (e.g., brain tumor, bowel blockage, drug overdose, Reye's syndrome)—Risperidone may prevent vomiting and hide these medical problems from you and your doctor.

• Phenylketonuria (PKU)—The oral disintegrating tablets may contain aspartame, which can make your condition worse.