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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 paliperidone in children below 18 years of age. Safety and efficacy have not been established.

Geriatric

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

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

  • Mesoridazine
  • Ranolazine
  • Thioridazine

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 vessel problems (e.g., history of stroke or heart attack) or
  • Dehydration or
  • Dementia or
  • Kidney disease—These conditions may increase the chance of side effects.
  • Breast cancer or
  • Diabetes or
  • Heart disease or
  • Heart rhythm problems (e.g., QT prolongation) or
  • Hypotension or
  • Neuroleptic malignant syndrome, or history of, or
  • Parkinson's disease or
  • Seizures, or history of—May make these conditions worse.
  • Stomach or intestinal problems (e.g., blocked bowels) or
  • Trouble with swallowing—Should not use in patients with these conditions.