Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Dependence: Physical dependence, psychological dependence, and abuse are possible at high doses. Do not take more of this medication than your doctor has prescribed. People with a history of past or current substance use problems may be at greater risk of developing abuse or addiction while taking this medication.
Drowsiness/reduced alertness: This medication may cause drowsiness or dizziness. Avoid activities that require mental alertness, such as driving or operating dangerous machinery until you know how this medication affects you.
Liver function: This medication can cause complications in people with decreased liver function. If you have liver disease such as cirrhosis, hepatitis, or decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Ulcerative colitis: If you have active ulcerative colitis, this medication may cause a severe complication called toxic megacolon. If you experience sudden, rapid abdominal distension (bloating), or if you have any other symptoms that worry you, contact your doctor immediately. Toxic megacolon is a medical emergency and must be treated quickly.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children less than 4 years of age.