Do NOT use Revia if:

• you are allergic to any ingredient in Revia
• you are taking narcotic medications for pain, are dependent on narcotics, are experiencing withdrawal symptoms from narcotics, have failed the challenge test with Revia, or have tested positive for narcotics
• you have hepatitis, liver failure, or liver disease.

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Revia. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have kidney or liver problems, or a history of suicidal thoughts or behavior with or without depression.

Some medicines may interact with Revia. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Narcotic analgesics (eg, codeine), narcotic cough/cold medicines, or medicines used for diarrhea because effectiveness may be decreased by Revia. Withdrawal symptoms may occur if you are physically dependent on opioid medicines.
• Thioridazine because side effects such as sleepiness and sluggishness may occur.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Revia may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

• Revia may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Revia. Using Revia alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Carry identification to alert health care providers that you are taking Revia. You can get a medication card from your doctor to use for this purpose.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Revia.
• Contact your health care provider at once if any of the following signs or symptoms of hepatitis occur while taking Revia: stomach pain lasting more than a few days; white bowel movements; dark urine; yellowing of the skin or eyes.
• Do not use narcotics while taking Revia, including opioid-containing medicines (eg, cough and cold products, pain relievers, heroin). Revia may increase your sensitivity to narcotics. Therefore, even very low doses may cause coma or be life-threatening.
• Before you have any medical or dental surgery or emergency treatments, tell the doctor or dentist that you are taking Revia.
• Lab tests, including liver function, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Revia with extreme caution in children younger than 18 years of age. Safety and effectiveness in this age group have not been confirmed.
• Pregnancy and breast-feeding: If you become pregnant, discuss with your doctor the benefits and risks of using Revia during pregnancy. It is unknown if Revia is excreted in breast milk. If you are or will be breast-feeding while you are using Revia, check with your doctor or pharmacist to discuss the risks to your baby.

If you are addicted to narcotics and are given Revia, you may experience withdrawal symptoms including anxiety; diarrhea; fever, runny nose or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Anxiety; appetite loss; chills; constipation; delayed ejaculation; diarrhea; dizziness; drowsiness; feeling down; headache; increased energy; increased thirst; irritability; joint and muscle pain; low energy; nausea; nervousness; sleeplessness; stomach pain/cramps; vomiting.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abdominal or stomach pain; cramping; dark urine; depression; suicidal thoughts or behaviors; unusual tiredness or weakness; vomiting; white bowel movements; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects.