ReVia blocks the effects of opioid medication, including pain relief or feelings of well-being that can lead to opioid abuse.

ReVia is used to prevent relapse in adults who became dependent on opioid medicine and then stopped using it. This medicine can help keep you from feeling a "need" to use the opioid.

ReVia is also used to treat alcoholism by reducing your urge to drink alcohol. This may help you drink less or stop drinking completely. This medicine will not cause you to "sober up" and will not decrease the effects of alcohol you recently consumed.

ReVia is not a permanent cure for drug addiction or alcoholism.

ReVia may also be used for purposes not listed in this medication guide.

You should not be treated with ReVia if you have liver failure or active hepatitis, if you are currently addicted to opioids or having opioid withdrawal symptoms, or if you have used any opioid pain medicine, methadone, or LAAM in the past 7 to 10 days.

High doses of naltrexone oral may harm your liver. Stop taking this medicine and call your doctor at once if you have right-sided upper stomach pain, vomiting, loss of appetite, dark urine, clay-colored stools, or yellowing of your skin or eyes.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Your doctor may recommend you have a family member or other caregiver make sure you take ReVia on schedule, to make sure you are using the medicine correctly as part of your treatment.

Take the ReVia tablet with a full glass of water.

Take with food if ReVia upsets your stomach.

In case of emergency, wear or carry medical identification to let others know you are using ReVia.

ReVia is only part of a complete treatment program that may also include additional forms of counseling and/or monitoring. Follow your doctor's instructions very closely.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

After taking ReVia, your body will be more sensitive to opioids. If you use an opioid medicine in the future, you will need to use less than before this medicine treatment. Using the same amount you used before could lead to overdose or death.

You should not receive ReVia if you are allergic to it, or if:

• you are currently addicted to opioids;

• you are having withdrawal symptoms from opioid addiction;

• you have used any opioid pain medicine within the past 7 to 10 days (including fentanyl, Vicodin, OxyContin, and many others);

• you have used methadone or LAAM in the past 7 to 10 days; or

• you have liver failure or active hepatitis.

Tell your doctor if you have ever had:

• liver disease; or

• kidney disease.

Tell your doctor if you are pregnant or breastfeeding.

It is not known whether ReVia will harm an unborn baby. However, if you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not use opioid medication, heroin, or other street drugs while you are taking ReVia. Never try to overcome the effects of naltrexone by taking large doses of opioids. Doing so could result in dangerous effects, including coma.

Ask your doctor before using any medicine to treat a cold, cough, diarrhea, or pain. These medicines may contain opioids and may not work as well while you are taking ReVia.

ReVia may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Using opioid medicine while you are taking ReVia could stimulate opioid withdrawal symptoms. Common withdrawal symptoms are craving for opioids, sweating, fever, stomach pain, vomiting, diarrhea, watery eyes, runny or stuffy nose, tingling, goose bumps, body aches, shaking, muscle twitching, trouble sleeping, and feeling anxious, depressed, fearful, restless or uneasy.

ReVia may cause serious side effects. Call your doctor at once if you have:

• severe nausea, vomiting, or diarrhea;

• confusion, mood changes, crying, hallucinations; or

• depression, thoughts about suicide or hurting yourself.

High doses of naltrexone oral may harm your liver. Stop taking ReVia and call your doctor at once if you have right-sided upper stomach pain, vomiting, loss of appetite, dark urine, clay-colored stools, or yellowing of your skin or eyes.

Common side effects of ReVia may include:

• nausea, vomiting, stomach pain;

• headache, dizziness, drowsiness;

• feeling anxious or nervous;

• sleep problems (insomnia); or

• muscle or joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect ReVia, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.