ReVia contains naltrexone hydrochloride, which is an opioid antagonist. It is available as scored film-coated tablets with each tablet containing 50 mg of naltrexone hydrochloride. The inactive ingredients include lactose monohydrate, microcrystalline cellulose, and magnesium stearate.

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not take this medication within 7 to 10 days of taking any opioid drugs. Keep taking it unless your care team tells you to stop. Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose and remember on the same day, take the missed dose. If you do not remember until the next day, ask your care team about rescheduling your doses. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date. To get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue -Thoughts of suicide or self-harm, worsening mood, feelings of depression Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Anxiety, nervousness -Dizziness -Headache -Fatigue -Nausea -Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Use of opioid-containing medications or alcohol within the past 7 to 10 days -Kidney disease -Liver disease -An unusual or allergic reaction to naltrexone, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following: -Opioids, such as codeine, heroin, methadone This medication may also interact with the following: -Disulfiram -Thioridazine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication. Visit your care team for regular checks on your progress. For this medication to be most effective, you should attend any counseling or support groups that your care team recommends. Do not try to overcome the effects of the medication by taking large amounts of opioids or by drinking large amounts of alcohol. This can cause severe problems, including death. Also, you may be more sensitive to lower doses of opioids after you stop taking this medication. If you are going to have surgery, tell your care team that you are taking this medication. Do not treat yourself for coughs, colds, pain, or diarrhea. Ask your care team for advice. Some ingredients may interact with this medication and cause side effects. Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.