Uses of Naltrexone Tablets:

• It is used to help keep you alcohol-free.
• It is used to keep a drug-free state.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Naltrexone Tablets?

• If you have an allergy to naltrexone or any other part of this medicine (naltrexone tablets).
• If you are allergic to this medicine (naltrexone tablets); any part of this medicine (naltrexone tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are taking an opioid drug like morphine or oxycodone, are addicted to an opioid drug, or are having withdrawal signs.
• If you have taken a pain drug within the past 7 to 14 days.

This is not a list of all drugs or health problems that interact with this medicine (naltrexone tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (naltrexone tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Naltrexone Tablets?

• Tell all of your health care providers that you take this medicine (naltrexone tablets). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (naltrexone tablets) affects you.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine (naltrexone tablets).
• Avoid drinking alcohol while taking this medicine (naltrexone tablets).
• Do not take pain drugs while you are taking this medicine (naltrexone tablets). Pain drugs will not work. Do not take more pain drugs to try to get them to work. Doing this may cause very bad injury, coma, or death. Talk with your doctor.
• People taking this medicine (naltrexone tablets) to keep a drug-free state may get more effects from pain drugs when this medicine (naltrexone tablets) is stopped. Even low doses of pain drugs may cause very bad and sometimes deadly effects in these people. Talk with your doctor.
• If you are addicted to pain drugs and are given this medicine (naltrexone tablets), you may have signs of withdrawal. Talk with your doctor.
• Have patient safety card with you at all times.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Naltrexone Tablets) best taken?

Use this medicine (naltrexone tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking this medicine (naltrexone tablets) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• New or worse behavior or mood changes like depression or thoughts of suicide.
• Feeling confused.
• Trouble breathing, slow breathing, or shallow breathing.
• Sex problems in men.

What are some other side effects of Naltrexone Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling nervous and excitable.
• Anxiety.
• Headache.
• Muscle cramps.
• Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry.
• More thirst.
• Trouble sleeping.
• Feeling dizzy, sleepy, tired, or weak.
• Back, muscle, or joint pain.
• Signs of a common cold.
• Tooth pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Naltrexone Tablets?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (naltrexone tablets), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Frequently asked questions

• What happens if you drink alcohol while taking naltrexone?
• What is low dose naltrexone (LDN)?
• What to avoid when taking naltrexone?
• Can you drink alcohol on Vivitrol or will you get sick?
• Should I take naltrexone in the morning or at night?
• Does naltrexone cause weight gain?
• Acamprosate vs naltrexone: How do they compare?
• What's the difference between naltrexone and naloxone?
• How does naltrexone make you feel?

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