DO NOT take naltrexone if you are taking ANY opioids or opiate drugs or if you are dependent on opioids or using methadone or buprenorphine, or if you are in opioid withdrawal. If you take opioids/opiates right after stopping naltrexone you may be more sensitive to them (and require lower doses) - which poses a risk of overdose. Please talk to your provider before initiating any amount of opioids/opiates after stopping naltrexone. Do not take this medication if you have a sensitivity to it or any of its components.

Before using naltrexone, tell your healthcare provider about your medical history, especially if you have:

• kidney disease
• liver disease (as it may cause liver dysfunction or hepatitis)
• depression/suicidality
• current or recent (7-14 days) use of any type of opioid or opiate drugs

This drug may make you dizzy or drowsy or impair your judgment. Please do not drive, operate heavy machinery, or perform any hazardous task until the effects of naltrexone are known to you. For anyone taking diabetes medications, please have a discussion with your prescribing clinician prior to taking naltrexone as your diabetes medications may need to be adjusted as you lose weight. You should wear medical identification stating that you are taking this drug so that appropriate treatment can be given in a medical emergency.

Tell your healthcare provider right away if you experience severe stomach or abdominal pain changes in vision, eye pain, burning or swollen eyes, chest pain, confusion, discomfort while urinating or frequent urination, fever, hallucinations or seeing, hearing, or feeling things that are not there, itching, mental depression or other mood or mental changes or suicidality, ringing or buzzing in the ears, shortness of breath, swelling of the face, feet, or lower legs or weight gain.

DO NOT take naltrexone if you are planning to become pregnant or if pregnant or breastfeeding.

Many people experience no side effects while taking naltrexone. Some of the most common side effects (but not extremely frequent) are:

• fatigue or low energy
• difficulty sleeping
• nervousness and anxiety
• headache
• nausea or vomiting
• joint and muscle pain
• stomach cramps or pain

Additional side effects include:

• loss of appetite
• diarrhea or constipation
• increased energy
• increased thirst
• dizziness
• skin rash
• sexual problems in males
• chills
• runny nose
• irritability or feeling down

These symptoms may subside after the body adjusts to the medication.

As with other medications, naltrexone can interact with certain prescription and non-prescription medications and herbal products, including dextromethorphan, diarrhea medication (such as diphenoxylate), disulfiram, opioid pain or cough relievers (such as codeine, hydrocodone) and thioridazine.

Please consult the pharmaceutical packaging for a full list of side effects, warnings, interactions and additional information.

To report suspected adverse reactions to naltrexone contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

In case of emergencies, please call 911 or go to the nearest emergency room.