Safety Information for Naltrexone®
In alcohol dependence, Naltrexone® is considered a safe medication. Control of liver values prior to initiation of treatment is recommended. There has been some controversy regarding the use of opioid-receptor antagonists, such as Naltrexone®, in the long-term management of opioid dependence due to the effect of these agents in sensitising the opioid receptors. That is, after therapy, the opioid receptors continue to have increased sensitivity for a period during which the patient is at increased risk of opioid overdose. This effect reinforces the necessity of monitoring of therapy and provision of patient support measures by medical practitioners.

WARNING!
Large doses of Naltrexone® may cause liver failure. Tell your doctor if you have liver or kidney disease. If you experience the following symptoms, stop taking Naltrexone® and call your doctor immediately: excessive tiredness, unusual bleeding or bruising, loss of appetite, pain in the upper right part of your stomach, dark urine, or yellowing of the skin or eyes.

Naltrexone® side effects
Side effects cannot be anticipated. If any side effects develop or change in intensity, tell your doctor immediately. Only your doctor can determine whether it is safe for you to continue taking Naltrexone®.

• Side effects of treatment for alcoholism may include:
Dizziness, fatigue, headache, nausea, nervousness, sleeplessness, vomiting

• Side effects of treatment for narcotic addiction may include:
Abdominal pain/cramps, anxiety, difficulty sleeping, headache, joint and muscle pain, low energy, nausea and/or vomiting, nervousness

Why should Naltrexone® not be prescribed?
If you are sensitive to or have ever had an allergic reaction to Naltrexone®, you should not take it. If you have acute hepatitis (liver disease) or liver failure, do not start therapy with Naltrexone®. Remember, too, that you must be narcotic-free before beginning Naltrexone® therapy.

Special warnings about Naltrexone®
Since Naltrexone® may cause liver damage when taken at high doses, if you develop symptoms that signal possible liver problems, you should stop taking Naltrexone® immediately and see your doctor as soon as possible. These symptoms include abdominal pain lasting more than a few days, white bowel movements, dark urine, or yellowing of your eyes. Your doctor may periodically test your liver function while you are on Naltrexone® therapy. Caution is also advisable if you have kidney problems.

If you are narcotic-dependent and accidentally take Naltrexone®, you may experience severe withdrawal symptoms lasting up to 48 hours, including confusion, sleepiness, hallucinations, vomiting, and diarrhea. If this occurs, seek help immediately.
Do not attempt to use narcotics while taking Naltrexone®. Small doses will have no effect, and large doses could lead to coma or even death.

Ask your doctor to give you a Naltrexone® medication card to alert medical personnel that you are taking Naltrexone® in case of an emergency. Carry this card with you at all times. If you do require medical treatment, be sure to tell the doctor that you are taking Naltrexone®. You should also tell your dentist and pharmacist that you are taking Naltrexone®.

The safety of Naltrexone® in children under 18 years of age has not been established.

Possible food and drug interactions when taking Naltrexone®
Since studies to evaluate the interaction of Naltrexone® with drugs other than narcotics have not been performed, do not take any medications, either over-the-counter or prescription, without first notifying your doctor.
Do not use Antabuse while you are taking Naltrexone®; both drugs can damage your liver.
Do not take Mellaril (a drug used to treat depression and anxiety) while on Naltrexone® therapy, as the combination may make you feel very sleepy and sluggish.
While taking Naltrexone® avoid medicines that contain narcotics, including cough and cold preparations, such as Actifed-C, Ryna-C, and Dimetane-DC; antidiarrheal medications such as Lomotil; and narcotic painkillers such as Percodan, Tylox, and Tylenol with Codeine.

Special information if you are pregnant or breastfeeding
The effects of Naltrexone® during pregnancy have not been adequately studied. If you are pregnant or are planning to become pregnant, tell your doctor immediately. Naltrexone® should be used during pregnancy only if clearly needed. Naltrexone® may appear in breast milk. If this medication is essential to your health, your doctor may tell you to discontinue breastfeeding your baby until your treatment with Naltrexone® is finished.

Overdosage
Any medication taken in excess can have serious consequences. If you suspect an overdose of Naltrexone®, seek medical attention immediately.