Active Substance:  Naltrexone Hydrochloride tablet

What is this medicine?

NALTREXONE helps you to remain free of your dependence on opiate drugs or alcohol. It blocks the ‘high’ that these substances can give you. This medicine is combined with counseling and support groups.

They need to know if you have any of these conditions:

• if you have used drugs or alcohol within 7 to 10 days
• kidney disease
• liver disease, including hepatitis
• an unusual or allergic reaction to naltrexone, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

Take this medicine by mouth with a full glass of water. Do not take this medicine within 7 to 10 days of taking any opioid drugs. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor’s advice.

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.

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 doctor or health care professional about rescheduling your doses. Do not take double or extra doses.

Do not take this medicine with any of the following medications:

• any prescription or street opioid drug like codiene, heroin, methadone

This medicine may also interact with the following medications:

• 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.

Visit your doctor or health care professional regularly.

Never try to overcome this medicine by taking large amounts of opioid drugs. You may cause an overdose, coma and death.

Tell all of your doctors and health care providers that you are taking this medicine. For emergencies, carry a medication card. Or, wear a medical identification bracelet or chain to say that you take this medicine.

Side effects that you should report to your doctor or health care professional as soon as possible:

• breathing problems
• changes in vision, hearing
• confusion
• dark urine
• depressed, thoughts of suicide
• diarrhea with vomiting
• fast, irregular heart beat
• hallucination, loss of contact with reality
• right upper belly pain
• unusually weak or tired
• white bowel movements
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• aches, pains
• change in sex drive or performance
• feeling anxious, dizzy, restless, tearful
• headache
• loss of appetite, nausea
• runny nose, sinus problems, sneezing
• stomach cramps
• trouble sleeping

This list may not describe all possible side effects.

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.