Bupropion; Naltrexone extended-release tablets

What is this medicine?

BUPROPION; NALTREXONE (byoo PROE pee on; nal TREX one) is a combination of two drugs that help you lose weight. This product is used with a reduced calorie diet and exercise. This product can also help you maintain weight loss.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. Swallow the tablets whole. You can take it with or without food. Do not take with high-fat meals as this may increase your risk of seizures. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

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

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in vision

• confusion

• elevated mood, decreased need for sleep, racing thoughts, impulsive behavior

• fast or irregular heartbeat

• hallucinations, loss of contact with reality

• increased blood pressure

• rash, fever, and swollen lymph nodes

• redness, blistering, peeling, or loosening of the skin, including inside the mouth

• seizures

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

• suicidal thoughts or other mood changes

• vomiting

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

• constipation

• headache

• loss of appetite

• indigestion, stomach upset

• tremors

What may interact with this medicine?

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

• any medicines used to stop taking opioids such as methadone or buprenorphine

• linezolid

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• methylene blue (injected into a vein)

• often take narcotic medicines for pain or cough

• other medicines that contain bupropion like Zyban or Wellbutrin

This medicine may also interact with the following medications:

• alcohol

• certain medicines for blood pressure like metoprolol, propranolol

• certain medicines for depression, anxiety, or psychotic disturbances

• certain medicines for HIV or hepatitis

• certain medicines for irregular heart beat like propafenone, flecainide

• certain medicines for Parkinson's disease like amantadine, levodopa

• certain medicines for seizures like carbamazepine, phenytoin, phenobarbital

• certain medicines for sleep

• cimetidine

• clopidogrel

• cyclophosphamide

• digoxin

• disulfiram

• furazolidone

• isoniazid

• nicotine

• orphenadrine

• procarbazine

• steroid medicines like prednisone or cortisone

• stimulant medicines for attention disorders, weight loss, or to stay awake

• tamoxifen

• theophylline

• thiotepa

• ticlopidine

• tramadol

• warfarin

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

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

• an eating disorder, such as anorexia or bulimia

• diabetes

• depression

• glaucoma

• head injury

• heart disease

• high blood pressure

• history of drug abuse or alcohol abuse problem

• history of a tumor or infection of your brain or spine

• history of heart attack or stroke

• history of irregular heartbeat

• if you often drink alcohol

• kidney disease

• liver disease

• low levels of sodium in the blood

• mental illness

• seizures

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• taken an MAOI like Carbex, Eldepryl, Marplan, Nardil, or Parnate in last 14 days

• an unusual or allergic reaction to bupropion, naltrexone, other medicines, foods, dyes, or preservatives

• breast-feeding

• pregnant or trying to become pregnant

What should I watch for while using this medicine?

Visit your doctor or healthcare provider for regular checks on your progress.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your healthcare provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

This medicine may affect blood sugar. Ask your healthcare provider if changes in diet or medicines are needed if you have diabetes.

Patients and their families should watch out for new or worsening depression or thoughts of suicide. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your healthcare provider.

Avoid alcoholic drinks while taking this medicine. Drinking large amounts of alcoholic beverages, using sleeping or anxiety medicines, or quickly stopping the use of these agents while taking this medicine may increase your risk for a seizure.

Do not drive or use heavy machinery until you know how this medicine affects you. This medicine can impair your ability to perform these tasks.

Women should inform their health care provider if they wish to become pregnant or think they might be pregnant. Losing weight while pregnant is not advised and may cause harm to the unborn child. Talk to your health care provider for more information.