Naltrexone Hydrochloride, Bupropion Hydrochloride Oral tablet, extended-release

What is this medicine?

BUPROPION; NALTREXONE (byoo PROE pee on; nal TREX one) is a combination product used to promote and maintain weight loss in obese adults or overweight adults who also have weight related medical problems. This medicine should be used with a reduced calorie diet and increased physical activity.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

• glaucoma

• head injury

• heart disease

• high blood pressure

• history of a drug or alcohol abuse problem

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

• history of stroke

• history of irregular heartbeat

• kidney disease

• liver disease

• mental illness such asbipolar disorder or psychosis

• seizures

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

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

  breast-feeding

• pregnant or trying to become pregnant

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine in the morning and in the evenings as directed by your healthcare professional. You can take it with or without food. Do not take with high-fat meals as this may increase your risk of seizures. Do not crush, chew, or cut these tablets. Do not take your medicine more often than directed. Do not stop taking this medicine suddenly except upon the advice of your doctor.

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.

Overdosage: If you think you've 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.

What if I miss a dose?

If you miss a dose, skip the missed dose and take your next tablet at the regular time. Do not take double or extra doses.

What may interact with this medicine?

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

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

• linezolid

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

• methylene blue (injected into a vein)

• other medicines that contain bupropion like Zyban or Wellbutrin

This medicine may also interact with the following medications:

• alcohol

• certain medicines for anxiety or sleep

• certain medicines for blood pressure like metoprolol, propranolol

• certain medicines for depression or psychotic disturbances

• certain medicines for HIV or AIDS like efavirenz, lopinavir, nelfinavir, ritonavir

• 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

• cimetidine

• clopidogrel

• cyclophosphamide

• 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

• thioridazine

• thiotepa

• ticlopidine

• tramadol

• warfarin

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.

What should I watch for while using this medicine?

This medicine is intended to be used in addition to a healthy diet and appropriate exercise. The best results are achieved this way. Do not increase or in any way change your dose without consulting your doctor or health care professional. Do not take this medicine with other prescription or over-the-counter weight loss products without consulting your doctor or health care professional. Your doctor should tell you to stop taking this medicine if you do not lose a certain amount of weight within the first 12 weeks of treatment.

Visit your doctor or health care professional for regular checkups. Your doctor may order blood tests or other tests to see how you are doing.

This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.

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 health care professional.

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.

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, hearing

• chest pain

• confusion

• dark urine

• depressed mood

• fast or irregular heart beat

• fever

• hallucination, loss of contact with reality

• increased blood pressure

• light-colored stools

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

• right upper belly pain

• seizures

• suicidal thoughts or other mood changes

• unusually weak or tired

• vomiting

• yellowing of the eyes or skin

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

• constipation

• diarrhea

• dizziness

• dry mouth

• headache

• nausea

• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.