Fitlab (Weight Loss)

Important Safety Information

What do I need to tell my doctor BEFORE I take Naltrexone and Bupropion?

• If you are allergic to naltrexone and bupropion; any part of naltrexone and bupropion; or any other drugs, foods, or substances
• Tell your doctor about the allergy and what signs you had
• If you have ever had seizures
• If you drink a lot of alcohol and you stop drinking all of a sudden
• If you use certain other drugs like drugs for seizures or anxiety and you stop using them all of a sudden
• If you have an eating problem, high blood pressure, or kidney problems
• If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen
• If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen
• If you are taking: carbamazepine, efavirenz, linezolid, lopinavir, methylene blue, phenobarbital, ritonavir, or another drug that has the same drug in it
• If you take drugs like methadone or buprenorphine to help you stop taking an opioid drug
• If you are taking an opioid drug like morphine, oxycodone, are addicted to an opioid drug, or are having withdrawal signs
• If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine
• If you have taken a pain drug within the past 7 to 14 days
• If you are pregnant or may be pregnant. Do not take naltrexone and bupropion if you are pregnant. If you are breast-feeding
• Do not breast-feed while you take naltrexone and bupropion. If the patient is a child
• Do not give naltrexone and bupropion to a child

This is not a list of all drugs or health problems that interact with naltrexone and bupropion.

• Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems.
• You must check to make sure that it is safe for you to take naltrexone and bupropion with all of your drugs and health problems.
• Do not start, stop, or change the dose of any drug without checking with your doctor.

How do I store and/or throw out Naltrexone and Bupropion?

• Store at room temperature
• Store in a dry place
• Do not store in a bathroom
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets
• Do not flush down a toilet or pour down a drain unless you are told to do so
• Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area

What are some things I need to know or do while I take Naltrexone and Bupropion?

• Tell all of your health care providers that you take naltrexone and bupropion. This includes your doctors, nurses, pharmacists, and dentists.
• Follow the diet and workout plan that your doctor told you about.
• This medicine may cause high blood pressure. Check blood pressure and heart rate as the doctor has told you.
• Call your doctor right away if you have signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating
• This medicine may raise the chance of seizures. The chance may be higher in people who have certain health problems, use certain other drugs, or drink a lot of alcohol. Talk to your doctor to see if you have a greater chance of seizures while taking naltrexone and bupropion.
• Some people may have a higher chance of eye problems with naltrexone and bupropion
• Talk with your doctor before taking opioid drugs like some cough and cold products, some diarrhea drugs, and some pain drugs. These drugs may not work as well. Do not take more of these drugs to try to get them to work better. Doing this may cause very bad injury, coma, or death. Talk with your doctor
• If you are 65 or older, use naltrexone and bupropion with care. You could have more side effects.
• Swallow whole. Do not chew, break, or crush
• Do not take naltrexone and bupropion more often than you are told. This may raise the risk of seizures. Be sure you know how far apart to take your doses
• Avoid drinking alcohol while taking naltrexone and bupropion

What should I do if I forget a dose?
If you forget a dose, skip the missed dose and go back to your normal time. Do not take a double dose to make up for a missed one.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug.

• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Hallucinations
• Restlessness
• Seizures
• Chest pain or pressure
• Fast or abnormal heartbeat
• Swollen gland
• Muscle or joint pain
• Shortness of breath
• Swelling
• Fever
• Skin Rash - Stevens-Johnson syndrome/toxic epidermal necrolysis may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness
• Headache
• Upset stomach or throwing up
• Diarrhea or constipation
• Dry mouth
• Trouble sleeping

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-332-1088.

You may also report side effects at https://www.fda.gov/medwatch. If OVERDOSE is suspected: If you think there has been an overdose, call your poison control center or get medical care right away.