This drug contains bupropion, which is the same active ingredient as certain antidepressants (Wellbutrin, Aplenzin), as well as a drug that aids in quitting smoking (Zyban). A tiny number of kids, teenagers, and young adults (up to 24 years old) who took mood-elevating antidepressants like bupropion in clinical research developed suicide thoughts (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental diseases may have a higher risk of committing suicide than those who do not take these medications. Bupropion and naltrexone together have not been found to be safe for use in children under the age of 18.

You should know that your mental health may change in unexpected ways when you take the combination of naltrexone and bupropion even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; anxiety or panic attacks; difficulty falling asleep or staying asleep; aggressive, angry, or violent behavior; irritability; acting without thinking; severe restlessness; abnormal thoughts or sensations; feeling that people are against you; hallucinations (seeing things or hearing voices that do not exist); feeling confused; frenzied abnormal excitement; or any other sudden or unusual changes in behavior. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

If you are taking naltrexone and bupropion together, your doctor will want to see you frequently, especially at the start of your treatment. Make sure to show up for all of your doctor’s appointment times.

The manufacturer’s patient information sheet (Medication Guide) will be provided to you by your doctor or pharmacist when you start treatment with the naltrexone and bupropion combination as well as each time you refill your prescription. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm).

The dangers of taking naltrexone and bupropion together should be discussed with your doctor.

Adults who are obese or overweight and have weight-related medical issues can utilise the combination of naltrexone and bupropion to lose weight and then maintain that weight loss together with a reduced calorie diet and activity programme. The drug naltrexone belongs to the group of drugs known as opiate antagonists. The drug bupropion belongs to the group of drugs known as antidepressants. These drugs diminish appetite and aid in desire control by acting simultaneously on the reward system and the hunger region of the brain.

The naltrexone and bupropion combination is available as a long-acting (extended-release) tablet to be swallowed. Typically, it is taken twice daily. Take this medication apart from a meal high in fat. Use bupropion and naltrexone at around the same times each day. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Use bupropion and naltrexone precisely as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

Do not split, chew, or crush the extended-release pills; instead, swallow them whole.

Your doctor will likely start you on a modest dose of the naltrexone and bupropion combination and progressively raise your dose over the course of four weeks, not more than once every week. Your doctor will check to see how much weight you have dropped after 16 weeks of treatment. Your doctor could advise you to stop taking the naltrexone and bupropion combination if you have not dropped a specific amount of weight because it is unlikely that you will continue to benefit from treatment.

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

Before taking the combination of naltrexone and bupropion,

• If you have any allergies, including to naltrexone, bupropion, other drugs, or any of the substances in naltrexone and bupropion tablets, let your doctor and pharmacist know right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
• Inform your doctor if you are currently taking an MAO inhibitor, such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), rasagiline (Azilect), selegiline (Emsam, Zelapar), or tranylcypromine (Parnate), or if you have just discontinued taking one. Most likely, your doctor will advise against using bupropion and naltrexone together. Your doctor would advise you to wait at least 14 days before starting an MAO inhibitor if you stop taking the combination of naltrexone and bupropion.
• Inform your doctor if you are using any opioid drugs, including heroin, prescription pain relievers like buprenorphine (Buprenex, Butrans, Sublocade), or methadone (Dolophine, Methadose), as well as any over-the-counter or prescription painkillers like tramadol (Ultram, Ultracet). Moreover, let your doctor know if you have taken any of these drugs within the last seven to ten days. If you are unsure whether a drug you have taken is an opioid, consult your doctor. If you have used or taken opioids in the last seven to ten days, your doctor will advise you against using the drug combination of naltrexone and bupropion.
• Do not use any prescription opioid medications or illegal opioid substances while receiving treatment with naltrexone and bupropion. Medications like naltrexone block the effects of both legal and illegal opioids. You might not experience the effects of these drugs if you take them or use them in low or normal amounts. Using or consuming higher dosages of prescription opioids or other drugs throughout your course of therapy with the naltrexone and bupropion combination could cause serious damage, coma, or even death.
• You should be aware that if you used opioid drugs before to beginning treatment with the naltrexone and bupropion combination, you may be more susceptible to their effects when it’s time for your next dose, if you forget to take a dose, when your treatment is over, or if you go through detoxification. Use of opioids in dosages similar to those taken prior to starting naltrexone and bupropion treatment can result in overdose and death. Once your course of therapy is complete, disclose your prior use of the drugs naltrexone and bupropion to any doctor who could prescribe medicine for you. It’s critical that you let your loved ones or carer know about your increased sensitivity to opioids and the possibility of an overdose. If you have any of the following symptoms, such as difficulty breathing, slow, shallow breathing, drowsiness, feeling faint, dizziness, or confusion, you or your carer should seek emergency medical attention right away.
• Antidepressants and products to help people quit smoking should not be taken at the same time as other products that include bupropion. If you use too much bupropion, you could have serious negative effects.
• Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Include any of the following medications: dexamethasone, digoxin (Lanoxin), doxepin (Silenor), efavirenz, citalopram (Celexa), amantadine (Osmolex ER), amitriptyline, amoxapine, carbamazepine (Carbatrol, Tegretol), desipramine (Norpramin), amitriptyline, amiox (Sustiva, in Atripla), levodopa (in Sinemet, in Stalevo), lopinavir (in Kaletra), methylprednisolone (Medrol), metoprolol (Lopressor, Toprol XL), nortriptyline, flecainide (Tambocor), fluoxetine (Prozac), fluvoxamine (Luvox), haloperidol (Haldol), imipramine (Tofranil), insulin or oral (Pamelor), theophylline (Theo-24, Theochron), thioridazine, ticlopidine, trimipramine (Surmontil), phenytoin (Dilantin), prednisone, propafenone (Rythmol SR), protriptyline (Vivactil), and other drugs used for weight loss. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Bupropion and naltrexone may interact with a wide range of other drugs, so be careful to inform your doctor about all the drugs you are taking, even if they do not appear on this list.
• Inform your doctor if you suffer from or have ever suffered from an eating disorder such as bulimia, anorexia nervosa, or unmanageable high blood pressure. Moreover, let your doctor know if you regularly consume significant amounts of alcohol but anticipate quitting abruptly; if you regularly take sedatives, hypnotics, benzodiazepines, or anti-seizure medications but anticipate quitting abruptly; or if you’re going through opioid withdrawal. Most likely, your doctor will advise against using bupropion and naltrexone together.
• Inform your doctor if you or anyone in your family has ever considered or attempted suicide, or if you or they have ever experienced depression, mania (an abnormally frenzied state of excitement), bipolar disorder (disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions), schizophrenia, or any other mental illness; if you are over 65; if you smoke; or if you intend to stop smoking; and if you already have diabetes, low blood sugar, low salt levels in the blood, heart, kidney, or liver problems, or if you have ever had a head injury, heart attack, stroke, tumour, infection of the brain, or spine.
• Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Call your doctor right away if you become pregnant while taking naltrexone and bupropion together.
• Inform your doctor or dentist that you are taking naltrexone and bupropion if you are undergoing surgery, including dental surgery.
• As you take naltrexone and bupropion together, inquire with your doctor about whether drinking alcohol is safe for you to do so. The negative effects of bupropion and naltrexone can be made worse by alcohol.
• You should be aware that taking bupropion and naltrexone together has been linked to increased blood pressure and heart rate. Before beginning treatment and periodically while you are on this medicine, your doctor will check your blood pressure and heart rate.
• You should be aware that taking naltrexone and bupropion together may result in angle-closure glaucoma (condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Before beginning this medicine, discuss with your doctor getting an eye check to see whether you are at risk for this condition. Call your doctor or get emergency medical attention right away if you experience eye pain, changes in your vision, or swelling or redness in or around your eye.

Keep eating normally unless your doctor instructs you otherwise.

Ignore the missed dose and carry on with my normal dosing routine. To make up for a missing dose, do not take a second one.

Naltrexone and bupropion together may have negative side effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

• Nausea
• Vomiting
• Diarrhea
• Constipation
• Mouth ache
• Alterations to your palate
• Headache
• Dizziness
• Tiredness
• Flushing
• Body part shaking that is uncontrollable
• Excessive perspiration
• Hearing ringing

Certain adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you experience any of the following symptoms or any of those mentioned in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections:

• Seizures
• Blisters or a rash
• Itching
• Hives
• Enlarged glands
• Painful sores around your eyes or in your mouth
• Breathing difficulty
• Enlargement of the tongue or lips
• Chest ache
• Fever
• Abdominal pain
• Dark faeces
• Eyes or skin that have a yellow tint
• Joinor muscle ache

Naltrexone and bupropion taken together could result in additional adverse effects. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

Keep this medication tightly closed in the original container and out of the reach of children. Keep it away from excessive heat and moisture at room temperature (not in the bathroom)

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at http://goo.gl/c4Rm4p for additional information.

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

• Seizure
• Seeing or hearing things or voices that are not there
• Consciousness is lost
• Hammering or fast heartbeat

Keep all of your appointments with your physician and the lab.

Inform your doctor and the lab staff that you are taking naltrexone and bupropion before undergoing any laboratory tests.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.