Bupropion

What it is used for

Bupropion hydrochloride extended-release tablets (XL) are a prescription medicine used to treat adults with a certain type of depression called major depressive disorder and for the prevention of autumn-winter seasonal depression (seasonal affective disorder).

How to take it

• Take bupropion hydrochloride extended-release tablets (XL) exactly as prescribed by your healthcare provider.

• Do not chew, cut, or crush bupropion hydrochloride extended-release tablets (XL).

• Take bupropion hydrochloride extended-release tablets (XL) at the same time each day.

• Take your doses of bupropion hydrochloride extended-release tablets (XL) at least 24 hours apart.

• You may take bupropion hydrochloride extended-release tablets (XL) with or without food.

• If you miss a dose, do not take an extra tablet to make up for the dose you missed. Wait and take your next tablet at the regular time. This is very important. Too much bupropion hydrochloride extended-release tablets (XL) can increase your chance of having a seizure.

• If you take too much bupropion hydrochloride extended-release tablets (XL), or overdose, call your local emergency room or poison control center right away.

• Do not take any other medicines while using bupropion hydrochloride extended-release tablets (XL) unless your healthcare provider has told you it is okay.

• If you are taking bupropion hydrochloride extended-release tablets (XL) for the treatment of major depressive disorder, it may take several weeks for you to feel that bupropion hydrochloride extended-release tablets (XL) is working. Once you feel better, it is important to keep taking bupropion hydrochloride extended-release tablets (XL) exactly as directed by your healthcare provider. Call your healthcare provider if you do not feel bupropion hydrochloride extended-release tablets (XL) is working for you.

• If you are taking bupropion hydrochloride extended-release tablets (XL) for the prevention of seasonal major depressive episodes associated with seasonal affective disorder, it is important to keep taking bupropion hydrochloride extended-release tablets (XL) through the autumn-winter season, or as directed by your healthcare provider.

• Do not change your dose or stop taking bupropion hydrochloride extended-release tablets (XL) without talking with your healthcare provider first.

Side effects, and when to stop

Bupropion hydrochloride extended-release tablets (XL) may cause serious side effects, including:

The most common side effects of bupropion hydrochloride extended-release tablets (XL) include:

• Dry mouth

• Nervousness

• Constipation

• Headache

• Shakiness

• Nausea and vomiting

• Trouble sleeping

• Dizziness

• Shakiness (tremor)

• Fast heartbeat

• Heavy sweating

If you have nausea, take your medicine with food. If you have trouble sleeping; do not take your medicine too close to bedtime.

Tell your healthcare provider right away about any side effects that bother you.

These are not all the possible side effects of bupropion hydrochloride extended-release tablets (XL). For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Who should not take it

Do not take bupropion hydrochloride extended-release tablets (XL) if you:

• have or had a seizure disorder or epilepsy.

• have or had an eating disorder such as anorexia nervosa or bulimia.

• are taking any other medicines that contain bupropion, including ZYBAN® (used to help people stop smoking), APLENZIN®, FORFIVO XL™, WELLBUTRIN® or WELLBUTRIN SR. Bupropion is the same active ingredient that is in bupropion hydrochloride extended-release tablets (XL).

• drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy) or benzodiazepines, or anti-seizure medicines, and you stop using them all of a sudden.

• take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.

• do not take an MAOI within 2 weeks of stopping bupropion hydrochloride extended-release tablets (XL) unless directed to do so by your healthcare provider.

• do not start bupropion hydrochloride extended-release tablets (XL) if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider.

• are allergic to the active ingredient in bupropion hydrochloride extended-release tablets (XL), bupropion hydrochloride, or to any of the inactive ingredients. See the end of this Medication Guide for a complete list of ingredients in bupropion hydrochloride extended-release tablets (XL).

What to say before you start

Tell your healthcare provider if you have ever had depression, suicidal thoughts or actions, or other mental health problems. See "Antidepressant Medicines, Depression, and Other Mental Illnesses, and Suicidal Thoughts or Actions."

Tell your healthcare provider about your other medical conditions including if you:

• have liver problems, especially cirrhosis of the liver.

• have kidney problems.

• have, or have had, an eating disorder such as anorexia nervosa or bulimia.

• have had a head injury.

• have had a seizure (convulsion, fit).

• have a tumor in your nervous system (brain or spine).

• have had a heart attack, heart problems, or high blood pressure.

• are a diabetic taking insulin or other medicines to control your blood sugar.

• drink alcohol.

• abuse prescription medicines or street drugs.

• are pregnant or plan to become pregnant.

• are breastfeeding. Bupropion hydrochloride passes into your milk in small amounts.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Many medicines increase your chances of having seizures or cause other serious side effects if you take them while you are taking bupropion hydrochloride extended-release tablets (XL).

What to avoid

• Limit or avoid using alcohol during treatment with bupropion hydrochloride extended-release tablets (XL). If you usually drink a lot of alcohol, talk with your healthcare provider before suddenly stopping. If you suddenly stop drinking alcohol, you may increase your chance of having seizures.

• Do not drive a car or use heavy machinery until you know how bupropion hydrochloride extended-release tablets (XL) affects you. Bupropion hydrochloride extended-release tablets (XL) can impair your ability to do these things safely.

Storing it

Store bupropion hydrochloride extended-release tablets (XL) at 20° to 25°C (68° to 77°F).

Keep bupropion hydrochloride extended-release tablets (XL) dry and out of light.

Keep bupropion hydrochloride extended-release tablets (XL) and all medicines out of the reach of children.

General information about bupropion hydrochloride extended-release tablets (XL)

• Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use bupropion hydrochloride extended-release tablets (XL) for a condition for which it was not prescribed. Do not give bupropion hydrochloride extended-release tablets (XL) to other people, even if they have the same symptoms you have. It may harm them.

• If you take a urine drug screening test, bupropion hydrochloride extended-release tablets (XL), may make the test result positive for amphetamines. If you tell the person giving you the drug screening test that you are taking bupropion hydrochloride extended-release tablets (XL), they can do a more specific drug screening test that should not have this problem.

This Medication Guide summarizes the most important information about bupropion hydrochloride extended-release tablets (XL). If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about bupropion hydrochloride extended-release tablets (XL) that is written for healthcare professionals.

Please address medical inquiries to, ([email protected]) Tel.: 1-877-993-8779.

What else do I need to know about antidepressant medicines?

• Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.

• Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.

• Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.

• Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.

• It is not known if bupropion hydrochloride extended-release tablets (XL) are safe and effective in children under the age of 18.

Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions

This section of the Medication Guide is only about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with drugs used to quit smoking.

Although bupropion hydrochloride extended-release tablets (XL) are not a treatment for quitting smoking, it contains the same active ingredient (bupropion hydrochloride) as ZYBAN which is used to help patients quit smoking.

Some people have had changes in behavior, hostility, agitation, depression, suicidal thoughts or actions while talking bupropion to help them quit smoking. These symptoms can develop during treatment with bupropion or after stopping treatment with bupropion.

If you, your family member, or your caregiver notice agitation, hostility, depression or changes in thinking or behavior that are not typical for you, or you have any of the following symptoms, stop taking bupropion and call your healthcare provider right away:

• thoughts about suicide or dying

• attempts to commit suicide

• new or worse depression

• new or worse anxiety

• panic attacks

• feeling very agitated or restless

• acting aggressive, being angry, or violent

• acting on dangerous impulses

• an extreme increase in activity and talking (mania)

• abnormal thoughts or sensations

• seeing or hearing things that are not there (hallucinations)

• feeling people are against you (paranoia)

• feeling confused

• other unusual changes in behavior or mood

When you try to quit smoking, with or without bupropion, you may have symptoms that may be due to nicotine withdrawal, including urge to smoke, depressed mood, trouble sleeping, irritability, frustration, anger, feeling anxious, difficulty concentrating, restlessness, decreased heart rate, and increased appetite or weight gain. Some people have even experienced suicidal thoughts when trying to quit smoking without medication. Sometimes quitting smoking can lead to worsening of mental health problems that you already have, such as depression.

Before taking bupropion, tell your healthcare provider if you have ever had depression or other mental illness. You should also tell your healthcare provider about any symptoms you had during other times you tried to quit smoking, with or without bupropion.

What Other Important Information Should I Know about Bupropion hydrochloride extended-release tablets (XL)?

• Seizures: There is a chance of having a seizure (convulsion, fit) with bupropion hydrochloride extended-release tablets (XL), especially in people:

• with certain medical problems

• who take certain medicines

The chance of having seizures increases with higher doses of bupropion hydrochloride extended-release tablets (XL). For more information, see the sections " Who should not take bupropion hydrochloride extended-release tablets (XL)? " and " What should I tell my healthcare provider before using bupropion hydrochloride extended-release tablets (XL)? " Tell your healthcare provider about all of your medical conditions and all the medicines you take. Do not take any other medicines while you are taking bupropion hydrochloride extended-release tablets (XL) unless your healthcare provider has said it is okay to take them.

If you have a seizure while taking bupropion hydrochloride extended-release tablets (XL), stop taking the tablets and call your healthcare provider right away. Do not take bupropion hydrochloride extended-release tablets (XL) again if you have a seizure.

• High blood pressure (hypertension): Some people get high blood pressure, that can be severe, while taking bupropion hydrochloride extended-release tablets (XL). The chance of high blood pressure may be higher if you also use nicotine replacement therapy (such as a nicotine patch) to help you stop smoking.

• Manic episodes: Some people may have periods of mania while taking bupropion hydrochloride extended-release tablets (XL), including:

• greatly increased energy

• severe trouble sleeping

• racing thoughts

• reckless behavior

• unusually grand ideas

• excessive happiness or irritability

• talking more or faster than usual

If you have any of the above symptoms of mania, call your healthcare provider.

• Unusual thoughts or behaviors: Some patients may have unusual thoughts or behaviors while taking bupropion hydrochloride extended-release tablets (XL), including delusions (believe you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your healthcare provider.

• Visual Problems

• eye pain

• changes in vision

• swelling or redness in or around the eye

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

• Severe allergic reactions: Some patients have severe allergic reactions to bupropion hydrochloride extended-release tablets (XL). Stop taking bupropion hydrochloride extended-release tablets (XL) and call your healthcare provider right away if you get a rash, itching, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, swelling of the lips or tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction.