Bupropion Hydrochloride

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• BOXED WARNING
• BUPROPION HYDROCHLORIDE DESCRIPTION
• CLINICAL PHARMACOLOGY
• INDICATIONS & USAGE
• BUPROPION HYDROCHLORIDE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• BUPROPION HYDROCHLORIDE ADVERSE REACTIONS
• DRUG ABUSE AND DEPENDENCE
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• HOW SUPPLIED
• SPL MEDGUIDE
• INACTIVE INGREDIENT
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

BUPROPION HYDROCHLORIDE DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS & USAGE

BUPROPION HYDROCHLORIDE CONTRAINDICATIONS

WARNINGS

• ●Patient factors: Predisposing factors that may increase the risk of seizure with bupropion use include history of head trauma or prior seizure, central nervous system (CNS) tumor, the presence of severe hepatic cirrhosis, and concomitant medications that lower seizure threshold.

• ●Clinical situations: Circumstances associated with an increased seizure risk include, among others, excessive use of alcohol or sedatives (including benzodiazepines); addiction to opiates, cocaine, or stimulants; use of over-the-counter stimulants and anorectics; and diabetes treated with oral hypoglycemics or insulin.

• ●Concomitant medications: Many medications (e.g., antipsychotics, antidepressants, theophylline, systemic steroids) are known to lower seizure threshold.

• ●

• ●the daily dose is administered 3 times daily, with each single dose not to exceed 150 mg to avoid high peak concentrations of bupropion and/or its metabolites, and

• ●the rate of incrementation of dose is very gradual.

• ●Bupropion should be administered with extreme caution to patients with a history of seizure, cranial trauma, or other predisposition(s) toward seizure, or patients treated with other agents (e.g., antipsychotics, other antidepressants, theophylline, systemic steroids, etc.) that lower seizure threshold.

PRECAUTIONS

BUPROPION HYDROCHLORIDE ADVERSE REACTIONS

DRUG ABUSE AND DEPENDENCE

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

SPL MEDGUIDE

• ●all risks and benefits of treatment with antidepressant medicines

• ●all treatment choices for depression or other serious mental illness

• ●What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

• ●Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

• ●Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

• ●Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

• ●attempts to commit suicide

• ●new or worse depression

• ●new or worse anxiety

• ●feeling very agitated or restless

• ●panic attacks

• ●trouble sleeping (insomnia)

• ●new or worse irritability

• ●acting aggressive, being angry, or violent

• ●acting on dangerous impulses

• ●an extreme increase in activity and talking (mania)

• ●other unusual changes in behavior or mood

• ●What else do I need to know about antidepressant medicines?

• ●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.

• ●Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child's healthcare provider for more information.

• ●Bupropion hydrochloride tablets USP have not been studied in children under the age of 18 and are not approved for use in children and teenagers.

• ●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.

• ●with certain medical problems.

• ●who take certain medicines.

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

• ●Severe allergic reactions. Some people have severe allergic reaction to bupropion hydrochloride tablets USP. Stop taking bupropion hydrochloride tablets USP and call your doctor 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.

• ●Unusual thoughts or behaviors. Some patients have unusual thoughts or behaviors while taking bupropion hydrochloride tablets USP, 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 doctor.

• ●What are bupropion hydrochloride tablets USP?

• ●are taking ZYBAN(bupropion hydrochloride sustained-release tablets) (used to help people stop smoking) or any other medicines that contain bupropion hydrochloride, such as WELLBUTRIN SR(bupropion hydrochloride sustained-release tablets) or WELLBUTRIN XL(bupropion hydrochloride extended-release tablets). Bupropion is the same active ingredient that is in bupropion hydrochloride tablets USP .

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

• ●have taken within the last 14 days medicine for depression called a monoamine oxidase inhibitor (MAOI), such as NARDIL(phenelzine sulfate), PARNATE(tranylcypromine sulfate), or MARPLAN(isocarboxazid).

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

• ●are allergic to the active ingredient in bupropion hydrochloride tablets USP, bupropion, or to any of the inactive ingredients. See the end of this leaflet for a complete list of ingredients in bupropion hydrochloride tablets USP.

• ●What should I tell my doctor before using bupropion hydrochloride tablets USP?

• ●are pregnant or plan to become pregnant. It is not known if bupropion hydrochloride tablets USP can harm your unborn baby.

• ●are breastfeeding. Bupropion passes through your milk. It is not known if bupropion hydrochloride tablets USP can harm your baby.

• ●have liver problems, especially cirrhosis of the liver.

• ●have kidney problems.

• ●have 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 a lot of alcohol.

• ●abuse prescription medicines or street drugs.

• ●Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Many medicines increase your chances of having seizures or other serious side effects if you take them while you are using bupropion hydrochloride tablets USP.

• ●How should I take bupropion hydrochloride tablets USP?

• ●Take bupropion hydrochloride tablets USP at the same time each day.

• ●Take your doses of bupropion hydrochloride tablets USP at least 6 hours apart.

• ●You may take bupropion hydrochloride tablets USP with or without food.

• ●If you miss a dose, do not take an extra tablet to make up for the dose you forgot. Wait and take your next tablet at the regular time. This is very important. Too many bupropion hydrochloride tablets USP can increase your chance of having a seizure.

• ●If you take too many bupropion hydrochloride tablets USP, or overdose, call your local emergency room or poison control center right away.

• ●Do not take any other medicines while using bupropion hydrochloride tablets USP unless your doctor has told you it is okay.

• ●It may take several weeks for you to feel that bupropion hydrochloride tablets USP are working. Once you feel better, it is important to keep taking bupropion hydrochloride tablets USP exactly as directed by your doctor. Call your doctor if you do not feel bupropion hydrochloride tablets USP are working for you.

• ●Do not change your dose or stop taking bupropion hydrochloride tablets USP without talking with your doctor first.

• ●What should I avoid while taking bupropion hydrochloride tablets USP?

• ●Do not drive a car or use heavy machinery until you know how bupropion hydrochloride tablets USP affect you. Bupropion hydrochloride tablets USP can impair your ability to perform these tasks.

• ●What are possible side effects of bupropion hydrochloride tablets USP?

• ●General Information about bupropion hydrochloride tablets USP.

• ●This Medication Guide summarizes important information about bupropion hydrochloride tablets USP. For more information, talk to your doctor. You can ask your doctor or pharmacist for information about bupropion hydrochloride tablets USP that is written for health professionals.

INACTIVE INGREDIENT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION