BUPROPION HYDROCHLORIDE- bupropion hydrochloride tablet
CIPLA USA INC.,
IMPORTANT: Be sure to read the three sections of this Medication Guide. The first section is about the risk of suicidal thoughts and actions with antidepressant medicines; the second section is about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with medicines used to quit smoking; and the third section is entitled “What Other Important Information Should I Know About Bupropion Hydrochloride Tablets?”
Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions
This section of the Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines.
What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?
1. Antidepressant medicines may increase the risk of suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment.
2. Depression or other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic- depressive illness) or suicidal thoughts or actions.
3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
Call your 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:
• thoughts about suicide or dying
• 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?
It is not known if bupropion hydrochloride tablets 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 tablet is not a treatment for quitting smoking, it contains the same active ingredient (bupropion hydrochloride) as ZYBAN® which is used to help patients quit smoking.
Talk to your healthcare provider or your family member’s healthcare provider about:
• all risks and benefits of quit-smoking medicines.
• all treatment choices for quitting smoking.
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
• decreased heart rate
• trouble sleeping
• feeling anxious
• increased appetite
• difficulty concentrating
• 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.
Some people have had serious side effects while taking bupropion to help them quit smoking, including:
New or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depression, or suicidal thoughts or actions. Some people had these symptoms when they began taking bupropion, and others developed them after several weeks of treatment, or after stopping bupropion. These symptoms happened more often in people who had a history of mental health problems before taking bupropion than in people without a history of mental health problems.
Stop taking bupropion hydrochloride tablets and call your healthcare provider right away if you, your family, or caregiver notice any of these symptoms. Work with your healthcare provider to decide whether you should continue to take bupropion hydrochloride tablets. In many people, these symptoms went away after stopping bupropion hydrochloride tablets, but in some people symptoms continued after stopping bupropion hydrochloride tablets. It is important for you to follow-up with your healthcare provider until your symptoms go away.
Before taking bupropion hydrochloride tablets, tell your healthcare provider if you have ever had depression or other mental health problems. 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 Tablets?
• Seizures: There is a chance of having a seizure (convulsion, fit) with bupropion hydrochloride tablets, especially in people:
The chance of having seizures increases with higher doses bupropion hydrochloride tablets. For more information, see the sections “Who should not take bupropion hydrochloride tablets?” and “What should I tell my healthcare provider before taking bupropion hydrochloride tablets?” 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 tablets unless your healthcare provider has said it is okay to take them.
If you have a seizure while taking bupropion hydrochloride tablets, stop taking the tablets and call your healthcare provider right away. Do not take bupropion hydrochloride tablets again if you have a seizure.
• High blood pressure (hypertension). Some people get high blood pressure that can be severe, while taking bupropion hydrochloride tablets. 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 (see the section of this Medication Guide called “How should I take bupropion hydrochloride tablets?”).
• Manic episodes. Some people may have periods of mania while taking bupropion hydrochloride tablets, including:
o Greatly increased energy
o Severe trouble sleeping
o Racing thoughts
o Reckless behavior
o Unusually grand ideas
o Excessive happiness or irritability
o 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 have unusual thoughts or behaviors while taking bupropion hydrochloride tablets, 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.
o eye pain
o changes in vision
o 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 people can have severe allergic reactions to bupropion hydrochloride tablets. Stop taking bupropion hydrochloride tablets 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.
What are bupropion hydrochloride tablet?
Bupropion hydrochloride tablet is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder.
Who should not take bupropion hydrochloride tablets?
Do not take bupropion hydrochloride tablets if you
What should I tell my healthcare provider before taking bupropion hydrochloride tablets?
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 Serious Mental Illnesses, and Suicidal Thoughts or Actions.”
Tell your healthcare provider about your other medical conditions including if you:
o have liver problems, especially cirrhosis of the liver.
o have kidney problems.
o have, or have had, an eating disorder, such as anorexia nervosa or bulimia.
o have had a head injury.
o have had a seizure (convulsion, fit).
o have a tumor in your nervous system (brain or spine).
o have had a heart attack, heart problems, or high blood pressure.
o are a diabetic taking insulin or other medicines to control your blood sugar.
o drink alcohol.
o abuse prescription medicines or street drugs.
o are pregnant or plan to become pregnant.
o are breastfeeding. Bupropion hydrochloride passes into your milk in small amounts.
Tell your healthcare provider about all the medicines you take, including prescription, over-the-counter 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 taking bupropion hydrochloride tablets.
How should I take bupropion hydrochloride tablets?
What should I avoid while taking bupropion hydrochloride tablets?
What are possible side effects of bupropion hydrochloride tablets?
Bupropion hydrochloride tablets can cause serious side effects. See the sections at the beginning of this Medication Guide for information about serious side effects of bupropion hydrochloride tablets.
The most common side effects of bupropion hydrochloride tablets include:
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 tablets. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Cipla Ltd. at 1-866-604-3268.
How should I store bupropion hydrochloride tablets?
• Store bupropion hydrochloride tablets at room temperature between 20oC to 25oC (68oF to 77oF).
• Keep bupropion hydrochloride tablets dry and out of the light.
Keep bupropion hydrochloride tablets and all medicines out of the reach of children.
General Information about the safe and effective use of bupropion hydrochloride tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use bupropion hydrochloride tablets for a condition for which it was not prescribed. Do not give bupropion hydrochloride tablets 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 tablets 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 tablets, they can do a more specific drug screening test that should not have this problem.
This Medication Guide summarizes important information about bupropion hydrochloride tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about bupropion hydrochloride tablets that is written for healthcare professionals.
For more information about bupropion hydrochloride tablets, call 1-877-354-3380.
What are the ingredients in bupropion hydrochloride tablets?
Active ingredient: bupropion hydrochloride, USP.
75 mg tablet – microcrystalline cellulose, hydroxypropyl methylcellulose, crospovidone, diluted HCl, colloidal silicon dioxide, stearic acid, magnesium stearate, talc, glycerol triacetate, D&C yellow no. 10 aluminum lake, titanium dioxide and FD&C yellow no. 6;
100 mg tablet – microcrystalline cellulose, hydroxypropyl methylcellulose, crospovidone, diluted HCl, colloidal silicon dioxide, stearic acid, magnesium stearate, glycerol triacetate, talc, titanium dioxide, FD&C Red no. 40 and FD&C yellow no. 6.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
All brand names mentioned are registered trademark of their respective owners and are not of Cipla Limited.
Cipla USA, Inc.
1560 Sawgrass Corporate Parkway, Suite 130
Sunrise, FL 33323
InvaGen Pharmaceuticals, Inc.
(a subsidiary of Cipla Ltd.)
Hauppauge, NY 11788