Just ONE tablet delivers 450 mg bupropion each day.

Download the Full Prescribing Information, including Boxed Warning, and Medication Guide.

MEDICATION GUIDE
FORFIVO XL®(Fore-fyel-voe Eks el)

(bupropion hydrochloride extended-release)Tablets

IMPORTANT: Be sure to read the three sections of this Medication Guide. The first section is about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with medicines used to quit smoking; the second section is about the risk of suicidal thoughts and actions with antidepressant medicines; and the third section is entitled “What Other Important Information Should I Know About FORFIVO XL?”

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:

What else do I need to know about antidepressant medicines?

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 FORFIVO XL is not a treatment for quitting smoking, it contains the same active ingredient (bupropion) as ZYBAN® which is used to help patients quit smoking.Talk to your healthcare provider or your family member’s healthcare provider about:

When you try to quit smoking, with or without bupropion you may have symptoms that may be due to nicotine withdrawal, including:

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 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 FORFIVO XL 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 FORFIVO XL. In many people, these symptoms went away after stopping bupropion, but in some people symptoms continued after stopping bupropion. It is important for you to follow-up with your healthcare provider until your symptoms go away. Before taking FORFIVO XL, 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 FORFIVO XL?

The chance of having seizures increases with higher doses of FORFIVO XL. For more information, see the sections “Who should not take FORFIVO XL?” and “What should I tell my healthcare provider before taking FORFIVO 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 FORFIVO XL unless your healthcare provider has said it is okay to take them.

If you have a seizure while taking FORFIVO XL, stop taking the tablets and call your healthcare provider right away. Do not take FORFIVO XL again if you have a seizure.

What is FORFIVO XL?

FORFIVO XL is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder.

Who should not take FORFIVO XL?

Do not take FORFIVO XL if you:

What should I tell my healthcare provider before using FORFIVO XL?

Tell your healthcare provider if you have ever had depression, suicidal thoughts or actions, 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. See “Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions.”

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 FORFIVO XL.

How should I take FORFIVO XL?

Do not take any other medicines while taking FORFIVO XL unless your healthcare provider has told you it is okay.

What should I avoid while taking FORFIVO XL?

What are the possible side effects of FORFIVO XL?

FORFIVO XL can cause serious side effects. See the sections at the beginning of this Medication Guide for information about serious side effects of FORFIVO XL.

The most common side effects of FORFIVO XL include:

If you have nausea, take FORFIVO XL with food.

If you have trouble sleeping, do not take FORFIVO XL 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 FORFIVO 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.

How should I store FORFIVO XL?

Store FORFIVO XL at room temperature between 68°F and 77°F (20°C to 25°C).

Keep FORFIVO XL and all medicines out of the reach of children.

General information about the safe and effective use of FORFIVO XL.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FORFIVO XL for a condition for which it was not prescribed. Do not give FORFIVO 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, FORFIVO XL may make the test result positive for amphetamines. If you tell the person giving you the drug screening test that you are taking FORFIVO XL, they can do a more specific drug screening test that should not have this problem.

This Medication Guide summarizes important information about FORFIVO XL. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about FORFIVO XL that is written for health professionals.

For more information about FORFIVO XL, go to www.forfivoxl.com or call
1-877-447-7979.

What are the ingredients in FORFIVO XL?

Active ingredient: bupropion hydrochloride.

Inactive ingredients: hydroxypropyl cellulose, hydrochloric acid, polyvinylpyrrolidone and polyvinyl acetate blend, polyethylene oxide, stearic acid, colloidal silicon dioxide, magnesium stearate, hydroxypropylmethyl cellulose, triacetin, talc, methacrylic acid copolymer, polyethylene glycol 8000, titanium dioxide and carboxymethyl cellulose sodium. The tablets are printed with edible black ink.

FORFIVO XL is a registered trademark of IntelGenx Corporation. All other products/brand names are trademarks of their respective owners.

Manufactured by: Pillar5 Pharma Inc. Arnprior, Ontario, K7S 0C9 Canada

Distributed by: Almatica Pharma, Inc. Pine Brook, NJ 07058 USA

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised May 2017

PL575-01


Download the Full Prescribing Information, including Boxed Warning, and Medication Guide.