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 fye' voe Eks el
(bupropion hydrochloride extended-release tablets)

Read this Medication Guide carefully before you start using FORFIVO XL and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. If you have any questions about FORFIVO XL, ask your healthcare provider or pharmacist.

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 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. Talk to your healthcare provider or your family member’s healthcare provider about:

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

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 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 taking 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:

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 FORFIVO XL?

The chance of having seizures increases with higher doses of bupropion. For more information, see the sections “Who should not take FORFIVO XL?” and “What should I tell my healthcare provider before using 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 about your other medical conditions including if you:

  1. have liver problems, especially cirrhosis of the liver
  2. have kidney problems
  3. have, or have had, an eating disorder such as anorexia nervosa or bulimia
  4. have had a head injury
  5. have had a seizure (convulsion, fit)
  6. have a tumor in your nervous system (brain or spine)
  7. have had a heart attack, heart problems, or high blood pressure
  8. are a diabetic taking insulin or other medications to control your blood sugar
  9. drink alcohol
  10. abuse prescription medicines or street drugs
  11. are pregnant or plan to become pregnant
  12. are breastfeeding. FORFIVO XL passes into your milk in small amounts.

Tell your healthcare provider about all the medicines you take, including prescription and overthecounter 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 using FORFIVO XL.

How should I take FORFIVO XL?

What should I avoid while taking FORFIVO XL?

What are the possible side effects of FORFIVO XL?

FORFIVO XL may cause serious side effects.

The most common side effects of FORFIVO XL 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 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.

You may also report side effects to Edgemont Pharmaceuticals, LLC at 1-888-594-4332.

How should I store FORFIVO XL?

Store FORFIVO XL between 68°F to 77°F (20°C to 25°C).

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

General information about FORFIVO XL

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

For more information about FORFIVO XL, go to www.forfivoxl.com or call
1-888-594-4332.

What are the ingredients in FORFIVO XL?

Active ingredient: bupropion hydrochloride.

Inactive ingredients: hydroxypropyl cellulose, hydrochloric acid, polyvinyl pyrrolidone 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.

Rx only

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

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

For:
Edgemont Pharmaceuticals, LLC
Austin, TX 78746

Revised August 2016

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