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

• Activation of mania/hypomania: Depression may be the early symptom of bipolar disorder. Using Forfivo XL can trigger mania/hypomania if you have bipolar disorder. Tell your healthcare provider all of your symptoms, and if you or a family member has ever had depression, suicidal thoughts or actions, bipolar disorder or other mental health problems. Your healthcare provider may check you for bipolar disorder.
• Seizures: There is a chance of having a seizure (convulsion, fit) with Forfivo XL, especially in people:
  • with certain medical problems.
  • who take certain medicines.

  For more information, see the sections Who should not take Forfivo XL? and 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 using 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.

• High blood pressure (hypertension): Some people get high blood pressure that can be severe, while taking Forfivo 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.
• Severe allergic reactions: Some people have severe allergic reactions to Forfivo XL. Stop taking Forfivo 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.
• Unusual thoughts or behaviors: Some patients have unusual thoughts or behaviors while taking Forfivo 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.

• Take Forfivo XL exactly as prescribed by your doctor.
• Do not chew, cut, or crush Forfivo XL tablets. If you do, the medicine will be released into your body too quickly. If this happens, you may be more likely to get side effects including seizures. You must swallow the tablets whole. Tell your healthcare provider if you cannot swallow medicine tablets.
• You may take Forfivo XL with or without food.
• If you take too much Forfivo XL, or overdose, call your healthcare provider or go to the nearest hospital emergency room right away.
• Do not take any other medicines while using Forfivo XL unless your healthcare provider has told you it is okay.
• If you are taking Forfivo XL for the treatment of major depressive disorder, it may take several weeks for you to feel that Forfivo XL is working. Once you feel better, it is important to keep taking Forfivo XL exactly as directed by your doctor. Call your healthcare provider if you do not feel Forfivo XL is working for you.
• Do not change your dose or stop taking Forfivo XL without talking with your healthcare provider first.

Do not take Forfivo XL if you:

• have or had a seizure disorder or epilepsy.
• are taking Zyban (used to help people stop smoking) or any other medicines that contain bupropion, such as Wellbutrin Tablets, or Wellbutrin SR Sustained-Release Tablets, or Wellbutrin XL Extended-Release Tablets or Aplenzin Extended-Release Tablets. Bupropion is the same active ingredient that is in Forfivo XL.
• 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 Forfivo XL, bupropion, or to any of the inactive ingredients. See the end of this leaflet for a complete list of ingredients in Forfivo XL.

Before using Forfivo XL

• 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. Tell your healthcare provider if you:
  • are pregnant or plan to become pregnant. It is not known if Forfivo XL can harm your unborn baby.
  • are breastfeeding. Forfivo XL passes through your milk. It is not known if Forfivo XL 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 alcohol.
  • abuse prescription medicines or street drugs.
• Tell your healthcare provider 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 Forfivo XL.

• Do not drink alcohol while taking Forfivo XL.
• Do not drive a car or use heavy machinery until you know how Forfivo XL affects you. Forfivo XL can impair your ability to perform these tasks.

Forfivo XL can cause serious side effects, including:

• See Important information about Forfivo XL

The most common side effects of Forfivo XL include:

• dry mouth
• nausea
• trouble sleeping
• dizziness
• sore throat
• stomach pain
• agitation
• anxiety
• shakiness
• fast heart beat
• sweating
• ringing in the ears
• muscle pain
• anorexia
• urinating more often than normal for you
• rash

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 side effects of Forfivo XL. For a complete list, 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.