EMSAM^® — INDICATION AND IMPORTANT SAFETY INFORMATION

EMSAM Transdermal System is a skin patch used to treat major depressive disorder.

What is the most important information I should know about EMSAM?

• Antidepressants may increase suicidal thoughts or actions in children, teenagers and young adults
• Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts or feelings. This is very important when an antidepressant is started or when the dose is changed
• Call a health care provider right away to report any new or sudden changes in mood, behavior, thoughts, or feelings
• EMSAM Transdermal System is not approved for use in patients under 18 years of age

  Call a health care provider right away if you or someone you care for have 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, anxiety or irritability; feeling very agitated or restless; panic attacks; trouble sleeping; acting aggressive, being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking; other unusual changes in behavior or mood.

• Consuming tyramine-rich foods and beverages can lead to a sudden, large increase in blood pressure called “hypertensive crisis.” This is a serious medical condition that may be life- threatening. Seek immediate medical care if you experience any of these symptoms: sudden severe headache, nausea, stiff neck, vomiting, a fast or slow heartbeat or a change in the way your heart beats (palpitations), tight chest pain, a lot of sweating, confusion, dilated pupils, and sensitivity to light

1. Do not eat or drink foods and beverages with high amounts of a substance called tyramine while on EMSAM 9 mg/24 hr or 12 mg/24 hr, and for 2 weeks after stopping these doses. Ask your health care professional or see the Medication Guide for a complete list of foods and drinks that must be avoided. EMSAM at any dose should not be used in children under 12 even when used with dietary modifications.
2. Tell your doctor about all medicines you take, including prescription and non- prescription medicines, vitamins and herbal supplements. Tell all of your health care professionals that you are using EMSAM.

   • Due to the potential for serious and life-threatening side effects, do not use the following medicines while using EMSAM at any dose, and for 2 weeks after stopping EMSAM:

• - Other medicines to treat depression (antidepressants) including other MAOI medicines; Medicines which contain selegiline (such as Eldepryl^®); St. John’s Wort; narcotic pain medicines that contain meperidine e.g., Demerol^®; pain medicines tramadol, methadone, or propoxyphene; medicines containing carbamazepine e.g., Tegretol^® a seizure medicine and oxcarbazepine, e.g., Trileptal^® a seizure medicine; cold/cough preparations, decongestants, over-the-counter diet pills or herbal weight-loss products containing pseudoephedrine, phenylephrine, phenylpropanolamine, dextromethorphan, or ephedrine; herbal or dietary supplements that contain tyramine; Flexeril^® (cyclobenzaprine), a medicine used to treat muscle spasms; amphetamines (stimulants or “uppers”); and BuSpar^® (buspirone), an anxiety medicine
• - Some of these medicines will have to be stopped for 1 week (or more) before you can start using EMSAM

What should I tell my doctor before starting EMSAM Transdermal System?

• Tell your health care professional about any medical conditions, including if you:

• - Have or had manic episodes (a mental condition that causes "high" moods)
• - Have any heart problems
• - Have or had seizures (convulsions or "fits")
• - Tend to get dizzy or faint
• - Are planning to have surgery
• - Are or intend to become pregnant
• - Are breast-feeding

What are the possible side effects of EMSAM Transdermal System?

• EMSAM may worsen your depression, give you suicidal thoughts, or cause unusual changes in behavior. Call your health care professional right away if you feel worse with EMSAM
• EMSAM may cause mania or hypomania in people who have a history of mania
• EMSAM may cause low blood pressure. Lie down if you feel dizzy, faint, or lightheaded and change positions gradually
• The most common side effect of EMSAM is a skin irritation where the patch is placed. Other common side effects with EMSAM include: headache, difficulty sleeping, diarrhea, dry mouth

How should I use EMSAM Transdermal System?

• Use EMSAM exactly as prescribed and do not stop or change treatment (even if you start to feel better) without talking to your health care professional
• Use only one patch at a time and change the patch once a day (every 24 hours). If you use more than one EMSAM patch at a time, remove the patches right away and call your doctor or Poison Control at 1-800-222-1222

General advice about EMSAM Transdermal System

• Avoid exposing the EMSAM application site to direct heat, such as heating pads, electric blankets, heat lamps, saunas, hot tubs, heated water beds, and prolonged direct sunlight
• Do not drive or operate hazardous machinery until you know how EMSAM affects you as EMSAM can reduce your judgment, ability to think, or coordination. Avoid drinking alcohol while using EMSAM
• Do not use EMSAM if you are allergic to anything in EMSAM. See the Medication Guide for a complete list of ingredients in EMSAM
• If you have any questions about your health or medicines, talk to your health care professional
  

  You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

  Please see full Prescribing Information, including Boxed Warning.

Please click here to see the Patient Medication Guide.

Please click here to see Important Safety Information, including Boxed Warning.