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  • Just before you apply the patch, remove it from its sealed pouch. Do not keep or store the patch outside of the sealed pouch. Never cut an EMSAM patch into smaller pieces to use.
  • Remove half of the protective backing and throw it away. (See Picture 1)
  • – Try not to touch the exposed side (sticky side) of the patch, because the medicine could come off on your fingers.
  • – With your fingertips, press the sticky side of the patch firmly against the skin site that was just washed and dried.
  • – Remove the second half of the protective liner and press the remaining sticky side firmly against your skin.
  • – Make sure that the patch is flat against the skin (there should be no bumps or folds in the patch) and is sticking securely.
  • – Be sure the edges are stuck to the skin surface. (See Picture 2)
EMSAM Application Step 1

Picture 1. Removing the protective
backing from an EMSAM patch

Remove the protective backing before applying an EMSAM patch.

Picture 2. Applying an EMSAM patch

  • After you have applied the patch, wash your hands well with soap and water to remove any medicine that may have gotten on them. Do not touch your eyes until after you have washed your hands.
  • After 24 hours, remove the patch slowly and carefully to avoid damaging the skin. Do not touch the sticky side. As soon as you have removed the patch, fold it so that the sticky side sticks to itself.
  • Throw away the folded patch so that children and pets cannot reach it. This patch still contains some medicine and could harm a child or pet.
  • Gently wash the old application site with warm water and a mild soap to remove any sticky material (adhesive) that stays on your skin after removing the patch. A small amount of baby oil may also be used to remove any adhesive. You may need to use a medical adhesive removal pad that you can get from your pharmacist. Alcohol or other dissolving liquids such as nail polish remover may cause skin irritation and should not be used.
  • Wash your hands with soap and water.
  • If the patch becomes loose, press it back in place. If your EMSAM patch falls off, apply a new EMSAM patch to a new site and resume your normal schedule for changing patches.
  • If you forget to change your patch after 24 hours, remove the old patch, put on a new patch in a different area and continue to follow your original schedule.

 

To view a short video on how to apply EMSAM, click here.

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 healthcare 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 healthcare 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.

  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 healthcare 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.
    • – 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
  2. Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Tell all of your healthcare 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 healthcare 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 healthcare 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 healthcare 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 and Medication Guide.