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EMSAM- selegiline patch


  1. What Is The Most Important Information I Should Know About Emsam?
  2. Depression And 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. How Can I Watch For And Try To Prevent Suicidal Thoughts And Actions?
  3. Call A Healthcare Provider Right Away If You Have Any Of The Following Symptoms, Especially If They Are New, Worse, Or Worry You:
  4. What Is Emsam?
  5. Who Should Not Use Emsam?
  6. If You Use Too Much Emsam (overdose) You May Have The Following Symptoms:
  7. Emsam May Cause Serious Side Effects, Including:
  8. Active Ingredient:
  9. Inactive Ingredients:
  10. Patient Information
  11. Suicide Risk:
  12. Tyramine Reactions:
  13. Concomitant Medication:
  14. Psychomotor Performance:
  15. Alcohol:
  16. Pediatrics:
  17. Pregnancy:
  18. Lactation:
  19. Detailed Instructions Are Provided In The Medication Guide. Prescribers Should Instruct Patients On The Following:
  20. If The Transdermal System Is Too Sticky On Your Skin, And You Need Something To Help You Remove It:

What Is The Most Important Information I Should Know About Emsam? 

1.
Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
2.

Depression And 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. How Can I Watch For And Try To Prevent Suicidal Thoughts And Actions? 

Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
Keep all follow-up visits with your healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call A Healthcare Provider Right Away If You 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
new or worse anxiety
feeling agitated, restless, angry or irritable
panic attacks
trouble sleeping
new or worse irritability
acting aggressive, being angry or violent
acting on dangerous impulses
an extreme increase in activity or talking (mania)
other unusual changes in behavior or mood

3.EMSAM is not for children less than 12 years of age. EMSAM may cause a severe increase in blood pressure in children less than 12 years of age.

What Is Emsam? 

EMSAM is a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD). EMSAM belongs to the class of medicines known as monoamine oxidase inhibitors (MAOI). EMSAM is a transdermal system (patch) you apply to your skin.

It is important to talk with your healthcare provider about the risks of treating depression and also the risk of not treating it. You should discuss all treatment choices with your healthcare provider.

Talk to your healthcare provider if you do not think that your condition is getting better with EMSAM treatment.

Who Should Not Use Emsam? 

Using EMSAM with certain antidepressants and certain pain, cold and cough symptom medicines may cause a potentially life-threatening problem called serotonin syndrome (

Read theInstructions for Useat the end of this Medication Guide for information about the right way to use EMSAM.
Use EMSAM exactly as your healthcare provider tells you to use it.
Use only 1 patch at a time.
Apply your patch right after you open the sealed pouch.
Change your patch 1 time each day at the same time each day. Choose a time of day that works best for you.
Your healthcare provider may need to change your dose of EMSAM until it is the right dose for you.

If You Use Too Much Emsam (overdose) You May Have The Following Symptoms: 

o
drowsiness
o
irritable
o
severe headache
o
your head, neck and spine arch backwards
o
fast or irregular pulse
o
blood circulation problem
o
high fever
o
dizziness
o
hyperactive
o

Avoid exposing the EMSAM application site to external sources of direct heat, such as heating pads or electric blankets, heat lamps, saunas, hot tubs, heated water beds, and prolonged direct sunlight.
Do noteat foods or drink beverages that contain high amounts of tyramine while using EMSAM 9 mg or EMSAM 12 mgorfor 2 weeks after you stop using EMSAM 9 mg or EMSAM 12 mg. Continue to avoid tyramine-rich foods or beverages for 2 weeks after a dose reduction to EMSAM 6 mg.
If you start and continue EMSAM 6 mg you do not need to make any diet changes.
The table below lists foods and drinks you should avoid while you use EMSAM 9 mg and EMSAM 12 mg.

Type of Food and Drink

Foods and drinks you should avoid that contain Tyramine

Meat, Poultry, and Fish

air dried, aged and fermented meats, sausages and salamis
pickled herring
any spoiled or improperly stored meat, poultry, and fish. These are foods that have a change in color, odor, or become moldy.
spoiled or improperly stored animal livers

Vegetables

broad bean pods (fava bean pods)

Dairy (milk products)

aged cheeses

Drinks

all tap beers and other beers that have not been pasteurized

Other

concentrated yeast extract (such as Marmite)
sauerkraut
most soybean products (including soy sauce and tofu)
over-the-counter supplements containing tyramine
All foods you eat must be fresh or properly frozen.
Avoid foods when you do not know how those foods should be stored.
Ask your healthcare provider if you are not sure if certain foods and drinks contain tyramine.
Do not drive, operate heavy machinery or do other dangerous activities until you know how EMSAM affects you.
You should not drink alcohol while using EMSAM.

Emsam May Cause Serious Side Effects, Including: 

Store EMSAM at room temperature between 68 F to 77 F (20 C to 25 C).
Store EMSAM in the sealed pouch it comes in until you are ready to use it.
Keep EMSAM and all medicines out of the reach of children.

General information about the safe and effective use of EMSAM.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use EMSAM for a condition for which it was not prescribed. Do not give EMSAM to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about EMSAM that is written for health professionals.

Active Ingredient: 

selegiline

Inactive Ingredients: 

acrylic adhesive, ethylene vinyl acetate, polyethylene, polyester, polyurethane, and silicon coated polyester.

Distributed by:Mylan Specialty L.P.,Morgantown, WV 26505 U.S.A.

Manufactured for:
Somerset Pharmaceuticals, Inc.
U.S.A.

For more information, go towww.EMSAM.comor call 1-800-395-3376.

This Medication Guide has been approved by the U.S. Food and Drug Administration
Issued: 07/2017

Patient Information 

See FDA-approved patient labeling (Medication GuideandInstructions for Use).

Advise patients and their caregivers about the benefits and risks associated with treatment with EMSAM and counsel them in its appropriate use. Advise patients and their caregivers to read the Medication Guide and assist them in understanding its contents. The complete text of the Medication Guide is reprinted at the end of this document.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking EMSAM.

Suicide Risk: 

Advise patients and caregivers to look for the emergence of suicidal ideation and behavior, especially early during treatment and when the dose is adjusted up or down[seeBoxed WarningandWarnings and Precautions (5.1)].

Tyramine Reactions: 

Patients should be advised that tyramine-rich foods and beverages should be avoided while on EMSAM 9 mg per 24 hours or EMSAM 12 mg per 24 hours, and for 2 weeks following discontinuation of EMSAM at these doses because of the risk of a tyramine reaction[seeWarnings and Precautions (5.3),Drug Interactions (7.2), andClinical Pharmacology (12.2)]. Patients should also be advised to avoid tyramine-containing nutritional supplements. Patients should be instructed to immediately report the occurrence of the following acute symptoms: severe headache, neck stiffness, heart racing or palpitations, or other sudden or unusual symptoms.

Concomitant Medication: 

Advise patients to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter medications, including herbals, because of a potential for dangerous interactions. Instruct patients not to take EMSAM with medication that is contraindicated or within two weeks of stopping such medication (5 weeks for fluoxetine). Contraindicated medication should not be started within two weeks of stopping EMSAM[seeContraindications (4)].

Psychomotor Performance: 

EMSAM has not been shown to impair psychomotor performance; however, any psychoactive drug may potentially impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that EMSAM therapy does not impair their ability to engage in such activities.

Alcohol: 

Patients should be told that, although EMSAM has not been shown to increase the impairment of mental and motor skills caused by alcohol, the concomitant use of EMSAM and alcohol in depressed patients is not recommended.

Pediatrics: 

Advise patients that EMSAM must not be used in children less than 12 years of age because of an increased risk of severe increases in blood pressure. Also, patients should be advised that EMSAM is not recommended for use in pediatric patients ages 12 to 17 years[seeUse in Specific Populations (8.4)].

Pregnancy: 

Advise the pregnant woman about the potential risk to the fetus[seeUse in Specific Populations (8.1)].

Lactation: 

Advise a woman that breastfeeding is not recommended during treatment with EMSAM treatment and for 5 days after the final dose[seeUse in Specific Populations (8.2)].

How to Use EMSAM

Detailed Instructions Are Provided In The Medication Guide. Prescribers Should Instruct Patients On The Following: 

EMSAM should be applied to dry, intact skin on the upper torso (below the neck and above the waist), upper thigh or the outer surface of the upper arm. A new application site should be selected with each new transdermal system toavoid re-application to the same site on consecutive days. Transdermal systems should be applied at approximately the same time each day.
Apply the transdermal system to an area of skin that is not hairy, oily, irritated, broken, scarred or calloused. Do not place the transdermal system where your clothing is tight, which could cause the transdermal system to rub off.
After you have selected the site for your transdermal system, wash the area gently and thoroughly with soap and warm water. Rinse until all soap is removed. Dry the area with a clean dry towel.
Just before you apply the transdermal system, remove it from the pouch by tearing at the notches (do not use scissors). Remove half of the release liner and throw it away. Try not to touch the exposed side (sticky side) of the transdermal system, because the medicine could come off on your fingers.
Press the sticky side of the transdermal system firmly against the skin site that was just washed and dried. Remove the second half of the release liner and press the remaining sticky side firmly against your skin. Make sure that the transdermal system is flat against the skin (there should be no bumps or folds in the transdermal system) and is sticking securely. Be sure the edges are stuck to the skin surface.
After you have applied the transdermal system,wash your handsthoroughly 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 your transdermal system slowly and carefully to avoid damaging your skin.

If The Transdermal System Is Too Sticky On Your Skin, And You Need Something To Help You Remove It: 

Gently wash the area with warm water and mild soap.
A small amount of oil-based product (petroleum jelly, olive oil, or mineral oil) may be needed to help remove the transdermal system. Gently apply and spread the oil underneath the transdermal system edges.
Apply an oil-based product or lotion to your skin if any adhesive (glue) remains after you remove your transdermal system. This will gently loosen and remove any adhesive that is left over.
Fold the used EMSAM transdermal system in half and press it together firmly so that the sticky side sticks to itself.
Safely throw away the folded transdermal system in a container with a lid right away so that children and pets cannot reach it.
Safely throw away any unused EMSAM transdermal systems that are left over from the prescription as soon as they are no longer needed.
Wash your handswith soap and water.
If your transdermal system falls off, apply a new transdermal system to a new site and resume your previous schedule.
Only one EMSAM transdermal system should be worn at a time.
Do not cut the EMSAM transdermal system into smaller portions.

#The brand name listed is a trademark of its respective owner.



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