EMSAM- selegiline patch 
Mylan Specialty

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MEDICATION GUIDE
EMSAM® [EM sam]
(selegiline transdermal system)

Read this Medication Guide carefully before you start using EMSAM and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

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 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.

It is not known if EMSAM is effective in children 12 to 17 years of age.

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 (See “What are the possible side effects of EMSAM?”).

Do not use EMSAM if you:

take certain medicines including:
o
selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, sertraline, or paroxetine
o
serotonin and norepinephrine reuptake inhibitors (SNRI) such as venlafaxine or duloxetine
o
clomipramine or imipramine (tricyclic antidepressants)
o
meperidine, tramadol, methadone, pentazocine, propoxyphene (opioid medicines)
o
dextromethorphan
o
carbamazepine
are less than 12 years of age
have a tumor on your adrenal gland called a pheochromocytoma

Ask your healthcare provider or pharmacist if you are not sure if you take these medicines.

What should I tell my healthcare provider before using EMSAM?

Tell your healthcare provider if you:

have high blood pressure
have mania or bipolar disorder (manic depression)
have or had seizures or convulsions
drink alcohol
have any other medical conditions
are pregnant or plan to become pregnant. It is not known if EMSAM will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if EMSAM passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use EMSAM.

Tell your doctor about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. EMSAM and some medicines may interact with each other, may not work as well, or may cause serious side effects when taken together.

Especially tell your healthcare provider if you take:

other medicines to treat depression (antidepressants) including other MAOI medicines
decongestant medicines to treat cold or cough symptoms
over-the-counter diet pills or herbal weight-loss products
any herbal or dietary supplement that contains tyramine
medicines called stimulants or uppers (amphetamines)
buspirone, an anxiety medicine

Some of these medicines need to be stopped for at least 1 week before you can start using EMSAM and for 2 weeks after you stop using EMSAM.

Ask your healthcare provider or pharmacist if you are not sure if you take these medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I use EMSAM?

Read the “Instructions for Use” at 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
dizziness
o
fainting
o
irritable
o
hyperactive
o
agitated
o
severe headache
o
seeing things that are not there
o
stiff jaw
o
your head, neck and spine arch backwards
o
seizures
o
coma
o
fast or irregular pulse high blood pressure
o
low blood pressure
o
blood circulation problem
o
chest pain
o
trouble breathing
o
high fever
o
sweating
o
cool, clammy skin

If you have any of these symptoms of EMSAM overdosage, remove your patch right away and call your healthcare provider or go to the nearest hospital emergency room right away. It may take up to 12 hours before you have these symptoms, and they may be worse 24 to 48 hours after you apply your EMSAM patch.

What should I avoid while using EMSAM?

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 not eat foods or drink beverages that contain high amounts of tyramine while using EMSAM 9 mg or EMSAM 12 mg or for 2 weeks after you stop using EMSAM 9 mg or EMSAM 12 mg. You do not have to make any diet changes when you use EMSAM 6 mg.

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.

What are the possible side effects of EMSAM?

EMSAM may cause serious side effects, including:

See “What is the most important information I should know about EMSAM?”
serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you use EMSAM while you take certain medicines called MAOIs. Symptoms of serotonin syndrome include:
o
agitation
o
fever
o
seeing things that are not there (hallucinations)
o
seizures
o
confusion
o
tremors
o
coma
o
stiff muscles
o
rapid pulse
o
muscle twitching
o
low blood pressure
o
become unstable
o
dizziness
o
nausea
o
sweating
o
vomiting
o
flushing
o
diarrhea

If you suddenly have these symptoms, go to the nearest hospital emergency room right away.

a sudden, severe increase in blood pressure (hypertensive crisis). A hypertensive crisis can happen when you eat certain foods and drink certain beverages while you use EMSAM. A hypertensive crisis can lead to stroke and death. See “What should I avoid while using EMSAM?”
 
A hypertensive crisis can also happen if you use EMSAM with certain other medicines. See “Who should not use EMSAM?”
 
Symptoms of a hypertensive crisis include:
o
sudden, severe headache
o
nausea
o
vomiting
o
stiff or sore neck
o
a fast heartbeat (palpitations) or a change in the way your heart beats
o
excessive sweating, sometimes with fever or cold, clammy skin
o
the pupils in your eyes increase in size
o
light bothers your eyes
o
fast or slow heart beat with chest pain
o
bleeding in your brain
 
If you suddenly have these symptoms, go to the nearest hospital emergency room right away.
mania or hypomania (manic episodes) in people who have a history of mania. Symptoms of manic episodes include:
o
greatly increased energy
o
severe problems sleeping
o
racing thoughts
o
reckless behavior
o
unusually grand ideas
o
excessive happiness or irritability
o
talking more or faster than usual

Common side effects in people who use EMSAM include:

a skin reaction where the patch is placed. You may see mild redness at the site when a patch is removed. This redness should go away within several hours after removing the patch. If irritation or itching continues, tell your healthcare provider.
headache
diarrhea
indigestion
trouble sleeping (insomnia)
dry mouth
rash
sore throat
sinus infection

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the side effects of EMSAM. 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.

How do I store EMSAM?

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 you have. It may harm them.

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

For more information, go to www.EMSAM.com or call 1-800-395-3376.

What are the ingredients in EMSAM?

Active Ingredient: selegiline

Inactive Ingredients: acrylic adhesive, ethylene vinyl acetate, polyethylene, polyester, polyurethane, and silicone coated polyester

Revised: 09/2014
 
Mylan Specialty