Emsam prevents the breakdown of chemicals in the brain that are often imbalanced in people with depression.

Emsam transdermal patches are used to treat major depressive disorder in adults and adolescents who are at least 12 years old.

Emsam may also be used for purposes not listed in this medication guide.

You should not use an Emsam patch if you have an adrenal gland tumor or if you are using certain other medicines. Many drugs can interact with selegiline, and some drugs should not be used together.

Some young people have thoughts about suicide when first using an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

If you need surgery, tell the surgeon ahead of time that you are using Emsam patches. You will need to stop using the patches for at least 10 days before a planned surgery. Do not stop using Emsam without first talking to your doctor. While using the 9-mg or 12-mg patches, do not drink alcohol or eat foods that are high in tyramine, listed in the "What should I avoid while using Emsam?" section of this leaflet. Eating tyramine while you are using selegiline can raise your blood pressure to dangerous levels and cause life-threatening symptoms.

Use Emsam patches exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Apply the Emsam patch to clean, dry, and hairless skin on your chest, back, thigh, or the outer part of your upper arm. Press the patch firmly into place. You may leave the patch on while bathing, showering, or swimming. Remove the skin patch after 24 hours and replace it with a new one. Choose a different place on your body to wear the patch each time you put on a new one.

Wash your hands with soap and water after applying a patch, and after removing one.

If a Emsam patch falls off, try sticking it back into place. If it does not stick well, put on a new patch and leave it on only for the rest of your wearing time. Do not change your patch removal schedule.

Do not wear more than one Emsam patch at a time. Using extra skin patches will not make the medication more effective. Never cut a skin patch. While you are wearing the patch, do not expose it to sunlight or other sources of heat such as a heating pad, electric blanket, hot tub, or sauna.

If you need surgery, tell the surgeon ahead of time that you are using Emsam. You may need to stop using the medicine for at least 10 days before a planned surgery. Do not stop using Emsam without first talking to your doctor.

Store the Emsam skin patches at room temperature away from heat and moisture. Keep each patch in the foil pouch until you are ready to apply one.

Keep both used and unused Emsam skin patches out of the reach of children or pets. The amount of selegiline in a used skin patch could be fatal to a child or pet who accidentally chews on the patch. Seek emergency medical attention if this happens.

Usual Adult Dose of Emsam for Depression:

Initial dose: Apply one 6 mg/24 hours transdermal patch to intact skin once every 24 hours
Maintenance dose: One 6 mg/24 hours to 12 mg/24 hours transdermal patch applied to the skin once a day
Maximum dose: 12 mg/24 hours transdermal patch applied to the skin once a day

Comments:
-Episodes of depression may require several months or more of sustained pharmacologic therapy
-If dose adjustments are necessary, they should be made in increments of 3 mg/24 hours at intervals of at least 2 weeks
-Full antidepressant effect may be delayed

Use: Treatment of major depressive disorder (MDD)

You should not use Emsam if you are allergic to selegiline, or if you have pheochromocytoma (tumor of the adrenal gland).

Some medicines can cause unwanted or dangerous effects when used with selegiline. Your doctor may need to change your treatment plan if you have used any of the following drugs within the past 2 to 5 weeks:

• carbamazepine;

• dextromethorphan (cough medicine);

• meperidine, methadone, pentazocine, or tramadol; or

• certain antidepressants--citalopram, clomipramine, desvenlafaxine, duloxetine, fluoxetine, imipramine, milnacipran, paroxetine, sertraline, venlafaxine, Cymbalta, Effexor, Savella, Pristiq, Prozac, Zoloft, and others.

To make sure Emsam is safe for you, tell your doctor if you have ever had:

• heart disease, high blood pressure;

• seizures or epilepsy; or

• bipolar disorder (manic depression) or suicide attempt.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

It is not known whether this medicine will harm an unborn baby. However, you may have a relapse of depression if you stop using your antidepressant. Tell your doctor right away if you become pregnant. Do not start or stop Emsam during pregnancy without your doctor's advice.

It is not known whether selegiline passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine and for at least 5 days after your last dose.

Emsam is not approved for use by anyone younger than 12 years old.

Apply a skin patch as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra patches to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may occur up to 12 hours after the overdose, and could get worse over the next 24 to 48 hours.

Overdose symptoms may include severe headache, hallucinations, fever, cold or clammy skin, fast or irregular heart rate, trouble breathing, feeling agitated or irritable, twisting muscle movements, unusual arching in your back or neck, fainting, or seizure.

Avoid drinking alcohol while you are using Emsam.

While using the 9-mg or 12-mg patches, and for 14 days after you stop, you must NOT eat foods that are high in tyramine, including:

• air dried meats, aged or fermented meats, sausage or salami (including cacciatore and mortadella), pickled herring, and any spoiled or improperly stored beef, poultry, fish, or liver;

• beer from a tap, beer that has not been pasteurized;

• aged cheeses (such as blue, Swiss, cheddar, Parmesan, or Romano cheese);

• over-the-counter supplements or cough and cold medicines that contain tyramine;

• sauerkraut, soy beans, soy sauce, tofu, fava beans; or

• yeast extracts (such as Marmite).

Eating tyramine while you are using selegiline can raise your blood pressure to dangerous levels which could cause life-threatening side effects. You should become very familiar with the list of foods to avoid while you are using Emsam 9-mg or 12-mg patches.

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Get emergency medical help if you have signs of an allergic reaction to Emsam: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Remove the skin patch and get emergency medical help if you have any of these signs of dangerously high blood pressure: sudden and severe headache, confusion, vision problems, chest pain, pounding in your neck or ears, sweating, vomiting, neck stiffness, fast or slow heartbeats, or dilated pupils.

Call your doctor at once if you have:

• sudden numbness or weakness (especially on one side of the body);

• problems with speech or balance;

• manic episodes--racing thoughts, increased energy, unusual risk-taking behavior, extreme happiness, being irritable or talkative.

Remove the patch and seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common Emsam side effects may include:

• redness or itching where the patch is worn;

• headache;

• diarrhea, upset stomach, dry mouth;

• sleep problems (insomnia);

• rash; or

• sinus pain or stuffy nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If you have been taking fluoxetine (Prozac, Sarafem), you must stop taking it for 5 weeks before you begin using Emsam.

Many drugs can interact with selegiline, and some drugs should not be used together. Tell your doctor about all your current medicines and any you start or stop using, especially:

• buspirone (BuSpar);

• any other antidepressant;

• cough or cold medicine that contains a decongestant such as phenylephrine or pseudoephedrine;

• prescription or over-the-counter diet pills;

• an herbal or dietary supplement that contains tyramine; or

• stimulant medicine such as Adderall or other medicines to treat attention deficit hyperactivity disorder (ADHD).

This list is not complete and many other drugs can interact with selegiline. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

After you stop using Emsam, you may need to wait at least 2 weeks before you start using other medicines.