Emsam 6 mg/24 hr transdermal 24 hour patch

Generic name:
Selegiline - transdermal

Pronunciation
(seh-LEDGE-uh-leen)

Brand name(s)
Emsam

Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

This medication must not be used by children younger than 12 years due to an increased risk of serious side effects (such as extremely high blood pressure). Also, this medication is not recommended for use by children between 12 and 17 years old. Studies have not shown it to work in children in this age group.

See also Warning section.

This medication is used to treat depression. Selegiline belongs to a class of drugs known as monoamine oxidase inhibitors (MAO inhibitors). It works by helping to restore the balance of certain natural substances in the brain. This medication is a patch for use on the skin.

Read the Medication Guide provided by your pharmacist before you start using selegiline and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Follow the package instructions for using this medication. Make sure you understand how to apply a new patch and dispose of the used product. Do not cut the patch into smaller sizes. Do not use the patch if it appears broken, cut or damaged. If you have any questions, consult your doctor or pharmacist.

Before applying the patch, wash the area you will be using for the patch gently and thoroughly with soap and water. Rinse and dry with a clean dry towel. Do not apply the patch to hairy/oily/red/cut/irritated/broken or scarred/calloused skin. Remove the patch from the foil pouch and apply as directed by the manufacturer. Apply one patch to an area of clean dry skin on the upper body (torso), upper thigh, or on the outside of the upper arm where it will not be rubbed by tight clothing. Change the patch daily at about the same time each day. Apply the patch to a different area on your body each time to avoid irritation. If your patch falls off, apply a new patch to a new area and continue on your same schedule.

Be sure to remove the old patch, fold it in half so it sticks to itself, and throw it away out of the reach of children and pets. Do not touch the sticky side with your fingers. Wash your hands with soap and water after handling the patch.

To reduce your risk of side effects, your doctor may start you at a low dose and gradually increase your dose. Once your condition improves and you are better for a while, your doctor may work with you to reduce your regular dose. Follow your doctor's instructions carefully. Do not apply more patches or leave the patch on for longer than prescribed. Your condition will not improve any faster and your risk of side effects will increase.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. It may take several weeks for the full benefits of this medication to be noticed. Do not stop using this medication without consulting your doctor.

Tell your doctor if your condition lasts or gets worse.

See also Warning section.

Dizziness, drowsiness, redness/irritation at the application site, tiredness, weakness, problems sleeping, constipation, and dry mouth may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• fainting
• mental/mood changes (such as agitation, confusion)
• muscle stiffness/twitching
• changes in sexual ability/interest
• shaking (tremor)
• swollen ankles/legs
• unusual weight gain/loss
• eye pain/swelling/redness
• vision changes (such as double/blurred vision)
• seizures

This drug may rarely cause an attack of extremely high blood pressure (hypertensive crisis), which may be fatal. Many drug and food interactions can increase this risk (See also Drug Interaction section.) Stop using selegiline and get medical help right away if any of these very serious side effects occur:

• frequent/severe headache
• fast/slow/irregular/pounding heartbeat
• chest pain
• neck stiffness/soreness
• severe nausea/vomiting
• sweating/clammy skin (sometimes with fever)
• widened pupils
• sudden sensitivity to light (photophobia)

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take. Get medical help right away if you develop some of the following symptoms:

• hallucinations
• unusual restlessness
• loss of coordination
• fast heartbeat
• severe dizziness
• unexplained fever
• severe nausea/vomiting/diarrhea
• twitching muscle

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using selegiline, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• a certain adrenal gland tumor (pheochromocytoma)
• cerebrovascular disease (such as stroke)
• heart problems (such as heart failure, heart attack)
• personal or family history of high blood pressure
• history of severe/frequent headaches
• personal/family history of mental/mood disorders (such as bipolar disorder, depression, schizophrenia)
• liver problems
• certain nervous system diseases (Parkinson's syndrome, seizures)
• overactive thyroid (hyperthyroidism)
• personal or family history of glaucoma (angle-closure type)

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Avoid exposing your skin to direct heat sources such as heating pads, electric blankets, heat lamps, saunas, hot tubs, heated water beds, or prolonged direct sunlight while wearing your selegiline patch. Heat sources may cause more drug to be released into your body, increasing the chance of side effects.

If you are going to have an MRI test, tell testing personnel that you are using this patch. Some patches may contain metals that can cause serious burns during an MRI. Ask your doctor whether you will need to remove your patch before the test and apply a new patch afterward, and how to do so properly.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). You may need to stop using selegiline before surgery. Follow your doctor's instructions carefully.

Older adults may be more sensitive to the side effects of this drug, especially the effects on blood pressure.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Since untreated mental/mood problems (such as depression) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 5 days after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with selegiline include:

• antidepressants (including bupropion, maprotiline, mirtazapine)
• other MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, tranylcypromine)
• appetite suppressants (such as diethylpropion)
• drugs for attention deficit disorder (such as atomoxetine, methylphenidate)
• apraclonidine
• buspirone
• carbamazepine/oxcarbazepine
• cyclobenzaprine
• deutetrabenazine
• certain herbal products (such as ephedra/ma huang)
• cold medications/nasal decongestants (such as phenylephrine, phenylpropanolamine, pseudoephedrine)
• fentanyl
• metoclopramide
• street drugs (such as LSD, mescaline)
• stimulants (such as amphetamines, ephedrine)
• supplements (such as tryptophan, tyramine)
• tetrabenazine
• certain "triptans" used to treat migraine headaches (such as rizatriptan, sumatriptan, zolmitriptan)
• valbenazine

The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, dextromethorphan, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine, TCAs such as amitriptyline/doxepin), certain opioid medications (such as meperidine, methadone, pentazocine, propoxyphene, tramadol, tapentadol), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.

Tell your doctor or pharmacist if you are using any of these medications before, during, or within 2 weeks after treatment with selegiline. Tell your doctor or pharmacist if you have taken fluoxetine during at least 5 weeks before starting selegiline. Discuss with your doctor how much time to wait between starting or stopping any of these drugs and taking selegiline.

Check the labels on all your medicines (such as allergy, cough-and-cold products, diet pills) because they may contain dextromethorphan, decongestants, or stimulants. Ask your pharmacist about the safe use of those products.

It is very important that you follow special dietary restrictions in order to limit the amount of tyramine in your diet if you are using the higher strength patches (9 or 12 milligrams). Avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas) or eating large amounts of chocolate. Caffeine can increase the side effects of this medication. Foods and beverages high in tyramine should be avoided while you are using this medication and for at least 2 weeks after you stop using this medication.

Foods high in tyramine include: aged cheeses (cheddar, camembert, emmenthaler, brie, stilton blue, gruyere, gouda, brick, bleu, roquefort, boursault, parmesan, romano, provolone, liederdranz, colby, edam), aged/dried/fermented/salted/smoked/pickled/processed meats and fish (includes bacon, summer sausage, liverwurst, hot dogs, corned beef, pepperoni, salami, bologna, ham, mortadella, pickled or dried herring), banana peel, beef/chicken liver (stored, not fresh), bouillon cubes, commercial gravies, concentrated yeast extracts, fava beans, Italian green beans, broad beans, fermented bean curd, homemade yeast-leavened bread, kim chee (Korean fermented cabbage), orange pulp, overripe or spoiled fruits, packaged soups, red wine, sauerkraut, sherry, snow pea pods, sourdough bread, soy sauce, soybeans, soybean paste/miso, tofu, tap beer and ale, vermouth.

Moderate-to-low tyramine content foods include: alcohol-free beer, avocados, bananas, bottled beer and ale, chocolate and products made with chocolate, coffee, cola, cultured dairy products (such as buttermilk, yogurt, sour cream), distilled spirits, eggplant, canned figs, fish roe (caviar), green bean pods, pate, peanuts, port wine, raisins, raspberries, red plums, spinach, tomatoes, white wine.

Get medical help right away if you notice symptoms of high blood pressure such as fast/slow heartbeat, vomiting, sweating, headache, chest pain, sudden vision changes, weakness on one side of the body, or trouble speaking.

Contact your healthcare professionals (such as doctor, pharmacist, dietician) for more information, including recommendations for your diet.

This medication may interfere with certain medical/lab tests (such as brain scan for Parkinson's disease), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

This medication patch may be harmful if chewed or swallowed. If someone has overdosed, remove the patch if possible. For serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, use it as soon as you remember unless it is close to the time for your next dose. In that case, skip the missed dose. Use your next dose at the regular time. Do not apply 2 doses to catch up.

Store at room temperature. Do not open the foil pouch until you are ready to use the patch. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed (See also How to Use section). Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.