Emsam transdermal

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. 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 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 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 selegiline 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 selegiline. You may need to stop using the medicine for at least 10 days before a planned surgery. Do not stop using selegiline without first talking to your doctor.

Store the 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 selegiline 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.

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.

If a patch becomes loose, press it back in place. If a patch falls off, apply a new one and go back to your regular schedule for patch changes.

There are many other medicines that can cause serious medical problems if you take them while using selegiline. 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. Give a list of all your medicines to any healthcare provider who treats you.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Chills
• cold sweats
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

• Confusion about identity, place, and time
• seeing things that are not there
• seizures

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning, itching, redness, skin rash, swelling, or soreness where the patch was placed
• diarrhea
• dry mouth
• headache
• trouble sleeping

• Belching
• body aches or pain
• change or problem with discharge of semen
• congestion
• cough
• dryness or soreness of the throat
• fever
• heartburn
• hoarseness
• indigestion
• pain or tenderness around the eyes and cheekbones
• rash
• runny nose
• stomach discomfort, upset, or pain
• stuffy or runny nose
• tender, swollen glands in the neck
• tightness of the chest
• trouble swallowing
• troubled breathing
• voice changes
• weight changes

• Decreased interest in sexual intercourse
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• not able to have an orgasm

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• tension

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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 persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 (e.g., agitation, confusion), muscle stiffness/twitching, changes in sexual ability/interest, shaking (tremor), shivering, swollen ankles/legs, unusual weight gain/loss, eye pain/swelling/redness, vision changes (e.g., double/blurred vision), severe stomach/abdominal pain, persistent nausea/vomiting, seizures, dark urine, yellowing eyes/skin.

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.

See also Warning section.

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 kind of adrenal gland tumor (pheochromocytoma), cerebrovascular disease (e.g., stroke), heart problems (e.g., congestive heart failure, heart attack), personal or family history of high blood pressure, history of severe/frequent headaches, personal/family history of mental/mood disorders (e.g., 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. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

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

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 you are on this medication. You may need to stop using this drug beforehand. Follow your doctor's instructions carefully.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the effects on blood pressure.

This medication should be used only when clearly needed during pregnancy. 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 not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

You should not use Emsam if you have an adrenal gland tumor or if you are using certain other medicines. Serious drug interactions can occur when certain medicines are used together with selegiline. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Emsam should never be used on a child younger than 12 years old because dangerous side effects could occur.

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 Emsam can raise your blood pressure to dangerous levels and cause life-threatening symptoms.

You may have thoughts about suicide when you first start using an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

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.

Common side effects of Emsam include: application site reaction and insomnia. Other side effects include: skin rash, weight loss, and orthostatic hypotension. See below for a comprehensive list of adverse effects.

Applies to selegiline: oral capsule, oral tablet, oral tablet disintegrating

Other dosage forms:

• transdermal patch extended release

Along with its needed effects, selegiline (the active ingredient contained in Emsam) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking selegiline:

• Twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

• Blurred vision
• bruising
• chest pain
• convulsions
• decreased urine
• difficult or labored breathing
• difficulty with swallowing
• discouragement
• dizziness
• dry mouth
• feeling sad or empty
• headache
• increased thirst
• irregular heartbeat
• irritability
• large, flat, blue or purplish patches in the skin
• loss of appetite
• loss of interest or pleasure
• mood changes
• muscle pain or cramps
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• pounding in the ears
• seeing, hearing, or feeling things that are not there
• shakiness and unsteady walk
• shakiness in the legs, arms, hands, or feet
• sleepiness or unusual drowsiness
• slow or fast heartbeat
• swelling or inflammation of the mouth
• tightness in the chest
• tiredness
• trouble concentrating
• trouble sleeping
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual tiredness or weakness

• Agitation
• diarrhea
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fever
• overactive reflexes
• poor coordination
• restlessness
• shivering
• sweating
• talking or acting with excitement you cannot control

Get emergency help immediately if any of the following symptoms of overdose occur while taking selegiline:

• Agitation
• chest pain
• difficulty opening the mouth or lockjaw
• dizziness (severe) or fainting
• fast or irregular pulse (continuing)
• high fever
• high or low blood pressure
• severe spasm where the head and heels are bent backward and the body arched forward
• troubled breathing

Some side effects of selegiline may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Dry skin
• hives, itching, or skin rash
• itching, scaling, severe redness, soreness, or swelling of the skin
• runny nose
• sneezing
• stuffy nose
• trouble sleeping

• Acid or sour stomach
• back pain
• belching
• bloated or full feeling
• body aches or pain
• congestion
• cough
• difficulty having a bowel movement (stool)
• difficulty with moving
• dryness or soreness of the throat
• excess air or gas in the stomach or intestines
• heartburn
• hoarseness
• indigestion
• joint pain
• leg cramps
• muscle aching or cramping
• muscle pains or stiffness
• passing gas
• stomach discomfort, upset, or pain
• swollen joints
• tender, swollen glands in the neck
• tooth problems
• voice changes