Eldepryl (Selegiline)

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. Do not change your doses or medication schedule without your doctor's advice.

ELDEPRYL capsules are usually taken twice a day, at breakfast and lunch. Follow your doctor's instructions.

The disintegrating tablet form of ELDEPRYL (Zelapar) should be taken once a day before breakfast and without any liquid.

While you are using ELDEPRYL and for 14 days after you stop, you must not eat foods listed in the "What should I avoid while using ELDEPRYL?" section of this leaflet. Eating these foods while you are using ELDEPRYL can raise your blood pressure to dangerous levels.

Foods that you MAY eat include:

• fresh meat, poultry, or fish (including lunch meat, hot dogs, breakfast sausage, and cooked sliced ham);
• any vegetables except broad bean pods (fava beans);
• processed cheese, mozzarella, ricotta, cottage cheese;
• pizza made with cheeses low in tyramine;
• soy milk, yogurt; or
• Brewer's or baker's yeast.

To take ELDEPRYL orally disintegrating tablets (Zelapar):

• Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may damage the tablet.
• Using dry hands, remove the tablet and place it on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. Swallow several times as the tablet dissolves.
• Do not drink or eat anything for at least 5 minutes after taking a Zelapar orally disintegrating tablet.

Do not stop taking ELDEPRYL suddenly or you may have harmful side effects. For best results, keep taking the medicine as prescribed.

Store this medicine at room temperature away from moisture and heat.

Keep each Zelapar tablet in the foil blister pack until you are ready to take it. Throw away any Zelapar tablets not used within 3 months after you have opened the pouch containing the blister pack.

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 ELDEPRYL 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 ELDEPRYL. You may need to stop using the medicine for at least 10 days before a planned surgery. Do not stop using ELDEPRYL 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 ELDEPRYL skin patches out of the reach of children or pets. The amount of ELDEPRYL 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.

Seek emergency medical attention or call the Poison Help line.

Overdose symptoms may include severe headache, hallucinations, vision problems, sweating, cool or clammy skin, fast or uneven heart rate, feeling light-headed, fainting, or seizure (convulsions).

Seek emergency medical attention or call the Poison Help line. 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, vision problems, sweating, fever, cold or clammy skin, fast or uneven heart rate, chest pain, trouble breathing, feeling drowsy or lightheaded, twisting muscle movements, unusual arching in your back or neck, fainting, or seizure.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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.

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

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• trouble breathing;
• confusion, hallucinations, unusual thoughts or behavior;
• increased tremors or uncontrolled muscle movements;
• worsening side effects of your other medications;
• high levels of serotonin in the body (when taken with an antidepressant)--agitation, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting; or
• dangerously high blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nausea, vomiting, severe chest pain, shortness of breath, pounding heartbeats, or seizure (convulsions).

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Common side effects may include:

• dizziness;
• nausea, stomach pain, constipation;
• skin rash or other irritation;
• sleep problems (insomnia); or
• mouth sores or ulcers, pain with swallowing (while using ELDEPRYL orally disintegrating tablets).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. Get emergency medical help if you have signs of an allergic reaction: 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, vision problems, pounding in your neck or ears, confusion, anxiety, sweating, vomiting, neck stiffness, chest pain, fast or pounding heartbeats, or shortness of breath.

Call your doctor at once if you have:

• sudden numbness or weakness (especially on one side of the body);
• problems with speech or balance; or
• high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Common 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.

You should not use ELDEPRYL 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 ELDEPRYL. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

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

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms.

You should not use ELDEPRYL if you are allergic to it, or if you have taken fluoxetine (Prozac, Sarafem and others) within the past 5 weeks.

Some medicines can cause unwanted or dangerous effects when used with ELDEPRYL. Your doctor may need to change your treatment plan if you use any of the following drugs:

• cough medicine that contains dextromethorphan;
• cyclobenzaprine (Flexeril);
• meperidine (Demerol) or other narcotic (opioid) pain medicine;
• methadone;
• St. John's wort;
• tramadol (Ultram, Ultracet);
• an antidepressant--citalopram, desvenlafaxine, duloxetine, escitalopram, fluvoxamine, levomilnacipran, milnacipran, mirtazapine, nefazodone, paroxetine, venlafaxine, vilazodone, vortioxetine, and others; or
• an MAO inhibitor--isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, ELDEPRYL, tranylcypromine, and others.

After you stop taking ELDEPRYL, you must wait at least 14 days before taking any of the medications listed above.

To make sure ELDEPRYL is safe for you, tell your doctor if you have:

• liver or kidney disease;
• high blood pressure; or
• phenylketonuria (ELDEPRYL orally disintegrating tablets may contain phenylalanine).

People with Parkinson's disease may have a higher risk of skin cancer (melanoma). Talk to your doctor about this risk and what skin symptoms to watch for.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether ELDEPRYL passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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

Some medicines can cause unwanted or dangerous effects when used with ELDEPRYL. Your doctor may need to change your treatment plan if you have used any of the following drugs within the past 14 days:

• carbamazepine (Equetro, Tegretol);
• dextromethorphan (cough medicine);
• meperidine, methadone, pentazocine, or tramadol; or
• any type of "SSRI" or "SNRI" antidepressant, such as citalopram (Celexa), clomipramine, duloxetine (Cymbalta), fluoxetine (Prozac), imipramine, paroxetine, sertraline (Zoloft), venlafaxine, and others.

After you stop using ELDEPRYL, you must wait at least 14 days before taking any medicine listed above. You must wait at least 5 weeks after stopping fluoxetine (Prozac) before you can start using ELDEPRYL transdermal.

To make sure ELDEPRYL is safe for you, tell your doctor if you have:

• heart disease, high or low blood pressure;
• seizures or epilepsy; or
• a personal or family history of 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 ELDEPRYL during pregnancy without your doctor's advice.

It is not known whether ELDEPRYL passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

ELDEPRYL transdermal is not approved for use by anyone younger than 18 years old. This medicine should never be used on a child younger than 12 years old because dangerous side effects could occur.

Avoid drinking alcohol while you are taking ELDEPRYL.

While taking ELDEPRYL 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;
• 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 ELDEPRYL 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 ELDEPRYL.

ELDEPRYL may impair your thinking or reactions. Some people taking this medicine have fallen asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Be careful if you drive or do anything that requires you to be alert.

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 ELDEPRYL 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 ELDEPRYL.

Avoid drinking alcohol while you are using ELDEPRYL.

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

Many drugs can interact with ELDEPRYL, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with ELDEPRYL. Give a list of all your medicines to any healthcare provider who treats you.

There are many other medicines that can cause serious medical problems if you take them while using ELDEPRYL. 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 ELDEPRYL. 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.