Emsam

Do not use this medication if you are allergic to selegiline, if you have an adrenal gland tumor (also called pheochromocytoma), or if you plan to have any type of surgery. Do not use selegiline if you have taken any of the following drugs within the past 14 days:

• carbamazepine (Tegretol) or oxcarbazepine (Trileptal);

• cyclobenzaprine (Flexeril);

• dextromethorphan (cough medicine);

• meperidine (Demerol), methadone (Dolophine, Methadose), propoxyphene (Darvon, Darvocet), or tramadol (Ultram, Ultracet);

• mirtazapine (Remeron);

• diet pills or cold medicines that contain dextromethorphan, ephedrine, pseudoephedrine, or phenylephrine;

• St. John’s wort;

• antidepressants such as amitriptyline (Elavil), amoxapine (Ascendin), bupropion (Wellbutrin, Zyban), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), protriptyline (Vivactil), sertraline (Zoloft), venlafaxine (Effexor), or trimipramine (Surmontil); or

• other MAO inhibitors such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or oral selegiline (Eldepryl).

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

Tell your doctor if you are allergic to any drugs, or 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.

You may have thoughts about suicide when you first start using an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether selegiline passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use more of the skin patches or use them for longer than recommended. Follow the directions on your prescription label.

While you are using selegiline and for 14 days after you stop, you must not eat foods listed in the "What should I avoid while using selegiline transdermal?” section of this leaflet. Eating these foods while you are using selegiline 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.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Before applying a skin patch, wash the skin with soap and water and dry completely. The patch can be worn on a dry, smooth, and hairless area of your back, upper arm, chest, or thigh. Do not apply the patch to a skin wound or irritated skin, or wear it under tight clothing.

Remove the patch after 24 hours, taking care not to touch the sticky side with your fingers. Fold the patch in half so that it sticks together. Throw the used patch away where children and pets cannot reach it.

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

Use only one patch at a time. 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.

Do not stop using selegiline suddenly or you may have harmful side effects. It may take several weeks of using selegiline before your symptoms improve. For best results, keep using the medication as directed.

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.

Apply a skin patch as soon as you remember. If it is almost time to apply your next patch, skip the missed dose and apply a patch at your next regularly scheduled time. 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 any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms 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.

Stop using selegiline and call your doctor at once if you have any of these serious side effects:

• sudden and severe headache, confusion, blurred vision, problems with speech or balance, nausea, vomiting, chest pain, seizure (convulsions), and sudden numbness or weakness (especially on one side of the body);

• feeling light-headed, fainting;

• twitching muscle movements; or

• painful or difficult urination.

Continue using selegiline and talk with your doctor if you have any of these less serious side effects:

• constipation, gas, loss of appetite;

• swelling, numbness or tingling, easy bruising, muscle pain;

• dry mouth, sore throat, cough;

• redness or itching where the patch is worn; or

• impotence, loss of interest in sex, or trouble having an orgasm.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

There are many other medicines that can cause serious medical problems if you take them while using selegiline. Tell your doctor about all other prescription and over-the-counter medications you use, including vitamins, minerals, and herbal products.

While using selegiline, do not drink alcohol or eat foods that are high in tyramine, listed in the "What should I avoid while using selegiline?” section of this leaflet. Eating tyramine while you are using selegiline 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.

Call your doctor at once if you have any new or worsening symptoms 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.

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, including blue, boursault, brick, brie, camembert, cheddar, emmenthaler, gruyere, parmesan, romano, roquefort, stilton, and swiss;

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

• sauerkraut, soy beans, soy sauce, tofu, miso soup, bean curd, 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 selegiline.

Avoid drinking alcohol while you are using selegiline.

Selegiline can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

There are many other medicines that can cause serious medical problems if you take them while using selegiline. Do not use selegiline before telling your doctor about all other prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Keep a list with you of all the medicines you use and show this list to any doctor, dentist, or other healthcare provider who treats you.

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a selegiline overdose may include severe headache, hallucinations, vision problems, sweating, cool or clammy skin, fast or uneven heart rate, feeling lightheaded, fainting, or seizure.