Selegiline

Selegiline stops the breakdown of a chemical in your brain known as dopamine (DO pa meen). Low levels of dopamine are linked to Parkinson's disease.

Selegiline is used along with other medicines to help treat symptoms of Parkinson's disease.

Selegiline may also be used for reasons not mentioned in this medication guide.

Follow all instructions on your prescription label. Your doctor may change your dose from time to time to ensure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than what is recommended. Do not change your doses or medication schedule without your doctor's advice.

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

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

While you are taking selegiline and for 14 days after you stop, you must not eat foods listed in the "What should I avoid while using selegiline?" 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.

To take selegiline 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 start to dissolve right away. Do not swallow the tablet whole. Let it 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 selegiline 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.

Serious drug interactions can happen when some medicines are taken with selegiline. Inform all your healthcare providers about all the medicines you are currently taking, as well as any medicine you begin or stop using.

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

Some medicines can cause unwanted or dangerous effects when used with selegiline. 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, selegiline, tranylcypromine, and others.

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

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

• liver or kidney disease;
• high blood pressure; or
• phenylketonuria (selegiline 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 selegiline will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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

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

Selegiline may cause serious side effects. Call your doctor right away if you experience:

• 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 selegiline. Talk to your doctor if this happens.

Common side effects of selegiline 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 selegiline 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. You can report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Parkinson's Disease:

Oral capsule and tablet: 5 mg orally twice a day taken at breakfast and lunchMaximum dose: 10 mg orally per dayOral disintegrating tablet:-Initial dose: 1.25 mg orally once a day for at least 6 weeks -After 6 weeks, the dose may be increased to 2.5 mg orally once a day if neededMaintenance dose: 1.25 to 2.5 mg orally once a day before breakfastMaximum dose: 2.5 mg orally once a dayComments:-Two to 3 days after initiating therapy with this drug, an attempt may be made to reduce the dose of levodopa-carbidopa; typically a 10% to 30% reduction is needed; further reductions may be possible during continued concomitant use. -There is no evidence that this drug has beneficial effect in the absence of concurrent levodopa therapy. Use: As an adjunct in the management of Parkinson's disease in patients being treated with levodopa-carbidopa who exhibit deterioration in the quality of their response to this therapy.

Usual Adult Dose for Depression:

Transdermal System: Initial dose: 6 mg/24 hours patch applied topically once a day-Based on clinical judgement, doses may be increased in increments of 3 mg/24 hours at intervals of no less than 2 weeks Maintenance dose: 6 mg/24 hours to 12 mg/24 hours patch applied topically once a day Maximum dose: 12 mg/24 hours Comments:-Full antidepressant effect may be delayed.-Tyramine-rich food should be avoided beginning on the first day of therapy with a dose of 9 mg/24 hours or 12 mg/24 hours and continued to be avoided for 2 weeks after these doses are reduced to 6 mg/24 hours or less. Use: Treatment of major depressive disorder (MDD)

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.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

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

Avoid drinking alcohol while you are taking selegiline.

While taking selegiline 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 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.

Selegiline may impair your thinking or reactions. Some people taking selegiline 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.

Many drugs can interact with selegiline, and some should not be used at the same time. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are included in this medication guide. Inform your doctor about all medicines you are using, as well as any that you start or stop while being treated with selegiline. Provide a list of all your medicines to any healthcare provider who treats you.