Zelapar Oral

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of selegiline in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of selegiline in the elderly. However, elderly patients are more likely to have unwanted effects (such as hypertension, orthostatic hypotension, unusual drowsiness), which may require caution for patients receiving selegiline.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amitriptyline
• Amoxapine
• Amphetamine
• Apraclonidine
• Atomoxetine
• Benzphetamine
• Brimonidine
• Bupropion
• Carbamazepine
• Carbinoxamine
• Citalopram
• Clomipramine
• Codeine
• Cyclobenzaprine
• Cyproheptadine
• Desipramine
• Desvenlafaxine
• Deutetrabenazine
• Dexfenfluramine
• Dexmethylphenidate
• Dextroamphetamine
• Dextromethorphan
• Diethylpropion
• Doxylamine
• Duloxetine
• Ephedrine
• Escitalopram
• Fenfluramine
• Fluoxetine
• Fluvoxamine
• Furazolidone
• Guanadrel
• Guanethidine
• Hydroxytryptophan
• Imipramine
• Iproniazid
• Isocarboxazid
• Isometheptene
• Levomethadyl
• Levomilnacipran
• Linezolid
• Lisdexamfetamine
• Maprotiline
• Mazindol
• Meperidine
• Methamphetamine
• Methotrimeprazine
• Methyldopa
• Methylene Blue
• Methylphenidate
• Milnacipran
• Mirtazapine
• Moclobemide
• Nefopam
• Nialamide
• Nortriptyline
• Opipramol
• Paroxetine
• Phendimetrazine
• Phenelzine
• Phenmetrazine
• Phentermine
• Phenylalanine
• Phenylephrine
• Phenylpropanolamine
• Procarbazine
• Propoxyphene
• Protriptyline
• Pseudoephedrine
• Rasagiline
• Reserpine
• Safinamide
• Sertraline
• Sibutramine
• St John's Wort
• Sumatriptan
• Tapentadol
• Tetrabenazine
• Tramadol
• Tranylcypromine
• Trazodone
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Vortioxetine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Alizapride
• Altretamine
• Amineptine
• Amisulpride
• Amitriptylinoxide
• Atropine
• Bromperidol
• Buprenorphine
• Buspirone
• Butorphanol
• Clovoxamine
• Dibenzepin
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Dolasetron
• Domperidone
• Dothiepin
• Doxepin
• Droperidol
• Ethchlorvynol
• Femoxetine
• Fentanyl
• Fluspirilene
• Frovatriptan
• Granisetron
• Guarana
• Haloperidol
• Hydrocodone
• Hydromorphone
• Iobenguane I 123
• Kava
• Levorphanol
• Licorice
• Lofepramine
• Lorcaserin
• Ma Huang
• Mate
• Melitracen
• Mephentermine
• Metaraminol
• Methadone
• Metoclopramide
• Metopimazine
• Midodrine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nefazodone
• Oxycodone
• Oxymetazoline
• Oxymorphone
• Palonosetron
• Penfluridol
• Pentazocine
• Pimozide
• Reboxetine
• Remifentanil
• Sufentanil
• Sulpiride
• Sultopride
• Tianeptine
• Tiapride
• Tyrosine
• Valbenazine
• Veralipride
• Ziprasidone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose
• Chlorpropamide
• Desogestrel
• Dienogest
• Dopamine
• Drospirenone
• Estradiol Cypionate
• Estradiol Valerate
• Ethinyl Estradiol
• Ethynodiol Diacetate
• Etonogestrel
• Ginseng
• Glimepiride
• Glipizide
• Glyburide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Levonorgestrel
• Medroxyprogesterone Acetate
• Mestranol
• Metformin
• Nateglinide
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Repaglinide
• Tolazamide
• Tolbutamide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Avocado
• Bitter Orange
• Tyramine Containing Food

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Dyskinesia (abnormal muscle movements) or
• Hypertension (high blood pressure) or
• Mental illness (eg, psychosis) or
• Postural hypotension (dizziness, lightheadedness, or fainting when getting up from a lying or sitting position)—Use with caution. May make these conditions worse.

• Kidney disease, severe—Use is not recommended in patients with this condition.

• Liver disease—Use with caution. Higher blood levels of selegiline may result, and cause an increase in side effects.

• Phenylketonuria (PKU)—The disintegrating tablet contains phenylalanine, which can make this condition worse.

This section provides information on the proper use of a number of products that contain selegiline. It may not be specific to Zelapar. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

It is best to take the capsules or tablets in the morning during breakfast and lunch. You should not use it with dinner because you may have trouble sleeping.

If you are using the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Do not break or split the tablet. Place the tablet on the top of your tongue, where it will melt quickly. Do not eat food or drink liquids for 5 minutes before or after taking this medicine. It is best to take this medicine before breakfast.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For Parkinson's disease:
  • For oral dosage forms (capsules or tablets):
    • Adults—5 milligrams (mg) two times a day, taken at breakfast and lunch. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (oral disintegrating tablets):
    • Adults—At first, 1.25 milligrams (mg) once a day before breakfast, for at least 6 weeks. After 6 weeks, your doctor may increase your dose to 2.5 mg once a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to check for any unwanted effects.

Do not take selegiline if you have used meperidine (eg, Demerol®) or an MAO inhibitor (MAOI) (eg, isocarboxazid, phenelzine, tranylcypromine, Marplan®, Nardil®, or Parnate®) within the past 14 days. If you do, you may develop agitation, confusion, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, or severe convulsions.

Do not take cyclobenzaprine, dextromethorphan (Robitussin®, Pediacare®), St. John's wort, or pain medicines (eg, methadone, propoxyphene, tramadol, Darvon®, Dolophine®, Ultram®) while you are using this medicine. Using these medicines together can cause unwanted effects.

Selegiline may cause a condition called serotonin syndrome when used together with certain MAO inhibitors (eg, phenelzine, rasagiline, tranylcypromine) and medicines to treat depression (eg, amitriptyline, doxepin, fluoxetine, fluvoxamine, nortriptyline, paroxetine, sertraline, Elavil®, Luvox®, Pamelor®, Paxil®, Prozac®, or Zoloft®). Symptoms of serotonin syndrome include: anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, seeing or hearing things that are not there.

When selegiline is taken at doses of 10 mg or less per day for the treatment of Parkinson's disease, there are no restrictions on food or beverages you eat or drink. However, the chance exists that dangerous reactions, such as sudden high blood pressure, may occur if doses higher than those used for Parkinson's disease are taken with certain foods, beverages, or other medicines. These foods, beverages, and medicines include:

• Foods that have a high tyramine content (most common in foods that are aged or fermented to increase their flavor), such as cheeses, fava or broad bean pods, yeast or meat extracts, smoked or pickled meat, poultry, or fish, fermented sausage (bologna, pepperoni, salami, summer sausage) or other fermented meat, sauerkraut, or any overripe fruit. If a list of these foods and beverages is not given to you, ask your doctor to provide one.
• Alcoholic beverages or alcohol-free or reduced-alcohol beer and wine.
• Large amounts of caffeine-containing food or beverages such as coffee, tea, cola, or chocolate.
• Any other medicine unless approved or prescribed by your doctor. This especially includes nonprescription (over-the-counter [OTC]) medicine, such as that for colds (including nose drops or sprays), cough, asthma, hay fever, and appetite control, “keep awake” products, or products that make you sleepy.

Also, for at least 2 weeks after you stop taking this medicine, these foods, beverages, and other medicines may continue to react with selegiline if it was taken in doses higher than those usually used for Parkinson's disease.

Check with your doctor or hospital emergency room immediately if severe headache, stiff neck, chest pains, fast heartbeat, or nausea and vomiting occur while you are taking this medicine. These may be symptoms of a serious side effect that should have a doctor's attention.

This medicine may make you drowsy. It may even cause you to fall asleep without warning while you drive, talk, or eat. Do not drive or do anything that could be dangerous until you know how this medicine affects you.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

Check with your doctor right away if you have pain when swallowing, pain in the mouth, redness, swelling, or sores in your mouth while receiving this medicine.

Selegiline may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor if you start having problems with gambling or increased interest in sex while using this medicine.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely.

It is important that your doctor check your skin regularly for signs of a skin cancer called melanoma. If you notice any unusual red, brown, or black spots on your skin, talk to your doctor right away.

Dizziness, abdominal pain, dry mouth, nausea, stomach upset, trouble sleeping, and headache may occur. Redness, pain, and swelling of the mouth/throat may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

If you are also taking levodopa, you may experience more side effects from the levodopa when taking selegiline. Tell your doctor right away if any of these side effects occur: nausea, shakiness, muscle stiffness, mental/mood changes such as hallucinations/abnormal dreams. Your doctor may need to change your medication or dose. Do not stop or change the dose of your levodopa without talking with your doctor first.

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.

Some people taking selegiline have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur anytime during treatment with selegiline even if you have used this medication for a long time. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk of this sleep effect is increased by using alcohol or other medications that can make you drowsy. See also Precautions section.

Tell your doctor right away if you have any serious side effects, including: fainting, loss of balance, mental/mood changes (e.g., agitation, confusion, depression, hallucinations), unusual strong urges (such as increased gambling, increased sexual urges), worsening muscle stiffness/twitching, changes in sexual ability/interest, increased shaking (tremor), swollen ankles/legs, difficulty urinating, unusual weight gain, easy bleeding/bruising, black/tarry stools, vomit that looks like coffee grounds.

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 Interactions section.) Get medical help right away if any of these 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, vision changes (e.g., double/blurred vision), 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), severe 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.

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, 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, 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 narcotic 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.

To prevent a very serious high blood pressure reaction, it is very important that you do not increase your dose. Follow any special diet your doctor or dietician recommends in order to limit your intake of tyramine while you are taking this medicine. If your doctor recommends a special diet, foods and beverages that are high in tyramine include: aged cheeses (e.g., bleu, cheddar, parmesan), dried/aged/fermented meats and sausages (e.g., salami, liverwurst), preserved fish (e.g., pickled herring), products containing large amounts of yeast (e.g., concentrated yeast extract, bouillon cubes, powdered soup/gravy, homemade or sourdough bread), fermented foods (e.g., sauerkraut, kim chee), most soybean products (e.g., soy sauce, tofu), broad/fava beans, red wine, sherry, tap beers, vermouth. Foods that are moderate in tyramine include: avocados, bananas, eggplant, green beans, raisins, raspberries, red plums, spinach, tomatoes, chocolate, cultured dairy products (e.g., buttermilk, yogurt, sour cream), fish eggs, pate, peanuts, coffee, cola, alcohol-free beer, bottled beer, distilled spirits, port, white wine. Consult your doctor or dietician for more details and a complete list of other tyramine-containing foods. Seek immediate medical attention if you notice symptoms of very high blood pressure such as unusually fast/slow heartbeat, vomiting, unexplained sweating, headache, chest pain, sudden vision changes, weakness on one side of the body, slurred speech.

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