PhenelzineSulfateMgTab

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

PHENELZINE – ORAL

(FEN-el-zeen)

COMMON BRAND NAME(S): Nardil

WARNING: Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

USES: Phenelzine is an antidepressant (monoamine oxidase inhibitor). This medication treats depression by restoring the balance of certain natural substances (neurotransmitters) in the brain. Phenelzine can improve your mood and feelings of well-being. Usually, this medication is used in persons who have not responded to treatment with other drugs.

HOW TO USE: Read the Medication Guide available from your pharmacist before you start using phenelzine and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth, usually 1 to 3 times a day as directed by your doctor. This medication may be taken with or without food. Dosage is based on your medical condition and response to therapy.

To reduce your risk of side effects, your doctor may start you at a low dose and gradually increase your dose. Once your condition improves and you are better for a while, your doctor may work with you to reduce your regular dose. Follow your doctor’s instructions carefully. Do not take more or less medication or take it more frequently than prescribed. Your condition will not improve any faster and your risk of side effects will increase.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day. It may take several weeks for the full benefits of this medication to be noticed. Do not stop taking this medication without consulting your doctor.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, confusion, hallucinations, headache, weakness, and diarrhea) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: See also Warning section.

Dizziness, drowsiness, 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 any of these unlikely but serious side effects occur: fainting, mental/mood changes (e.g., agitation, confusion), muscle stiffness, changes in sexual ability/interest, shaking (tremor), shivering, swollen ankles/legs, unusual weight gain, eye pain/swelling/redness, vision changes (e.g., double/blurred vision).

Tell your doctor right away if any of these highly unlikely but very serious side effects occur: 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 taking phenelzine and seek immediate medical attention 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, sudden sensitivity to light (photophobia).

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. 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 (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: 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.

PRECAUTIONS: Before taking phenelzine, 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain kind of adrenal gland tumor (pheochromocytoma), cerebrovascular disease (e.g., stroke), heart problems (e.g., congestive heart failure, heart attack), high blood pressure, history of severe/frequent headaches, liver problems, severe kidney disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal/family history of mental/mood disorders (e.g., schizophrenia, bipolar disorder), family history of high blood pressure, heart disease (e.g., coronary artery disease, history of chest pain), mild/moderate kidney disease, diabetes, certain nervous system diseases (Parkinson’s syndrome, seizures), overactive thyroid (hyperthyroidism), personal/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.

Before having surgery or any procedures requiring use of contrast dye (e.g., myelography), tell your doctor or dentist you are on this medication. You may need to stop taking this drug beforehand. Follow your doctor’s instructions carefully.

If you have heart disease, this medication may mask chest pain. Avoid strenuous exercise while taking this medication.

If you have diabetes, phenelzine may lower your blood sugar levels. Check your blood sugar regularly, and share the results with your doctor. Tell your doctor right away if you have symptoms of low blood sugar such as cold sweat, shaking, rapid heart rate, fainting, and hunger. Your anti-diabetic medication or diet may need to be adjusted.

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 whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: 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 this drug include: other antidepressants (including maprotiline, mirtazapine, nefazodone, TCAs such as amitriptyline/nortriptyline), appetite suppressants (such as diethylpropion), drugs for attention deficit disorder (such as atomoxetine, methylphenidate), apraclonidine, bupropion, buspirone, carbamazepine, cyclobenzaprine, dextromethorphan, certain drugs for high blood pressure (such as guanethidine, methyldopa, beta blockers such as atenolol, clonidine, rauwolfia alkaloids such as reserpine, “water pills”/diuretics such as hydrochlorothiazide), other MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, procarbazine, rasagiline, selegiline, tranylcypromine), certain narcotic medications (such as fentanyl, meperidine, methadone, tapentadol), certain drugs for Parkinson’s (such as entacapone, levodopa, tolcapone), street drugs (such as LSD, mescaline), stimulants (such as amphetamines, cocaine, dopamine, epinephrine, phenylalanine), tetrabenazine, “triptan” migraine drugs (such as sumatriptan, rizatriptan), tramadol, tyrosine, tryptophan.

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, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), 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 phenelzine. Tell your doctor or pharmacist if you have taken fluoxetine during at least 5 weeks before starting phenelzine. Discuss with your doctor how much time to wait between starting or stopping any of these drugs and taking phenelzine.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (such as diphenhydramine), anti-seizure drugs (such as phenytoin), medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (such as codeine), psychiatric medicines (such as chlorpromazine, lithium, risperidone, trazodone).

Check the labels on all your medicines (such as allergy, cough-and-cold products, decongestants, diet pills) because they may contain dextromethorphan, decongestants, stimulants, or drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

It is very important that you follow special dietary restrictions in order to limit the amount of tyramine in your diet. Avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas) or eating large amounts of chocolate. Caffeine can increase the side effects of this medication. Foods and beverages high in tyramine should be avoided while you are taking this medication and for at least 2 weeks after you stop using this medication.

Foods high in tyramine include: aged cheeses (cheddar, camembert, emmenthaler, brie, stilton blue, gruyere, gouda, brick, bleu, roquefort, boursault, parmesan, romano, provolone, liederdranz, colby, edam), aged/dried/fermented/salted/smoked/pickled/processed meats and fish (includes bacon, summer sausage, liverwurst, hot dogs, corned beef, pepperoni, salami, bologna, ham, mortadella, pickled or dried herring), banana peel, beef/chicken liver (stored, not fresh), bouillon cubes, commercial gravies, concentrated yeast extracts, fava beans, Italian green beans, broad beans, fermented bean curd, homemade yeast-leavened bread, kim chee (Korean fermented cabbage), orange pulp, overripe or spoiled fruits, packaged soups, red wine, sauerkraut, sherry, snow pea pods, sourdough bread, soy sauce, soybeans, soybean paste/miso, tofu, tap beer and ale, vermouth.

Moderate-to-low tyramine content foods include: alcohol-free beer, avocados, bananas, bottled beer and ale, chocolate and products made with chocolate, coffee, cola, cultured dairy products (such as buttermilk, yogurt, sour cream), distilled spirits, eggplant, canned figs, fish roe (caviar), green bean pods, pate, peanuts, port wine, raisins, raspberries, red plums, spinach, tomatoes, white wine.

Tell your doctor or pharmacist right away if you notice symptoms of high blood pressure such as fast/slow heartbeat, vomiting, sweating, headache, chest pain, sudden vision changes, weakness on one side of the body, or slurred speech.

Contact your healthcare professionals (e.g., doctor, pharmacist, dietician) for more information, including recommendations for your diet.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., blood pressure, liver function) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take as soon as you remember unless the next scheduled dose is within 2 hours. In that case, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised August 2016. Copyright(c) 2016 First Databank, Inc.