Uses

This medication is used to treat depression. It works by restoring the balance of certain natural substances (neurotransmitters) in the brain. Moclobemide can improve your mood and feelings of well-being. It belongs to a class of drugs known as monoamine oxidase (MAO) inhibitors. Usually, this medication is used in persons who have not responded to treatment with other drugs.

How To Use

Take this medication by mouth, usually twice daily immediately after meals or as directed by your doctor. Dosage is based on your medical condition and response to treatment.

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 times 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.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as restlessness, confusion, hallucinations, headache, weakness, and diarrhea). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used moclobemide for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Tell your doctor if your condition lasts or gets worse.

Side Effects

See also Warning and Drug Interactions sections.

Dizziness, drowsiness, headache, constipation, dry mouth, loss of appetite, or change in sexual ability/interest may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 you have any serious side effects, including:

• stomach pain
• restlessness
• shaking (tremor)
• fast/pounding/irregular heartbeat
• seizures

Get medical help right away if you have any very serious side effects, including:

• eye pain/swelling/redness
• widened pupils
• vision changes (such as seeing rainbows around lights at night, double/blurred vision)

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 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.

Precautions

Before taking moclobemide, 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• a certain kind of adrenal gland tumor (pheochromocytoma)
• cerebrovascular disease (such as stroke)
• high blood pressure
• history of severe/frequent headaches
• liver problems
• personal/family history of mental/mood disorders (such as schizophrenia, bipolar disorder)
• heart disease (such as heart failure, heart attack, coronary artery disease)
• kidney disease
• certain nervous system diseases (Parkinson's disease, seizures)
• overactive thyroid (hyperthyroidism)
• personal or family history of glaucoma (angle-closure type)

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

To reduce 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 (such as myelography), tell your doctor or dentist you are taking this medication. You may need to stop taking this drug before the surgery/procedure. Follow your doctor's instructions carefully.

In people with heart disease, this medication may prevent you from feeling the chest pain you would normally experience during a heart attack or with other heart problems (such as angina), making it more difficult to know when you need emergency medical attention. To reduce this risk, people with heart disease should avoid strenuous exercise while taking this medication.

If you have diabetes, moclobemide may lower your blood sugar. 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 sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Older adults may be more sensitive to the side effects of this drug, especially the effects on blood pressure.

During pregnancy, this medication should be used only when clearly needed. 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.

This medication passes into breast milk. Breast-feeding while using this medication is not recommended. 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 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
• deutetrabenazine
• dextromethorphan
• herbal products (such as ginseng, ephedra/ma huang)
• certain drugs for high blood pressure (such as guanethidine, methyldopa)
• other MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine)
• metoclopramide
• certain opioid medications (such as fentanyl, meperidine, methadone, tapentadol)
• certain drugs for Parkinson's disease (such as levodopa, entacapone, tolcapone)
• papaverine
• street drugs (such as LSD, mescaline)
• stimulants (such as amphetamines, cocaine, ephedrine, epinephrine, phenylalanine)
• tetrabenazine
• tramadol
• tyrosine
• tryptophan
• 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, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), maprotiline, trimipramine, "triptan" migraine drugs (such as sumatriptan, rizatriptan), 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 moclobemide. Tell your doctor or pharmacist if you have taken fluoxetine during at least 5 weeks before starting moclobemide. Discuss with your doctor how much time to wait between starting or stopping any of these drugs and taking moclobemide.

Other medications can affect the removal of moclobemide from your body, which may affect how moclobemide works. Examples include azole antifungals (such as itraconazole), cimetidine, macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), ritonavir, St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

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

Depending on your medical history, your doctor may direct you to restrict your dietary intake of tyramine during and for 2 weeks after stopping the use of moclobemide. Certain foods and beverages are high in tyramine. Consult your doctor or pharmacist for more details if needed.

Patients taking other MAO inhibitors (such as phenelzine, isocarboxazid) without restricting the amount of tyramine in their diets have experienced very serious (sometimes fatal) attacks of very high blood pressure. Tell your doctor right away if you develop 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, stiff neck, or trouble speaking.

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. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center. Symptoms of overdose may include: confusion, trouble speaking, seizures.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature away from heat and light. Do not store in the bathroom. Keep all medications 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.

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).