MEDICATION GUIDE

What is the most important information I should know about tranylcypromine sulfate tablets?
Tranylcypromine sulfate tabletscan cause serious side effects including:

• Increase in suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment and when the tranylcypromine sulfate tablet dose is changed. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions.These include people who have, or have a family history of, bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. Tranylcypromine sulfate tablets are not for use in children.

How can I watch for and try to prevent suicidal thoughts and actions?

• Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
• Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms

Call a healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:

• A sudden, severe increase in blood pressure (hypertensive crisis). A hypertensive crisis can happen when you eat certain foods and drinks certain beverages during or after tranylcypromine sulfate tablets  treatment. A hypertensive crisis can lead to stroke and death. People who have thyroid problems (hyperthyroidism) may have a higher chance of having a hypertensive crisis. Symptoms of a hypertensive crisis may include:

A hypertensive crisis can also happen if you take tranylcypromine sulfate tablets with certain other medicines. See, “Who should not take tranylcypromine sulfate tablets?”
Avoid foods and drinks with a lot of tyramine while taking tranylcypromine sulfate tabletsand for 2 weeks after you stop taking it. For a list of some of the foods and drinks you should avoid during treatment with tranylcypromine sulfate tablets see, “What should I avoid while taking tranylcypromine sulfate tablets?”

What are tranylcypromine sulfate tablets?
Tranylcypromine sulfate tablets are a prescription medicine used to treat adults with a certain type of depression called major depressive disorder (MDD) who have not responded well to treatment with other medicines used to treat depression (antidepressants). Tranylcypromine sulfate tablets belong to a class of medicines called monoamine oxidase inhibitors (MAOIs)

• It is important to talk with your healthcare provider about the risks of treating depression and the risk of not treating it. Talk with your healthcare provider about all your treatment choices.
• Tranylcypromine sulfate tablets are not for use as the first medicine to treat MDD.
• It is not known if tranylcypromine sulfate tablets are safe and effective for use in children.

Who should not take tranylcypromine sulfate tablets?
Taking tranylcypromine sulfate tablets with certain antidepressants and certain pain, allergy symptom, and cold and cough symptom medicines may cause a potentially life-threatening hypertensive crisis or a problem called serotonin syndrome. See, “What is the most important information I should know about tranylcypromine sulfate tablets?” and “What are the possible side effects of tranylcypromine sulfate tablets?”

Do not take tranylcypromine sulfate tablets if you:

• take certain medicines, including:
  • antidepressants, such as:
    • other monoamine oxidase inhibitors (MAOIs)
    • selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs)
    • tricyclic antidepressants
    • other antidepressants, such as amoxapine, bupropion, maprotiline, nefazodone, trazodone, vilazodone, vortioxetine
    • amphetamines and methylphenidates
  • medicines that can raise blood pressure (sympathomimetic medicine), such as pseudoephedrine, phenylephrine and ephedrine. These medicines are in some cold, hay fever or weight-loss medicines.
  • sympathomimetic herbal medicines or dietary supplements
  • antihistamines (allergy medicines)
  • triptans
  • buspirone
  • carbamazepine
  • dextromethorphan
  • dopamine
  • hydroxytryptophan and tryptophan
  • levodopa and methyldopa
  • meperidine
  • rasagline
  • resperine
  • s-adenosyl-L-methionine (SAM-e)
  • tapentadol
  • tetrabenazin

Ask your healthcare provider or pharmacist if you are not sure if you take any of these medicines.

• have a tumor on your adrenal gland called a pheochromocytoma or a type of tumor called a paraganglioma.

Before taking tranylcypromine sulfate tablets, tell your healthcare provider about all your medical conditions, including if you:

• have high or low blood pressure
• have heart problems
• have cerebrovascular problems or have had a stroke
• have headaches
• have, or have a family history of, bipolar disorder, mania, or hypomania
• plan to have surgery
• have liver or thyroid problems
• have or have had seizures or convulsions
• have diabetes
• are pregnant or plan to become pregnant. Tranylcypromine sulfate tablets may harm your unborn baby.
• are breastfeeding or plan to breastfeed. Tranylcypromine sulfate  passes into your breast milk. Do not breastfeed during treatment tranylcypromine sulfate tablets. Talk to your healthcare provider about the best way to feed your baby while taking tranylcypromine sulfate tablets.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tranylcypromine sulfate tabletsand some other medicines may affect each other causing serious side effects. Tranylcypromine sulfate tabletsmay affect the way other medicines work, and other medicines may affect how tranylcypromine sulfate tablets work.

Some medicines need to be stopped for a period of time before you can start taking tranylcypromine sulfate tablets and for a period of time after you stop taking tranylcypromine sulfate tablets .

Know the medicines you take. Keep a list of them to show your healthcare providers, pharmacist, and dentist when you get a new medicine.

How should I take tranylcypromine sulfate tablets?

• Take tranylcypromine sulfate tablets exactly as your healthcare provider tells you to take it.
• Your healthcare provider may need to change your dose of tranylcypromine sulfate tablets until it is the right dose for you.
• Do not stop taking tranylcypromine sulfate tablets without first talking to your healthcare provider. Stopping tranylcypromine sulfate tablets suddenly may cause withdrawal symptoms. See, “What are the possible side effects of tranylcypromine sulfate tablets?”
• Tell your healthcare provider if you think your condition has gotten worse during treatment with tranylcypromine sulfate tablets.
• If you take too many tranylcypromine sulfate tablets (overdose) call your healthcare provider or poison control, or go to the nearest hospital emergency room right away. 

What should I avoid while taking tranylcypromine sulfate tablets?

• Do not eat foods or have drinks that have high amounts of tyramine while taking tranylcypromine sulfate tabletsor for 2 weeks after you stop taking tranylcypromine sulfate tablets.
  • All foods you eat should be fresh or properly frozen.
  • Avoid foods when you do not know how those foods should be stored.
  • Ask your healthcare provider if you are not sure if certain foods and drinks contain tyramine.

The table below lists some of the foods and drinks you should avoid while you take tranylcypromine sulfate tablets.

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how tranylcypromine sulfate tablets affects you.
• Do not drink alcohol while taking tranylcypromine sulfate tablets.

What are the possible side effects of tranylcypromine sulfate tablets?
Tranylcypromine sulfate tablets may cause serious side effects, including:

• See “What is the most important information I should know about tranylcypromine sulfate tablets?”
• Serotonin Syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take tranylcypromine sulfate tabletswith certain other medicines. See, "Who should not take tranylcypromine sulfate tablets ?" Symptoms of serotonin syndrome may include:
  

  agitation, confusion	seeing or hearing things that are not real (hallucinations)
  coma	rapid pulse
  changes in blood pressure	dizziness
  sweating	flushing
  high body temperature (hyperthermia)	fever
  seizures	tremors, stiff muscles, or muscle twitching
  becoming unstable	nausea, vomiting, diarrhea

  If you have any of these symptoms, call your healthcare provider or go to the nearest hospital emergency room right away.
• Mania or hypomania (manic episodes) in people who have a history of bipolar disorder.

  greatly increased energy	severe problems sleeping
  racing thoughts	reckless behavior
  unusually grand ideas	excessive happiness or irritability
  talking more or faster than usual

• Low blood pressure (hypotension) including a drop in your blood pressure when you stand or sit up (postural hypotension). This can happen more often in people who have high blood pressure (hypertension) and when the tranylcypromine sulfate tablet  dose is changed. Postural hypotension may cause you to feel dizzy and faint (syncope).
• Changes in your blood pressure (hypotension or hypertension) during surgery and during the time around surgery (perioperative). Taking tranylcypromine sulfate tablets  with certain medicines used for anesthesia can cause hypotension or hypertension. If you plan to have surgery, tell your surgeon or the healthcare provider who will give you anesthesia that you take tranylcypromine sulfate tablet . Your healthcare provider should stop tranylcypromine sulfate tablets  at least 10 days before you have surgery.

Withdrawal symptoms. Talk with your healthcare provider before you stop taking tranylcypromine sulfate tablets . Symptoms of withdrawal may include

• Liver problems
• Seizures (convulsions). Seizures have happened in people who take too much tranylcypromine sulfate tablets .
• Low blood sugar (hypoglycemia). Hypoglycemia has happened in people with diabetes who take medicines to lower blood sugar. Talk with your healthcare provider about checking your blood sugar during treatment with tranylcypromine sulfate tablets . Tell your healthcare provider if your blood sugar gets low.
• Worsening of symptoms that can happen with depression, such as anxiety and agitation.

These are not all the side effects of tranylcypromine sulfate tablets .
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How do I store tranylcypromine sulfate tablets?

• Store tranylcypromine sulfate tablets between 59°F to 86°F (15°C to 30°C).
• Store tranylcypromine sulfate tablets in a tight, light resistant container.

Keep tranylcypromine sulfate tablets and all medicines out of the reach of children.

General information about the safe and effective use of tranylcypromine sulfate tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take tranylcypromine sulfate tablets for a condition for which they were not prescribed. Do not give tranylcypromine sulfate tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about tranylcypromine sulfate tablets that is written for health professionals.

What are the ingredients in tranylcypromine sulfate tablets?
Active Ingredient: tranylcypromine sulfate
Inactive Ingredients: microcrystalline cellulose, anhydrous citric acid, croscarmellose sodium, D&C Red No. 7, FD&C Blue No. 2, FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, talc, titanium dioxide, carnauba wax, polyethylene glycol 400 and 8000 and hypromellose

Made in Italy
Manufactured for:
Teva Pharmaceuticals USA, Inc.
Parsippany, NJ 07054

For more information, contact Teva at 1-888-838-2872.