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|Emsam System

Emsam System

Emsam System is used for:

Treating depression. It may also be used for other conditions as determined by your doctor.

Emsam System is a monoamine oxidase inhibitor (MAOI). Exactly how Emsam System works to treat depression is unknown.

Do NOT use Emsam System if:

• you are allergic to any ingredient in Emsam System
• you are taking fluoxetine or have taken it within the past 5 weeks
• you are taking bupropion, buspirone, cyclobenzaprine, dextromethorphan, meperidine, methadone, a norepinephrine reuptake inhibitor (eg, atomoxetine), propoxyphene, a selective serotonin reuptake inhibitor (SSRI) (eg, paroxetine), a serotonin and norepinephrine reuptake inhibitor (eg, duloxetine, venlafaxine), St. John"s wort, a tetracyclic antidepressant (eg, mirtazapine), tramadol, or a tricyclic antidepressant (eg, amitriptyline), or if you have taken any of these medicines within the past 7 days
• you are taking oral selegiline, another MAOI (eg, phenelzine), a sympathomimetic, including an amphetamine, a cold product, or certain diet pills or preparations (eg, ephedrine, phenylephrine, phenylpropanolamine, pseudoephedrine), or sibutramine, or if you have taken any of these medicines within the past 7 days
• you are taking a 5-HT₁ agonist (eg, sumatriptan), apraclonidine, carbamazepine, methylphenidate, oxcarbazepine, or nefazodone
• you will be undergoing elective surgery with general anesthesia or will be receiving cocaine or local anesthesia containing sympathomimetic vasoconstrictors
• you have certain adrenal gland problems (eg, pheochromocytoma)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Emsam System:

Some medical conditions may interact with Emsam System. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of bipolar disorder, mania, mood or mental problems, suicidal thoughts or attempts, or uncontrolled muscle movements (eg, twitching of the face and tongue and involuntary movements of the arms and legs)
• if you have a history of ulcer, heart problems, recent heart attack, seizures, blood problems, or a metabolism disorder

Some MEDICINES MAY INTERACT with Emsam System. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Bupropion, cyclobenzaprine, dextromethorphan, MAOIs (eg, phenelzine), meperidine, methadone, norepinephrine reuptake inhibitors (eg, atomoxetine), oral selegiline, propoxyphene, serotonin and norepinephrine reuptake inhibitors (eg, duloxetine, venlafaxine), sibutramine, SSRIs (eg, fluoxetine), St. John"s wort, sympathomimetics (eg, amphetamine, ephedrine, phenylephrine, phenylpropanolamine, pseudoephedrine), tetracyclic antidepressants (eg, mirtazapine), or tricyclic antidepressants (eg, amitriptyline) because serotonin syndrome (eg, fever, muscle stiffness or rigidity, vital sign changes, mental or mood changes, coma) may occur
• Apraclonidine or buspirone because severe high blood pressure may occur
• Nefazodone or tryptophan because nausea, dizziness, mental or mood changes, seizures, fever, or breathing or heart problems may occur
• Tramadol because the risk of seizures may be increased
• Carbamazepine or oxcarbazepine because they may increase the risk of Emsam System"s side effects
• 5-HT₁ agonists (eg, sumatriptan), insulin, meglitinide antidiabetics (eg, nateglinide), methylphenidate, or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by Emsam System

This may not be a complete list of all interactions that may occur. Ask your health care provider if Emsam System may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Emsam System:

Use Emsam System as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Emsam System comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Emsam System refilled.
• Wear only 1 patch at a time. Change the patch at about the same time each day.
• Do not cut or tear the patch. Do not apply to an area of skin that is hairy, oily, irritated, broken, scarred, or calloused. Do not place the patch under tight clothing.
• Apply to dry, intact skin on the upper torso, upper thigh, or outer surface of the upper arm. Use a new application site with each new patch.
• Wash the area gently with soap and warm water before applying the patch. Rinse until all soap is removed. Dry the area with a clean, dry towel.
• Apply the patch as directed by your doctor or on the package labeling. If you have questions about how to apply the patch, check with your doctor or pharmacist.
• Wash your hands thoroughly with soap and water after applying the patch. Do not touch your eyes until after you have washed your hands.
• Avoid exposing the application site to direct heat, such as heating pads or electric blankets, heat lamps, saunas, hot tubs, heated water beds, and prolonged direct sunlight.
• After 24 hours, remove the used patch. Do not touch the sticky side, but fold the patch in half with the sticky sides together. Discard the patch out of the reach of children and away from pets. Wash your hands with soap and water after removing the patch.
• Continue to use Emsam System even if you feel well. Do not miss any doses.
• If your patch falls off or if you miss a dose of Emsam System, apply a new patch to a new site and resume your previous schedule.

Ask your health care provider any questions you may have about how to use Emsam System.

Important safety information:

• Emsam System may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Emsam System with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol while you are using Emsam System.
• Emsam System may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Do not suddenly stop using Emsam System. The risk of side effects may be increased if Emsam System is suddenly stopped. Check with your doctor before you change your dose or stop Emsam System.
• Children and teenagers who take Emsam System may be at increased risk for suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. The risk may also be greater in patients who have had bipolar (manic-depressive) illness, or if their family members have had it. Watch patients who take Emsam System closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
• Eating foods high in tyramine (eg, aged cheeses, certain types of wine and beer, certain meats and sausages, liver, sour cream, soy sauce, raisins, bananas, avocados) while you use an MAOI may cause severe high blood pressure. This could occur for up to 2 weeks after you stop taking an MAOI. Do not eat foods high in tyramine while you take Emsam System. Ask your health care provider for a complete list of foods you should avoid. Seek medical attention at once if symptoms of severe high blood pressure occur. These may include severe headache, fast or irregular heartbeat, sore or stiff neck, nausea, vomiting, sweating, enlarged pupils, or sensitivity to light.
• Avoid dietary supplements containing tyramine or nonprescription products containing dextromethorphan, pseudoephedrine, or phenylephrine while you are using Emsam System.
• Tell your doctor or dentist that you take Emsam System before you receive any medical or dental care, emergency care, or surgery. Emsam System should be discontinued at least 10 days before elective surgery.
• If your doctor tells you to stop taking Emsam System, you will need to wait at least 14 days before beginning to take certain other medicines (eg, medicines for depression, anxiety, pain, cough, congestion, weight loss, seizures, or Parkinson disease; muscle relaxants). Ask your doctor if you are unsure when you should start to take your new medicines after you have stopped taking Emsam System.
• Diabetes patients - Emsam System may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests, including blood pressure, may be performed while you use Emsam System. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Emsam System with caution in the ELDERLY; they may be more sensitive to its effects, especially rash.
• Emsam System should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Emsam System while you are pregnant. It is not known if Emsam System is found in breast milk. If you are or will be breast-feeding while you use Emsam System, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Emsam System:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; dry mouth; sleeplessness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; changes in sexual ability or desire; chest pain; enlarged pupils; fast, slow, or irregular heartbeat; increased sweating; memory loss; nausea; neck stiffness or soreness; new or worsening agitation, aggressiveness, anxiety, exaggerated feeling of well-being, hostility, impulsiveness, inability to sit still, irritability, panic attacks, or sleeplessness; painful menstruation; sensitivity to light; severe headache; swelling of the arms or legs; vomiting.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include coma; cool, clammy skin; difficulty breathing; excessive sweating; fast or irregular heartbeat; fever; hallucinations; hyperactivity; seizures; severe dizziness, drowsiness, or headache.

Store Emsam System at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep Emsam System out of the reach of children and away from pets.

General information:

• If you have any questions about Emsam System, please talk with your doctor, pharmacist, or other health care provider.
• Emsam System is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Emsam System. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.