|Fabricant:||DAVA Pharmaceuticals, Inc.
Mylan Pharmaceuticals Inc.
Emsam is indicated for the treatment of major depressive disorder.
Use Emsam exactly as directed on the label, or as it has been prescribed by your doctor. Do not use more than recommended. Follow the directions on your prescription label.
For patients using Emsam: While you are using Emsam and for 14 days after you stop, you must not eat foods high in tyramine (listed in the “What should I avoid?” section of this leaflet. Eating these foods while you are taking Emsam can raise your blood pressure to dangerous levels.
Foods that you MAY eat include:
- fresh meat, poultry, or fish (including lunch meat, hot dogs, breakfast sausage, and cooked sliced ham);
- any vegetables except broad bean pods (fava beans);
- processed cheese, mozzarella, ricotta, cottage cheese;
- pizza made with cheeses low in tyramine;
- soy milk, yogurt; or
- Brewer’s or baker’s yeast.
This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Do not stop using Emsam suddenly or you may have harmful side effects. It may take several weeks of using Emsam before your symptoms improve. For best results, keep using the medication as directed. Store Emsam at room temperature away from heat and moisture.
If you missed a dose – take it as soon as you remember. If it is almost time to take the next pill, skip the missed dose and take the medication at your next regularly scheduled time. Do not take extra pills to make up the missed dose.
The recommended starting dose and target dose for Emsam (selegiline transdermal system) is 6 mg/24 hours.
Store Emsam at 20º to 25º C (68º to 77º F).[See USP Controlled Room Temperature.] Keep away from children, pets or others.
Do not use Emsam if you are allergic to selegiline, if you have an adrenal gland tumor (also called pheochromocytoma), or if you plan to have any type of surgery. Do not use Emsam if you have taken any of the following drugs within the past 14 days:
- buspirone (BuSpar);
- carbamazepine (Tegretol) or oxcarbazepine (Trileptal);
- cyclobenzaprine (Flexeril);
- dextromethorphan (cough medicine);
- meperidine (Demerol), methadone (Dolophine, Methadose), propoxyphene (Darvon, Darvocet), or tramadol (Ultram, Ultracet);
- mirtazapine (Remeron);
- diet pills, ADHD medications, or cold medicines that contain dextromethorphan, ephedrine, pseudoephedrine, or phenylephrine;
- St. John’s wort;
- antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), bupropion (Wellbutrin, Zyban), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), protriptyline (Vivactil), sertraline (Zoloft), venlafaxine (Effexor), or trimipramine (Surmontil); or
- other MAO inhibitors such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or oral selegiline (Eldepryl).
After you stop using Emsam, you must wait at least 14 days before taking any of the medications listed above.You must wait at least 5 weeks after stopping fluoxetine (Prozac) before you can start using Emsam.
Tell your doctor if you are allergic to any drugs, or if you have:
- heart disease, high or low blood pressure;
- seizures or epilepsy; or
- a personal or family history of bipolar disorder (manic depression) or suicide attempt.
You may have thoughts about suicide when you first start using an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.
Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.
FDA pregnancy category C. Emsam may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Emsam passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Stop using Emsam and call your doctor at once if you have any of these serious side effects:
- sudden and severe headache, confusion, blurred vision, problems with speech or balance, nausea, vomiting, chest pain, seizure (convulsions), and sudden numbness or weakness (especially on one side of the body);
- feeling light-headed, fainting;
- twitching muscle movements; or
- painful or difficult urination.
Less serious side effects may include:
- constipation, gas, loss of appetite;
- swelling, numbness or tingling, easy bruising, muscle pain;
- dry mouth, sore throat, cough;
- redness or itching where the patch is worn; or
- impotence, loss of interest in sex, or trouble having an orgasm.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.