"The U.S. Food and Drug Administration today approved Brintellix (vortioxetine) to treat adults with major depressive disorder.
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Emsam Consumer (continued)
Dizziness, drowsiness, redness/irritation at the application site, 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 you have any serious side effects, including: fainting, mental/mood changes (e.g., agitation, confusion), muscle stiffness/twitching, changes in sexual ability/interest, shaking (tremor), shivering, swollen ankles/legs, unusual weight gain/loss, vision changes (e.g., double/blurred vision), 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 using selegiline and get medical help right away if any of these very 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), enlarged pupils, sudden sensitivity to light (photophobia).
This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome. 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. Get medical help right away if you develop some of the following symptoms: hallucinations, unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, unexplained fever, severe nausea/vomiting/diarrhea, twitching muscle.
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), 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.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Emsam (selegiline transdermal system) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: See also Warning section.
Before using selegiline, 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 (e.g., stroke), heart problems (e.g., congestive heart failure, heart attack), personal or family history of high blood pressure, history of severe/frequent headaches, personal/family history of mental/mood disorders (e.g., bipolar disorder, depression, schizophrenia), liver problems, certain nervous system diseases (Parkinson's syndrome, seizures), overactive thyroid (hyperthyroidism).
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.
Avoid exposing your skin to direct heat sources such as heating pads, electric blankets, heat lamps, saunas, hot tubs, heated water beds, or prolonged direct sunlight while wearing your selegiline patch. Heat sources may cause more drug to be released into your body, increasing the chance of side effects.
If you are going to have an MRI test, tell testing personnel that you are using this patch. Some patches may contain metals that can cause serious burns during an MRI. Ask your doctor whether you will need to remove your patch before the test and apply a new patch afterward, and how to do so properly.
Before having surgery, tell your doctor or dentist you are on this medication. You may need to stop using this drug beforehand. Follow your doctor's instructions carefully.
If you have diabetes, selegiline may make it more difficult to control your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high/low blood sugar such as increased thirst or urination, hunger, unexplained sweating. 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 if this medication passes into breast milk. Consult your doctor before breast-feeding.
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