"The U.S. Food and Drug Administration today approved Brintellix (vortioxetine) to treat adults with major depressive disorder.
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Eskalith Consumer (continued)
Drowsiness, dizziness, tiredness, increased thirst, increased frequency of urination, weight gain, and mildly shaking hands (fine tremor) may occur. These should go away as your body adjusts to the medication. If any of these effects persist or worsen, tell 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: diarrhea, vomiting, fever, unsteady walk, confusion, slurred speech, blurred vision, severe hand trembling (coarse tremor), vision changes (such as growing blind spot, vision loss), joint swelling/pain, muscle weakness, pain/discoloration of finger/toes, cold hands/feet.
Get medical help right away if you have any very serious side effects, including: severe dizziness, fainting, slow/fast/irregular heartbeat, shortness of breath, seizures.
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.
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 Eskalith (lithium carbonate) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking lithium, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as propylene glycol), 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: heart disease, kidney disease, urinary problems (such as difficulty urinating), underactive thyroid (hypothyroidism), seizures, Parkinson's disease, leukemia, severe dehydration (severe loss of body water), any infection with high fever, a certain skin disorder (such as psoriasis).
Lithium treatment may infrequently reveal an existing condition that affects the heart rhythm (Brugada syndrome). Brugada syndrome is an inherited, life-threatening heart problem that some people may have without knowing it. It can cause a serious (possibly fatal) abnormal heartbeat and other symptoms (such as severe dizziness, fainting, shortness of breath) that need medical attention right away. Brugada syndrome may cause death suddenly. Before starting lithium treatment, tell your doctor if you have any of the following risk factors: Brugada syndrome, unexplained fainting, family history of certain heart problems (Brugada syndrome, sudden unexplained death before 45 years old).
This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.
If heavy sweating or severe diarrhea occurs, check with your doctor immediately how to best continue taking lithium. Take care in hot weather or during activities that cause you to sweat heavily, such as during hot baths, saunas, or exercise.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details.
Lithium passes into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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