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February 10, 2012
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mirtazapine - oral, Remeron (cont.)

SIDE EFFECTS: See also the Warning section.Dizziness, drowsiness, lightheadedness, increased appetite, weight gain, dry mouth, or constipation may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute.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 immediately if any of these unlikely but serious side effects occur: swelling of the hands/feet, shaking (tremor), confusion.Tell your doctor immediately if any of these rare but very serious side effects occur: unusual or severe mental/mood changes, signs of infection (e.g., fever, persistent sore throat).A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is used with certain other drugs (see Drug Interactions section). 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 muscles.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.

PRECAUTIONS: Before taking this medication, 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: history or family history of psychiatric disorders (e.g., bipolar/manic-depressive disorder), history or family history of suicide attempts, liver disease, kidney disease, seizures, high blood cholesterol or triglyceride levels, heart disease (e.g., recent heart attack, angina), stroke, severe loss of body fluids (dehydration), low blood pressure.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. Limit alcoholic beverages.To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially drowsiness.This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.If this medication is used during the last 3 months of pregnancy, infrequently your newborn may develop symptoms including feeding or breathing difficulties, seizures, muscle stiffness, jitteriness, or constant crying. However, do not stop taking this medication unless your doctor directs you to do so. Report any such symptoms to your doctor promptly.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.



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