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February 10, 2012
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dextroamphetamine sustained-action capsule - oral, Dexedrine (cont.)

SIDE EFFECTS: Nausea, stomach upset, cramps, loss of appetite, diarrhea, dry mouth, headache, nervousness, dizziness, trouble sleeping, sweating, weight loss, irritability or restlessness may occur. If any of these effects persist or worsen, notify your doctor promptly.Remember that your doctor has prescribed this medicine 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: mental/mood/behavior changes (e.g., agitation, aggression, mood swings, depression, hallucinations, abnormal thoughts/behavior), uncontrolled movements, muscle twitching/shaking, outbursts of words/sounds, change in sexual ability/interest, swelling of the ankles/feet, extreme tiredness, significant unexplained weight loss.Seek immediate medical attention if any of these rare but very serious side effects occur: shortness of breath, chest pain, severe headache, fast/pounding/irregular heartbeat, jaw/left arm pain, seizures, weakness on one side of the body, slurred speech, confusion, fainting, blurred vision.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 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 to other sympathomimetic amines (e.g., epinephrine, ephedrine); or if you have any other allergies.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain mental/mood conditions (e.g., severe agitation, psychosis), heart/blood vessel disease (irregular heartbeat, coronary artery disease, angina, heart failure, cardiomyopathy), problems with heart structure (e.g., valve problems), moderate or severe high blood pressure (hypertension), overactive thyroid (hyperthyroidism), history of heart attack or stroke, a certain eye problem (glaucoma), personal or family history of regular use/abuse of drugs/alcohol.Before using this medication, tell your doctor or pharmacist your medical history, especially of: family history of sudden death/irregular heartbeat, family/personal history of mental/mood disorders (e.g., bipolar disorder, depression, psychotic disorder, suicidal thoughts), seizures, personal or family history of uncontrolled movements or outbursts of words/sounds (e.g., due to Tourette's syndrome), mild high blood pressure (hypertension).This drug may make you dizzy 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.Before having surgery, tell your doctor or dentist that you are taking this medication.Caution is advised when using this drug in children because it may affect weight, growth rate, and final height. The doctor may recommend temporarily stopping the medication from time to time to reduce this risk. Monitor your child's weight and height and consult your doctor or pharmacist for more details.This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Infants born to mothers who are dependent on this medication may be born too soon (premature) and have low birth weight. They may also have withdrawal symptoms. Tell your doctor immediately if you notice possible mood changes, agitation, or unusual tiredness in your newborn.This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.



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