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February 10, 2012
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clomipramine - oral, Anafranil (cont.)

PRECAUTIONS: Before taking clomipramine, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (e.g., imipramine, nortriptyline); 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.This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have had: a recent heart attack.Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (e.g., purpura, thrombocytopenia), breathing problems (e.g., asthma, chronic bronchitis), certain eye problems (e.g., glaucoma, increased intraocular pressure), eating disorders (e.g., bulimia), heart problems (e.g., arrhythmias, coronary artery disease), intestinal problems (e.g., chronic constipation, ileus), liver problems, kidney problems, personal or family history of other mental/mood conditions (e.g., bipolar disorder, schizophrenia), history of hospitalization for a very serious reaction to certain medications (neuroleptic malignant syndrome), heartburn/stomach acid in the esophagus (e.g., due to hiatal hernia), seizures, overactive thyroid (hyperthyroidism), trouble urinating (urinary retention, enlarged prostate), any condition that may increase your risk of seizures (e.g., alcohol/sedative dependency, use of electroconvulsive therapy, brain injury/disease), certain types of tumors (e.g., pheochromocytoma, neuroblastoma).Clomipramine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using clomipramine, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using clomipramine safely.This drug may make you dizzy or drowsy or cause temporary 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.To decrease dizziness and lightheadedness, get up slowly when rising from a seated or lying position.Before having surgery, tell your doctor or dentist that you are taking this medication.Caution is advised when using this drug in children who participate in active sports because it may increase the risk of heart problems. (See also the Warning section.)Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug (e.g., bleeding, confusion, dizziness).This medication should be used only when clearly needed during pregnancy. Newborns exposed to clomipramine during pregnancy may experience withdrawal symptoms or side effects. Tell your doctor immediately if you notice jitteriness, shaking, feeding problems, fast breathing, or seizures in your newborn. Discuss the risks and benefits with your doctor.This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.



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