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TADALAFIL-ORAL (cont.)

PRECAUTIONS: Before taking tadalafil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Before using this medication, tell your doctor or pharmacist your medical history, especially of: penis conditions (e.g., angulation, fibrosis/scarring, Peyronie's disease), history of painful/prolonged erection (priapism), sickle cell anemia, blood system cancers (e.g., leukemia or myeloma), eye problems (e.g., retina diseases like retinitis pigmentosa), kidney disease, liver disease, bleeding disorders, active stomach ulcers, heart problems (e.g., recent heart attack or serious arrhythmia within past 6 months, heart failure, coronary artery disease with unstable angina, aortic stenosis, idiopathic hypertrophic subaortic stenosis), recent stroke within past 6 months, very high or low blood pressure. This drug may make you dizzy or cause vision changes; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position. Alcohol may increase this effect. Limit alcoholic beverages. This drug is not indicated for use in women or children.

DRUG INTERACTIONS: See also How To Use section for drug-food interactions. This drug should not be used with the following medications because very serious (possibly fatal) interactions may occur: certain alpha-blocker medication (alfuzosin, doxazosin, prazosin, terazosin, or doses greater than 0.4mg daily of tamsulosin), nitrates (e.g., nitroglycerin, isosorbide), nitroprusside (or any "nitric oxide donor" drugs), recreational drugs called "poppers" containing amyl or butyl nitrite. If you are currently using any of these medications, tell your doctor or pharmacist before starting tadalafil. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs that affect certain liver enzymes (CYP 3A4 substrates, inhibitors and inducers such as cimetidine, rifamycins, St. John's wort, or certain anti-seizure drugs), high blood pressure medicines, other medications for impotence. If you are taking ritonavir, erythromycin, ketoconazole, or itraconazole (examples of potent inhibitors of CYP 3A4), do not take more than a 10mg dose of tadalafil in a 72 hour period. For more details contact your doctor or pharmacist. Do not start or stop any medicine without doctor or pharmacist approval.




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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