IMPORTANT NOTE The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

TITLE TADALAFIL - ORAL

HOW TO PRONOUNCE (tah-DA-la-fil)

COMMON BRAND NAMES Cialis

USES Tadalafil is used to treat male sexual function problems (impotence or erectile dysfunction) by blocking a certain enzyme (phosphodiesterase-PDE5) in the body. In combination with sexual stimulation, tadalafil helps blood flow into the penis to achieve and maintain an erection. This drug is not indicated for use in women. Use of this drug does not protect against sexually transmitted diseases (e.g., HIV, hepatitis B, gonorrhea, syphilis). Practice "safe sex" such as using latex condoms. Consult your doctor or pharmacist for more details.

HOW TO TAKE This drug is taken by mouth as needed, at least 30 minutes before sexual activity with or without food; or use as directed by your doctor. This medication's effect on sexual ability may last up to 36 hours. Therefore, do not take more than once daily as needed. Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit juice can increase the amount of certain medications in your bloodstream. Consult your doctor or pharmacist for more details. The dosage is based on your medical condition, response to therapy, and other medications you may be taking (see also Drug Interactions section). Consult your doctor or pharmacist for more details. Read the patient information leaflet provided by your pharmacist and ask questions if any of the information is unclear.

SIDE EFFECTS Headache, stomach upset, back pain, muscle pain, nasal stuffiness, flushing, pain in arms or legs, dizziness, or vision changes may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Sexual activity may put extra strain on your heart, especially if you have heart problems. If you have heart problems or experience any of the following serious side effects during sex, stop and tell your doctor immediately of: severe dizziness, fainting, chest pain. In the unlikely event you have a painful or prolonged erection (lasting more than 4 hours), stop using this drug and seek immediate medical attention or permanent problems could occur. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, unusual swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

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), 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, tamsulosin. 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.

OVERDOSE If overdose is suspected, contact your local poison control center at 1-800-222-1222 (USA) or emergency room immediately.

NOTES Do not share this medication with others, since they may have a problem that is not effectively treated by this drug, or they may have a condition that is complicated by this drug.

MISSED DOSE Not applicable.

STORAGE Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59 and 86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.