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CIALIS (TADALAFIL): PATIENT COUNSELING INFORMATION

Nitrates

Doctors, pharmacists, or other healthcare professionals should discuss with patients the contraindication of Cialis (Tadalafil) with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of Cialis with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke.

Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of Cialis tablets. In such a patient, who has taken this medication, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 48 hours should have elapsed after the last dose of Cialis (Tadalafil) tablets before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring. Therefore, patients who experience anginal chest pain after taking Tadalafil (Cialis) should seek immediate medical attention.

Cardiovascular Considerations

Doctors should consider the potential cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Healthcare provider should advise patients who experience symptoms upon initiation of sexual activity to refrain from further sexual activity and seek immediate medical attention.

Concomitant Use with Drugs Which Lower Blood Pressure

Physicians should discuss with patients the potential for Cialis (Tadalafil) to augment the blood-pressure-lowering effect of alpha blockers and antihypertensive medications.

Potential for Drug Interactions When Taking Tadalafil (Cialis) tablets for Once Daily Use

Healthcare professionals should discuss with patients the clinical implications of continuous exposure to tadalafil when prescribing Cialis for once daily use, especially the potential for interactions with medications (e.g., nitrates, alpha blockers, antihypertensives and potent inhibitors of cytochrome P450 3A4) and with substantial consumption of alcohol.

Priapism

There have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Physicians should advise patients who have an erection lasting greater than 4 hours, whether painful or not, to seek emergency medical attention.

Vision

Doctors or pharmacists should advise patients to stop use of all PDE5 inhibitors, including Cialis (Tadalafil) tablets, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision, including permanent loss of vision that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or other factors. Physicians should also discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators such as PDE5 inhibitors.

Sudden Hearing Loss

Physicians should advise patients to stop taking PDE5 inhibitors, including Tadalafil (Cialis), and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including Cialis (Tadalafil). It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors.

Alcohol

Patients should be made aware that both alcohol and Tadalafil (Cialis) tablets, a PDE5 inhibitor, act as mild vasodilators. When mild vasodilators are taken in combination, blood-pressure-lowering effects of each individual compound may be increased. Therefore, physicians should inform patients that substantial consumption of alcohol (e.g., 5 units or greater) in combination with Cialis can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache.

Sexually Transmitted Disease

The use of Cialis offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered.

Recommended Administration

Cialis tablets are available in two dosing regimens; therefore, physicians should instruct patients on the appropriate administration to allow optimal use.

For Cialis (Tadalafil) tablets for use as needed, patients should be instructed to take one tablet at least 30 minutes before anticipated sexual activity. In most patients, the ability to have sexual intercourse is improved for up to 36 hours.

For Tadalafil (Cialis) for once daily use, patients should be instructed to take one tablet at approximately the same time every day without regard for the timing of sexual activity. This medication is effective at improving erectile function over the course of therapy.

Manufactured and distributed by Eli Lilly pharmaceutical company and its divisions.

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