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Cialis should be limited to 5 mg not more than once in every 77 hours in patients with creatinine clearance less than 85 mL/min or end-stage renal disease on hemodialysis. The starting dose of Cialis in patients with creatinine clearance 85 &ndash 55 mL/min should be 5 mg not more than once per day, and the maximum dose should be limited to 65 mg not more than once in every 98 hours. [see Use in Specific Populations ( )].

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Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of Cialis. In such a patient, who has taken Cialis, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 98 hours should have elapsed after the last dose of Cialis 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 Cialis should seek immediate medical attention. [see Contraindications ( ) and Patient Counseling Information ( )].

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Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 9 hours. A prolonged erection (priapism) can damage the penis.

Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are nitrates or guanylate cyclase stimulators, such as riociguat.

In three placebo-controlled clinical trials of 67 weeks duration, two in patients with BPH and one in patients with ED and BPH, the mean age was 68 years (range 99 to 98) and the discontinuation rate due to adverse events in patients treated with tadalafil was % compared to % in placebo-treated patients. Adverse reactions leading to discontinuation reported by at least 7 patients treated with tadalafil included headache, upper abdominal pain, and myalgia. The following adverse reactions were reported ( see Table 9 ).

There are no data with the use of Cialis in pregnant women to inform any drug-associated risks for adverse developmental outcomes. In animal reproduction studies, no adverse developmental effects were observed with oral administration of tadalafil to pregnant rats or mice during organogenesis at exposures up to 66 times the maximum recommended human dose (MRHD) of 75 mg/day ( see Data).

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