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In patients with mild or moderate hepatic impairment, the dose of Cialis should not exceed 65 mg. Because of insufficient information in patients with severe hepatic impairment, use of Cialis in this group is not recommended [see Use in Specific Populations ( )].

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Tell all of your healthcare providers that you take Cialis. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took Cialis.

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Cialis for once daily use has not been extensively evaluated in patients with mild or moderate hepatic impairment. Therefore, caution is advised if Cialis for once daily use is prescribed to these patients. Because of insufficient information in patients with severe hepatic impairment, use of Cialis in this group is not recommended [see Use in Specific Populations ( )].

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Digestive abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, GGTP increased, loose stools, nausea, upper abdominal pain, vomiting, gastroesophageal reflux disease, hemorrhoidal hemorrhage, rectal hemorrhage

In Study K, the effect of Cialis 5 mg once daily on Q max was evaluated as a safety endpoint. Mean Q max increased from baseline in both the treatment and placebo groups (Cialis 5 mg: mL/sec, placebo: mL/sec) however, these changes were not significantly different between groups.

In Study J, the effect of Cialis 5 mg once daily on maximum urinary flow rate (Q max ) was evaluated as a secondary efficacy endpoint. Mean Q max increased from baseline in both the treatment and placebo groups (Cialis 5 mg: mL/sec, placebo: mL/sec) however, these changes were not significantly different between groups.

There is no information on the presence of tadalafil and/or metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Tadalafil and/or its metabolites are present in the milk of lactating rats at concentrations approximately -fold greater than found in the plasma.

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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 Warnings and Precautions ( )].

In each of these trials, conducted without regard to the timing of dose and sexual intercourse, Cialis demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 7 and 8 of the SEP diary ( see Table 67 ). When taken as directed, Cialis was effective at improving erectile function.

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