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FINAL PROGRAM www.essm.org 10th Congress of the European ...

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For men with ED• CIALIS works fast, as early as 16-minutes1• CIALIS lasts long, for up to 36 hours*CIALIS (TADALAFIL) ABBREVIATED PRESCRIBING INFORMATIONFor oral use. CIALIS is available as 2.5, 5, 10, and 20 mg film-coated tablets.Use in adult menIn general, <strong>the</strong> recommended dose is 10 mg taken prior to anticipated sexual activity and with or without food.In those patients in whom tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried. It may be taken at least 30 minutes prior to sexual activity.The maximum dose frequency is once per day.Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use.In responder patients to on-demand regimen who anticipate a frequent use <strong>of</strong> CIALIS (i.e., at least twice weekly) a once daily regimen with <strong>the</strong> lowest doses <strong>of</strong>CIALIS might be considered suitable, based on patient choice and <strong>the</strong> physician’s judgement.In <strong>the</strong>se patients <strong>the</strong> recommended dose is 5 mg taken once-a-day at approximately <strong>the</strong> same time <strong>of</strong> day. The dose may be decreased to 2.5 mg once-a-day basedon individual tolerability.The appropriateness <strong>of</strong> continued use <strong>of</strong> <strong>the</strong> daily regimen should be reassessed periodically.Use in elderly menDose adjustments are not required in elderly patients.Use in men with impaired renal functionDose adjustments are not required in patients with mild to moderate renal impairment. For patients with severe renal impairment 10 mg is <strong>the</strong> maximumrecommended dose. Once-a-day dosing <strong>of</strong> tadalafil is not recommended in patients with severe renal impairment.(See sections 4.4 and 5.2).Use in men with impaired hepatic functionThe recommended dose <strong>of</strong> CIALIS is 10 mg taken prior to anticipated sexual activity and with or without food. There is limited clinical data on <strong>the</strong> safety<strong>of</strong> CIALIS in patients with severe hepatic impairment (Child-Pugh Class C); if prescribed, a careful individual benefit/risk evaluation should be undertaken by<strong>the</strong> prescribing physician. There are no available data about <strong>the</strong> administration <strong>of</strong> doses higher than 10 mg <strong>of</strong> tadalafil to patients with hepatic impairment.Once-a-day dosing has not been evaluated in patients with hepatic impairment; <strong>the</strong>refore, if prescribed, a careful individual benefit/risk evaluation should beundertaken by <strong>the</strong> prescribing physician. (See section 5.2).Use in men with diabetesDose adjustments are not required in diabetic patients.Use in children and adolescentsCIALIS should not be used in individuals below 18 years <strong>of</strong> age.A full updated SPC is available at <strong>the</strong> booth upon request.Reference 1. Cialis SPC.* CIALIS ® is a registered trademark <strong>of</strong> Eli Lilly and Company.Up to 36 hours <strong>of</strong> efficacy*

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