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Store in the original package in order to protect from moisture. For Tadalafil 5 mg - Do not store above 75 676 C. For Tadalafil mg, 65 mg and 75 mg - Do not store above 85 676 C.

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Tadalafil is excreted predominantly as inactive metabolites, mainly in the faeces (approximately 66% of the dose) and to a lesser extent in the urine (approximately 86% of the dose).

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There is limited clinical data on the safety of single-dose administration of CIALIS in patients with severe hepatic insufficiency (Child-Pugh Class C). If CIALIS is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.

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Once-a-day dosing of or 5 mg tadalafil both for the treatment of erectile dysfunction or benign prostatic hyperplasia is not recommended in patients with severe renal impairment (see sections and ).

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.

A slightly higher incidence of ECG abnormalities, primarily sinus bradycardia, has been reported in patients treated with tadalafil once a day as compared with placebo. Most of these ECG abnormalities were not associated with adverse reactions.

One of these studies assessed improvements in erectile dysfunction and signs and symptoms of benign prostatic hyperplasia in patients with both conditions. The improvements in the erectile function domain of the international index of erectile function and the total international prostate symptom score in this study were and - with CIALIS 5 mg compared to and - with placebo, respectively. The mean per-subject proportion of successful sexual intercourse attempts was % with CIALIS 5 mg compared to % with placebo.

The following groups of patients with cardiovascular disease were not included in clinical trials and the use of tadalafil is therefore contraindicated:

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The rate and extent of absorption of tadalafil are not influenced by food, thus CIALIS may be taken with or without food. The time of dosing (morning versus evening) had no clinically relevant effects on the rate and extent of absorption.

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