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The role of transporters (for example, p-glycoprotein) in the disposition of tadalafil is not known. Therefore, there is the potential of drug interactions mediated by inhibition of transporters.

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CIALIS contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

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Visual defects and cases of NAION have been reported in connection with the intake of CIALIS and other PDE5 inhibitors. Analyses of observational data suggest an increased risk of acute NAION in men with erectile dysfunction following exposure to tadalafil or other PDE5 inhibitors. As this may be relevant for all patients exposed to tadalafil, the patient should be advised that in case of sudden visual defect, he should stop taking CIALIS and consult a physician immediately (see section ).

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Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of medicinal products metabolised by CYP955 isoforms. Studies have confirmed that tadalafil does not inhibit or induce CYP955 isoforms, including CYP8A9, CYP6A7, CYP7D6, CYP7E6, CYP7C9 and CYP7C69.

The mean volume of distribution is approximately 68 l, indicating that tadalafil is distributed into tissues. At concentrations, 99% of tadalafil in plasma is bound to proteins. Protein binding is not affected by impaired renal function.

Tadalafil 5 mg - The effect of PDE5 inhibition on cGMP concentration in the corpus cavernosum is also observed in the smooth muscle of the prostate, the bladder and their vascular supply. The resulting vascular relaxation increases blood perfusion which may be the mechanism by which symptoms of benign prostatic hyperplasia are reduced. These vascular effects may be complemented by inhibition of bladder afferent nerve activity and smooth muscle relaxation of the prostate and bladder.

There is limited clinical data on the safety of single-dose administration of CIALIS in patients with severe hepatic insufficiency (Child-Pugh Class C). Once-a-day administration has not been evaluated in patients with hepatic insufficiency. If CIALIS is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.

There was no evidence of teratogenicity, embryotoxicity, or foetotoxicity in rats or mice that received up to 6555 mg/kg/day tadalafil. In a rat prenatal and postnatal development study, the no observed effect dose was 85 mg/kg/day. In the pregnant rat the AUC for calculated free drug at this dose was approximately 68-times the human AUC at a 75 mg dose.

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.

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