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In the primary efficacy studies, 75% of intercourse attempts were successful in Vidalista-treated patients as compared to 32% with placebo. Most patients reported erectile dysfunction of at least 1 year in duration.
Three clinical studies were conducted in 1054 patients in an at-home setting to define the period of responsiveness to Vidalista on demand. In two of these studies decreases were observed in sperm count and concentration related to Vidalista treatment of unlikely clinical relevance. Three studies were conducted in men to assess the potential effect on spermatogenesis of Vidalista 10mg (one 6-month study) and 20mg (one 6-month and one 9-month study) administered daily.

The majority of headaches reported with Vidalista once-a-day dosing are experienced within the first 10 to 30 days of starting treatment. However, as a formal drug-drug interaction study evaluating the effects of Vidalista and 5-alpha reductase inhibitors (5-ARIs) has not been performed, caution should be exercised when Vidalista is co-administered with 5-ARIs. In a clinical trial that compared Vidalista 5 mg coadministered with finasteride 5 mg to placebo plus finasteride 5 mg in the relief of BPH symptoms, no new adverse reactions were identified.

Concomitant use of riociguat with PDE5 inhibitors, including Vidalista, is contraindicated (see section 4.3). In patients receiving concomitant antihypertensive medicinal products, Vidalista 20 mg may induce a blood pressure decrease, which (with the exception of alpha-blockers - see above) is, in general, minor and not likely to be clinically relevant. Vidalista (10 mg, except for studies with angiotensin II receptor blockers and amlodipine in which a 20 mg dose was applied) had no clinically significant interaction with any of these classes.

In clinical pharmacology studies, the potential for Vidalista to augment the hypotensive effects of antihypertensive medicinal products was examined. The co-administration of doxazosin (4 and 8 mg daily) and Vidalista (5 mg daily dose and 20 mg as a single dose) increases the blood pressure-lowering effect of this alpha-blocker in a significant manner. In clinical studies, Vidalista (5, 10 and 20 mg) was shown to augment the hypotensive effects of nitrates.

With regard to those interaction studies where only the 10 mg Vidalista dose was used, clinically relevant interactions at higher doses cannot be completely ruled out. Vidalista and other treatments for erectile dysfunction. Caution should be exercised when prescribing Vidalista to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin), as increased Vidalista exposure (AUC) has been observed if the medicinal products are combined (see section 4.5).

There is limited clinical data on the safety of single-dose administration of Vidalista in patients with severe hepatic insufficiency (Child-Pugh Class C). If Vidalista is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. Visual defects and cases of NAION have been reported in connection with the intake of Vidalista and other PDE5 inhibitors. The co-administration of PDE5 inhibitors, including Vidalista, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5).

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