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In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. Therefore, administration of CIALIS to patients who are using any form of organic nitrate is contraindicated (see section ).

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The most commonly reported adverse reactions in patients taking CIALIS for the treatment of erectile dysfunction or benign prostatic hyperplasia were headache, dyspepsia, back pain and myalgia, in which the incidences increase with increasing dose of CIALIS. The adverse reactions reported were transient, and generally mild or moderate. The majority of headaches reported with CIALIS once-a-day dosing are experienced within the first 65 to 85 days of starting treatment.

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About 85 million men occasionally have a problem with getting or keeping an erection, according to the Urology Care Foundation. When ED becomes a problem, many men turn to oral ED medications. These drugs often help. Cialis, Levitra, and Viagra each work in similar ways. But there are also some differences, such as when you take them, how long they work, and what their side effects are.

Cialis, Levitra, and Viagra are oral medications used to treat erectile dysfunction (ED). You may also know them by their generic names, tadalafil (Cialis), vardenafil (Levitra), and sildenafil (Viagra).

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 ).

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 safety and efficacy of combinations of CIALIS and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied. The patients should be informed not to take CIALIS in such combinations.

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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