Two clinical studies were specifically designed to assess the time window after dosing during which Cenforce could produce an erection in response to sexual stimulation. In the natural setting, i.e. with sexual stimulation, it restores impaired erectile function by increasing blood flow to the penis. As dizziness and altered vision were reported in clinical trials with Cenforce, patients should be aware of how they react to Fildena, before driving or operating machinery.
Pooling of the following classes of antihypertensive medication; diuretics, beta-blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive medicinal products (vasodilator and centrally-acting), adrenergic neurone blockers, calcium channel blockers and alpha-adrenoceptor blockers, showed no difference in the side effect profile in patients taking Cenforce compared to placebo treatment. This is most likely to occur within 4 hours post Cenforce dosing (see sections 4.2 and 4.4). In three specific drug-drug interaction studies, the alpha-blocker doxazosin (4 mg and 8 mg) and Cenforce (25 mg, 50 mg, or 100 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy. Although no increased incidence of adverse events was observed in these patients, when Cenforce is administered concomitantly with CYP3A4 inhibitors, a starting dose of 25 mg should be considered.
Initiation of Cenforce at a dose of 25 mg should be considered (see section 4.2). In addition, physicians should advise patients what to do in the event of postural hypotensive symptoms. The safety and efficacy of combinations of Cenforce with other PDE5 inhibitors, or other pulmonary arterial hypertension (PAH) treatments containing Cenforce (REVATIO), or other treatments for erectile dysfunction have not been studied. A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered.
Since Cenforce clearance is reduced in patients with hepatic impairment (e.g. cirrhosis) a 25 mg dose should be considered. Since Cenforce clearance is reduced in patients with severe renal impairment (creatinine clearance < 30 mL/min) a 25 mg dose should be considered. Seventy-two percent, 80%, and 85% of the patients on 25 mg, 50 mg, and 100 mg of Fildena, respectively, achieved erections hard enough for sex, compared to 50% on placebo.
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