What is Vivanza?
Vivanza is a medicine that contains the active substance vardenafil. It is available as orange round tablets (5, 10 and 20 mg).
What is Vivanza used for?
Vivanza is used to treat adult men with erectile dysfunction (also called impotence), which is the inability to achieve or maintain an erection sufficient for satisfactory sexual activity. Sexual stimulation is required for Vivanza to take effect.
The medicine can only be obtained with a prescription .
How is Vivanza used?
The recommended dose of Vivanza is 10 mg taken with or without food, about 25 to 60 minutes before sexual activity. If Vivanza is taken with a high-fat meal, the effect can be delayed. Depending on the efficacy and side effects, the dose may be increased to 20 mg or reduced to 5 mg. Patients with liver problems or severe kidney problems should start treatment with a dose of 5 mg. It is recommended not to take more than one tablet a day.
How does Vivanza work?
The active substance in Vivanza, vardenafil, belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). It works by blocking the enzyme phosphodiesterase which normally reduces the levels of a substance called cyclic guanosine monophosphate (cGMP). During normal sexual stimulation the penis produces cGMP which causes relaxation of the spongy tissue of the penis (cavernous bodies), allowing the flow of blood into the corpora cavernosa, which produces an erection. By blocking the reduction of cGMP, Vivanza restores erectile function. Sexual stimulation is always required to produce an erection.
What studies have been carried out on Vivanza?
On Vivanza, four main studies were carried out on 2 431 male patients aged between 20 and 83 years, in which the medicine was compared to a placebo (a dummy treatment). One study was conducted on diabetic men and another on patients whose prostate was removed. The main measure of effectiveness was the ability to obtain and maintain an erection, detected through two completed questionnaires at home.
What benefit has Vivanza shown during the studies?
Vivanza was significantly more effective than placebo in all measures and in all studies.
What are the risks associated with Vivanza?
The most common side effects (seen in more than 1 patient in 10) are headache and redness of the skin. For the full list of all side effects reported with Vivanza, see the Package Leaflet.
Vivanza should not be used in people who may be hypersensitive (allergic) to vardenafil or any of the other ingredients. It should not be used in cases where sexual activity is not recommended (eg in men who have serious heart problems, such as unstable angina or severe heart failure). Nor should the medicine be taken by people who have suffered loss of vision due to problems with blood flow to the optic nerve (non-arteritic anterior ischemic optic neuropathy - NAION). Vivanza should not be taken in conjunction with nitrates (medicines used to treat angina). Because Vivanza has not been studied in patients with severe liver or kidney disorders, people who have pressure problems or who have had a stroke or heart attack within the last six months should not use it.
Vivanza should not be taken with medicines, such as ketoconazole and itraconazole (to treat fungal infections), by men over the age of 75 or ritonavir and indinavir (to treat AIDS patients).
Why has Vivanza been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Vivanza's benefits are greater than its risks for the treatment of men with erectile dysfunction. The Committee therefore recommended that Vivanza be given marketing authorization.
More information on Vivanza
On 4 March 2003, the European Commission issued a marketing authorization for Vivanza, valid throughout the European Union. The marketing authorization was renewed on 4 March 2008. The marketing authorization holder is Bayer Schering Pharma AG.
For the full EPAR of Vivanza, click here.
Last update of this summary: 07-2009.
