What is Vizarsin?
Vizarsin is a medicine that contains the active substance sildenafil. It is available as white, oblong tablets (25, 50 and 100 mg).
Vizarsin is a "generic medicine". This means that it is similar to a "reference drug" already authorized in the European Union (EU) called Viagra. For more information on generic medicines, see the questions and answers by clicking here.
What is Vizarsin used for?
Vizarsin 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. In order for Vizarsin to work, sexual stimulation is required.
The medicine can only be obtained with a prescription.
How is Vizarsin used?
The recommended dose of Vizarsin is 50 mg taken as needed about an hour before sexual activity. If Vizarsin is taken during a meal, its effect may be delayed compared to fasting. Depending on the efficacy and side effects, the dose may be increased to 100 mg or reduced to 25 mg. Patients with liver problems or severe kidney problems should start treatment with a dose of 25 mg. It is recommended not to take more than one tablet a day.
How does Vizarsin work?
The active substance in Vizarsin, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). The substance 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 aforementioned bodies, which produces an erection. By blocking the reduction in cGMP, Vizarsin restores erectile function. Sexual stimulation is always required to produce an erection.
What studies have been carried out on Vizarsin?
Because Vizarsin is a generic medicine, studies have been limited to tests to show that it is bioequivalent to the reference medicine, Viagra. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the risks and benefits associated with Vizarsin?
Because Vizarsin is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are supposed to be the same.
Why has Vizarsin been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Vizarsin has been shown to have comparable quality and to be bioequivalent to Viagra. It is therefore the opinion of the CHMP that, as in the case of Viagra, the benefits outweigh the risks identified. The committee recommended the granting of a marketing authorization for Vizarsin.
More information on Vizarsin
On 21 September 2009, the European Commission issued a marketing authorization for Vizarsin, valid throughout the European Union, to Krka, dd, Novo mesto.
The full EPAR for Vizarsin can be found here.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 07-2009.
