Active Substance: sildenafil
Common Name: sildenafil
ATC Code: G04BE03
Marketing Authorisation Holder: Krka, d.d., Novo mesto
Active Substance: sildenafil
Authorisation Date: 2009-09-21
Therapeutic Area: Erectile Dysfunction
Pharmacotherapeutic Group: Urologicals
Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
In order for Vizarsin to be effective, sexual stimulation is required.
What is Vizarsin?
Vizarsin is a medicine that contains the active substance sildenafil. It is available as film-coated tablets (25, 50 and 100 mg) and as orodispersible tablets (25, 50 and 100 mg). Orodispersible means that the tablet dissolves in the mouth.
Vizarsin is a ‘generic medicine’. This means that Vizarsin is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Viagra.
What is Vizarsin used for?
Vizarsin is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity. For Vizarsin to be effective, 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 one hour before sexual activity. If Vizarsin is taken with food, the onset of activity may be delayed compared with taking Vizarsin without food. The dose may be increased to a maximum of 100 mg or decreased to 25 mg depending on the effectiveness and side effects. Patients with reduced liver or severely reduced kidney function should start treatment with the 25-mg dose. The maximum recommended dosing frequency is one tablet per day.
How does Vizarsin work?
The active ingredient in Vizarsin, sildenafil, belongs to a group of medicines called phosphodiesterase-type-5 (PDE5) inhibitors. It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP). During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax. This allows blood to flow into the corpora, producing the erection. By blocking the breakdown of cGMP, Vizarsin restores erectile function. Sexual stimulation is still needed to produce an erection.
How has Vizarsin been studied?
Because Vizarsin is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Viagra. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
What are the benefit and risk of Vizarsin?
Because Vizarsin is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Why has Vizarsin been approved?
The CHMP concluded that, in accordance with EU requirements, Vizarsin has been shown to have comparable quality and to be bioequivalent to Viagra. Therefore, the CHMP’s view was that, as for Viagra, the benefit outweighs the identified risk. The Committee recommended that Vizarsin be given marketing authorisation.
Other information about Vizarsin
The European Commission granted a marketing authorisation valid throughout the European Union for Vizarsin on 21 September 2009.
For more information about treatment with Vizarsin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Source: European Medicines Agency