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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/216428/2012

EMEA/H/C/001076

EPAR summary for the public

Vizarsin

sildenafil

This is a summary of the European public assessment report (EPAR) for Vizarsin. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Vizarsin.

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. For more information on generic medicines, see the question-and-answer document here.

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.

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© European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.

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 benefits and risks 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.

The full EPAR for Vizarsin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Vizarsin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The full EPAR for the reference medicine can also be found on the Agency's website.

This summary was last updated in 04-2012.

Vizarsin

EMA/216428/2012