Generic Sildenafil Teva

Generic Sildenafil Teva is a medicine that contains the active substance sildenafil. It is available as blue, round diamond-shaped tablets (25, 50 and 100 mg). Generic Sildenafil Teva is a ‘generic medicine’. This means that it is similar to genuine Viagra already authorised in the European Union (EU).


 What is Generic Sildenafil Teva used for?

Generic Sildenafil Teva 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 Generic Sildenafil Teva to be effective, sexual stimulation is required. The medicine can only be obtained with a prescription.

 How is Generic Sildenafil Teva used?

The recommended dose of Generic Sildenafil Teva is 50 mg taken as needed about one hour before sexual activity. If Generic Sildenafil Teva is taken with food, the onset of activity may be delayed compared with taking 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 liver problems or severe kidney problems should start treatment with the 25-mg dose. The maximum recommended dosing frequency is one tablet per day.

 How does Generic Sildenafil Teva work?

The active ingredient in Generic Sildenafil Teva 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, Generic Sildenafil Teva restores erectile function. Sexual stimulation is still needed to produce an erection.

 How has Generic Sildenafil Teva been studied?

Because Generic Sildenafil Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to genuine 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 Generic Sildenafil Teva?

Because Generic Sildenafil Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as genuine Viagra.

Why has Generic Sildenafil Teva been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Generic Sildenafil Teva has been shown to have comparable quality and to genuine Viagra.

Therefore, the CHMP’s view was that, as for genuine Viagra the benefit outweighs the identified risk.

The Committee recommended that Generic Sildenafil Teva be given marketing authorisation. 

Other information about Generic Sildenafil Teva

The European Commission granted a marketing authorisation valid throughout the European Union for Generic Sildenafil Teva to Teva Pharma B.V. on 30 November 2009. The marketing authorisation is valid for five years, after which it can be renewed.