Sildenafil Teva

What is Sildenafil Teva?

Sildenafil Teva is a medicine that contains the active substance sildenafil. It is available in blue, round, diamond-shaped tablets (25, 50 and 100 mg).
Sildenafil Teva is a 'generic medicine'. This means that it is similar to a 'reference medicine' 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 Sildenafil Teva used for?

Sildenafil Teva is used to treat adult men with erectile dysfunction (also sometimes called impotence), which is the inability to achieve or maintain an erection sufficient for satisfactory sexual activity. Sexual stimulation is required for Sildenafil Teva to be effective.
The medicine can only be obtained with a prescription.

How is Sildenafil Teva used?

The recommended dosage of Sildenafil Teva is 50 mg as needed, to be taken approximately one hour before sexual activity. If Sildenafil Teva is taken with meals, the onset of action may be delayed compared to taking it in the fasted state. Depending on the efficacy and side effects, the dose may be increased to 100 mg or decreased to 25 mg. Patients with liver problems or severe kidney problems should start treatment with a dose of 25 mg. The maximum recommended dosage is one tablet per day.

How does Sildenafil Teva work?

The active substance in Sildenafil Teva, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. The substance works by blocking the phosphodiesterase enzyme which normally breaks down a substance called cyclic guanosine monophosphate (cGMP). During normal sexual stimulation the penis produces cGMP which causes relaxation of the muscles of the spongy tissue of the penis (corpora cavernosa), allowing the influx. of the blood in the aforementioned bodies, which produces an erection. By blocking the breakdown of cGMP, Sildenafil Teva restores erectile function. Sexual stimulation is always required to produce an erection.

How has Sildenafil Teva been studied?

Since Sildenafil Teva is a generic medicine, the studies were limited to tests to establish that the medicine 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 Sildenafil Teva?

Because Sildenafil Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.

Why has Sildenafil Teva been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Sildenafil Teva has been shown to have comparable quality and to be bioequivalent to Viagra. It is therefore the view of the CHMP that, as in the case of Viagra, the benefits outweigh the identified risks. The Committee recommended that Sildenafil Teva be given marketing authorization.

Other information about Sildenafil Teva:

On 30 November 2009, the European Commission issued Teva Pharma B.V. a "Marketing Authorization" for Sildenafil Teva, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which it can be renewed.
For the full version of the Sildenafil Teva EPAR click here.
The full EPAR version of the reference medicine can also be found on the Agency's website.

Last update of this summary: 10-2009

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