What is Sildenafil Teva?
Sildenafil Teva is a medicine containing 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 (sometimes also called impotence), which is the inability to achieve or maintain an erection sufficient for satisfactory sexual activity. In order for Sildenafil Teva to be effective, sexual stimulation is required.
The medicine can only be obtained with a prescription.
How is Sildenafil Teva used?
The recommended dosage of Sildenafil Teva is 50 mg taken as needed about an hour before sexual activity. If Sildenafil Teva is taken with meals, the onset of action 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. 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 inhibitors (PDE5). The substance works by blocking the enzyme phosphodiesterase which normally breaks down a substance called cyclic guanosine monophosphate (cGMP). During normal sexual stimulation the penis produces cGMP which causes the 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 cGMP degradation, Sildenafil Teva restores erectile function. Sexual stimulation is always required to produce an erection.
What studies have been performed on Sildenafil Teva?
Because Sildenafil Teva is a generic medicine, studies have been limited to tests to determine that the medicine 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 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 believed 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 opinion of the CHMP that, as in the case of Viagra, the benefits outweigh the risks identified. The committee recommended the granting of the marketing authorization for Sildenafil Teva.
More information on Sildenafil Teva:
On 30 November 2009, the European Commission granted Teva Pharma BV 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.
The full EPAR for Sildenafil Teva can be found here.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 10-2009
