What is Sildenafil Actavis?
Sildenafil Actavis is a medicine that contains the active substance sildenafil. It is available as blue, oval-shaped tablets (25, 50 and 100 mg).
Sildenafil Actavis is a "generic medicine". This means that it is similar to a 'reference medicine' already authorized in the European Union (EU) called Viagra.
What is Sildenafil Actavis used for?
Sildenafil Actavis is used to treat adult men with erectile dysfunction (sometimes called impotence), which is the inability to achieve or maintain an erection sufficient for satisfactory sexual activity. For Sildenafil Actavis to be effective, sexual stimulation is required.
The medicine can only be obtained with a prescription.
How is Sildenafil Actavis used?
The recommended dose of Sildenafil Actavis is 50 mg taken as needed about an hour before sexual activity. If Sildenafil Actavis 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 up 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 Actavis work?
The active substance in Sildenafil Actavis, 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 the degradation of cGMP, Sildenafil Actavis restores erectile function. Sexual stimulation is always required to produce an erection.
What studies have been performed on Sildenafil Actavis?
Because Sildenafil Actavis is a generic medicine, studies have been limited to demonstrating bioequivalence with 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 Actavis?
Because Sildenafil Actavis 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 Actavis been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Sildenafil Actavis 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 that Sildenafil Actavis be given marketing authorization.
More information on Sildenafil Actavis
On December 10, 2009, the European Commission released Actavis Group PTC ehf. a marketing authorization for Sildenafil Actavis, valid throughout the European Union. The marketing authorization is valid for five years, after which it can be renewed.
The full EPAR for Sildenafil Actavis 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
