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 also called impotence), which is the inability to achieve or maintain an erection sufficient for satisfactory sexual activity. Sexual stimulation is required for Sildenafil Actavis to be effective.
The medicine can only be obtained with a prescription.
How is Sildenafil Actavis used?
The recommended dose of Sildenafil Actavis is 50 mg as needed, to be taken approximately one hour before sexual activity. If Sildenafil Actavis 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 Actavis work?
The active substance in Sildenafil Actavis, 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 Actavis restores erectile function. Sexual stimulation is always required to produce an erection.
How has Sildenafil Actavis been studied?
Since Sildenafil Actavis is a generic medicine, the studies carried out were limited to showing bioequivalence with 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 associated with Sildenafil Actavis?
Because Sildenafil Actavis 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 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 view of the CHMP that, as in the case of Viagra, the benefits outweigh the identified risks. The Committee recommended that Sildenafil Actavis be given marketing authorization.
More information about Sildenafil Actavis
On 10 December 2009, the European Commission released PTC ehf to Actavis Group. 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.
For the full version of the Sildenafil Actavis 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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