What is Sildenafil Ratiopharm?
Sildenafil ratiopharm is a medicine that contains the active substance sildenafil. It is available as blue oval tablets (25, 50 and 100 mg).
Sildenafil ratiopharm is a "generic medicine". This implies that it is similar to a "reference drug" already authorized in the European Union (EU) called Viagra.
What is Sildenafil Ratiopharm used for?
Sildenafil ratiopharm is used in the treatment of adult men with erectile dysfunction (sometimes also called impotence), which is the inability to achieve or maintain an erection sufficient for satisfactory sexual activity. For Sildenafil ratiopharm to be effective, sexual stimulation is required.
The medicine can only be obtained with a prescription.
How is Sildenafil Ratiopharm used?
The recommended dose of Sildenafil ratiopharm is 50 mg taken as needed about an hour before sexual activity. If Sildenafil ratiopharm is taken with meals, the onset of action may be delayed compared to fasting. Depending on the efficacy and side effects, the dose can be increased up to a maximum of 100 mg or reduced to 25 mg. Patients with liver problems or severe kidney problems should start treatment with the 25 mg dose. The maximum recommended dosage frequency is one tablet per day.
How does Sildenafil Ratiopharm work?
The active substance of Sildenafil ratiopharm, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). It works by blocking the enzyme phosphodiesterase, which normally decomposes 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 corpora cavernosa and producing an erection. By blocking the decomposition of cGMP, Sildenafil ratiopharm restores erectile function. In order to get an erection, however, sexual stimulation is always necessary.
What studies have been performed on Sildenafil Ratiopharm?
Because Sildenafil ratiopharm 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 Ratiopharm?
Because Sildenafil ratiopharm 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 Ratiopharm been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Sildenafil ratiopharm 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 ratiopharm.
More information on Sildenafil Ratiopharm
On December 23, 2009, the European Commission granted ratiopharm GmbH a marketing authorization valid throughout the European Union for Sildenafil ratiopharm. The marketing authorization is valid for five years and can be renewed upon expiry.
For the full EPAR of Sildenafil ratiopharm, click here.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 11-2009.
