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 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 ratiopharm to be effective.
The medicine can only be obtained with a prescription.
How is Sildenafil Ratiopharm used?
The recommended dose of Sildenafil ratiopharm is 50 mg as needed, to be taken approximately one hour before sexual activity. If Sildenafil ratiopharm 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 a maximum of 100 mg or reduced to a maximum of 100 mg. 25 mg. Patients with liver problems or severe kidney problems should start treatment with the 25 mg dose. The maximum recommended dosing frequency is one tablet per day.
How does Sildenafil Ratiopharm work?
The active substance in Sildenafil ratiopharm, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It 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 relaxation of the spongy muscles of the penis (corpora cavernosa), allowing the influx of blood into the corpora cavernosa and producing an erection. By blocking the breakdown of cGMP, Sildenafil ratiopharm restores erectile function. Sexual stimulation is always required to achieve an erection.
How has Sildenafil Ratiopharm been studied?
Since Sildenafil ratiopharm 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 Ratiopharm?
Because Sildenafil ratiopharm 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 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 view of the CHMP that, as in the case of Viagra, the benefits outweigh the identified risks. The Committee recommended that Sildenafil ratiopharm be given a Marketing Authorization.
More information about Sildenafil Ratiopharm
On 23 December 2009, the European Commission granted ratiopharm GmbH a "Marketing Authorization" for Sildenafil ratiopharm valid throughout the European Union. The "Marketing Authorization" is valid for five years and can be renewed upon expiry. .
For the full version of Sildenafil ratiopharm 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: 11-2009.
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