What is Mysildecard - Sildenafil and what is it used for?
Mysildecard is a medicine used to treat adults and children from one year of age with pulmonary arterial hypertension (PAH, higher than normal blood pressure in the pulmonary arteries). In adults, Mysildecard is used in patients with PAH class II (ie with a slight limitation of physical activity) or class III (ie with marked limitation of physical activity).
Mysildecard contains the active substance sildenafil. It is a 'generic medicine'. This means that Mysildecard is similar to a 'reference medicine' already authorized in the European Union (EU) called Revatio. For more information on generic medicines, please see the questions and answers by clicking here.
How is Mysildecard used - Sildenafil?
Mysildecard can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of PAH.
Mysildecard is available as tablets (20 mg). In adults, Mysildecard is given at a dose of 20 mg three times a day. A lower dose of Mysildecard may be needed in patients taking certain medicines that affect the way Mysildecard is broken down in the body.
For children and adolescents from 1 to 17 years of age with a body weight of more than 20 kg, the recommended dose is 20 mg three times a day. Higher doses should not be used. For children and adolescents with a body weight of less than 20 kg the maximum recommended dose is 10 mg three times a day, but Mysildecard can only be used when a 20 mg dose is given. For lower doses, medicinal products containing sildenafil should therefore be used.
How does Mysildecard - Sildenafil work?
PAH is a debilitating disease in which severe constriction (narrowing) of the blood vessels in the lungs occurs. This leads to high blood pressure in the vessels that carry blood from the heart to the lungs and to a reduction in the amount of oxygen that passes into the blood within the lungs, making physical activity more difficult. The active substance in Mysildecard, sildenafil , belongs to a group of medicines called 'phosphodiesterase type 5 (PDE5) inhibitors', which block the enzyme PDE5. This enzyme is found in the blood vessels of the lungs. When blocked, a substance called cyclic guanosine monophosphate (cGMP) cannot be broken down and the enzyme remains in the blood vessels causing them to relax and widen. In patients with PAH, sildenafil dilates the blood vessels of the lungs, which causes blood pressure to drop and symptoms to improve.
What benefit has Mysildecard - Sildenafil shown during the studies?
As the efficacy and safety of sildenafil in cases of PAH is already well established, studies in patients have been limited to trials to determine its bioequivalence compared to another authorized medicine containing sildefanil. Two medicines are bioequivalent when they produce the same. levels of the active ingredient in the body. In this case Mysildecard was not compared with the reference medicine Revatio, but with Viagra. This was considered acceptable as Revatio and Viagra have the same qualitative composition and are produced by the same company.
Because Mysildecard is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
What are the risks associated with Mysildecard - Sildenafil?
Because Mysildecard is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Why has Mysildecard - Sildenafil been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Mysildecard has been shown to be comparable to Revatio. Therefore, the CHMP considered that, as in the case of Revatio, the benefits of Mysildecard outweigh the identified risks. and recommended that Mysildecard be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Mysildecard - Sildenafil?
The recommendations and precautions to be observed by healthcare professionals and patients for Mysildecard to be used safely and effectively have been set out in the summary of product characteristics and package leaflet.
More information about Mysildecard - Sildenafil
For the complete version of the Mysildecard EPAR, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Mysildecard therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The full EPAR version of the reference medicine can also be found on the Agency's website.
The information on Mysildecard - Sildenafil published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
