What is Mysildecard - Sildenafil used for 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 a 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, see the questions and answers by clicking here.
How is Mysildecard - Sildenafil used?
Mysildecard can only be obtained with a prescription and treatment must be started and supervised by a doctor experienced 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. Patients treated with certain medications that affect the way in which Mysildecard is broken down in the body may require a lower dosage of Mysildecard.
For children and adolescents 1 to 17 years of age with a body weight over 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. Therefore, sildenafil-containing medicines should be used for lower doses.
How does Mysildecard - Sildenafil work?
PAH is a debilitating disease in which there is a strong constriction (narrowing) of the blood vessels of the lungs. This leads to high blood pressure in the blood-carrying vessels from the heart to the lungs and a reduction in the amount of oxygen that passes into the blood inside the lungs, making physical activity more difficult. The active substance in Mysildecard, sildenafil, belongs to a group of medicines called "phosphodiesterase type 5 inhibitors (PDE5)", 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 relaxation and enlargement. In patients with PAH, sildenafil dilates the blood vessels in the lungs, which causes a drop in blood pressure and an improvement in symptoms.
What benefit has Mysildecard - Sildenafil shown during the studies?
Because the efficacy and safety of sildenafil in PAH cases is already well established, patient studies have been limited to tests to determine its bioequivalence compared to another authorized sildefanil-containing medicinal product. Two medicines are bioequivalent when they produce the same levels of 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 considered to be the same as those of the reference medicine.
What are the risks associated with Mysildecard - Sildenafil?
Because Mysildecard is a generic medicine, its benefits and risks are considered to be the same as those of the reference medicine.
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 to approve the use of Mysildecard in the EU.
What measures are being taken to ensure the safe and effective use of Mysildecard - Sildenafil?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mysildecard have been included in the summary of product characteristics and the package leaflet.
More information on Mysildecard - Sildenafil
The full EPAR for Mysildecard can be found on the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Mysildecard, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
The full EPAR for the reference medicine can also be found on the Agency's website.
