What is Granpidam - Sildenafil used for?
Granpidam is a medicine used in the treatment of adults and children, from 1 year of age, suffering from pulmonary arterial hypertension (PAH, abnormally high blood pressure in the arteries of the lungs). In adults, it is used in patients with class II PAH (slight limitation of physical activity) or class III (marked limitation of physical activity).
Granpidam contains the active substance sildenafil. It is a "generic medicine". This means that Granpidam 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 Granpidam used - Sildenafil?
Granpidam can only be obtained with a prescription. Treatment should be initiated and supervised by a physician experienced in the treatment of PAH.
Granpidam is available as tablets (20 mg). In adults, Granpidam is taken at a dose of 20 mg three times a day. Lower doses of Granpidam may be needed in patients taking certain medicines that affect how Granpidam is decomposed in the body.
In children aged 1 to 17 years, the recommended dose is 20 mg three times a day for those weighing more than 20 kg. Higher dosages should not be used. In children weighing less than 20 kg the maximum recommended dose would be 10 mg three times a day, but Granpidam can only be used when a 20 mg dose is to be given. Therefore, for lower dosages other medicines containing sildenafil should be used.
How does Granpidam - Sildenafil work?
PAH is a debilitating disease in which there is a strong constriction (constriction) of the blood vessels of the lungs. This leads to high blood pressure in the vessels that carry blood from the heart to the lungs and reduces the amount of oxygen that can enter the blood in the lungs, making physical activity more difficult. The active substance in Granpidam, sildenafil, belongs to a group of medicines called "phosphodiesterase type 5 inhibitors (PDE5)", which means it blocks 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, so that it remains in the blood vessels causing relaxation and enlargement. In patients with PAH, sildenafil widens the blood vessels of the lungs, which lowers blood pressure and improves symptoms.
What benefit has Granpidam - Sildenafil shown during the studies?
Since the efficacy and safety of sildenafil in PAH are already well established, studies in patients have been limited to tests to determine its bioequivalence compared to another authorized sildenafil-containing tablet. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body. In this case Granpidam was not compared with the reference product Revatio, but with Viagra. This was considered acceptable because Revatio and Viagra have the same composition and are made in the same way by the same manufacturer.
Because Granpidam 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 Granpidam - Sildenafil?
Because Granpidam is a generic medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Granpidam - Sildenafil been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Granpidam was considered comparable to Revatio. Therefore, the CHMP considered that, as in the case of Revatio, the benefits of Granpidam outweigh the identified risks and recommended to approve the use of Granpidam in the EU.
What measures are being taken to ensure the safe and effective use of Granpidam - Sildenafil?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Granpidam have been included in the summary of product characteristics and the package leaflet.
Other information on Granpidam - Sildenafil
For the full EPAR for Granpidam, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Granpidam therapy, 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
