What is Talmanco - Tadalafil used for?
Talmanco is a medicine used to treat adults with pulmonary arterial hypertension (PAH) in order to improve their ability to exercise (the possibility of exercising). PAH refers to an elevated blood pressure above the norm in the arteries of the lungs. Talmanco is used in patients with class II PAH (subject to a slight limitation of physical activity) or class III (subject to a marked limitation of physical activity).
Talmanco contains the active ingredient tadalafil.
Talmanco is a "generic medicine". This means that Talmanco contains the same active ingredient and acts in the same way as a "reference medicine" already authorized in the European Union (EU), called Adcirca. For more information on generic medicines, see the questions and answers by clicking here.
How is Talmanco - Tadalafil used?
Talmanco can only be obtained with a prescription and treatment must be started and supervised by a doctor experienced in the treatment of PAH.
It is available as 20 mg tablets. The recommended dose is two tablets (40 mg) once a day. In patients with mild to moderate disorders of renal and hepatic function treatment should be started at a lower dose. Talmanco is not recommended in patients with severe kidney or liver problems.
How does Talmanco - Tadalafil work?
PAH is a debilitating disease in which a severe narrowing of the blood vessels in the lungs occurs. 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 circulating in the lungs, making physical activity more difficult. The active substance in Talmanco, tadalafil, belongs to a group of medicines called "phosphodiesterase type 5 inhibitors (PDE5)" that block the PDE5 enzyme. This enzyme is found in the blood vessels of the lungs. When it is blocked, the degradation of a substance called "cyclic guanosine monophosphate" (cGMP) becomes impossible, which remains in the blood vessels causing their dilation. In patients with PAH, this action lowers blood pressure in the lungs and reduces symptoms.
What benefit has Talmanco - Tadalafil shown during the studies?
With the reference medicine (Adcirca), studies have already been carried out on the benefits and risks of the active ingredient for the approved use, which therefore should not be repeated for Talmanco.
As with any medicine, the company has provided Talmanco quality studies. In addition, he carried out studies that showed that Talmanco is "bioequivalent" to the reference medicine. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body, so they are expected to have the same effect.
Because Talmanco 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.
What are the risks associated with Talmanco - Tadalafil?
Because Talmanco 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 Talmanco - Tadalafil been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Talmanco has been shown to have comparable quality and to be bioequivalent to Adcirca. Therefore, the CHMP considered that, as in the case of Adcirca, the benefits outweigh the identified risks and recommended approving the use of Talmanco in the EU.
What measures are being taken to ensure the safe and effective use of Talmanco - Tadalafil?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Talmanco have been included in the summary of product characteristics and the package leaflet.
More information about Talmanco - Tadalafil
On 9 January 2017, the European Commission granted a marketing authorization for Tadalafil Generics. The name of the medicine was changed to Talmanco on 1 March 2017.
For the full Talmanco EPAR, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Talmanco 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.
Last update of this summary: 05-2017
