Talmanco - Tadalafil

What is Talmanco - Tadalafil and what is it used for?

Talmanco is a medicine used to treat adults with pulmonary arterial hypertension (PAH) to improve their ability to exercise (the ability to exercise). PAH refers to a blood pressure that is elevated above normal in the arteries of the lungs. Talmanco is used in patients with PAH class II (subject to slight limitation of physical activity) or class III (subject to marked limitation of physical activity).

Talmanco contains the active substance tadalafil.

Talmanco is a 'generic medicine'. This means that Talmanco contains the same active substance and works 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 used - Tadalafil?

Talmanco 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.

It is available in the form of 20 mg tablets. The recommended dose is two tablets (40 mg) once a day. In patients with mild to moderate impaired 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 severe 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 circulating to the lungs, making physical activity more difficult. The active substance in Talmanco, tadalafil, 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. breakdown of a substance called cyclic guanosine monophosphate (cGMP), which remains in the blood vessels causing them to dilate.In patients with PAH, this action lowers blood pressure in the lungs and relieves symptoms.

What benefit has Talmanco - Tadalafil shown during the studies?

Studies on the benefits and risks of the active substance for approved use have already been performed with the reference medicine (Adcirca) and therefore do not need to be repeated for Talmanco.

As with any medicine, the company made available studies on the quality of Talmanco. It also carried out studies which found Talmanco to be 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance 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 taken as being the same as the reference medicine's.

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 taken as being the same as the reference medicine's.

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 that Talmanco be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Talmanco - Tadalafil?

The recommendations and precautions that healthcare professionals and patients need to observe in order for Talmanco to be used safely and effectively have been set out in the Summary of Product Characteristics and Package Leaflet.

More information about Talmanco - Tadalafil

On 9 January 2017, the European Commission issued a "Marketing Authorization" for Tadalafil Generics. The name of the medicine was changed to Talmanco on 1 March 2017.

For the complete version of Talmanco's EPAR, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Talmanco 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.

Last update of this summary: 05-2017


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