This is a summary of the European public assessment report (EPAR) for Tadalafil Generics. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Tadalafil Generics.
For practical information about using Tadalafil Generics, patients should read the package leaflet or contact their doctor or pharmacist.
- What is Tadalafil Generics and what is it used for?
Tadalafil Generics is a medicine used to treat adults with pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity). PAH is abnormally high blood pressure in the arteries of the lungs. Tadalafil Generics is used in patients with class-II (slight limitation of physical activity) or class-III (marked limitation of physical activity) PAH.
Tadalafil Generics contains the active substance tadalafil.
Tadalafil Generics is a ‘generic medicine’. This means that Tadalafil Generics contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Adcirca.
- How is Tadalafil Generics used?
Tadalafil Generics can only be obtained with a prescription and treatment should be started and monitored by a doctor who has experience in the treatment of PAH.
Tadalafil Generics is available as 20 mg tablets. The recommended dose is two tablets (40 mg) once a day. Patients with mild or moderate kidney or liver problems should be started on a lower dose. Tadalafil Generics is not recommended for patients with severe kidney or liver problems.
- How does Tadalafil Generics work?
PAH is a debilitating disease where there is severe narrowing of the blood vessels of the lungs. This leads to high blood pressure in the vessels taking blood from the heart to the lungs and reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult. The active substance in Tadalafil Generics, tadalafil, belongs to a group of medicines called ‘phosphodiesterase type 5 (PDE5) inhibitors’, which means that it blocks the PDE5 enzyme. This enzyme is found in the blood vessels of the lungs. When the enzyme is blocked, a substance called ‘cyclic guanosine monophosphate’ (cGMP) cannot be broken down and remains in the vessels where it causes widening of the blood vessels. In patients with PAH, this lowers the blood pressure in the lungs and improves symptoms.
- How has Tadalafil Generics been studied?
Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Adcirca, and do not need to be repeated for Tadalafil Generics.
As for every medicine, the company provided studies on the quality of Tadalafil Generics. The company also carried out studies that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
- What are the benefits and risks of Tadalafil Generics?
Because Tadalafil Generics 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 is Tadalafil Generics approved?
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Tadalafil Generics has been shown to have comparable quality and to be bioequivalent to Adcirca. Therefore, the CHMP’s view was that, as for Adcirca, the benefit outweighs the identified risk. The Committee recommended that Tadalafil Generics be approved for use in the EU.
- What measures are being taken to ensure the safe and effective use of Tadalafil Generics?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tadalafil Generics have been included in the summary of product characteristics and the package leaflet.
- Other information about Tadalafil Generics
The European Commission granted a marketing authorisation valid throughout the European Union for Tadalafil Generics on 09 January 2017.
For more information about treatment with Tadalafil Generics, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This EPAR was last updated on 26/01/2017 .
09/01/2017 Tadalafil Generics -EMEA/H/C/004297 --
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Tadalafil Generics is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.
Changes since initial authorisation of medicine
|Name||Language||First published||Last updated|
Initial marketing-authorisation documents
|Name||Language||First published||Last updated|
|Tadalafil Generics : EPAR - Public assessment report||HR = Hrvatski||2017-01-26|
|CHMP summary of positive opinion for Tadalafil Generics||HR = Hrvatski||2016-11-11|