Adcirca (previously Tadalafil Lilly)

tadalafil

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This is a summary of the European public assessment report (EPAR) for Adcirca. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Adcirca.

What is Adcirca?

Adcirca is a medicine that contains the active substance tadalafil. It is available as tablets (20 mg).

What is Adcirca used for?

Adcirca is 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. Adcirca is used in patients with class-II or -III disease. The ‘class’ reflects the seriousness of the disease: ‘class II’ involves slight limitation of physical activity and ‘class III’ involves marked limitation of physical activity. Adcirca has been shown to be effective in PAH with no identified cause and in PAH caused by collagen vascular disease.

The medicine can only be obtained with a prescription.

How is Adcirca used?

Adcirca treatment should only be started and monitored by a doctor who has experience in the treatment of PAH.

Adcirca is taken as two tablets (40 mg) once a day, with or without food. Patients with mild or moderate kidney or liver problems should start with a lower dose, but this can be increased if necessary depending on the patient’s response. Adcirca is not recommended for patients with severe kidney or liver problems.

How does Adcirca work?

PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs. It causes high blood pressure in the vessels taking blood from the heart to the lungs. This pressure reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult. The active substance in Adcirca, 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 the relaxation and widening of the blood vessels. In patients with PAH, Adcirca widens the blood vessels of the lungs, which lowers the blood pressure and improves symptoms.

How has Adcirca been studied?

Four doses of Adcirca (2.5, 10, 20 and 40 mg once a day) have been compared with placebo (a dummy treatment) in one main study involving 406 patients with PAH, most of whom had class-II or class-III disease that was of unknown cause or caused by collagen vascular disease. The main measure of effectiveness was the change in exercise capacity (the ability to carry out physical activity) measured by the distance the patients could walk in six minutes after 16 weeks of treatment.

What benefit has Adcirca shown during the studies?

Adcirca was more effective than placebo at improving exercise capacity. Before treatment, the patients could walk an average of 343 metres in six minutes. After 16 weeks, this distance had increased by 26 metres more in the patients taking 40 mg Adcirca than in the patients taking placebo.

What is the risk associated with Adcirca?

The most common side effects with Adcirca (seen in more than 1 patient in 10) are headache, flushing (reddening of the skin), nasopharyngitis (inflammation of the nose and throat) including a blocked or runny nose and blocked sinuses, nausea (feeling sick), dyspepsia (heartburn) including stomach ache, myalgia (muscle pain), back pain and pain in the extremities (arms, hands, legs and feet).  

Adcirca must not be used in patients who have had an acute myocardial infarction (sudden heart attack) within the last three months, or who have severe hypotension (low blood pressure). Adcirca must not be taken with nitrates (a group of medicines used to treat angina) or medicines of the class ‘guanylate cyclase stimulators’ such as riociguat (another medicine to treat pulmonary hypertension). It must not be used in patients who have ever had loss of vision because of a problem called non-arteritic anterior ischaemic optic neuropathy (NAION) that affects the blood flow to the nerve in the eye.

For the full list of all side effects and restrictions with Adcirca, see the package leaflet.

Why has Adcirca been approved?

The CHMP decided that Adcirca’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Adcirca?

A risk management plan has been developed to ensure that Adcirca is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Adcirca, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Adcirca

The European Commission granted a marketing authorisation valid throughout the EU for Tadalafil Lilly on 1 October 2008. This authorisation was based on the authorisation granted to Cialis in 2002 (‘informed consent’). The name of the medicine was changed to Adcirca on 21 October 2009.

For more information about treatment with Adcirca, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Adcirca : EPAR - Summary for the public BG = bălgarski 16/10/2008 29/09/2015
Adcirca : EPAR - Summary for the public ES = español 16/10/2008 29/09/2015
Adcirca : EPAR - Summary for the public CS = čeština 16/10/2008 29/09/2015
Adcirca : EPAR - Summary for the public DA = dansk 16/10/2008 29/09/2015
Adcirca : EPAR - Summary for the public DE = Deutsch 16/10/2008 29/09/2015
Adcirca : EPAR - Summary for the public ET = eesti keel 16/10/2008 29/09/2015
Adcirca : EPAR - Summary for the public EL = elliniká 16/10/2008 29/09/2015
Adcirca : EPAR - Summary for the public EN = English 16/10/2008 29/09/2015
Adcirca : EPAR - Summary for the public FR = français 16/10/2008 29/09/2015
Adcirca : EPAR - Summary for the public IT = italiano 16/10/2008 29/09/2015
Adcirca : EPAR - Summary for the public LV = latviešu valoda 16/10/2008 29/09/2015
Adcirca : EPAR - Summary for the public LT = lietuvių kalba 16/10/2008 29/09/2015
Adcirca : EPAR - Summary for the public HU = magyar 16/10/2008 29/09/2015
Adcirca : EPAR - Summary for the public MT = Malti 16/10/2008 29/09/2015
Adcirca : EPAR - Summary for the public NL = Nederlands 16/10/2008 29/09/2015
Adcirca : EPAR - Summary for the public PL = polski 16/10/2008 29/09/2015
Adcirca : EPAR - Summary for the public PT = português 16/10/2008 29/09/2015
Adcirca : EPAR - Summary for the public RO = română 16/10/2008 29/09/2015
Adcirca : EPAR - Summary for the public SK = slovenčina 16/10/2008 29/09/2015
Adcirca : EPAR - Summary for the public SL = slovenščina 16/10/2008 29/09/2015
Adcirca : EPAR - Summary for the public FI = suomi 16/10/2008 29/09/2015
Adcirca : EPAR - Summary for the public SV = svenska 16/10/2008 29/09/2015
Adcirca : EPAR - Summary for the public HR = Hrvatski 16/10/2008 29/09/2015

This EPAR was last updated on 21/03/2016 .

Authorisation details

Product details

Product details for Adcirca (previously Tadalafil Lilly)
NameAdcirca (previously Tadalafil Lilly)
Agency product numberEMEA/H/C/001021
Active substance

tadalafil

International non-proprietary name (INN) or common name

tadalafil

Therapeutic area Hypertension, Pulmonary
Anatomical therapeutic chemical (ATC) code G04BE08

Publication details

Publication details for Adcirca (previously Tadalafil Lilly)
Marketing-authorisation holder

Eli Lilly Nederland B.V.

Revision9
Date of issue of marketing authorisation valid throughout the European Union01/10/2008

Contact address:

Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Product information

Product information

23/02/2016  Adcirca (previously Tadalafil Lilly) -EMEA/H/C/001021 -IG/00662

Name Language First published Last updated
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - Product Information HR = Hrvatski 16/10/2008 21/03/2016

Contents

  • 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.


Name Language First published Last updated
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016
Adcirca : EPAR - All Authorised presentations HR = Hrvatski 16/10/2008 21/03/2016

Pharmacotherapeutic group

Urologicals

Therapeutic indication

Adcirca is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as World Health Organization functional class II and III, to improve exercise capacity (see section 5.1).

Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Tadalafil Lilly : EPAR - Public assessment report HR = Hrvatski 16/10/2008  
Committee for medicinal products for human use, summary of positive opinion for Tadalafil Lilly HR = Hrvatski 24/07/2008  

Authorised

This medicine is approved for use in the European Union