Tadalafil Mylan

tadalafil

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This is a summary of the European public assessment report (EPAR) for Tadalafil Mylan. 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 Mylan.

For practical information about using Tadalafil Mylan, patients should read the package leaflet or contact their doctor or pharmacist.

What is Tadalafil Mylan and what is it used for?

Tadalafil Mylan is used to treat men with erectile dysfunction (sometimes called impotence) when they cannot get, or keep, a hard penis (erection) sufficient for satisfactory sexual activity. For Tadalafil Mylan to be effective in this condition, sexual stimulation is required.

Tadalafil Mylan can also be used in men to treat the signs and symptoms of benign prostatic hyperplasia (enlarged prostate gland that is not cancerous), which involve problems with the flow of urine.

Tadalafil Mylan contains the active substance tadalafil. It is a ‘generic medicine’. This means that Tadalafil Mylan is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Cialis.

How is Tadalafil Mylan used?

For treating erectile dysfunction, the recommended dose of Tadalafil Mylan is 10 mg taken ‘on demand’ at least 30 minutes before sexual activity. The dose may be increased to 20 mg for men who do not respond to the 10 mg dose. The maximum recommended dosing frequency is once per day, but continuous daily use of 10 or 20 mg Tadalafil Mylan is not recommended. Tadalafil Mylan can be used at a lower dose once a day in men who intend to use it frequently (twice a week or more), based on the doctor’s judgment. The dose is 5 mg once a day, but can be lowered to 2.5 mg once a day depending on how well it is tolerated. The medicine should be taken around the same time every day and the appropriateness of the once-a-day dosing should be re-assessed regularly.

For treating men with benign prostatic hyperplasia, or men with both benign prostatic hyperplasia and erectile dysfunction, the recommended dose is 5 mg once a day.

Patients with severely impaired liver or kidney function should not take more than 10 mg in one dose. Once-a-day dosing is not recommended in patients with severely impaired kidney function, and should only be prescribed to patients with impaired liver function after a careful evaluation of the benefits and risks of taking the medicine.

Tadalafil Mylan can only be obtained with a prescription.

How does Tadalafil Mylan work?

The active substance of Tadalafil Mylan, tadalafil, belongs to a group of medicines called 'phosphodiesterase type-5 (PDE5) inhibitors'. It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP). During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax, allowing the flow of blood into the corpora, producing the erection. Men with erectile dysfunction do not have enough cGMP to produce or maintain an erection. By blocking the breakdown of cGMP, Tadalafil Mylan restores erectile function. However, sexual stimulation is still needed. By blocking the phosphodiesterase enzyme and preventing the breakdown of cGMP, Tadalafil Mylan also improves the blood flow to, and relaxes the muscles of, the prostate and bladder. This may reduce the problems with the flow of urine which are symptoms of benign prostatic hyperplasia

How has Tadalafil Mylan been studied?

Because Tadalafil Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Cialis. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Tadalafil Mylan?

Because Tadalafil Mylan 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 Mylan approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Tadalafil Mylan has been shown to have comparable quality and to be bioequivalent to Cialis. Therefore, the CHMP’s view was that, as for Cialis, the benefit outweighs the identified risk. The Committee recommended that Tadalafil Mylan be approved for use in the EU.

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

A risk management plan has been developed to ensure that Tadalafil Mylan 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 Tadalafil Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Tadalafil Mylan

The European Commission granted a marketing authorisation valid throughout the European Union for Tadalafil Mylan on 21 November 2014.

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

Name Language First published Last updated
Tadalafil Mylan : EPAR - Summary for the public BG = bălgarski 2014-12-19  
Tadalafil Mylan : EPAR - Summary for the public ES = español 2014-12-19  
Tadalafil Mylan : EPAR - Summary for the public CS = čeština 2014-12-19  
Tadalafil Mylan : EPAR - Summary for the public DA = dansk 2014-12-19  
Tadalafil Mylan : EPAR - Summary for the public DE = Deutsch 2014-12-19  
Tadalafil Mylan : EPAR - Summary for the public ET = eesti keel 2014-12-19  
Tadalafil Mylan : EPAR - Summary for the public EL = elliniká 2014-12-19  
Tadalafil Mylan : EPAR - Summary for the public EN = English 2014-12-19  
Tadalafil Mylan : EPAR - Summary for the public FR = français 2014-12-19  
Tadalafil Mylan : EPAR - Summary for the public IT = italiano 2014-12-19  
Tadalafil Mylan : EPAR - Summary for the public LV = latviešu valoda 2014-12-19  
Tadalafil Mylan : EPAR - Summary for the public LT = lietuvių kalba 2014-12-19  
Tadalafil Mylan : EPAR - Summary for the public HU = magyar 2014-12-19  
Tadalafil Mylan : EPAR - Summary for the public MT = Malti 2014-12-19  
Tadalafil Mylan : EPAR - Summary for the public NL = Nederlands 2014-12-19  
Tadalafil Mylan : EPAR - Summary for the public PL = polski 2014-12-19  
Tadalafil Mylan : EPAR - Summary for the public PT = português 2014-12-19  
Tadalafil Mylan : EPAR - Summary for the public RO = română 2014-12-19  
Tadalafil Mylan : EPAR - Summary for the public SK = slovenčina 2014-12-19  
Tadalafil Mylan : EPAR - Summary for the public SL = slovenščina 2014-12-19  
Tadalafil Mylan : EPAR - Summary for the public FI = suomi 2014-12-19  
Tadalafil Mylan : EPAR - Summary for the public SV = svenska 2014-12-19  
Tadalafil Mylan : EPAR - Summary for the public HR = Hrvatski 2014-12-19  
Name Language First published Last updated
Tadalafil Mylan : EPAR - Risk-management-plan summary (English only) 2014-12-19  

This EPAR was last updated on 03/08/2017 .

Authorisation details

Product details

Product details for Tadalafil Mylan
NameTadalafil Mylan
Agency product numberEMEA/H/C/003787
Active substance

tadalafil

International non-proprietary name (INN) or common name

tadalafil

Therapeutic area Erectile Dysfunction
Anatomical therapeutic chemical (ATC) code G04BE08
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Tadalafil Mylan
Marketing-authorisation holder

Generics (UK) Limited

Revision5
Date of issue of marketing authorisation valid throughout the European Union21/11/2014

Contact address:

Generics (UK) Limited
Station Close
Potters Bar
Hertfordshire EN6 1TL
United Kingdom

Product information

Product information

27/06/2017  Tadalafil Mylan -EMEA/H/C/003787 -IB/0008

Name Language First published Last updated
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03
Tadalafil Mylan : EPAR - Product Information EN = English 2014-12-19 2017-08-03

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
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30
Tadalafil Mylan : EPAR - All Authorised presentations EN = English 2014-12-19 2017-03-30

Pharmacotherapeutic group

Urologicals

Therapeutic indication

Treatment of erectile dysfunction in adult males. In order for tadalafil to be effective, sexual stimulation is required.

Tadalafil Mylan is not indicated for use by women.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Tadalafil Mylan : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2016-01-27 2017-08-03
Tadalafil Mylan-H-A31-1450-C-003787-0005 : EPAR - Assessment Report - Article 31 EN = English 2017-07-10  
Tadalafil Mylan : EPAR - Scientific Conclusion EN = English 2017-07-10  
Tadalafil Mylan : EPAR - Scientific Conclusion EN = English 2017-07-10  
Tadalafil Mylan : EPAR - Scientific Conclusion EN = English 2017-07-10  
Tadalafil Mylan : EPAR - Scientific Conclusion EN = English 2017-07-10  
Tadalafil Mylan : EPAR - Scientific Conclusion EN = English 2017-07-10  
Tadalafil Mylan : EPAR - Scientific Conclusion EN = English 2017-07-10  
Tadalafil Mylan : EPAR - Scientific Conclusion EN = English 2017-07-10  
Tadalafil Mylan : EPAR - Scientific Conclusion EN = English 2017-07-10  
Tadalafil Mylan : EPAR - Scientific Conclusion EN = English 2017-07-10  
Tadalafil Mylan : EPAR - Scientific Conclusion EN = English 2017-07-10  
Tadalafil Mylan : EPAR - Scientific Conclusion EN = English 2017-07-10  
Tadalafil Mylan : EPAR - Scientific Conclusion EN = English 2017-07-10  
Tadalafil Mylan : EPAR - Scientific Conclusion EN = English 2017-07-10  
Tadalafil Mylan : EPAR - Scientific Conclusion EN = English 2017-07-10  
Tadalafil Mylan : EPAR - Scientific Conclusion EN = English 2017-07-10  
Tadalafil Mylan : EPAR - Scientific Conclusion EN = English 2017-07-10  
Tadalafil Mylan : EPAR - Scientific Conclusion EN = English 2017-07-10  
Tadalafil Mylan : EPAR - Scientific Conclusion EN = English 2017-07-10  
Tadalafil Mylan : EPAR - Scientific Conclusion EN = English 2017-07-10  
Tadalafil Mylan : EPAR - Scientific Conclusion EN = English 2017-07-10  
Tadalafil Mylan : EPAR - Scientific Conclusion EN = English 2017-07-10  
Tadalafil Mylan : EPAR - Scientific Conclusion EN = English 2017-07-10  
Tadalafil Mylan : EPAR - Scientific Conclusion EN = English 2017-07-10  

Initial marketing-authorisation documents

Name Language First published Last updated
Tadalafil Mylan : EPAR - Public assessment report EN = English 2014-12-19  
CHMP summary of positive opinion for Tadalafil Mylan EN = English 2014-09-26  

Authorised

This medicine is approved for use in the European Union

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