Fortacin

lidocaine / prilocaine

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

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

What is Fortacin and what is it used for?

Fortacin is a medicine containing the active substances lidocaine and prilocaine. It is used to treat men with primary (lifelong) premature ejaculation (when ejaculation regularly occurs before, or too early during, penetration).

How is Fortacin used?

Fortacin can only be obtained with a prescription and is available as a spray-on solution that supplies 7.5 mg of lidocaine and 2.5 mg of prilocaine per spray. The recommended dose is three sprays onto the head (glans) of the penis before intercourse. Doses should not be repeated more frequently than every 4 hours, and no more than three doses should be used in 24 hours. For further information, see the package leaflet.

How does Fortacin work?

The active substances in the medicine, lidocaine and prilocaine, are local anaesthetics that temporarily numb the contact area by reversibly blocking the transmission of signals in the nerves. This reduces sensitivity to stimulation, helping to increase the time taken to ejaculate.

What benefits of Fortacin have been shown in studies?

The effectiveness of Fortacin has been shown in two main studies involving a total of 256 and 300 heterosexual adult men with premature ejaculation, respectively; both studies compared the medicine with a placebo (dummy) spray over 12 weeks. The main measures of effectiveness were the time taken to ejaculate after penetration and the amount of control over ejaculation, sexual satisfaction and distress reported by the patients. In the first study, the average time to ejaculation in patients treated with Fortacin was 2.6 minutes, compared with 0.8 minutes in those using placebo; in the second study, average ejaculation time in patients using the medicine was 3.8 minutes compared with 1.1 minutes in the placebo group. In both studies, patients given the medicine reported substantially greater improvements in reported control, sexual satisfaction and distress than patients given the placebo. Some patients were monitored for up to 9 months in an extension of the initial studies and continued to show similar benefit.

What are the risks associated with Fortacin?

The most common side effects with Fortacin (which may affect up to 1 in 10 people) are hypoaesthesia (reduced sensation) and a burning sensation in the genital area in both men and their female sexual partners, and erectile dysfunction (inability to maintain a normal erection) in men. For the full list of all side effects reported with Fortacin, see the package leaflet. Fortacin must not be used in patients who are hypersensitive (allergic) to any of the ingredients of the medicine or to other local anaesthetics with a structure related to the active ingredients (amide-type local anaesthetics). Fortacin must also not be used in patients whose partners are hypersensitive to these substances.

Why is Fortacin approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) considered that the active ingredients are a well-known local anaesthetic combination, and the use of a local spray minimises the amount of active substance absorbed and hence the risk of side effects affecting the body as a whole. There were positive psychological benefits to patients and their partners, and side effects were local and generally manageable. The CHMP therefore decided that Fortacin’s benefits are greater than its risks and recommended that it be approved for use in the EU.

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

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

Other information about Fortacin

The European Commission granted a marketing authorisation valid throughout the European Union for Fortacin on 15 November 2013.

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

Name Language First published Last updated
Fortacin : EPAR - Summary for the public BG = bălgarski 2013-11-25 2014-12-08
Fortacin : EPAR - Summary for the public ES = español 2013-11-25 2014-12-08
Fortacin : EPAR - Summary for the public CS = čeština 2013-11-25 2014-12-08
Fortacin : EPAR - Summary for the public DA = dansk 2013-11-25 2014-12-08
Fortacin : EPAR - Summary for the public DE = Deutsch 2013-11-25 2014-12-08
Fortacin : EPAR - Summary for the public ET = eesti keel 2013-11-25 2014-12-08
Fortacin : EPAR - Summary for the public EL = elliniká 2013-11-25 2014-12-08
Fortacin : EPAR - Summary for the public EN = English 2013-11-25 2014-12-08
Fortacin : EPAR - Summary for the public FR = français 2013-11-25 2014-12-08
Fortacin : EPAR - Summary for the public IT = italiano 2013-11-25 2014-12-08
Fortacin : EPAR - Summary for the public LV = latviešu valoda 2013-11-25 2014-12-08
Fortacin : EPAR - Summary for the public LT = lietuvių kalba 2013-11-25 2014-12-08
Fortacin : EPAR - Summary for the public HU = magyar 2013-11-25 2014-12-08
Fortacin : EPAR - Summary for the public MT = Malti 2013-11-25 2014-12-08
Fortacin : EPAR - Summary for the public NL = Nederlands 2013-11-25 2014-12-08
Fortacin : EPAR - Summary for the public PL = polski 2013-11-25 2014-12-08
Fortacin : EPAR - Summary for the public PT = português 2013-11-25 2014-12-08
Fortacin : EPAR - Summary for the public RO = română 2013-11-25 2014-12-08
Fortacin : EPAR - Summary for the public SK = slovenčina 2013-11-25 2014-12-08
Fortacin : EPAR - Summary for the public SL = slovenščina 2013-11-25 2014-12-08
Fortacin : EPAR - Summary for the public FI = suomi 2013-11-25 2014-12-08
Fortacin : EPAR - Summary for the public SV = svenska 2013-11-25 2014-12-08
Fortacin : EPAR - Summary for the public HR = Hrvatski 2013-11-25 2014-12-08

This EPAR was last updated on 13/11/2017 .

Authorisation details

Product details

Product details for Fortacin
NameFortacin
Agency product numberEMEA/H/C/002693
Active substance

lidocaine / prilocaine

International non-proprietary name (INN) or common name

lidocaine / prilocaine

Therapeutic area Sexual Dysfunction, Physiological
Anatomical therapeutic chemical (ATC) code N01BB20

Publication details

Publication details for Fortacin
Marketing-authorisation holder

Plethora Solutions Limited

Revision5
Date of issue of marketing authorisation valid throughout the European Union15/11/2013

Contact address:

Recordati Ireland Ltd.
Raheens East
Ringaskiddy, Co. Cork,
Ireland

Product information

Product information

30/10/2017  Fortacin -EMEA/H/C/002693 -T/0019

Name Language First published Last updated
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13
Fortacin : EPAR - Product Information HR = Hrvatski 2013-11-25 2017-11-13

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
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07
Fortacin : EPAR - All Authorised presentations HR = Hrvatski 2013-11-25 2017-09-07

Pharmacotherapeutic group

Anesthetics

Therapeutic indication

Treatment of primary premature ejaculation in adult men.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Fortacin : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2014-12-08 2017-11-13

Initial marketing-authorisation documents

Name Language First published Last updated
Lidocaine/Prilocaine Plethora : EPAR - Public assessment report HR = Hrvatski 2013-11-25  
CHMP summary of positive opinion for Lidocaine/Prilocaine Plethora HR = Hrvatski 2013-09-20  

Authorised

This medicine is approved for use in the European Union