Efracea capsules

Product Information *

  • Company:

    Galderma International S.A.S. c/o Galderma (U.K) Ltd.
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 28 May 2021

File name

ie-spc-clean-11May2021_1622191047.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 01 September 2020

File name

Efracea_PIL_UK__IRE_V14_(P28227-1)-vertical_1598953628.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 09 February 2020

File name

ie-spc-current-Efracea-Jan20_1581288598.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
  • File format updated to PDF

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 04 December 2017

File name

PIL_14729_220.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 December 2017

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 13 April 2016

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Removal of Interaction with oral contraceptives

Updated on 13 April 2016

Reasons for updating

  • Change to drug interactions

Updated on 13 April 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 03 December 2014

Reasons for updating

  • Addition of manufacturer

Updated on 02 December 2014

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update section 4.8 of the SmPC and section4 of the PIL for ADR reporting to include the Health Products RegulatoryAuthority (HPRA) name, replacing the Irish Medicines Board (IMB) name, 

Updated on 15 May 2014

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SPC updated in line with QRD.  Sectin 4.8 updated to include information on how to report as adverse event.

Updated on 16 April 2014

Reasons for updating

  • Change to side-effects
  • Addition of information on reporting a side effect.

Updated on 01 April 2014

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.8 (undesirable effects), unknown frequency: photo-onycholysis has been added.

Updated on 11 July 2012

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

An additional pack size of 14 capsules has been added.

Updated on 03 July 2012

Reasons for updating

  • Change to name of manufacturer
  • Introduction of new pack/pack size

Updated on 03 November 2011

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2 - Addition of "Oral Use"
Section 4.3 - Additoin of "Concomitant treatment with oral retinoids due to the risk of increased intracranial pressure (See section 4.5).
Section 4.4 - Confirmation that Efracea yields anti-inflammatory plasma levels added to boxed text
Section 4.6 - Addition of "Oral administration of doxycycline to male and female Sprague-Dawley rats adversely affected fertility and reproductive performance (see section 5.3). The effect of EFRACEA on human fertility is unknown."
Section 4.8 - Addition of "Benign intracranial hypertension and headache (unknown frequency: cannot be estimated from the available data) have been reported during EFRACEA postmarketing surveillance."
Section 6.1 - Deleted 3cP/6cP from Hypromellose

Updated on 25 October 2011

Reasons for updating

  • Change of inactive ingredient
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 23 June 2010

Reasons for updating

  • New PIL for new product

Updated on 22 June 2010

Reasons for updating

  • New SPC for new product
  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided