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MSD Ireland (Human Health) Limited

Red Oak North, South County Business Park, Leopardstown, Dublin 18, Ireland
Telephone: +353 1 299 8700
Fax: +353 1 299 8701
Medical Information e-mail: medinfo_ireland@merck.com
Summary of Product Characteristics last updated on medicines.ie: 19/04/2017
SPC Mercilon

When a pharmaceutical company changes an SPC or PIL, 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 19/04/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07-Apr-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



 Updates to sections 4.2, 4.4, 4.5, 4.8, 5.2 and 10 as a result of approval of Type II variation to update Drug interaction information (SE/H/XXXX/WS/143)

Updated on 30/04/2015 and displayed until 19/04/2017
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   28-Apr-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 4.8 – Undesirable effects and section 10 date of revision (to update the AE reporting text in the SPC)
Updated on 26/06/2014 and displayed until 30/04/2015
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   20-Jun-2014
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Changes to Sections 7- Marketing Authorisation Holder, 8- Marketing Authorisation Number and section 10 date of revision.
Updated on 29/05/2014 and displayed until 26/06/2014
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   26-May-2014
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Updates to sections 4.3 - to remove contraindication for use in pregnancy
Updated on 26/05/2014 and displayed until 29/05/2014
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • 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 - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   12-May-2014
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Updates to sections 4.1, 4.3, 4.4, 4.6, 4.8 and 10 due to an Article 31 Referral for Combined Hormonal Contraceptives
Updated on 23/05/2013 and displayed until 26/05/2014
Reasons for adding or 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   16-May-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Updates to sections:  4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 5.1, 5.2, 5.3, 6.6 and 10.
Updated on 19/07/2011 and displayed until 23/05/2013
Reasons for adding or 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   31-Jan-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



       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 4.5 – Interaction with other medicinal products and other forms of interaction

       Change to section 4.8 - Undesirable effects

       Change to section 5.1 - Pharmacodynamic properties

       Change to section 9 – Date of first authorisation/Renewal of authorisation

       Change to section 10 - Date of revision of the text

Updated on 15/05/2009 and displayed until 19/07/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   16-Jan-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

In section 2 - reference to excipient Lactose Monohydrate added.
In section 3 - colour of tablet "white" is added to description.
In section 4.2 - reference is made to Section 4.6, full section title is also added.
In section 4.3 - reference is made to Section 4.4, full section title is also added.
In section 4.8 - reference is made to Section 4.4, full section title is also added.
In section 9 - renewal date is updated.
In section 10 - revision date is updated.
Updated on 14/08/2008 and displayed until 15/05/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4 - Clinical particulars
  • Change to section 5 - Pharmacological properties
  • Change to section 6 - Pharmaceutical particulars
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   02/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change to section 2- slight rewording to text
Change to section 3- rewording of text to aid readability
Change to section 4- all clinical sections updated inline with new clinical information as outlined in company core data sheet
Change to section 5- all clinical sections updated inline with new clinical information as outlined in company core data sheet
Change to section 6- changes include updated to excipient names and 6.6  section heading change.
Change to section 10- date of revision of text updated
Updated on 31/07/2006 and displayed until 14/08/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 26/07/2004 and displayed until 31/07/2006
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Updated on 23/06/2003 and displayed until 26/07/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Ethinylestradiol
   Desogestrel