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Mercilon 150/20 microgram Tablets

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Pharmacy Only: Prescription

Updated on 20 September 2022

File name

IE-MERCILON-EN-SPC-WS607-20220915-CRT.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Updated on 20 September 2022

File name

IE-MERCILON-EN-PIL-WS607-20220915-CRT.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 12 October 2021

File name

IE-MERCILON-EN-SPC MAT Oct21 CRT.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 12 October 2021

File name

MERCILON-EN-PIL-QRD-PRACMAT21 -CRT.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 29 July 2021

File name

IE-MERCILON-EN-SPC-PRAC-20210728-CRT.pdf

Reasons for updating

  • 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 - how to report a side effect
  • 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

To implement the outcome of PSUSA/00001307/202007

Updated on 29 July 2021

File name

IE_MERCILON_EN_PIL_QRD-PRAC-20210728-CRT.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 23 April 2019

File name

Mercilon_PIL_QRD_PRAC_CRT.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 23 April 2019

File name

IE-MERCILON-EN-SPC-PRAC-CRT.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Change to section 4.4: addition of safety warning for increased risk of suicidality with hormonal contraceptives

 

Updated on 23 April 2019

File name

IE-MERCILON-EN-SPC-PRAC-CRT.

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Change to section 4.4: addition of safety warning for increased risk of suicidality with hormonal contraceptives

 

Updated on 23 January 2019

File name

Mercilon Tablets_QRD_PIL_TypeIA_Removal Organon Swords.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 14 January 2019

File name

Mercilon_PIL_QRD_Deletion Organon DPM_Jan 2019_CRT.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 10 May 2018

Reasons for updating

  • New SPC for new product

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

Updated on 31 July 2017

Reasons for updating

  • New SPC for new product

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

Updated on 31 July 2017

Reasons for updating

  • 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 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

Change to section 4.3;4.4; 4.5: addition of contraindication with products containing ombitasvir/paritaprevir/ritonavir and dasabuvir

Updated on 28 July 2017

File name

PIL_11525_325.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 July 2017

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 25 April 2017

Reasons for updating

  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 19 April 2017

Reasons for 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

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 April 2015

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

Section 4.8 – Undesirable effects and section 10 date of revision (to update the AE reporting text in the SPC)

Updated on 03 February 2015

Reasons for updating

  • Correction of spelling/typing errors

Updated on 08 December 2014

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 14 July 2014

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 26 June 2014

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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

Changes to Sections 7- Marketing Authorisation Holder, 8- Marketing Authorisation Number and section 10 date of revision.

Updated on 29 May 2014

Reasons for updating

  • Change to section 4.3 - Contraindications

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 May 2014

Reasons for 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

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 May 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change due to harmonisation of PIL

Updated on 24 June 2013

Reasons for updating

  • Correction of spelling/typing errors

Updated on 06 June 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to date of revision

Updated on 23 May 2013

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 4.5 - 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

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 July 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 4.5 - 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

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 20 May 2011

Reasons for updating

  • Change to improve clarity and readability

Updated on 15 May 2009

Reasons for 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

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 15 May 2009

Reasons for updating

  • Change to storage instructions
  • Change to further information section
  • Change to appearance of the medicine

Updated on 14 August 2008

Reasons for 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

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

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 14 August 2008

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation
  • Change to improve clarity and readability

Updated on 03 October 2006

Reasons for updating

  • New PIL for medicines.ie

Updated on 31 July 2006

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 26 July 2004

Reasons for 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

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

Updated on 23 June 2003

Reasons for updating

  • New SPC for medicines.ie

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