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Micardis 40 mg Tablets

  • Name:

    Micardis 40 mg Tablets

  • Company:
    info
  • Active Ingredients:

    Telmisartan

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/06/18

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Summary of Product Characteristics last updated on medicines.ie: 17/11/2017
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Boehringer Ingelheim Limited

Boehringer Ingelheim Limited

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Medicine Name Micardis 20 mg Tablets Active Ingredients Telmisartan
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1 - 0 of 47 items.Total: Infinity pages

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 21 June 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 5 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 January 2018 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 21 November 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to other sources of information section
  • Change to MA holder contact details
  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 17 November 2017 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.4 - 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
  • Change from individual to joint SPC

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

Free text change information supplied by the pharmaceutical company

The following sections of the SPC have been updated to combine the SPCs and align with the current European Template 1, 2, 3, 4.2, 4.5, 4.8, 4.9, 5.2, 6.3, 6.5, 6.6, 8 and 10. A minor editorial correction has also been made to section 4.4.

Section 10, date of revision of the text has also been updated.

Updated on 17 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 26 September 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 24 September 2014 SmPC

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 - how to report a side effect
  • 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)

Free text change information supplied by the pharmaceutical company

The SPCs have been updated to been revised to take into account the updated wording for concomitant use with ARBs or aliskiren in the contraindication, warning and interactions section of SPC following conclusion of the EU Art 31 Referral Procedure on RAS acting agents – class labelling request (ref EMEA-H-A-31-1370).  Date of EC decision is 4 September 2014 with final text being available 10 September. Sections affected are 4.2, 4.3, 4.4, 4.5 also with revision to 5.1. In addition, in section 4.8 the Irish Authority contact details for Adverse Event reporting have been revised following the recent authority name change. Date of revision has also been updated to September 2014.

Updated on 27 January 2014 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Section 4.8 Undesirable Effects

Dysgeusia has been added to the tabulated summary of adverse reactions (in the Gastrointestinal disorders details) of this section.

 

New text regarding the reporting of suspected adverse reactions in the UK, Ireland and Malta has been added at the end of this section.  In total, four new paragraphs have been added.

 

Section 10 Date of Revision of the Text

The date has been amended from May 2013 to December 2013.

 

Updated on 27 January 2014 PIL

Reasons for updating

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

Updated on 17 October 2013 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 17 October 2013 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 20 June 2013 SmPC

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

Section 1; 2; 3; 6.3; 6.5; 8 updates due to splitting into separate documents relating to different strengths

Section 4.4 has been updated with a warning statement that concomitant use of Telmisartan with aliskiren is contraindicated in patients with diabetes or renal impairment under the subheading ‘Dual blockade of the Renin-Angiotensin-Aldosterone System’.

Sections 4.2, 4.3 and 4.5
Related statements to that in section 4.4 have also been included.

Section 4.5
Also includes new information on co-administration of telmisartan with digoxin.

Sections 5.1, 5.2 and 5.3
Minor/editorial updates have been made.

Section 10
Date of revision of the text has also been updated to May 2013.

Updated on 20 June 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to drug interactions
  • Change to date of revision
  • Change to MA holder contact details

Updated on 4 March 2013 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 6 July 2012 PIL

Reasons for updating

  • Change of manufacturer
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about driving or using machinery
  • Change to how the medicine works
  • Change to further information section
  • Change to date of revision

Updated on 19 July 2011 PIL

Reasons for updating

  • Change to MA holder contact details
  • Change to name of manufacturer

Updated on 6 June 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Introduction of new pack/pack size

Updated on 23 December 2009 PIL

Reasons for updating

  • Change to, or new use for medicine

Updated on 9 October 2009 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 9 June 2009 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 25 March 2009 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 22 August 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 11 September 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 12 June 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 17 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie