MicardisPlus 80 mg/12.5 mg tablets *
Pharmacy Only: Prescription

Updated on 27 September 2022

File name

633305900598b.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Following sections updated:

Section 4.4: New subheadingAcute Respiratory Toxicity’ and inclusion of information related to very rare severe cases of acute respiratory toxicity, including acute respiratory distress syndrome (ARDS) reported after taking hydrochlorothiazide. 

Section 4.8: Inclusion ofRespiratory, thoracic and mediastinal disorders’ section into the side effects for the use of hydrochlorothiazide alone table


Updated on 27 September 2022

File name

6332bb69b56c1.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 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 4.4: New subheading ‘Acute Respiratory Toxicity’ and inclusion of information related to very rare severe cases of acute respiratory toxicity, including acute respiratory distress syndrome (ARDS) reported after taking hydrochlorothiazide. 
  • Section 4.8: Inclusion of ‘Respiratory, thoracic and mediastinal disorders’ section into the side effects for the use of hydrochlorothiazide alone table
  • Section 10 date of revision has also been updated to 11.08.2022.


Updated on 18 March 2022

File name

PIL 80mg 12.5mg - IAin 0122G_1647615421.pdf

Reasons for updating

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

Updated on 14 July 2021

File name

PIL 80mg 12.5mg_1626275662.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 2 - excipient warnings
  • 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 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 13 July 2021

File name

M3b;40_12.5,80_12.5-All-SPC-7 - medicines.ie_1626181374.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

The following sections of the SmPC have been updated:

  • Section 2 Qualitative and quantitative composition: Excipients with known effect were updated to include the amount of lactose monohydrate that is equivalent to lactose anhydrous for each dosage.
  • Section 4.4 Special warnings and precautions for use: Added warning/precautions for Lactose and Sorbitol
  • Section 4.8 Undesirable side effects: AE details were updated to include “United Kingdom (Northern Ireland)”
  • Section 10 Date of revision of the SmPC has also been updated to 17 June 2021 to align with the date of Positive Opinion.

Other editorial changes have been made throughout the SmPC.

Updated on 21 May 2020

File name

8012.5mg PIL_1590069820.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 21 May 2020

File name

M3b;40_12.5,80_12.5-All-SPC-6-medicines.ie_1590054879.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 10 - Date of revision of the text

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

Updated on 27 March 2020

File name

8012.5mg PIL_1585312293.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product looks like and pack contents
  • Change to date of revision

Updated on 27 March 2020

File name

M3b;40_12.5,80_12.5-All-SPC-5-medicines.ie_1585308540.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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

Update of the SmPC to more accurately describe the shape of the tablets from Oval to Oblong:

  • Section 3: Change in description of the tablet from “oval” to “oblong”.
  • Section 4.8: Update to the Irish adverse reporting contact information.
  • Section 10: Date of revision has been updated to 19 March 2020.

Updated on 20 December 2018

File name

IG1011 PRAC annex text 80_12.5 new date_1545315400.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 18 December 2018

File name

M3b;40_12.5,80_12.5-All-SPC-4_1545140909.pdf

Reasons for updating

  • 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 only update to the previous versions, implemented on 04 December 2018, is to section 10 date of revision

Updated on 06 December 2018

File name

IG1011 PRAC annex text 80_12.5_1544099467.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 05 December 2018

File name

M3b;40_12.5,80_12.5-All-SPC-3_1544008538.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 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
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Sections 4.4, 4.8 and 5.1 of the SmPCs have been updated. In addition a minor editorial update has been made to the section 4.8 AE reporting details. A minor correction has also been made to the SmPC title for the 40 mg/12.5 mg and 80 mg/12/5 mg tablets.

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

Updated on 11 July 2018

File name

Annex PIL text - 80 mg - 12.5 mg.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 10 July 2018

File name

medie M3b;40_12.5,80_12.5-All-SPC-2.docx

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

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

Updated on 10 August 2017

File name

PIL_10926_202.pdf

Reasons for updating

  • New PIL for new product

Updated on 10 August 2017

Reasons for updating

  • Improved presentation of PIL

Updated on 01 June 2017

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 6 - date of revision
  • Change to other sources of information section

Updated on 30 May 2017

Reasons for updating

  • New SPC for new product

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

Updated on 30 May 2017

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 4.1 - Therapeutic indications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

-Sections 1, 2, 3, 4.1, 8 updated as a result of merging the 40/12.5 mg and 80 mg/12.5 mg SPCs

-Sections updated in line with CCDS 0252-11  4.2, 4.4, 4.5, 4.7, 4.8, 5.1, 5.2, 6.6.

 

4.2, 4.5, 4.8, 5.1 (Clarification of sub-headings and minor editorial clarifications)

4.4 (update to contraindication for  patients with severe renal impairment)

4.5 (Detail added regarding interactions with Calcium salts)

4.7 (Clarification of instructions on driving and use machines)

4.8 (Hydrochlorothiazide adverse reactions frequencies revised for: Thrombocytopenia, hypomagnesaemia, hypercalcaemia, hypochloraemic alkalosis, headache, nausea, erythema multiforme)

5.1 (Section rearranged with revised sub-headings)

Paediatric population detail added

5.2 (Details regarding Linearity/non-linearity updated)

6.6 (Updated disposal instructions)

 


-Section 4.8 was updated to include the  revised adverse drug reaction reporting Maltese address.

-Sections 2 Typographical change

-Section 10 revision date updated in line with PO (06Apr17).

Updated on 03 October 2016

Reasons for updating

  • Change of contraindications
  • Change to instructions about overdose
  • Change to side-effects
  • Change to information about drinking alcohol
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 24 September 2014

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 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.

 

Further to the above, an error has been corrected within Section 4.8 regarding the frequency of hyperkalaemia together with an additional minor/editorial update. These changes were made to align with the final approved texts and impact the 40/12.5 mg and 80/12.5 mg strength only.

Updated on 24 September 2014

Reasons for updating

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

Updated on 04 December 2013

Reasons for updating

  • 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

Section 4.8 Undesirable Effects

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 5.1 Pharmacodynamic Properties

A new sub-heading (and corresponding text) regarding Cardiovascular prevention has been added to this section.  In total, 7 new paragraphs have been added.

 

The previous text of The effects of telmisartan on mortality and cardiovascular morbidity are currently unknown has been deleted from this section.  The text was previously located between the In the “Prevention Regimen for Effectively avoiding Second Strokes” … and Hydrochlorothiazide is a thiazide diuretic … paragraphs.

 

Section 10 Date of Revision of the Text

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

 

Updated on 04 December 2013

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 26 June 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to further information section
  • Change to date of revision

Updated on 21 June 2013

Reasons for updating

  • Addition of separate SPCs covering individual presentations

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 11 July 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Change to MA holder contact details

Updated on 15 February 2012

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 19 July 2011

Reasons for updating

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

Updated on 08 May 2010

Reasons for updating

  • Change to side-effects

Updated on 09 June 2009

Reasons for updating

  • Improved electronic presentation

Updated on 22 August 2008

Reasons for updating

  • Improved electronic presentation

Updated on 11 September 2007

Reasons for updating

  • Improved electronic presentation

Updated on 12 June 2006

Reasons for updating

  • New PIL for medicines.ie