MicardisPlus 80 mg/25 mg

  • Name:

    MicardisPlus 80 mg/25 mg

  • Company:
    info
  • Active Ingredients:

    Hydrochlorothiazide, Telmisartan

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/12/18

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Summary of Product Characteristics last updated on medicines.ie: 18/12/2018

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Boehringer Ingelheim Limited

Boehringer Ingelheim Limited

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Medicine Name MicardisPlus 80 mg/12.5 mg tablets Active Ingredients Hydrochlorothiazide, Telmisartan
Medicine Name MicardisPlus 80 mg/25 mg Active Ingredients Hydrochlorothiazide, Telmisartan
1 - 0 of 50 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 20 December 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 18 December 2018 SmPC

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 6 December 2018 PIL

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 5 December 2018 SmPC

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

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

Updated on 11 July 2018 PIL

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 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 10 August 2017 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 1 June 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 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 30 May 2017 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 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

2 Typographical change
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)
4.8 was updated to include the  revised adverse drug reaction reporting Maltese address

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

Updated on 30 May 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 6 October 2016 PIL

Reasons for updating

  • Change of contraindications
  • Change to instructions about overdose
  • Change to information about drinking alcohol
  • 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 24 September 2014 PIL

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 4 December 2013 PIL

Reasons for updating

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

Updated on 4 December 2013 SmPC

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 26 June 2013 PIL

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 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
  • Change to section 4.9 - Overdose
  • 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, 4.3 and 4.4
Updated with a statement that concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes or renal impairment.

Section 4.5
Updated with a statement that concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes or renal impairment, and including further information regarding concomitant use of telmisartan with aliskiren and new information on co-administration of telmisartan with digoxin.

Section 4.8
Updated to include acute myopia as additional adverse reaction associated with the use of hydrochlorothiazide alone.  Minor editorial updates to align with final approved texts.

Section 4.9
Minor editorial updates to align with final approved texts.

Section 10
Date of revision amended.

Updated on 6 December 2012 SmPC

Reasons for updating

  • 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 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 Special Warnings and Precautions for Use

A new final sub-heading and corresponding text regarding Acute Myopia and Angle-Closure Glaucoma have been added to this section.

 

Section 4.6 Pregnancy and Lactation

A typographical error has been corrected in the final paragraph of the Pregnancy sub-heading of this section i.e. the word Hydorchlorothiazide has been amended to Hydrochlorothiazide.

 

Section 4.8 Undesirable Effects

The text …, acute angle-closure glaucoma has been added to the Eye disorders details of the Hydrochlorothiazide sub-heading of this section.

 

Section 10 Date of Revision of the Text

The date has been amended from May 2012 to October 2012.

 

Updated on 11 July 2012 PIL

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 20 June 2012 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 6.5 - Nature and contents of container
  • 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

MicardisPlus 80/25 mg SPC ref M3b;80_25mg/All/SPC/8 dated May 2012

Editorial changes have been made to the following sections

2 Qualitative and Quantitative Composition
4.1Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.5 Interaction with other medicinal products and other forms of interaction
4.7 Effects on ability to drive and use machines
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
10 Date of revision of the text

Major changes have been made to the following sections

4.4 Special Warnings and precautions
Section under “Dual blockade of the renin-angiotensin-aldosterone system” has been revised.
Section under “Metabolic and endocrine effects” has been changed extensively.

4.6 Fertility, pregnancy and lactation
Under both Pregnancy and Breastfeeding sections “hydrochlorothiazide during pregnancy” has been updated extensively. Additional side effects added plus editorial changes.

4.8 Undesirable effects
The section has been updated extensively.

Updated on 17 February 2012 PIL

Reasons for updating

  • Change of manufacturer
  • 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 20 May 2011 SmPC

Reasons for updating

  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • 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 3 Pharmaceutical Form

Size of tablets details (in mm) have been added to this section.

 

Section 4.2 Posology and Method of Administration

The text … once daily with liquid, with or without food has been deleted from the first sentence of the first paragraph of this section.

 

A new sub-heading entitled Special populations has been added to this section.

 

The previous sub-heading entitled Children has been updated to now read Paediatric population.  This sub-heading paragraph has had both text added to and removed from it.

 

New sub-headings and corresponding text entitled Method of administration and Precautions to be taken before handling or administering the medicinal product have been added to this section.

 

Section 4.4 Special Warnings and Precautions for Use

The text … ,including hydrochlorothiazide has been added to the end of the fourth to last sentence of this section.

 

Section 4.6 Fertility, Pregnancy and Lactation

The header of this section has been amended from Pregnancy and Lactation to Fertility, Pregnancy and Lactation.

 

The sub-heading Lactation has been deleted and replaced with Breastfeeding.

 

A new final sub-heading and corresponding text entitled Fertility has been added to this section.

 

Section 4.8 Undesirable Effects

A new first sub-heading (a. Summary of the safety profile) and corresponding text has been added to this section.

 

A new second sub-heading (b. Tabulated summary of adverse reactions) has been added to this section.

 

The following frequency grouping details within the section b. sub-heading have been amended, with text being deleted from and added to: Infections and infestations, Immune system disorders, Metabolism and nutrition disorders, Gastrointestinal disorders, Hepatobiliary disorders and Skin and subcutaneous tissue disorders.

 

Points 1 and 2 at the end of the frequency grouping details have been added.

 

All of the frequency grouping details within the Telmisartan sub-heading have had both text added to and deleted from.  All Not knowns have been replaced with either Uncommon or Rare.

 

Point 3 at the end of the frequency grouping details has been added.

 

The typographical error Sialoadenitis has been corrected to Sialadenitis in the Infections and infestations frequency grouping of the Hydrochlorothiazide sub-heading.

 

The word Aplastic has been moved to now come before the word Anaemia in the Blood and lymphatic system disorders grouping of the Hydrochlorothiazide sub-heading.

 

A new sub-heading (c. Description of selected adverse reactions) and corresponding text (points 1 and 2) has been added to this section.

 

Section 5.3 Preclinical Safety Data

A new last but one paragraph has been added to this section i.e. regarding no evidence of a teratogenic effect.

 

Section 10 Date of Revision of the Text

The date has been updated from 27 April 2010 to 02 May 2011.

Updated on 14 June 2010 PIL

Reasons for updating

  • Change to side-effects
  • Change to further information section

Updated on 11 May 2010 PIL

Reasons for updating

  • Change to side-effects

Updated on 16 July 2009 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company



Sections 4.8 and 5.1 have been updated to include adverse event data obtained with telmisartan in clinical trials of patients over 50 at risk of cardiovascular events.

 

Section 4.8 (Undesirable effects)

“sepsis including fatal outcome” has been added to the list of adverse events reported with telmisartan alone, the frequency is not known.

The following related information has also been added to section 4.8:

“*In the PRoFESS trial, an increased incidence of sepsis was observed with telmisartan compared with placebo. The event may be a chance finding or related to a mechanism currently not known (see section 5.1).”

 

Section 5.1 has been updated with the following information:

“In the "Prevention Regimen For Effectively avoiding Second Strokes" (PRoFESS) trial in patients 50 years and older, who recently experienced stroke, an increased incidence of sepsis was noted for telmisartan compared with placebo, 0.70 % vs. 0.49 % [RR 1.43 (95 % confidence interval 1.00 - 2.06)]; the incidence of fatal sepsis cases was increased for patients taking telmisartan (0.33 %) vs. patients taking placebo (0.16 %) [RR 2.07 (95 % confidence interval 1.14 - 3.76)]. The observed increased occurrence rate of sepsis associated with the use of telmisartan may be either a chance finding or related to a mechanism not currently known.”

Updated on 16 June 2009 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 24 April 2009 SmPC

Reasons for updating

  • 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 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

 

Reason for update:

Change to sections 4.3, 4.4, 4.6 and 10

 

Main changes

The SPC has been updated following the EMEA approval of the EU class labelling for lactation on the 18/03/09.

 

Lactation has been removed from section 4.3, contraindications.

 

The information on lactation in section 4.6 has been replaced with the following:

Because no information is available regarding the use of Micardis during breast-feeding, Micardis is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.

Updated on 4 March 2009 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • 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

4.4       Special warnings and precautions for use 

Information on cases of photosensitivity reported with thiazide diuretics has been added.

 

4.8              Undesirable effects

This section has been entirely reformatted.  Details of the side effects and their frequencies have been updated in this section.

 

4.9              Overdose

Information on the effects of telmisartan overdose has been added:

The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia, dizziness, vomiting, increase in serum creatinine, and acute renal failure have also been reported. 

Updated on 11 September 2008 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 August 2008 SmPC

Reasons for updating

  • New SPC for new product

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