MicardisPlus 80 mg/25 mg
*Company:
Boehringer Ingelheim LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 05 March 2024
File name
PIL 80mg 25mg - WS2573_clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - driving and using machines
- 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 looks like and pack contents
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 28 February 2024
File name
M3b;80_25 mg-EU-SPC-21_medicines(ie).pdf
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 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 08 November 2022
File name
PIL 80mg 25mg - IAin IG-1564-G.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 27 September 2022
File name
PIL 80mg 25mg - IAin IG-1549.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 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
Updated on 27 September 2022
File name
M3b80_25 mg-EU-SPC-20 - medicines.ie.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 25mg - IAin 0122G.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 25mg.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;80_25 mg-All-SPC-19 - medicines.ie.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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
8025mg PIL.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;80_25 mg-All-SPC-18-medicines.ie.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
8025mg PIL.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;80_25 mg-All-SPC-17-medicines.ie.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_25 new date.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 18 December 2018
File name
M3b;80_25 mg-All-SPC-16.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_25.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;80_25 mg-All-SPC-15.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
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
File name
Annex PIL text -80 mg - 25 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;80_25 mg-All-SPC-14.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_13680_271.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 - 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
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 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 06 October 2016
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
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
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
- 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
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 06 December 2012
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
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
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
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
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 20 May 2011
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
Reasons for updating
- Change to side-effects
- Change to further information section
Updated on 11 May 2010
Reasons for updating
- Change to side-effects
Updated on 16 July 2009
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
Reasons for updating
- Improved electronic presentation
Updated on 24 April 2009
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
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 04 March 2009
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
Reasons for updating
- New PIL for medicines.ie
Updated on 27 August 2008
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)