Micardis 40 mg Tablets
*Company:
Boehringer Ingelheim LimitedStatus:
UpdatedLegal 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 20 December 2024
File name
40 mg Annex PIL text - PRAC-IA-angioedema.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 20 December 2024
File name
M3a-40&80mg-EU-SPC-29.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
The SmPC has been updated to align with the PRAC recommendation to include the signal for intestinal angioedema with Angiotensin II receptor blockers in sections 4.4 and 4.8. The date of revision (section 10) has been updated to 12/2024.
Updated on 19 October 2023
File name
40 mg Annex PIL text -WS-2489-G.pdf
Reasons for updating
- Change to section 2 - driving and using machines
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Update to section 2 and 4 and section 6. Minor editorial changes and the term antagonists/antagonist changed to blockers/blocker throughout the PIL.
Updated on 17 October 2023
File name
M3a-40&80mg-EU-SPC-28.pdf
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 4.7 - 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 4.9 - Overdose
- 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
The following sections of the SmPCs have been updated:
- Section 4.2: Moving of text under sub-headings – Posology and update to text under sub-headings - Renal impairment; Method of administration
- Section 4.4: Updated sub-headings - Volume and/or sodium depleted patients and Ischaemic heart disease
- Section 4.7: Replacing the terms “dizziness” and “drowsiness” by “syncope” and “vertigo” to align with ADR table in section 4.8
- Section 4.8: Addition of ADR “hyponatraemia” with frequency “rare”; minor editorial changes throughout the ADR table. Minor editorial update to AE reporting for Malta
- Section 4.9: Update to text under sub-heading – Management of telmisartan overdose
- Section 5.3: Addition of a new statement regarding telmisartan has no effect on male or female fertility
- Section 10: The date of revision has been updated to 09/2023
Updated on 08 November 2022
File name
40 mg Annex PIL text - IAin IG1564-G.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 06 September 2022
File name
M3a-40&80mg-EU-SPC-27.pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
We have split the current combined EU SmPC for Micardis 20 mg, 40 mg and 80 mg tablets into an SmPC for Micardis 20mg tablets and a combined SmPC for Micardis 40mg and 80mg tablets.
Updated on 31 March 2022
File name
40 mg Annex PIL text - IAin 0122G.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 31 March 2022
File name
M3a-EU-SPC-26.pdf
Reasons for updating
- 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
The following sections of the SmPC have been updated:
- SmPC Heading: Updated to include Northern Ireland
- Section 4.8: Updated to include AE reporting details for Northern Ireland
- Section 10: Date of revision has been updated to 02/2022
Updated on 03 December 2020
File name
40 mg Annex PIL text - WS 1950.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 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
Updated on 03 December 2020
File name
M3a-ALL-SPC-25 - medicines.ie.pdf
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 4.8 – Undesirable effects - how to report a side effect
- Change to section 7 - Marketing authorisation holder
- 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: The sub-section ‘Elderly’ under Posology has been moved (editorial update with no change to the text).
- Section 4.4: Update to the information related to the excipient ‘sorbitol’ including moving of this section. Information related to the excipient ‘sodium’ has been added.
- Section 4.8: Update to the Irish AE reporting details.
- Section 7: Minor update to the MA Holder address (removal of “D-” from the zip code).
- Section 10: Date of revision has been updated.
Updated on 21 June 2018
File name
40mg V0114G text.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 05 January 2018
File name
PIL_8963_157.pdf
Reasons for updating
- New PIL for new product
Updated on 05 January 2018
Reasons for updating
- Improved presentation of PIL
Updated on 21 November 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 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
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 17 November 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 4.2 - 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 26 September 2014
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
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
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
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
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 17 October 2013
Reasons for updating
- Improved electronic presentation
Updated on 20 June 2013
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 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
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 04 March 2013
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 06 July 2012
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
Reasons for updating
- Change to MA holder contact details
- Change to name of manufacturer
Updated on 06 June 2011
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
Reasons for updating
- Change to, or new use for medicine
Updated on 09 October 2009
Reasons for updating
- Improved electronic presentation
Updated on 09 June 2009
Reasons for updating
- Improved electronic presentation
Updated on 25 March 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
- Improved electronic presentation
Updated on 17 September 2004
Reasons for updating
- New PIL for medicines.ie