Omesar Plus 40 mg/12.5 mg & 40 mg/25 mg film-coated tablets
*Company:
A. Menarini Pharmaceuticals Ireland LtdStatus:
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 14 June 2023
File name
Omesar Plus 40mg SmPC Clean Approved May 23.pdf
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 5.3 - minor update to text
Updated on 07 April 2022
File name
Omesar Plus 40mg SmPC Clean Approved March 22.pdf
Reasons for updating
- 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 4.8 - AI Hepatitis added to Hepato-biliary disorders
Section 10 - date of revision updated
Updated on 07 April 2022
File name
Omesar Plus 40mg PIL Clean Approved March 22.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 4 - new side effect - Hepatitis added
Section 6 - date of revision updated
Updated on 31 January 2022
File name
Omesar Plus 40mg SmPC Clean Approved Jan 22.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 section added on Acute Respiratory Toxicity
Section 4.8 - New adverse event added - Acute Respiratory Distress Syndrome (ARDS)
Section 10 - Date of revision updated
Updated on 31 January 2022
File name
Omesar Plus 40mg PIL Clean Approved Jan 22.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
Section 2 - New warning added under "tell your doctor" regarding lung problems
Section 4 - New adverse event added "acute respiratory distress"
Section 6 - Date of revision updated
Updated on 18 August 2020
File name
ie-pl-Omesar Plus 40 mg clean 8-7-20.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
Updated on 18 August 2020
File name
ie-spc-Omesar Plus 40mg clean 8-7-20.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
Updated on 27 March 2019
File name
ie-pl-Omesar Plus 40 mg clean 14-3-19.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 27 March 2019
File name
ie-spc-Omesar Plus 40mg clean 14-3-19.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 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)
Updated on 10 January 2017
File name
PIL_14813_661.pdf
Reasons for updating
- New PIL for new product
Updated on 10 January 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 10 January 2017
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: Special warnings and precautions for use
Addition of warning on Acute Myopia and Secondary Angle-Closure Glaucoma:
Section 4.8 Undesirable effects
Addition of Acute myopia, acute angle-closure glaucoma – frequency not known.
Updated on 10 January 2017
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 June 2016
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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 9 - Date of renewal of authorisation
- 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
To update the warning on sprue-like enteropathy. With reference to the very rare reported cases, it has been clarified that if a patient develops symptoms of severe, chronic diarrhoea with substantial weight loss and in absence of other apparent etiologies "olmesartan treatment should be immediately discontinued and should not be restarted. If diarrhoea does not improve during the week after the discontinuation, further specialist (e.g. a gastro-enterologist) advice should be considered"
Minor changes to other sections of the SmPC to align to the latest QRD template.
Updated on 18 December 2014
Reasons for updating
- 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 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 4.3 Contraindications
New contra-indication added on the concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment.
Section 4.4 Special warnings and precautions
New warning added regarding the dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is not recommended,
Section 4.5 Interactions with other medicinal products and other forms of interaction
New interaction added for ACE-inhibitors, angiotensin II receptor blockers or aliskiren.
Section 5.1 Pharmacodynamic properties
Details of two studies added with details about the use of combination of an ACE-inhibitor with an angiotensin II receptor blocker.
Information added on a further study to test the benefit of adding aliskiren to a standard therapy of an ACE-inhibitor or an angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both.
Section 10 Date of revision of the text
Updated to December 2014
Updated on 18 December 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to drug interactions
- Change to date of revision
Updated on 25 November 2014
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 4.5 Interaction with other medicinal products
Interaction with colesevelam added
Section 10 Date of revision of the text
Date of revision updated to November 2014
Updated on 25 November 2014
Reasons for updating
- Change to drug interactions
- Change to date of revision
Updated on 28 October 2014
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
Section 4.4 Special warnings and precautions for use
Information on Sprue-like enteropathy added
Section 4.8 Undesirable effects
- Sprue-like enteropathy added as a very rare side-effect
- Reporting of suspected adverse reactions – updated with HPRA details
Section 5.1 Pharmacodynamic properties
Information on the risk of cardiovascular mortality in patients with Type II - diabetes following the outcome of ORIENT/ROADMAP studies.
Section 10 Date of revision of the text
Date of revision updated to Oct 2014
Updated on 28 October 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 11 February 2014
Reasons for updating
- 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 4.3 - 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 - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 9 - Date of renewal of authorisation
- 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 on 11 February 2014
Reasons for updating
- Change to improve clarity and readability
- Addition of information on reporting a side effect.
Updated on 02 November 2012
Reasons for updating
- Change to date of revision
- Addition of manufacturer
Updated on 27 April 2012
Reasons for updating
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to further information section
- Change to date of revision
Updated on 02 February 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 31 January 2012
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- 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
- Implementation of the Guideline on Summary of Product Characteristics (SmPC) 2009. Sections 4.1, 4.2, 4.7, 5.1, 5.2, 6.6, 9, 10 have been amended.
- Section 4.8 Undesirable effects: A single table listing all adverse events reported with the combination and the individual active substances.
Updated on 02 February 2011
Reasons for updating
- Change to side-effects
- Change to drug interactions
Updated on 05 October 2010
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 05 October 2010
Reasons for updating
- New PIL for new product