Omesar 10mg, 20mg and 40mg 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 07 April 2022
File name
Omesar 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 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 23 April 2020
File name
ie-leaflet clean 9-4-20.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to date of revision
Updated on 21 March 2019
File name
ie-spc clean 22-2-19.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to Section 3 Pharmaceutical Form - to update the description of the bossing of the tablets from ‘embossed’ to ‘debossed’.
Updated on 22 June 2017
File name
PIL_7908_296.pdf
Reasons for updating
- New PIL for new product
Updated on 22 June 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 June 2017
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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
A new therapeutic indication has been added in section 4.1: Treatment of hypertension in children and adolescents from 6 to less than 18 years of age.
The posology for the paediatric indication has been added in section 4.2 and other relevant changes have been introduced in section 4.5.
Updated on 22 June 2017
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 3 - use in children/adolescents
- Change to section 6 - date of revision
Updated on 04 August 2016
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to improve clarity and readability
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
Sprue-like enteropathy:
In very rare cases severe, chronic diarrhoea with substantial weight loss has been reported in patients taking olmesartan few months to years after drug initiation, possibly caused by a localized delayed hypersensitivity reaction. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan, and in the 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.
Also, amend ‘older people’ to ‘elderly’ and other minor administrative changes.
Updated on 04 August 2016
Reasons for updating
- Change to improve clarity and readability
Updated on 09 June 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic 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
Information on use in the paediatric population is added to the following sections of the SmPC:
4.2 Posology and method of administration
Posology:
Paediatric population
The safety and efficacy of olmesartan medoxomil in children and adolescents below 18 years has not been established. Currently available data are described in section 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Olmesartan medoxomil should not be used in children below 1 years of age because of safety concerns and lack of data in this age group.
4.8 Undesirable effects
Paediatric population
The safety of olmesartan medoxomil was monitored in 361 children and adolescents, aged 1-17 years old during 2 clinical trials. Whilst the nature and severity of the adverse events are similar to that of the adults, the frequency of the following is higher in the children:
- Epistaxis is a common adverse event in children (i.e. ≥ 1/100 to < 1/10) that has not been reported in adults.
- During the 3 weeks of double blind study, the incidence of treatment emergent dizziness and headache nearly doubled in children 6-17 years of age in the high olmesartan medoxomil dose group.
The overall safety profile for olmesartan medoxomil in paediatric patients does not differ significantly from the safety profile in adults.
Further information on use in the paediatric population is also added to sections 5.1 Pharmacodynamic properties and 5.2 Pharmacokinetic properties.
Updated on 09 June 2016
Reasons for updating
- Change to side-effects
- Change to date of revision
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 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 28 May 2013
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
The main changes are to implement the current Guideline on Summary of Product Characteristics (Revision 2) as well as the current QRD template (Revision 09), as follows:
· change in the SmPC section 4.8 with the introduction of a single table listing all adverse events reported in clinical trials, post-authorisation safety studies and spontaneous reporting, due to the different way of estimation of adverse reaction frequencies prescribed in the current SmPC guideline;
· editorial revisions.
Updated on 28 May 2013
Reasons for updating
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 20 May 2011
Reasons for updating
- Change to date of revision
- Addition of manufacturer
Updated on 30 November 2010
Reasons for updating
- Change to improve clarity and readability
Updated on 17 November 2009
Reasons for updating
- Change to section 4.3 - Contraindications
- 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
4.3 Contraindications
Lactation (see section 4.6) – removed
4.6 Pregnancy and lactation
The first sentence is put into a box:
The use of angiotensin II antagonists is not recommended during the first trimester of pregnancy (see section 4.4). The use of angiotensin II antagonists is contra-indicated during the 2nd and 3rd trimester of pregnancy (see sections 4.3 and 4.4).
Information on lactation expanded. The use of Omesar is not recommended during breast-feeding.
Updated on 12 November 2009
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 12 August 2008
Reasons for updating
- Change due to harmonisation of patient information leaflet
Updated on 07 August 2008
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - 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 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- 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 18 September 2007
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 5.2 - Pharmacokinetic 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
Updated on 18 September 2007
Reasons for updating
- Change to dosage and administration
Updated on 23 November 2006
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
- Change to section 5.2 - Pharmacokinetic 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
Updated on 23 November 2006
Reasons for updating
- Change of manufacturer
- Change to side-effects
Updated on 04 May 2006
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 17 November 2005
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 November 2004
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 November 2004
Reasons for updating
- Change to warnings or special precautions for use
Updated on 05 August 2004
Reasons for updating
- New PIL for new product
Updated on 04 August 2004
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)