Omesar Plus 20 mg/12.5 mg & 20 mg/25 mg Film-coated tablets

  • Name:

    Omesar Plus 20 mg/12.5 mg & 20 mg/25 mg Film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Hydrochlorothiazide, olmesartan medoxomil

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/08/20

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 18/8/2020

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A. Menarini Pharmaceuticals Ireland Ltd

A

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Medicine Name Drynol 2.5 mg/ml oral solution Active Ingredients Bilastine
Medicine Name Drynol 20 mg tablets Active Ingredients Bilastine
Medicine Name Eklira Genuair 322 micrograms inhalation powder Active Ingredients Aclidinium Bromide
Medicine Name Fastum 2.5% w/w gel Active Ingredients Ketoprofen
Medicine Name Frovex Active Ingredients Frovatriptan succinate monohydrate
Medicine Name Keral 25 mg granules for oral solution Active Ingredients Dexketoprofen trometamol
Medicine Name Keral 25mg Tablets Active Ingredients Dexketoprofen trometamol
Medicine Name Keral 50 mg/2ml Solution for injection/infusion Active Ingredients Dexketoprofen trometamol
Medicine Name Konverge film-coated tablets Active Ingredients Amlodipine besilate, olmesartan medoxomil
Medicine Name Konverge Plus film-coated tablets Active Ingredients Amlodipine besilate, Hydrochlorothiazide, olmesartan medoxomil
Medicine Name Nebilet Active Ingredients Nebivolol hydrochloride
Medicine Name Nebilet Plus 5 mg / 12.5 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Nebivolol hydrochloride
Medicine Name Nebilet Plus 5 mg / 25 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Nebivolol hydrochloride
Medicine Name Omesar 10mg, 20mg and 40mg Film-Coated Tablets Active Ingredients olmesartan medoxomil
Medicine Name Omesar Plus 20 mg/12.5 mg & 20 mg/25 mg Film-coated tablets Active Ingredients Hydrochlorothiazide, olmesartan medoxomil
Medicine Name Omesar Plus 40 mg/12.5 mg & 40 mg/25 mg film-coated tablets Active Ingredients Hydrochlorothiazide, olmesartan medoxomil
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1 - 0 of 31 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 18 August 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

The change is to update the PL in line with the PRAC recommendation on signals on choroidal effusion with hydrochlorothiazide.

The PIL is updated in Section 2 warnings and precautions and Section 4 side-effects.

Updated on 18 August 2020 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 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 change is to update the SmPC in line with the PRAC recommendation on the signal of choroidal effusion with hydrochlorothiazide.

Updates are made to sections 4.4 Warnings and precautions and 4.8 Undesirable effects.  

 

Updated on 27 March 2019 PIL

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 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 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Updates are made to sections 4.4 Warnings and precautions, 4.8 Undesirable effects and 5.1 Pharmacodynamic properties in line with the PRAC signal recommendation on skin cancer with hydrochlorothiazide

Updated on 10 January 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 10 January 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 10 January 2017 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 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 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 6 - date of revision

Updated on 4 August 2016 SmPC

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 4 August 2016 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 18 December 2014 PIL

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 18 December 2014 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - 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 25 November 2014 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 25 November 2014 SmPC

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 28 October 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 28 October 2014 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

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 11 February 2014 PIL

Reasons for updating

  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 11 February 2014 SmPC

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

SmPC update in order to align to CMDh QRD template, revision 7, dated April 2013 and also minor editorial amendments,

Updated on 2 November 2012 PIL

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 14 August 2012 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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 6.3: Shelf life updated from 3 to 5 years

Updated on 8 December 2011 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 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, 4.6, 4.7, 5.1, 5.2 have been amended accordingly.
  • Section 4.8 Undesirable effects: A single table listing all adverse events reported with the combination and the individual active substances has been added which replaces the previous separate tables.

Updated on 7 December 2011 PIL

Reasons for updating

  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to further information section
  • Change to date of revision

Updated on 4 November 2011 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 25 October 2011 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Section 4.2 Posology and method of administration – delete details on the maximum daily dose not being exceeded.  Clarification that elderly means age 65 years or older.

 

Section 4.6 Pregnancy and lactation update section on lactation and provide information for olmesartan medoxomil and hydrochlorothiazide.

 

Section 4.8 Undesirable side-effects – Add information on clinical trials in 40 mg strengths and update Adverse Events table to add side-effects and amend the frequencies of existing side-effects for all fixed dose combination strengths.  Update Adverse Events tables for olmesartan medoxomil and hydrochlorothiazide also.

 

Section 9 Date of first authorization/renewal - Date of last renewal added.

 

Section 10 Date of revision of the test - Date of last revision updated to October 2011

Amend typographical errors throughout the SmPC. 

Updated on 18 October 2011 PIL

Reasons for updating

  • Change due to harmonisation of PIL
  • Addition of joint PIL covering all presentations

Updated on 17 December 2009 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 4.3 - Contraindications
  • 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 5.2 - Pharmacokinetic properties

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 as follows:

2. Qualitative and Quantitative Composition

Excipients statement added re lactose

 

4.2 Posology and method of administration

4.4 Special warnings and precautions

5.2 Pharmacokinetic properties

Hepatic impairment – use with caution in patients with mild to moderate hepatic impairment.  Do not use in patients with severe hepatic impairment, cholestasis and biliary obstruction.

 

4.3 Contraindications

Lactation contraindication removed

 

4.4 Special warnings and precautions for use

4.6 Pregnancy and lactation

Do not use in first trimester of pregnancy.  Contra-indication in 2nd and third trimester of pregnancy.

Do not initiate during pregnancy, change to alternative anti-hypertensive treatments for planned pregnancies, stop treatment immediately in pregnancy and start alternative therapy if appropriate.

Lactation: Not recommended and alternative treatments during breast-feeding are preferable.

 

4.8 Side –effects

Re-formatted tables included with updated frequencies

 

Updated on 9 December 2009 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 23 November 2006 PIL

Reasons for updating

  • Change of manufacturer

Updated on 4 May 2006 SmPC

Reasons for updating

  • New SPC for new product

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

Updated on 4 May 2006 PIL

Reasons for updating

  • New PIL for new product