Teveten 600mg Film-coated Tablets

  • Name:

    Teveten 600mg Film-coated Tablets

  • Company:
    info
  • Active Ingredients:

    Eprosartan mesilate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 29/05/18

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Summary of Product Characteristics last updated on medicines.ie: 14/6/2019

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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

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1 - 0 of 97 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 14 June 2019 SmPC

Reasons for updating

  • Change to improve clarity and readability

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

Updated on 29 May 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 29 May 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 14 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 13 July 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 13 July 2017 SmPC

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)

Free text change information supplied by the pharmaceutical company

In section 6.5, deletion of bottles as immediate packaging container

Updated on 13 July 2017 PIL

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Free text change information supplied by the pharmaceutical company

In section 6.5, deletion of bottles as immediate packaging container

Updated on 5 July 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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

7.  MARKETING AUTHORISATION HOLDER

Mylan IRE Healthcare Limited

Unit 35/36

Grange Parade

Baldoyle Industrial Estate

Dublin 13

Ireland

BGP Products Ireland Limited

4051 Kingswood Drive,

Citywest Business Campus,

Dublin 24

8. MARKETING AUTHORISATION NUMBER

 

PA 2010/17/2 2007/14/2

10. DATE OF REVISION OF THE TEXT

 

June 2017

Updated on 5 July 2017 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

7.  MARKETING AUTHORISATION HOLDER

Mylan IRE Healthcare Limited

Unit 35/36

Grange Parade

Baldoyle Industrial Estate

Dublin 13

Ireland

BGP Products Ireland Limited

4051 Kingswood Drive,

Citywest Business Campus,

Dublin 24

8. MARKETING AUTHORISATION NUMBER

 

PA 2010/17/2 2007/14/2

10. DATE OF REVISION OF THE TEXT

 

June 2017

Updated on 14 April 2015 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Free text change information supplied by the pharmaceutical company

Section 7:
MA Holder changed from Abbott Healthcare Products Limited to BGP Products Ltd

Section 8:
PA Number changed from PA 108/23/4 to PA 2007/14/2 

Updated on 14 April 2015 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

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

Free text change information supplied by the pharmaceutical company

Section 7:
MA Holder changed from Abbott Healthcare Products Limited to BGP Products Ltd

Section 8:
PA Number changed from PA 108/23/4 to PA 2007/14/2 

Updated on 27 January 2015 PIL

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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data

Free text change information supplied by the pharmaceutical company

Section 4.3 Contraindications
Addition of bullet point - The concomitant use of Teveten with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GRF < 60ml/min/1.73 m2) (see section 4.5 and 5.1)

Section 4.4 Special warnings and precautions for use
Addition of a separate paragraph in relation to Doal blockade of the renin-angiotensin-aldosterone system (RAAS)
Updating "Eprosartan" with "angiotensin II receptor blockers"

Section 4.5 Interaction with other medicinal products and other forms of interaction
Deletion of the following paragraphs:
"No effect on the pharmacokinetics of digoxin and the pharmacodynamics of warfarin or glyburide (glibenclamide) has been shown with eprosartan.  Similarly no effect on eprosartan pharmacokinetics has been shown with ranitidine, ketoconazole or fluconazole"
"Eprosartan can be used concomitantly with thiazide diuretics (e.g. hydrochlorothiazide) and calcium channel blockers (e.g. sustained-release nifedipine) without evidence of clinically significant adverse interactions"

Addition of the following paragraph:
"Clinical trial data has shown that dual-blockade of the renin-angiotensis-alderstone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1)"    
 
Section 4.6 Pregnancy and lactation
Updating "eprosartan" with "angiotensin II receptor blockers"

Section 4.8 Undesirable Effects
Updating with a paragraph in relation to Reporting of Suspected Adverse Reactions

Section 5.1 Pharmacodynamic Pproperties
Addition of a paragraph in relation to two large randomised, controlled trials - ONTARGET and ALTITUDE

Section 5.3 Preclinical safety data
Removal of the following line in relation to Reproductive and Developmental toxicity in pregnant rabbits
"This is most likely due to effects on the renin-angiotensin aldosterone system"

Updated on 27 January 2015 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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 4.3 Contraindications
Addition of bullet point - The concomitant use of Teveten with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GRF < 60ml/min/1.73 m2) (see section 4.5 and 5.1)

Section 4.4 Special warnings and precautions for use
Addition of a separate paragraph in relation to Doal blockade of the renin-angiotensin-aldosterone system (RAAS)
Updating "Eprosartan" with "angiotensin II receptor blockers"

Section 4.5 Interaction with other medicinal products and other forms of interaction
Deletion of the following paragraphs:
"No effect on the pharmacokinetics of digoxin and the pharmacodynamics of warfarin or glyburide (glibenclamide) has been shown with eprosartan.  Similarly no effect on eprosartan pharmacokinetics has been shown with ranitidine, ketoconazole or fluconazole"
"Eprosartan can be used concomitantly with thiazide diuretics (e.g. hydrochlorothiazide) and calcium channel blockers (e.g. sustained-release nifedipine) without evidence of clinically significant adverse interactions"

Addition of the following paragraph:
"Clinical trial data has shown that dual-blockade of the renin-angiotensis-alderstone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1)"    
 
Section 4.6 Pregnancy and lactation
Updating "eprosartan" with "angiotensin II receptor blockers"

Section 4.8 Undesirable Effects
Updating with a paragraph in relation to Reporting of Suspected Adverse Reactions

Section 5.1 Pharmacodynamic Pproperties
Addition of a paragraph in relation to two large randomised, controlled trials - ONTARGET and ALTITUDE

Section 5.3 Preclinical safety data
Removal of the following line in relation to Reproductive and Developmental toxicity in pregnant rabbits
"This is most likely due to effects on the renin-angiotensin aldosterone system"

Updated on 14 November 2014 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Section 7 changed:
 
from:

Abbott Healthcare Products Limited.,
Mansbridge Road
West End
Southampton
SO18 3JD
UK



to:

Abbott Healthcare Products Limited.,

Abbott House,

Vanwall Business Park,

Vanwall Road,

Maidenhead,

SL6 4XE,

UK.

Updated on 14 November 2014 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Section 7 changed:
 
from:

Abbott Healthcare Products Limited.,
Mansbridge Road
West End
Southampton
SO18 3JD
UK



to:

Abbott Healthcare Products Limited.,

Abbott House,

Vanwall Business Park,

Vanwall Road,

Maidenhead,

SL6 4XE,

UK.

Updated on 5 December 2012 SmPC

Reasons for updating

  • 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


The following sentence has been added to section 4.9 Overdose:

There have been individual reports from postmarketing experience where doses up to 12,000 mg had been ingested. Most patients reported no symptoms. In one subject circulatory collapse occurred after ingestion of 12,000 mg eprosartan. The subject recovered completely.

Updated on 5 December 2012 PIL

Reasons for updating

  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company


The following sentence has been added to section 4.9 Overdose:

There have been individual reports from postmarketing experience where doses up to 12,000 mg had been ingested. Most patients reported no symptoms. In one subject circulatory collapse occurred after ingestion of 12,000 mg eprosartan. The subject recovered completely.

Updated on 30 November 2011 PIL

Reasons for updating

  • 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

Free text change information supplied by the pharmaceutical company

Update of sections 4.4, 4.5 & 4.8 of the SPC in line with the EU Core Safety Profile for Eprosartan

Updated on 30 November 2011 SmPC

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

Update of sections 4.4, 4.5 & 4.8 of the SPC in line with the EU Core Safety Profile for Eprosartan

Updated on 17 June 2010 SmPC

Updated on 17 June 2010 PIL

Updated on 23 December 2008 SmPC

Reasons for updating

  • 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

Section 5.1 Inclusion of MOSES trial data into the SPC

Updated on 23 December 2008 PIL

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Free text change information supplied by the pharmaceutical company

Section 5.1 Inclusion of MOSES trial data into the SPC

Updated on 21 January 2005 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Updated on 21 January 2005 PIL

Reasons for updating

  • Change to section 6.3 - Shelf life

Updated on 16 November 2004 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

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

Updated on 16 November 2004 PIL

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

Updated on 27 June 2003 SmPC

Reasons for updating

  • New SPC for new product

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

Updated on 27 June 2003 PIL

Reasons for updating

  • New SPC for new product