Teveten 600mg Film-coated Tablets
*Company:
Mylan IRE Healthcare 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 20 October 2020
File name
ie-spc-de0114-600mg-WS712-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 October 2020
File name
ie-mt-pil-de0114-400mg600mg-WS712-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 14 June 2019
File name
IE_SmPC_600mg_CRN2204187_27Apr2018_clean.pdf
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
File name
IE_SmPC_600mg_CRN2204187_27Apr2018_clean.docx
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
File name
IE_PIL_400_600_CRN2204187_27Apr2018_emc.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 14 December 2017
File name
PIL_13635_113.pdf
Reasons for updating
- New PIL for new product
Updated on 13 July 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 13 July 2017
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
Updated on 13 July 2017
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Free text change information supplied by the pharmaceutical company
Updated on 05 July 2017
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 05 July 2017
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
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
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
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
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
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
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
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
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
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
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
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Free text change information supplied by the pharmaceutical company
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 05 December 2012
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 05 December 2012
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
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
Updated on 30 November 2011
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
Updated on 17 June 2010
Reasons for updating
- 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 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
Warnngs and precautions concerning use in pregnancy and lactation have been updated and the name of the MAH has changed to reflect new ownership.
The information on the use during pregnancy (sections 4.4 and 4.6) has been revised by including more detail of the possible risk to the foetus to enable prescribers to make a better informed treatment decision.
In section 7, the name of the MAH has been changed to Abbott Healthcare Products Ltd.
Updated on 17 June 2010
Reasons for updating
- 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 7 - Marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Warnngs and precautions concerning use in pregnancy and lactation have been updated and the name of the MAH has changed to reflect new ownership.
The information on the use during pregnancy (sections 4.4 and 4.6) has been revised by including more detail of the possible risk to the foetus to enable prescribers to make a better informed treatment decision.
In section 7, the name of the MAH has been changed to Abbott Healthcare Products Ltd.
Updated on 23 December 2008
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
Updated on 23 December 2008
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Free text change information supplied by the pharmaceutical company
Updated on 21 January 2005
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
Reasons for updating
- Change to section 6.3 - Shelf life
Updated on 16 November 2004
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
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
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
Reasons for updating
- New SPC for new product