Atacand 8mg 16mg Tablets
- Name:
Atacand 8mg 16mg Tablets
- Company:
AstraZeneca Pharmaceuticals (Ireland) DAC
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/01/19
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AstraZeneca Pharmaceuticals (Ireland) DAC
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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 4 January 2019 SPC
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
Change to section 7 – Marketing Authorisation Holder details updated
Change to section 8 – Marketing Authorisation Numbers updated
Change to section 10 – date of revision of the text updated
Updated on 4 January 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 11 December 2018 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 11 December 2018 SPC
Reasons for updating
- 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 10 - editorial change to the SmPC revision date
Updated on 11 December 2018 SPC
Reasons for updating
- 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 10 - editorial change to the SmPC revision date
Updated on 5 June 2018 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 5 June 2018 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 22 June 2017 SPC
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 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- 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 2: Editorial change
Section 4.2: Editorial changes to the sub-headings.
Section 4.4: Editorial changes to the sub-heading of Paediatric population
Section 10: Date of revision has been amended.
Updated on 5 June 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 5 June 2017 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 9 March 2016 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- 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 8 - MA number
- Change to section 10 - Date of revision of the text
- Change to joint SPC covering all presentations
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 1 – inclusion of details for all other strengths (combined SmPC created)
Section 2 – inclusion of details for all other strengths (combined SmPC created)
Section 3 - inclusion of details for all other strengths (combined SmPC created)
Section 4.1 – replaced “essential” with “primary” before “hypertension”.
Section 4.2 – minor editorial changes
Section 4.4 – inclusion of “co-trimoxazole also known as trimethoprim/sulfamethoxazole” under subheading “Hyperkalaemia” and minor editorial and formatting changes.
Section 4.8 – minor editorial changes.
Section 5.2 – minor editorial changes.
Section 8 – inclusion of details for all other strengths (combined SmPC created)
Section 10 – update to date of revision of text.
Updated on 8 March 2016 PIL
Reasons for updating
- Change to drug interactions
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 11 March 2015 SPC
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- 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 6.5 – addition of 90 tablet blister pack
- Section 10 – update to date of revision
Updated on 9 March 2015 PIL
Reasons for updating
- Change to date of revision
- Introduction of new pack/pack size
Updated on 24 December 2014 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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 4.1
· Minor formatting to paragraph 1 to move the ‘the’ to the start of each bullet point
· Art 31 wording update
§ cross referencing
§ amendment to heart failure indication
Section 4.2
· formatting updates
· Art 31 wording update
§ cross referencing,
§ update to posology in heart failure section to include addition of information on co-adminstration of Atacand tablets with an ACE-inhibitor
Section 4.3
· Art 31 wording
§ addition of contraindication with Aliskiren
Section 4.4
· Art 31 wording
§ Dual blockade of renin-angiotensin-aldosterone system added
· Information added to concomitant therapy with an ACE-inhibitor in heart failure
· Updated information on kidney transplantation.
Section 4.5
· Art 31 update
§ Information on dual blockade of the RAAS system through combined use of ACE-inhibitors compared to single agents and frequency of adverse events.
Section 4.8
· minor formatting, addition of commas into frequencies in the first paragraph
· updated to include reflect the name change of the HPRA
Section 5.1
· Art 31 update
§ addition of trial data - ONTARGET and VA NEPHRON-D
Section 6.3
· formatting
Section 10
· Updated date of revision
Updated on 19 December 2014 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to further information section
- Change to date of revision
- Improved electronic presentation
Updated on 2 January 2014 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- 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 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic 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 2: Change “the” è “a”
Section 3: “halves” è “doses”
Section 4.1: New bullet: Treatment of hypertension in children and adolescents aged 6 to <18 years.
Section 4.2: A large new sub-section titled “Paediatric Population” is added in “Posology in Hypertension” section.
A small change in section Paediatric population just deleting hypertension and (as information has now been added re hypertension).
Section 4.3: A cross ref to where the excipients are listed is added and a Contraindication in Children aged below 1 year (with a cross reference) is added.
Section 4.4: A new section titled Use in paediatric patient, including patients with renal impairment is added and extra paragraphs in sections on Hypotension and Pregnancy.
Section 4.5: A new section titled Paediatric population is added.
Section 4.6: Title is updated and Lactation heading is changed to Breastfeeding.
Section 4.8: A new section titled Paediatric population is added.
“adult” is added to the section on Treatment of Heart Failure (because there is now info on paeds elsewhere in the SmPC).
A new section titled Reporting of suspected adverse reactions is added.
Section 4.9: “in an adult” has been added to the first paragraph (because there is now info on paeds elsewhere in the SmPC)
Section 5.1 Some headings have been added for clarity.
A new sub-section titled Paediatric population - hypertension is added.
Section 5.2: A new section titled Paediatric population is added.
Section 5.3: A new paragraph is added about neonatal and juvenile rats and a new paragraph about renal development.
Updated on 23 December 2013 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
- Change to improve clarity and readability
- Addition of information on reporting a side effect.
Updated on 21 November 2012 PIL
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
Updated on 22 June 2012 SPC
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- 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 6.5
Update to list of pack sizes
Section 10
Date of Revision changed to 15th June 2012
Updated on 19 June 2012 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 22 December 2011 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
- 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 2 - Update to be in line with CMC harmonised wording
Section 3 - Update to be in line with CMC harmonised wording
Section 6.1 – update to list of excipients for details related to iron oxide
Section 10 - Date of revision changed to 9th December 2011
Updated on 21 December 2011 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 15 July 2011 PIL
Reasons for updating
- Change to storage instructions
Updated on 20 May 2011 PIL
Reasons for updating
- Change to side-effects
Updated on 4 February 2011 PIL
Reasons for updating
- Discontinuation of one or more strengths
Updated on 22 December 2010 PIL
Reasons for updating
- Change due to harmonisation of PIL
Updated on 24 February 2009 PIL
Reasons for updating
- Change to appearance of the medicine
Updated on 4 June 2008 PIL
Reasons for updating
- Change due to harmonisation of patient information leaflet
- Change due to user-testing of patient information
Updated on 8 June 2006 PIL
Reasons for updating
- Change to drug interactions
- Change to date of revision
Updated on 12 August 2005 PIL
Reasons for updating
- Change to packaging
- Change to date of revision
Updated on 15 February 2005 PIL
Reasons for updating
- Change to date of revision
Updated on 6 October 2004 PIL
Reasons for updating
- Change to date of revision
Updated on 29 July 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 23 May 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)