Atacand 8mg 16mg Tablets

  • Name:

    Atacand 8mg 16mg Tablets

  • Company:
    info
  • Active Ingredients:

    Candesartan Cilexetil

  • 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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Summary of Product Characteristics last updated on medicines.ie: 4/1/2019

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AstraZeneca Pharmaceuticals (Ireland) DAC

AstraZeneca Pharmaceuticals (Ireland) DAC

Company Products

Medicine NameActive Ingredients
Medicine Name Alvesco 160 micrograms pressurised inhalation,solution Active Ingredients Ciclesonide
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Medicine Name Arimidex Active Ingredients Anastrozole
Medicine Name Atacand 8mg 16mg Tablets Active Ingredients Candesartan Cilexetil
Medicine Name Atacand Plus 16/12.5mg Active Ingredients Candesartan Cilexetil, Hydrochlorothiazide
Medicine Name Bricanyl Turbohaler Active Ingredients Terbutaline sulfate
Medicine Name Brilique 60 mg film-coated tablets Active Ingredients Ticagrelor
Medicine Name Brilique 90 mg film coated tablets Active Ingredients Ticagrelor
Medicine Name Brilique 90 mg Orodispersible Tablets Active Ingredients Ticagrelor
Medicine Name Bydureon 2 mg powder and solvent for prolonged-release suspension for injection in pre-filled pen Active Ingredients Exenatide
Medicine Name Byetta 5 micrograms solution for injection, prefilled pen. Byetta 10 micrograms solution for injection, prefilled pen Active Ingredients Exenatide
Medicine Name Casodex 50mg Tablets Active Ingredients Bicalutamide
Medicine Name Crestor 5 mg, 10 mg, 20 mg and 40 mg Tablets Active Ingredients Rosuvastatin Calcium
Medicine Name Daxas 250 mcg Film-Coated Tablets Active Ingredients roflumilast
Medicine Name Daxas 500 mcg Film-coated Tablets Active Ingredients roflumilast
Medicine Name Fasenra 30 mg solution for injection in pre filled syringe Active Ingredients Benralizumab
Medicine Name Faslodex Active Ingredients Fulvestrant
Medicine Name Forxiga 10 mg Film coated tablets Active Ingredients Dapagliflozin propanediol monohydrate
Medicine Name Forxiga 5 mg film coated tablets Active Ingredients Dapagliflozin propanediol monohydrate
Medicine Name IMFINZI 50 mg/mL concentrate for solution for infusion Active Ingredients durvalumab
Medicine Name IRESSA 250 mg film-coated tablets Active Ingredients gefitinib
Medicine Name Komboglyze 2.5mg-1000mg Tablets Active Ingredients Metformin Hydrochloride, Saxagliptin hydrochloride
Medicine Name Komboglyze 2.5mg-850mg Tablets Active Ingredients Metformin Hydrochloride, Saxagliptin hydrochloride
Medicine Name Losec MUPS 10mg Gastro-resistant Tablets Active Ingredients omeprazole magnesium
Medicine Name Losec MUPS 20mg Gastro-resistant Tablets Active Ingredients omeprazole magnesium
1 - 0 of 56 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 4 January 2019 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

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 SmPC

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 SmPC

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 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 5 June 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 22 June 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 22 June 2017 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 4.4 - 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 SmPC

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 SmPC

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 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - 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 SmPC

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 titledPaediatric 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 SmPC

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 SmPC

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 SmPC

Reasons for updating

  • New SPC for medicines.ie

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