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Atacand Plus 16/12.5mg

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/04/19

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Summary of Product Characteristics last updated on medicines.ie: 16/4/2019

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AstraZeneca Pharmaceuticals (Ireland) DAC

AstraZeneca Pharmaceuticals (Ireland) DAC

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Medicine Name Atacand 8mg 16mg Tablets Active Ingredients Candesartan Cilexetil
Medicine Name Atacand Plus 16/12.5mg Active Ingredients Candesartan Cilexetil, Hydrochlorothiazide
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1 - 0 of 53 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 16 April 2019 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 16 April 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
  • 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 - Additional information on non-melanoma skin cancer has been added

Section 4.8 - Adverse event ‘Neoplasms benign, malignant and unspecified (incl cysts and polyps)’ has been added

Section 5.1 - Additional information on non-melanoma skin cancer has been added

Section 10 - Date of revision updated

Updated on 8 January 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 8 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 9 August 2018 SmPC

Reasons for updating

  • 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

Change to section 4.8 as per the PRAC recommendation i.e., addition of diarrhoea 

Updated on 27 June 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 12 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 20 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 20 March 2018 SmPC

Reasons for updating

  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 9 - Date of first authorisation/renewal of the 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

Section 3:            Addition of tablet dimensions

Section 4.2:         Amendment of statement from “chronic liver disease” to “hepatic impairment”.

Section 4.3:         Minor formatting changes

Section 4.5:         Correction of spelling

Section 9:             Addition of latest renewal date

Section 10:          Updated date of revision

Updated on 19 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 March 2018 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 2 June 2016 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision
  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

Updated on 2 June 2016 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
  • Change to joint SPC covering all presentations
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 3 - Pharmaceutical form

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 other strength (combined SmPC created)

Section 2 – inclusion of details for other strength (combined SmPC created)

Section 3 - inclusion of details for other strength (combined SmPC created)

Section 4.1 – replaced “essential” with “primary” before “hypertension”.

Section 4.4 – inclusion of “co-trimoxazole also known as trimethoprim/sulfamethoxazole” under subheading “Electrolyte imbalance” and minor editorial and formatting changes.

Section 4.5 – inclusion of “co-trimoxazole also known as trimethoprim/sulfamethoxazole” and minor editorial changes.

Section 6.5 – inclusion of details for other strength (combined SmPC created)

Section 8 – inclusion of details for other strength (combined SmPC created)

Section 10 – update to date of revision of text.



Also this SmPC has been update to present information on another strength.

Updated on 17 March 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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company



- Improved presentation (QRD changes)

- Section 4.3 – Addition of Aliskiren containing medicines

- Section 4.4 – Addition of informaiton on RAAS medicines

- Section 4.5 - Addition of Aliskiren containing medicines

- Section 4.8 – New side effect frequency

- Section 4.8 Adverse Event reporting statement
- Change to date of revision

Updated on 16 March 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 19 November 2012 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 18 October 2012 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients
  • 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 6.1


List of excipients updated.

Section 6.5

 

Blister packs updated to include:

15x1 (single dose unit)

30x1 (single dose unit)

90 tablets

 

Section 10

 

Date of revision amended to 11th October 2012.

Updated on 17 October 2012 PIL

Reasons for updating

  • Change to date of revision
  • Introduction of new pack/pack size
  • Correction of spelling/typing errors

Updated on 3 April 2012 SmPC

Reasons for updating

  • 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 4.8

Addition of ADRs ‘acute myopia’ and ‘acute angle-closure glaucoma’ under SOC ‘Eye Disorders’ with frequency of ‘Not known’.

Section 10

Date of revision changed to 22nd March 2012

Updated on 30 March 2012 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 15 December 2011 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

 

Text updated to:


16/12.5 mg tablets: PVC-PVDC/Al blister packs of 7, 14, 15, 28, 28x1 (single dose unit), 30, 50, 50x1 (single dose unit), 56, 56x1 (single dose unit), 98, 98x1 (single dose unit), 100 and 300 tablets.

16/12.5 mg tablets: HDPE bottles of 100 tablets.

Section 10

 

Date of Revision amended to: 9th December 2011

 

Updated on 26 July 2011 PIL

Reasons for updating

  • Change to date of revision
  • Addition of marketing authorisation holder

Updated on 22 November 2010 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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • 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

SPC Changes due to Harmonisation – Atacand Plus 16mg/12.5mg

 

 

Section 1

Now reads,

“Atacand Plus 16/12.5 mg tablets.”

 

Section 2

Now reads,

” One Atacand Plus tablet contains 16 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide.

Each tablet contains 68 mg lactose monohydrate.

For a full list of excipients, see 6.1.”

 

Section 3

Now reads,

“Tablet.

Atacand  Plus are peach, oval, biconvex tablets with a score on both sides and engraved on one side.”

 

Section 6.1

Now reads,

“Carmellose calcium, hydroxypropylcellulose, iron oxide reddish-brown (E 172), iron oxide yellow (E 172), lactose monohydrate, magnesium stearate, maize starch and macrogol.”

 

Section 6.2

Now reads,

“Not applicable.”

 

Section 6.3

“3 years.”

 

Section 6.5

Now reads,

“16/12.5 mg tablet: PVC/PVDC blister packs of 7, 14, 15, 28, 28x1 (single dose unit), 30, 50, 50x1 (single dose unit), 56, 56x1 (single dose unit), 98, 98x1 (single dose unit), 100 and 300 tablets.

HDPE bottles of 100 tablets.

Not all pack sizes may be marketed.”

 

Section 10

Now reads,

“10th November 2010”

Updated on 19 November 2010 PIL

Reasons for updating

  • Change to date of revision
  • Change due to harmonisation of patient information leaflet

Updated on 15 October 2008 PIL

Reasons for updating

  • Change to further information section

Updated on 9 May 2008 PIL

Reasons for updating

  • Change due to harmonisation of patient information leaflet
  • Change due to user-testing of patient information

Updated on 6 July 2007 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

Section 2

Following new text added (in bold) to Section 2:

Each tablet contains 68 mg lactose monohydrate.

For a full list of excipients, see 6.1.

 

 

 

Section 4.8

Undesired events are now listed by body system and frequencies in a table. Text is as follows:

 

The frequencies used in the tables throughout this section are: very common (¡Ý 1/10) common (¡Ý1/100 <1/10), uncommon (¡Ý1/1000, <1/100 ), rare (¡Ý1/10 000, <1/1000) and very rare (<1/10 000):

System Organ Class

Frequency

Undesirable Effect

Nervous system disorders

Common

Dizziness/vertigo

 

The following adverse reactions have been reported with candesartan cilexetil in post marketing experience:

System Organ Class

Frequency

Undesirable Effect

Blood and lymphatic system disorders

Very rare

Leukopenia, neutropenia and agranulocytosis

Metabolism and nutrition disorders

Very rare

Hyperkalaemia, hyponatraemia

Nervous system disorders

Very rare

Dizziness, headache

Gastrointestinal disorders

Very rare

Nausea

Hepatobiliary disorders

Very rare

Increased liver enzymes, abnormal hepatic function or hepatitis

Skin and subcutaneous tissue disorders

Very rare

Angioedema, rash, urticaria, pruritus

Musculoskeletal, connective tissue and bone disorders

Very rare

Back pain, arthralgia, myalgia

Renal and urinary disorders

Very rare

Renal impairment, including renal failure in susceptible patients (see section 4.4)

 

The following adverse reactions have been reported with hydrochlorothiazide monotherapy, usually with doses of 25 mg or greater.

  

System Organ Class

Frequency

Undesirable Effect

Blood and lymphatic system disorders

Rare

 

Leucopenia, neutropenia/agranulocytosis, thrombocytopenia, aplastic anaemia, bone marrow depression, haemolytic anaemia

Immune system disorders

Rare

Anaphylactic reactions

Metabolism and nutrition disorders

Common

Hyperglycaemia, hyperuricaemia, electrolyte imbalance (including hyponatraemia and hypokalaemia)

Psychiatric disorders

Rare

 

Sleep disturbances, depression, restlessness

Nervous system disorders

Common

Light-headedness, vertigo

 

Rare

Paraesthesia

Eye disorders

Rare

Transient blurred vision

Cardiac disorders

Rare

Cardiac arrhythmias

Vascular disorders

Uncommon

Postural hypotension

 

Rare

Necrotising angiitis (vasculitis, cutaneous vasculitis)

Respiratory, thoracic and mediastinal disorders

Rare

Respiratory distress (including pneumonitis and pulmonary oedema)

Gastrointestinal disorders

Uncommon

 

Anorexia, loss of appetite, gastric irritation, diarrhoea, constipation

 

Rare

Pancreatitis

Hepatobiliary disorders

Rare

Jaundice (intrahepatic cholestatic jaundice)

Skin and subcutaneous tissue disorders

Uncommon

Rash, urticaria, photosensitivity reactions

 

Rare

 

Toxic epidermal necrolysis, cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus

Musculoskeletal, connective tissue and bone disorders

Rare

 

Muscle spasm

Renal and urinary disorders

Common

Glycosuria

 

Rare

Renal dysfunction and interstitial nephritis

General disorders and administration site conditions

Common

Weakness

Rare

Fever

Investigations

Common

Increases in cholesterol and triglycerides

 

Rare

Increases in BUN and serum creatinine

 

 

Section 6.1

Hyprolose deleted from the list of excipients and replaced by hydroxypropylcellulose
 

 

 

Section 6.6

Heading of section 6.6 changed from ¡®Instructions for use and handling and disposal¡¯ to ¡®Special precautions for disposal and other handling¡¯

 
 

 

Section 9

Date changed to

23rd June 2000/ 28th April 2007

 

 
 

Section 10

Date changed to 8th June 2007

Updated on 8 June 2006 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 24 May 2006 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)

Updated on 28 November 2005 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

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

Updated on 10 August 2004 SmPC

Reasons for updating

  • 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)

Updated on 9 August 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)