Aldactone 100mg film coated tablets

  • Name:

    Aldactone 100mg film coated tablets

  • Company:
    info
  • Active Ingredients:

    Spironolactone

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/11/19

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Summary of Product Characteristics last updated on medicines.ie: 4/1/2017
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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

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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 November 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 4 January 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 4 January 2017 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 6.4 - Special precautions for storage

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.3 Contraindications: The following text "or other conditions associated with hyperkalemia" has been deleted from the statement "Addison's disease or other conditions associated with hyperkalemia."

Section 6.4: The text “in order to protect from light” has been added to the storage conditions.

Updated on 22 December 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 22 December 2016 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 22 February 2016 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

update sections 4.4, 4.5 and 4.8 of the SmPC to add 1) information on the risk of severe hyperkalaemia (wording already implemented in SPC), 2) information on the concomitant use of trimethoprim/sulfamethoxazole with spironolactone, and 3) the adverse reaction pemphigoid with an unknown frequency. Additionally, the spelling of ‘indomethacin’ and ‘gynecomastia’ was corrected in sections 4.5 and 4.8 respectively

Updated on 19 February 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 27 October 2015 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

the latest renewal date has been corrected to 1st April 2008 in line with the schedules received from the HPRA.

Updated on 23 October 2015 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.1, Therapeutic indications

 

Children should only be treated under guidance of a paediatric specialist. There is limited paediatric data available (see sections 5.1 and 5.2)

 

Section 4.2, Posology and method of administration

 

Children Paediatric population

 

Initial daily dosage should provide 1- 3 mg of spironolactone per kilogram body weight

given in divided doses. Dosage should be adjusted on the basis of response and tolerance (see

sections 4.3, and 4.4 and 6.6). If necessary a suspension may be prepared by crushing Aldactone

tablets.

 

Children should only be treated under guidance of a paediatric specialist. There is limited paediatric data available (see sections 5.1 and 5.2)

 

Method of Administration

 

Use in the paediatric population:

If necessary a suspension may be prepared by crushing Aldactone tablets

 

Section 4.3, Contraindications

 

Spironolactone is contraindicated in adult and paediatric patients with the following:

(…)

·         paediatric patients with moderate to severe renal impairment

 

Spironolactone is contraindicated in paediatric patients with moderate to severe renal impairment.

(…)

 

Section 4.4, Special warnings and precautions for use

 

Potassium-sparing diuretics should be used with caution in hypertensive paediatric patients with mild renal insufficiency because of the risk of hyperkalaemia. (Spironolactone is contraindicated for use in paediatric patients with moderate or severe renal impairment; see section 4.3).

 

Section 5.1, Pharmacodynamic properties

 

Paediatric population:

 

There is a lack of substantive information from clinical studies on spironolactone in children.

This is a result of several factors: the few trials that have been performed in the paediatric population, the use of spironolactone in combination with other agents, the small numbers of patients evaluated in each trial, and the different indications studied. The dosage recommendations for paediatrics are based upon clinical experience and case studies documented in the scientific literature.

 

Section 5.2, Pharmacokinetic properties

 

Paediatric population:

There are no pharmacokinetic data available in respect of use in paediatric population. The dosage recommendations for paediatrics are based upon clinical experience and case studies documented in the scientific literature.

Updated on 22 October 2015 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to date of revision

Updated on 17 December 2014 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

·         Section 4.4 Special warnings and precautions for use: to include concomitant use of spironolactone with NSAIDs may lead to hyperkalemia

·         Section 4.5 Interaction with other medicinal products and other forms of interaction: to include the interaction between NSAIDs (as a class instead of only aspirin, indomethacin, and mefenamic acid as is currently listed) and diuretics.Additionally been updated in line with the current QRD template version 9 and the new HPRA name incorporated with these changes.

Updated on 16 December 2014 PIL

Reasons for updating

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

Updated on 27 June 2013 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 20 June 2013 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

update Section 4.3, 4.4, 4.5 and 4.8

Updated on 17 June 2013 PIL

Reasons for updating

  • Change to side-effects

Updated on 13 June 2013 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

Updated on 6 July 2012 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to the MAH name and MA numbers (Pharmacia Ireland to Pfizer Healthcare Ireland).

Updated on 3 July 2012 PIL

Reasons for updating

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

Updated on 23 April 2012 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update SPC Section 4.4

Updated on 19 April 2012 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to dosage and administration

Updated on 13 February 2012 PIL

Reasons for updating

  • PIL re-instated

Updated on 16 December 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about driving or using machinery
  • Changes to therapeutic indications

Updated on 20 October 2011 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

section 7 marketing authorisation holder: from “pharmacia ireland limited” to “pharmacia ireland”
section 10: change to date of revision of text

Updated on 19 October 2011 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 23 March 2011 SmPC

Reasons for updating

  • 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 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2: Text has been added to include dosing for sever heart failure (NYHA Class III – IV).
Section 4.3: Contraindications have been turned into bullet points to improve readability.
Section 4.4: A warning for hyperkalaemia has been added in relation to the dosing instructions for sever heart failure.
Section 5.1: Data from the RALES study has been incorporated into section 5.1.

Updated on 1 February 2010 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 19 August 2009 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 10 Version code added

Updated on 14 October 2008 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 19 August 2008 PIL

Reasons for updating

  • Change to date of revision

Updated on 19 August 2008 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 21 November 2007 PIL

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 28 June 2007 PIL

Reasons for updating

  • Change of special precautions for disposal

Updated on 6 October 2005 PIL

Reasons for updating

  • New PIL for medicines.ie