We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the medicines.ie website. Find out more

Pfizer Healthcare Ireland

9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 467 6500
Fax: +353 1 467 6501
Medical Information Direct Line: 1 800 633 363
Medical Information Website: http://www.pfizermedicalinformation.ie
Summary of Product Characteristics last updated on medicines.ie: 04/01/2017
SPC Aldactone 100mg film coated tablets

When a pharmaceutical company changes an SPC or PIL, 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 04/01/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   01-Dec-2016
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 22/02/2016 and displayed until 04/01/2017
Reasons for adding or 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
Date of revision of text on the SPC:   01-Feb-2016
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 27/10/2015 and displayed until 22/02/2016
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   01-Oct-2015
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 23/10/2015 and displayed until 27/10/2015
Reasons for adding or 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
Date of revision of text on the SPC:   01-Oct-2015
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 17/12/2014 and displayed until 23/10/2015
Reasons for adding or 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
Date of revision of text on the SPC:   01-Dec-2014
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 20/06/2013 and displayed until 17/12/2014
Reasons for adding or 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
Date of revision of text on the SPC:   03-Jun-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

update Section 4.3, 4.4, 4.5 and 4.8
Updated on 06/07/2012 and displayed until 20/06/2013
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
Date of revision of text on the SPC:   01-Jun-2012
Legal Category:   Product subject to restricted prescription (C)

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 23/04/2012 and displayed until 06/07/2012
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   01-Apr-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Update SPC Section 4.4
Updated on 20/10/2011 and displayed until 23/04/2012
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10-Oct-2011
Legal Category:   Product subject to restricted prescription (C)

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 23/03/2011 and displayed until 20/10/2011
Reasons for adding or 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
Date of revision of text on the SPC:   01-Mar-2011
Legal Category:   Product subject to restricted prescription (C)

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 19/08/2009 and displayed until 23/03/2011
Reasons for adding or updating:
  • Improved electronic presentation
Date of revision of text on the SPC:   01-Apr-2008
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Section 10 Version code added
Updated on 19/08/2008 and displayed until 19/08/2009
Reasons for adding or updating:
  • New SPC for medicines.ie

Document Links

 
  View all medicines
from this company
View Document
Bookmark and Share

Active Ingredients

 
   Spironolactone