Aldactone 50 mg Film-coated tablets.

  • Name:

    Aldactone 50 mg 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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1 - 0 of 227 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 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 6.4 - Special precautions for storage
  • Change to section 4.3 - Contraindications

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 4 January 2017 PIL

Reasons for updating

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

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 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 22 February 2016 PIL

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

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 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 27 October 2015 PIL

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

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 PIL

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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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 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 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 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 17 December 2014 PIL

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

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 June 2013 SmPC

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 20 June 2013 PIL

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Free text change information supplied by the pharmaceutical company

None provided