Aldactone 50 mg Film-coated tablets.
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 16 October 2024
File name
Reg SPC AN 18_0 50mg IE-clean (1).pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 October 2024
File name
Reg PIL AN 19_0 IE-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 28 September 2023
File name
Reg SPC AN 17_2 50 mg IE clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 September 2023
File name
Reg PIL AN 18_2 IE clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 15 December 2022
File name
Reg SPC AN 16_1 50 mg IE clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 November 2022
File name
RegPILAN170IEclean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 03 February 2022
File name
RegSPCAN13050mgIEclean.pdf
Reasons for updating
- 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 4.5:
Addition of Spironolactone binds to the androgen receptor and may increase prostate specific antigen (PSA) levels in abiraterone-treated prostate cancer patients. Use with abiraterone is not recommended.
Updated on 03 February 2022
File name
RegSPCAN13050mgIEclean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 08 February 2021
File name
DEC202108105_Reg PIL AN 16_1 IE-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 26 June 2020
File name
DEC202042539_Reg SPC AN 12_3 50mg IE-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 June 2020
File name
DEC202042539_Reg PIL AN 15_2 IE-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 04 November 2019
File name
DEC201960473_Reg PIL AN 14_0 IE - clean.pdf
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 04 January 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 January 2017
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 04 January 2017
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
File name
PIL_10425_479.pdf
Reasons for updating
- New PIL for new product
Updated on 22 February 2016
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 respectivelyUpdated on 22 February 2016
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 respectivelyUpdated on 27 October 2015
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
Updated on 27 October 2015
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
Free text change information supplied by the pharmaceutical company
Updated on 23 October 2015
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 23 October 2015
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 17 December 2014
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
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
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
Updated on 20 June 2013
Reasons for updating
- New individual SPC (was previously included in combined SPC)