Aldactone 25mg film-coated tablets
- Name:
Aldactone 25mg film-coated tablets
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- 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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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Pfizer Healthcare Ireland
Company Products
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 4 January 2017 PIL
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 6.4 - Special precautions for storage
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 respectivelyUpdated 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 respectivelyUpdated 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
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
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 4.4 - Special warnings and precautions for use
- 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 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 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
Updated on 20 June 2013 PIL
Reasons for updating
- New individual SPC (was previously included in combined SPC)