ALDACTONE

This brand name is authorized in Australia, Brazil, Canada, Germany, Ecuador, Spain, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Malta, Mexico, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

Active ingredients

The drug ALDACTONE contains one active pharmaceutical ingredient (API):

1 Spironolactone
UNII 27O7W4T232 - SPIRONOLACTONE

Spironolactone, as a competitive aldosterone antagonist, increases sodium excretion whilst reducing potassium loss at the distal renal tubule. It has a gradual and prolonged action.

Read about Spironolactone

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
ALDACTONE Film-coated tablets Medicines & Healthcare Products Regulatory Agency (GB) MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
C03DA01 Spironolactone C Cardiovascular system → C03 Diuretics → C03D Potassium-sparing agents → C03DA Aldosterone antagonists
Discover more medicines within C03DA01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: AU Pharmaceutical Benefits Scheme Identifier(s): 2339D, 2340E
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 522717110064717, 522717110064817, 522717110064917
Country: CA Health Products and Food Branch Identifier(s): 00028606, 00285455
Country: DE Bundesinstitut für Arzneimittel und Medizinprodukte Identifier(s): 00029009, 01193030, 01826966, 02475003, 06135310, 06453317
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 27.028-05-06, 27.172-07-06
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 39059, 54900
Country: FR Base de données publique des médicaments Identifier(s): 64565845, 67368301, 68492540
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 101506, 13479, 13498, 13499, 13507
Country: HK Department of Health Drug Office Identifier(s): 19636
Country: HR Agencija za lijekove i medicinske proizvode Identifier(s): HR-H-496664168, HR-H-516520022, HR-H-977451139
Country: IE Health Products Regulatory Authority Identifier(s): 10510, 11053, 28910, 79596, 79782
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 3060
Country: IT Agenzia del Farmaco Identifier(s): 019822028, 019822030
Country: JP 医薬品医療機器総合機構 Identifier(s): 2133001C1097, 2133001F1522, 2133001F2057
Country: MT Medicines Authority Identifier(s): MA505/00701
Country: MX Comisión Federal para la Protección contra Riesgos Sanitarios Identifier(s): 58500, 87911
Country: SG Health Sciences Authority Identifier(s): 02222P
Country: TN Direction de la Pharmacie et du Médicament Identifier(s): 10803231, 10803232, 4133031
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699543010021, 8699543010038, 8699543011165
Country: US FDA, National Drug Code Identifier(s): 0025-1001, 0025-1031, 0025-1041
Country: ZA Health Products Regulatory Authority Identifier(s): H/18.1/2

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