ALDACTONE

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

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 more about Spironolactone

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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