ALDACTONE
As listed in the register: ALDACTONE 75 mg, comprimé sécable
75 mg · comprimé sécable
- Prescription only
- Active substance
- Spironolactone
- Made by
- PFIZER HOLDING FRANCE
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (spironolactone). It describes the substance, not this exact product.
Spironolactone and its active metabolites are specific pharmacologic antagonists of aldosterone, acting primarily through competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule.
Spironolactone causes increased amounts of sodium and water to be excreted, while potassium is retained.
Spironolactone is rapidly and extensively metabolized.
The metabolites are excreted primarily in the urine and secondarily in bile.
Effect of food: Food increased the bioavailability of spironolactone (as measured by AUC) by approximately 95.4%.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-09-15
Safety of the active substance
From the US prescribing label for the same active substance (spironolactone). It describes the substance, not this exact product.
- Spironolactone tablets are contraindicated in the patients with: Hyperkalemia Addison's disease Concomitant use of eplerenone Spironolactone tablets are contraindicated in patients with ( 4 ): Hyperkalemia Addison's disease Concomitant use of eplerenone
The most common adverse reaction with spironolactone treatment is gynecomastia ( 5.4, 6 ).
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
European UnionNo exact match for this strength and form
CanadaNo exact match for this strength and form
Details
| Made by | PFIZER HOLDING FRANCE |
|---|---|
| Active substance | Spironolactone |
| Strength | 75 mg |
| Form | comprimé sécable |
| Route | orale |
| Dispensing (as stated by the register) | liste II |
| Marketed | Yes, according to the register |
| Authorisation procedure | Procédure nationale |
| Name in the register | ALDACTONE 75 mg, comprimé sécable |
| Packs | plaquette(s) PVC-Aluminium de 100 comprimé(s) · plaquette(s) PVC-Aluminium de 30 comprimé(s) · plaquette(s) PVC-Aluminium de 90 comprimé(s) |
| CIS | 68492540 |
| CIP13 | 3400932608072 |
| CIP13 | 3400935125453 |
| CIP13 | 3400937296069 |
Source: Base de données publique des médicaments · 2026-09-30 · not reviewed by a clinician
Source : Base de données publique des médicaments (ANSM / Ministère de la Santé), sous Licence Ouverte. Reuse terms: Licence Ouverte / Open Licence (Etalab).
Other strengths and forms
3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.