ALDACTONE Film-coated tablets Ref.[7105] Active ingredients: Spironolactone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Product name and form

Aldactone 25 mg Film-coated Tablets.

Pharmaceutical Form

Film-coated Tablets.

Buff film-coated tablets with “SEARLE 39” engraved on one side.

Qualitative and quantitative composition

Each tablet contains 25 mg spironolactone.

For the full list of excipients, see section 6.1.

Active Ingredient Description
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.

List of Excipients

Calcium sulfate dihydrate
Corn starch
Polyvinyl pyrrolidone
Magnesium stearate
Felocofix peppermint
Hypromellose
Polyethylene glycol
Opaspray yellow (contains E171 and E172)

Pack sizes and marketing

Amber glass or plastic bottles containing 100 or 500 tablets.

HDPE containers of 50 or 1,000 tablets.

PVC/foil blister packs containing 100 or 500 tablets and PVC/foil blister calendar pack of 28 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Marketing authorization dates and numbers

PL 00057/0928

Date of change of ownership: 16 September 2014
Date of latest renewal: 10 February 2002

Drugs

Drug Countries
ALDACTONE 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

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