QAIALDO Oral suspension Ref.[51071] Active ingredients: Spironolactone

Source: European Medicines Agency (EU)  Revision Year: 2026  Publisher: Lipomed GmbH, Hegenheimer Strasse 2, 79576 Weil am Rhein, Germany

Product name and form

Qaialdo 10 mg/ml oral suspension.

Pharmaceutical Form

Oral suspension.

White to off white viscous oral suspension.

Qualitative and quantitative composition

Each ml of suspension contains 10 mg spironolactone.

Each bottle of 150 ml contains 1 500 mg of spironolactone.

Excipients with known effect:

This medicine contains 0.75 mg sodium benzoate and 400 mg sucrose in each ml.

For the full list of excipients, see section 6.1.

Active Ingredient

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

Sodium benzoate (E211)
Sucrose
Sodium citrate (E331)
Citric acid monohydrate (E330)
Strawberry flavour liquid
Masking flavour
Polysorbate 80 (E433)
Simeticone emulsion 30%
Xanthan gum (E415)
Purified water

Pack sizes and marketing

Amber type III glass bottle with tamper evident child-resistant closure (high density polyethylene-HDPE with expanded polyethylene liner) containing 150 ml of oral suspension.

Each pack contains one bottle, a low density polyethylene (LDPE) bottle adaptor and 2 dosing syringes (a 1 ml syringe graduated in 0.01 ml increments and a 5 ml syringe graduated in 0.2 ml increments).

Marketing authorization holder

Lipomed GmbH, Hegenheimer Strasse 2, 79576 Weil am Rhein, Germany

Marketing authorization dates and numbers

EU/1/23/1731/001

Date of first authorisation: 26 May 2023

Drugs

Drug Countries
QAIALDO Austria, Estonia, Croatia, Ireland, Italy, Lithuania, United Kingdom

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