Basic Information
EMA regulatory identification and product classification information
EMA Identifiers
Overview Summary
Comprehensive product overview and regulatory summary
Qaialdo is a medicine used to manage refractory oedema (swelling due to fluid build-up that does not respond to standard treatments) associated with any of the following conditions:
- congestive heart failure (when the heart does not pump blood as well as it should and fluid builds up around the heart and in the legs);
- hepatic cirrhosis (liver scarring) with ascites (fluid build-up in the belly) and oedema (fluid build-up in the legs, feet and ankles);
- malignant ascites (ascites caused by cancer cells spreading to the organs in the belly);
- nephrotic syndrome (a group of symptoms associated with kidney damage, such as the presence of protein in the urine or oedema);
- essential hypertension (high blood pressure without a known cause).
It can also be used to diagnose and treat primary aldosteronism, a condition in which the body produces too much of the hormone aldosterone, which also results in oedema.
Qaialdo is a ‘hybrid medicine’. This means that the medicine is similar to a ‘reference medicine’ containing the same active substance, but Qaialdo is available as a liquid to be taken by mouth while the reference medicine is available as tablets. The reference medicine for Qaialdo is Aldactone.
Qaialdo contains the active substance spironolactone.
Active Substances (1)
spironolactone
Documents (8)
Qaialdo : EPAR - Public assessment report
July 25, 2023
CHANGES_SINCE_INITIAL_AUTHORISATION
Qaialdo : EPAR - Medicine overview
July 25, 2023
OVERVIEW_DOCUMENT
Qaialdo: EPAR - Product information
July 25, 2023
DRUG_PRODUCT_INFORMATION
Qaialdo : EPAR - Procedural steps taken and scientific information after the authorisation
February 20, 2025
CHANGES_SINCE_INITIAL_AUTHORISATION
Qaialdo-H-C-PSUSA-00002780-202403 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
February 20, 2025
CHANGES_SINCE_INITIAL_AUTHORISATION
Qaialdo : EPAR - All authorised presentations
July 25, 2023
AUTHORISED_PRESENTATIONS
CHMP summary of positive opinion for Qaialdo
March 31, 2023
CHANGES_SINCE_INITIAL_AUTHORISATION
Qaialdo : EPAR - Risk-management-plan summary
July 25, 2023
RISK_MANAGEMENT_PLAN_SUMMARY
Overview Q&A (7)
Question
How is Qaialdo used?
Answer
The medicine can only be obtained with a prescription, and children should only be treated under supervision of a paediatric specialist.
Qaialdo is available as a suspension (a liquid with solid particles in it) to be taken by mouth once a day.
For more information about using Qaialdo, see the package leaflet or contact your doctor or pharmacist.
Question
How does Qaialdo work?
Answer
The active substance in Qaialdo, spironolactone, works by blocking the effects of aldosterone, a hormone that helps control water balance in the body. The medicine blocks specific receptors (targets) for aldosterone in the kidneys. This increases the elimination of salt and water in the form of urine while keeping levels of potassium from getting too low. This, in turn, reduces oedema.
Question
What benefits of Qaialdo have been shown in studies?
Answer
Spironolactone has been used in the European Union for several decades to treat refractory oedema. As for every medicine, the company provided studies on the quality of Qaialdo. The company also carried out studies that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Because Qaialdo is bioequivalent to the reference medicine, its benefits are taken as being the same as the reference medicine’s.
Question
What are the risks associated with Qaialdo?
Answer
For the full list of side effects and restrictions with Qaialdo, see the package leaflet.
Because Qaialdo is bioequivalent to the reference medicine, its risks are taken as being the same as the reference medicine’s.
The most common side effects with Qaialdo (which may affect more than 1 in 10 people) include hyperkalaemia (high blood potassium levels, which can cause tiredness, muscle weakness, feeling sick and heart rhythm disturbances). Gynaecomastia (breast growth in men) and breast pain are seen in up to 1 in 10 males.
Question
Why is Qaialdo authorised in the EU?
Answer
Qaialdo has been shown to be comparable to the reference medicine. Therefore, the Agency’s view was that, as for Aldactone, the benefits of Qaialdo outweigh the identified risks and it can be authorised for use in the EU.
Question
What measures are being taken to ensure the safe and effective use of Qaialdo?
Answer
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Qaialdo have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Qaialdo are continuously monitored. Suspected side effects reported with Qaialdo are carefully evaluated and any necessary action taken to protect patients.
Question
Other information about Qaialdo
Answer
Qaialdo received a marketing authorisation valid throughout the EU on 26 May 2023.