Qaialdo

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

spironolactone

Available from:

Nova Laboratories Ireland Limited

ATC code:

C03DA01

INN (International Name):

spironolactone

Therapeutic group:

Antihypertensives and diuretics in combination

Therapeutic area:

Edema; Heart Failure; Liver Cirrhosis; Ascites; Nephrotic Syndrome; Hyperaldosteronism; Essential Hypertension

Therapeutic indications:

In the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension.Neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5.1 and 5.2). 

Authorization status:

Authorised

Authorization date:

2023-05-26

Patient Information leaflet

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
QAIALDO 10 MG/ML ORAL SUSPENSION
spironolactone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Qaialdo is and what it is used for
2.
What you need to know before you take Qaialdo
3.
How to take Qaialdo
4.
Possible side effects
5.
How to store Qaialdo
6.
Contents of the pack and other information
1.
WHAT QAIALDO IS AND WHAT IT IS USED FOR
Qaialdo contains the active substance spironolactone. Spironolactone
belongs to a group of medicines
called ‘diuretics’ (water tablets). Spironolactone works by
blocking the effects of aldosterone, a
hormone that helps control water balance in the body. Spironolactone
causes you to excrete excess salt
and water and keeps your potassium levels from getting too low. This
reduces oedema. Spironolactone
is used to treat various conditions in newborns, children and adults.
Qaialdo is used to treat refractory oedema (persistent swelling due to
the build-up of fluid that has not
responded to other treatment) associated with:
- congestive heart failure (when the heart does not pump blood as well
as it should with build-up
of fluid around the heart causing shortness of breath, tiredness and
ankle swelling);
- hepatic cirrhosis (a type of liver disease) with ascites (a build-up
of fluid in the abdomen) and
oedema (swelling);
- malignant ascites (a condition in which fluid containing cancer
cells collect in the abdomen);
- nephrotic syndrome (kidney disorder causing the kidneys to leak too
much prot

Summary of Product characteristics

1 ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Qaialdo 10 mg/ml oral suspension
2.
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.
3.
PHARMACEUTICAL FORM
Oral suspension
White to off white viscous oral suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In the management of refractory oedema associated with congestive
cardiac failure; hepatic cirrhosis
with ascites and oedema, malignant ascites, nephrotic syndrome,
diagnosis and treatment of primary
aldosteronism, essential hypertension.
Neonates, children and adolescents should only be treated under
guidance of a paediatric specialist.
There is limited paediatric data available (see sections 5.1 and 5.2).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
_Congestive heart failure with oedema _
Usual dose - 100 mg/day. In difficult or severe cases the dose may be
gradually increased up to
200 mg/day. When oedema is controlled, the usual maintenance level is
75 mg/day to 200 mg/day.
_Severe heart failure in conjunction with standard therapy (New York
Heart Association Class III-IV)_
Based on the randomized aldactone evaluation study (RALES), treatment
in conjunction with standard
therapy should be initiated at a dose of spironolactone 25 mg once
daily in patients with a serum
potassium ≤ 5.0 mEq/L and serum creatinine ≤ 2.5 mg/dL. Patients
who tolerate 25 mg once daily may
have their dose increased to 50 mg once daily as clinically indicated.
Patients who do not tolerate 25 mg
once daily may have their dose reduced to 25 mg every other day. See
section 4.4 for advice on
monitoring serum potassium and serum creatinine.
_Hepatic cirrhosis with ascites and oedema _
If urinary Na
+
/K
+
ratio is greater than 1.0, 100 mg per day. If the ratio is less th