Aldactone 100 mg Film-coated tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Spironolactone

Saatavilla:

Pfizer Healthcare Ireland

ATC-koodi:

C03DA; C03DA01

INN (Kansainvälinen yleisnimi):

Spironolactone

Annos:

100 milligram(s)

Lääkemuoto:

Film-coated tablet

Prescription tyyppi:

Product subject to prescription which may not be renewed (A)

Terapeuttinen alue:

Aldosterone antagonists; spironolactone

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

1975-03-13

Pakkausseloste

Page 1 of 6
2023-0085145
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALDACTONE
® 25MG FILM-COATED TABLETS
ALDACTONE
® 50MG FILM-COATED TABLETS
ALDACTONE
® 100MG FILM-COATED TABLETS
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 Aldactone is and what it is used for
2.
What you need to know before you take Aldactone
3.
How to take Aldactone
4.
Possible side effects
5.
How to store Aldactone
6.
Contents of the pack and other information
1.
WHAT ALDACTONE IS AND WHAT IT IS USED FOR
Aldactone belongs to a group of medicines called ‘diuretics’ –
you may know these as ‘water’ tablets.
You may have gone to your doctor because you had swollen ankles or
were short of breath. This can
happen when your heart's pumping action has become weak because of too
much fluid in your body.
This is called 'congestive heart failure'. Pushing extra fluid around
your body means your heart has to
work harder. Your doctor has given you Aldactone to help you lose the
extra fluid from your body.
This will mean your heart has to do less work. You lose the extra
fluid as urine, so you may need to go
to the toilet more often while you are taking Aldactone.
Your doctor may also give you Aldactone if your blood pressure is
higher than it should be. This is
called ‘hypertension’. High blood pressure occurs when there is
increased pressure of blood within the
walls of your blood vessels. By taking fluid from within your blood
vessels, Aldactone reduces the
pressure on the walls of the blood vessel

Valmisteyhteenveto

Health Products Regulatory Authority
27 September 2023
CRN00DP3M
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aldactone 100 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg of spironolactone.
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Film coated tablet (Tablets)
Round, buff coloured, biconvex tablet with a peppermint odour embossed
‘SEARLE over 134’ on one side and the other side
plain.
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.
Children 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
Administration of Aldactone once daily with a meal is recommended.
Posology
ADULTS
CONGESTIVE HEART FAILURE: Usual dose - 100 mg/day. In difficult or
severe cases the dosage 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