Aldactone 25 mg Film-coated Tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Spironolactone

Dostępny od:

Pfizer Healthcare Ireland

Kod ATC:

C03DA; C03DA01

INN (International Nazwa):

Spironolactone

Dawkowanie:

25 milligram(s)

Forma farmaceutyczna:

Film-coated tablet

Typ recepty:

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

Dziedzina terapeutyczna:

Aldosterone antagonists; spironolactone

Status autoryzacji:

Marketed

Data autoryzacji:

1978-04-01

Ulotka dla pacjenta

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

Charakterystyka produktu

Health℃Products℃Regulatory℃Authority
27℃September℃2023
CRN00DP3M
Page℃1℃of℃8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aldactone℃25℃mg℃Film-coated℃Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each℃tablet℃contains℃25℃mg℃of℃spironolactone.
For℃a℃full℃list℃of℃excipients,℃see℃section℃6.1
3 PHARMACEUTICAL FORM
Film-coated℃tablet℃(Tablets)
Round℃buff℃coloured,℃biconvex℃tablets℃with℃a℃peppermint℃odour,℃embossed℃‘SEARLE℃over℃39’℃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�