Aldactone 25mg film-coated Tablet

Land: Malta

Tungumál: enska

Heimild: Malta Medicines Authority

Virkt innihaldsefni:

SPIRONOLACTONE

Fáanlegur frá:

Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece

ATC númer:

C03DA01

INN (Alþjóðlegt nafn):

SPIRONOLACTONE 25 mg

Lyfjaform:

FILM-COATED TABLET

Samsetning:

SPIRONOLACTONE 25 mg

Gerð lyfseðils:

POM

Lækningarsvæði:

DIURETICS

Leyfisstaða:

Authorised

Leyfisdagur:

2007-02-21

Upplýsingar fylgiseðill

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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

Vara einkenni

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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 the 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 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.
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HEPATIC CIRRHOSIS WITH ASCITES AND OEDEMA:
If urinary Na
+
/K
+
ratio is greater than 1.0, 100 mg/day. If
the r