Aldactone 25 mg Film-coated Tablets

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Spironolactone

Fáanlegur frá:

Primecrown 2010 Limited

ATC númer:

C03DA; C03DA01

INN (Alþjóðlegt nafn):

Spironolactone

Skammtar:

25 milligram(s)

Lyfjaform:

Film-coated tablet

Gerð lyfseðils:

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

Lækningarsvæði:

Aldosterone antagonists; spironolactone

Leyfisstaða:

Authorised

Leyfisdagur:

2013-09-13

Upplýsingar fylgiseðill

ALDACTONE
®
25 MG FILM-COATED TABLETS
spironolactone
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 vessels and so lowers your
blood
pressure.
You can also take Aldactone for the following illnesses:

‘Nephrotic syndrome' - a kidney disorder that causes too much fluid
in your body

‘Ascites’ - too much fluid in your abdomen and ‘Oedema’ -
accumulation
of fluid beneath skin or in one or more cavities of the body that
produces
swelling, for example caused by cirrhosis of the liver

‘Malignant ascites’ – fluid containing cancer cells that collect
in the
abdomen

‘Primary aldosteronism’ - extra fluid in your body caused by too
much of
a hormone called 'aldosterone'.
If you have these illnesses, Aldactone will help

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aldactone 25mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25mg of spironolactone
For a full list of excipients see 6.1.
3 PHARMACEUTICAL FORM
Film- coated tablet (Tablets)
_Product imported from Spain_:
Round white coloured, biconvex tablets, embossed ‘SEARLE over 39’
on one side and the other side half scored
4 CLINICAL PARTICULARS
As per PA0822/110/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0822/110/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Calcium sulphate dihydrate
Corn Starch
Povidone
Peppermint Flavour
Magnesium stearate
Coating:
Hydroxy propyl methy cellulose
Polyethylene glycol
Opaspray White M-1-7111 B
6.2 INCOMPATIBILITIES
Not Applicable
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
blister strips and outer carton of the product as
marketed in the country of origin
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C. Keep the blisters in the outer carton.
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6.5 NATURE AND CONTENTS OF CONTAINER
PVC/foil blister packs of 20 and 50 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Primecrown 2010 Limited
4/5 Northolt Trading Estate
Belvue Road
No