Aldactone 25mg Film-coated Tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Spironolactone

Verfügbar ab:

Imbat Limited

ATC-Code:

C03DA; C03DA01

INN (Internationale Bezeichnung):

Spironolactone

Dosierung:

25 milligram(s)

Darreichungsform:

Film-coated tablet

Verschreibungstyp:

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

Therapiebereich:

Aldosterone antagonists; spironolactone

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2014-08-01

Gebrauchsinformation

Page 1 of 2
PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
ALDACTONE
® 25MG FILM-COATED TABLETS
(spironolactone)
Your medicine is available using the name Aldactone 25mg
Film-coated Tablets but will be referred to as Aldactone
throughout this leaflet.
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,
Aldact

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aldactone 25mg 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
_Product imported from Spain:_
White, round, biconvex tablets, marked with ‘SEARLE 39’ on one
side and scored on the other.
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:
Hyproxypropylmethylcellulose
Polyethylene glycol
Opaspray M-1-7111 B (white)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blister strips and outer carton of the product as
marked 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
Outer carton containing blister strips
Pack size: 100 tablets (4 x 25 tablets)
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT
No specia