Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Spironolactone
Primecrown 2010 Limited
C03DA; C03DA01
Spironolactone
25 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Aldosterone antagonists; spironolactone
Authorised
2013-09-13
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 Aqra d-dokument sħiħ
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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _9_ _/_ _1_ _2_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _5_ _2_ _4_ _4_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 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 Aqra d-dokument sħiħ