Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Spironolactone
Imbat Limited
C03DA; C03DA01
Spironolactone
25 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Aldosterone antagonists; spironolactone
Authorised
2014-08-01
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 Прочетете целия документ
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. 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_ _4_ _/_ _0_ _6_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _2_ _1_ _6_ _0_ _4_ _5_ _7_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 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 Прочетете целия документ