Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Spironolactone
Pfizer Healthcare Ireland
C03DA; C03DA01
Spironolactone
25 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Aldosterone antagonists; spironolactone
Marketed
1978-04-01
Page 1 of 6 2023-0085145 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 Baca dokumen lengkap
Health℃Products℃Regulatory℃Authority 27℃September℃2023 CRN00DP3M Page℃1℃of℃8 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℃a℃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 Baca dokumen lengkap