Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Spironolactone
Accord Healthcare Limited
C03DA; C03DA01
Spironolactone
100 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Aldosterone antagonists; spironolactone
Marketed
2016-01-29
PACKAGE LEAFLET: INFORMATION FOR THE USER SPIRONOLACTONE 25 MG FILM-COATED TABLETS SPIRONOLACTONE 50 MG FILM-COATED TABLETS SPIRONOLACTONE 100 MG FILM-COATED TABLETS spironolactone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 iftheir signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Spironolactone film-coated tablet is and what it is used for 2. What you need to know before you take Spironolactone film-coated tablets 3. How to take Spironolactone film-coated tablets 4. Possible side effects 5. How to store Spironolactone film-coated tablets 6. Contents of the pack and other information 1. WHAT SPIRONOLACTONE FILM-COATED TABLET IS AND WHAT IT IS USED FOR The active ingredient of the tablets is Spironolactone. Spironolactone belongs to a particular group of medicines, known as aldosterone antagonists, which inhibit the action of the hormone aldosterone. One of the functions of aldosterone is to ensure that the body retains sodium. It forms part of a system that regulates the balance of fluids and salts in the body (‘RAAS’, renin angiotensin aldosterone system). Spironolactone promotes the excretion of urine in patients in whom there is an accumulation of fluid in the tissues (oedema) or in the abdominal cavity (ascites) by increasing the amount of sodium (salt) excreted in the urine. Potassium loss as a possible consequence of using certain diuretics is reduced. The antihypertensive effect relies on the excretion of water and salt. Spironolactone film-coated tablets may be prescribed by your doctor for the treatment of: accumul Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Spironolactone 100 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Spironolactone 100 mg film-coated tablets contain 100 mg spironolactone Excipients with known effect: Lactose Each tablet contains 300 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Spironolactone 100 mg film-coated tablets are white to pale white, round, biconvex tablets printed with “AF” on one side and no imprint on the other side. 100mg tablet diameter is approximately 11.2 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Oedema associated with congestive heart failure • Severe heart failure, (NYHA III-IV) • As an adjuvant in treatment of resistant hypertension • Nephrotic syndrome • Liver cirrhosis with ascites and oedema • Diagnosis and treatment of primary hyperaldosteronism (Conn’s syndrome) 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 _Posology_ Adults The dosage should be determined individually depending on the condition and the degree of diuresis required. Dosage up to100 mg daily may be administered as a single dose or in divided doses. _Oedema associated with congestive heart failure_ For management of oedema an initial daily dose of 100 mg of spironolactone administered in either single or divided doses is recommended, but may range from 25 to 200 mg daily. Maintenance dose should be individually determined. _Severe heart failure (NYHA Class III-IV)_ Treatment in conjunction with standard therapy should be initiated at a dose of spironolactone 25 mg once daily if serum potassium is 5.0 mEq/L and serum creatinine is 2.5 mg/dL (221 µmol/L). Patients who tolerate 25 mg once daily may have their dose increased to 50 mg once daily as clinically indicated. Patients who do not tolerate 25 mg once daily may have their dose r Olvassa el a teljes dokumentumot