Страна: Израиль
Язык: английский
Источник: Ministry of Health
SPIRONOLACTONE
TEVA ISRAEL LTD
C03DA01
TABLETS
SPIRONOLACTONE 100 MG
PER OS
Required
TEVA ISRAEL LTD, ISRAEL
SPIRONOLACTONE
SPIRONOLACTONE
Edematous conditions: congestive heart failure; cirrosis of the liver accompanied by edema and/or ascites nephrotic syndrome. Essential hypertention. Primary hyperaldostronism. Hypokalemia.
2021-11-30
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor's prescription only SPIRONOLACTONE TEVA 25 MG SPIRONOLACTONE TEVA 100 MG TABLETS TABLETS COMPOSITION: COMPOSITION: Each tablet contains: Each tablet contains: Spironolactone 25 mg Spironolactone 100 mg For information about inactive ingredients see section 6 - “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have additional questions, refer to the doctor or the pharmacist. This medicine has been prescribed for your treatment. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Treatment of congestive heart failure, cirrhosis of the liver accompanied by edema and ascites, lowering blood pressure, adrenal gland overactivity (hyperaldosteronism), hypokalemia (low levels of potassium in the blood). THERAPEUTIC CLASS: Spironolactone belongs to a group of medicines called potassium-sparing diuretics. 2. BEFORE USING THE MEDICINE Do not use this medicine if: • You are sensitive (allergic) to the active ingredient or to any of the other ingredients this medicine contains (see section 6 – “additional information”). • You suffer from urinary retention. • You suffer from a severe kidney disease. • You suffer from Addison’s disease (a disease characterized by a feeling of exhaustion, loss of weight and low blood pressure). • You suffer from hyperkalemia (excess potassium in the blood). • You are breastfeeding. • You are taking potassium-sparing diuretics or potassium supplements. • You are taking a medicine that contains the active ingredient eplerenone (administered to treat heart failure). • Do not use the medicine in children suffering from moderate to severe kidney disease. SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE BEFORE TREATMENT WITH SPIRONOLACTONE TEV Прочитать полный документ
Spironolactone Teva 100mg MF Notification 10/2022 CLEAN SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Spironolactone Teva 100mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100mg spironolactone. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Spironolactone Teva 100mg tablets are white, round flat tablets with beveled edges, engraved "TEVA" on one side, scored in half on the other, with peppermint odor. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Edematous conditions: Congestive heart failure Cirrhosis of the liver accompanied by edema and/or ascites Nephrotic syndrome Essential hypertension Primary hyperaldosteronism Hypokalemia 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Administration of Spironolactone Teva once daily with a meal is recommended. Children should only be treated under guidance of a paediatric specialist. There is limited paediatric data available (see sections 5.1 and 5.2). POSOLOGY ADULTS CONGESTIVE CARDIAC FAILURE WITH OEDEMA 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 mg to 200 mg daily. Maintenance dose should be individually determined. SEVERE HEART FAILURE (NEW YORK HEART ASSOCIATION CLASS III-IV) Based on the Randomized Aldactone (spironolactone) Evaluation Study (RALES: see also section 5.1), 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. 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 reduced to 25 mg every other day. See section 4.4 for advice on monitoring serum potassium and serum creatinine. HEPATIC CIRRHOSIS WITH ASCITES AND OEDEMA If urinary Na+/K+ ratio is gre Прочитать полный документ