Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
spironolactone, Quantity: 100 mg
Alphapharm Pty Ltd
Tablet, uncoated
Excipient Ingredients: sunset yellow FCF aluminium lake; maize starch; povidone; magnesium stearate; Peppermint Oil; sodium starch glycollate; purified talc; erythrosine aluminium lake; polysorbate 80; quinoline yellow aluminium lake; lactose monohydrate; microcrystalline cellulose
Oral
100 tablets
(S4) Prescription Only Medicine
Essential hypertension; oedematous disorders such as oedema and ascites of congestive cardiac failure, cirrhosis of the liver and nephrotic syndrome; diagnosis and treatment of primary aldosteronism; as adjunctive therapy in malignant hypertension; in diuretic induced hypokalaemia when other measures are considered inappropriate or inadequate; prophylaxis of hypokalaemia in patients taking digitalis when other measures are considered inadequate or inappropriate; hirsutism. Essential hypertension. Spironolactone, when used alone, is effective in lowering both systolic and diastolic blood pressure. Spironolactone improves the hypotensive action of thiazide diuretics, while at the same time reducing or preventing potassium loss due to the thiazide. Spironolactone enhances the effectiveness of other antihypertensive agents such as beta-blockers, vasodilators, etc. Congestive cardiac failure. When used alone, spironolactone is effective in the management of oedema and sodium retention associated with congestive cardiac failure. Spironolactone may be used in combination with a thiazide or other conventional diuretics for achieving diuresis in patients whose oedema is resistant to a thiazide or other conventional diuretics. Unlike conventional diuretics, spironolactone does not produce hypokalaemia. When administered with a thiazide or other conventional diuretics, spironolactone offsets hypokalaemia induced by these diuretics. The prevention of potassium loss is particularly important in the treatment of digitalised patients, since digitalis intoxication may be precipitated if hypokalaemia is induced by conventional diuretic therapy. Hepatic cirrhosis with ascites and oedema. When used alone, spironolactone is frequently adequate for the relief of ascites and oedema associated with hepatic cirrhosis. It provides a mild and even diuresis and prevents excessive potassium excretion caused by thiazide diuretics, thus avoiding possible precipitation of hepatic coma. Nephrotic syndrome. Although glucocorticoids, whose anti-inflammatory activity appears to benefit the primary pathological process in the renal glomerulus, should probably be employed first, spironolactone either alone or in combination with a conventional diuretic is useful for inducing diuresis. Primary hyperaldosteronism. Spironolactone may be used to establish the diagnosis of primary hyperaldosteronism by therapeutic trial. Spironolactone may also be used for the short-term preoperative treatment of patients with primary hyperaldosteronism, long-term maintenance therapy for patients with discrete aldosterone producing adrenal adenomas who are judged to be poor operative risks (or who decline surgery), and long-term maintenance therapy for patients with bilateral micro- or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Hirsutism in females. Spironolactone is effective in the treatment of females with hirsutism, an androgen related increase in facial and body hair. A reduction in hair growth, hair shaft diameter and hair pigmentation is seen. Use of Spiractin should be considered only after all other alternatives of non-drug therapy have been explored. For women of childbearing age, see Contraindications and Use in Pregnancy.
Visual Identification: 11mm pale orange, normal convex, peppermint flavoured tablet marked "SP" breakline "2" on one side, "alpha" symbol on the reverse.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
2020-08-19
SPIRONOLACTONE VIATRIS S P I R O N O L A C T O N E V I A T R I S CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING SPIRONOLACTONE VIATRIS? SPIRONOLACTONE VIATRIS contains the active ingredient spironolactone. SPIRONOLACTONE VIATRIS is used to treat essential hypertension, oedematous disorders, primary aldosteronism, malignant hypertension, low potassium and hirsutism. For more information, see Section 1. Why am I using SPIRONOLACTONE VIATRIS? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE SPIRONOLACTONE VIATRIS? Do not use if you have ever had an allergic reaction to spironolactone or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use SPIRONOLACTONE VIATRIS? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with SPIRONOLACTONE VIATRIS and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE SPIRONOLACTONE VIATRIS? Daily doses of SPIRONOLACTONE VIATRIS in adults can range from 25 mg to 400 mg. Depending on the dose and your condition, SPIRONOLACTONE VIATRIS may be taken once a day or divided into separate doses. In the treatment of hirsutism (excess body hair) in females, your doctor may tell you to take SPIRONOLACTONE VIATRIS every day or in repeating cycles with a break in between. Doses of SPIRONOLACTONE VIATRIS in children are measured according to body weight and will be calculated by your doctor. More instructions can be found in Section 4. How do I use SPIRONOLACTONE VIATRIS? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING SPIRONOLACTONE VIATRIS? THINGS YOU SHOULD DO • Remind any doctor or dentist you visit that you are usi Aqra d-dokument sħiħ
AUSTRALIAN PRODUCT INFORMATION SPIRONOLACTONE VIATRIS _Spironolactone uncoated tablet _ 1 NAME OF THE MEDICINE Spironolactone 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each SPIRONOLACTONE VIATRIS 25 tablet contains 25 mg of spironolactone as the active ingredient. Each SPIRONOLACTONE VIATRIS 100 tablet contains 100 mg of spironolactone as the active ingredient. Excipients with known effect: sugars as lactose and trace quantities of galactose and sulfites. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM _SPIRONOLACTONE VIATRIS 25,_ 25 mg tablet: 7 mm pale orange, normal convex, peppermint flavoured, marked "SP" breakline "1" on one side, "α" symbol on the reverse. _SPIRONOLACTONE VIATRIS 100,_ 100 mg tablet: 11 mm pale orange, normal convex, peppermint flavoured, marked "SP" breakline "2" on one side, "α" symbol on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ESSENTIAL HYPERTENSION._ Spironolactone, when used alone, is effective in lowering both systolic and diastolic blood pressure. Spironolactone improves the hypotensive action of thiazide diuretics, while at the same time reducing or preventing potassium loss due to the thiazide. Spironolactone enhances the effectiveness of other antihypertensive agents such as β-blockers, vasodilators, etc. _AS ADJUNCTIVE THERAPY IN MALIGNANT HYPERTENSION. _ _IN DIURETIC-INDUCED HYPOKALAEMIA WHEN OTHER MEASURES ARE CONSIDERED INAPPROPRIATE OR INADEQUATE. _ _PROPHYLAXIS OF HYPOKALAEMIA IN PATIENTS TAKING DIGITALIS WHEN OTHER MEASURES ARE CONSIDERED INADEQUATE _ _OR INAPPROPRIATE. _ _CONGESTIVE CARDIAC FAILURE._ When used alone, spironolactone is effective in the management of oedema and sodium retention associated with congestive cardiac failure. Spironolactone may be used in combination with a thiazide or other conventional diuretics for achieving diuresis in patients whose oedema is resistant to a thiazide or other conventional diuretics. Unlike conventional diuretics, spironolactone does not produce hypokala Aqra d-dokument sħiħ