Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
spironolactone, Quantity: 25 mg
Alphapharm Pty Ltd
Tablet, uncoated
Excipient Ingredients: quinoline yellow aluminium lake; Peppermint Oil; purified talc; sodium starch glycollate; lactose monohydrate; povidone; microcrystalline cellulose; magnesium stearate; polysorbate 80; sunset yellow FCF aluminium lake; erythrosine aluminium lake; maize starch
Oral
100 tablets
(S4) Prescription Only Medicine
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. 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
Visual Identification: 7mm pale orange, normal convex, peppermint flavoured tablet marked "SP" breakline "1" 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
1993-10-14
SPIRACTIN S P I R A C T I N 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 SPIRACTIN? SPIRACTIN contains the active ingredient spironolactone. SPIRACTIN 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 SPIRACTIN? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE SPIRACTIN? Do not use if you have ever had an allergic reaction to SPIRACTIN 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 SPIRACTIN? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with SPIRACTIN 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 SPIRACTIN? Daily doses of SPIRACTIN in adults can range from 25 mg to 400 mg. Depending on the dose and your condition, SPIRACTIN 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 SPIRACTIN every day or in repeating cycles with a break in between. Doses of SPIRACTIN 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 SPIRACTIN? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING SPIRACTIN? THINGS YOU SHOULD DO • Remind any doctor or dentist you visit that you are using SPIRACTIN. • If you are about to have any blood tests, tell your doctor that you are taking SPIRACTIN. • Tell your doctor if you are taking other types of medicines to treat high blood pressure or to prevent blood clo Læs hele dokumentet
AUSTRALIAN PRODUCT INFORMATION SPIRACTIN _Spironolactone uncoated tablet _ 1 NAME OF THE MEDICINE Spironolactone 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 25 mg tablet contains 25 mg of spironolactone as the active ingredient. Each 100 mg 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 25 mg tablet: 7 mm pale orange, normal convex, peppermint flavoured, marked "SP" breakline "1" on one side, "α" symbol on the reverse. 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 hypokalaemia. When administered with a thiazide or other conventional diuretics, spironolactone offsets hypokalaemia ind Læs hele dokumentet