Aldactone 25mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

spironolactone, Quantity: 25 mg

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: macrogol 400; hypromellose; maize starch; calcium sulfate dihydrate; magnesium stearate; povidone; Flavour; titanium dioxide; purified water; iron oxide yellow; iron oxide red; industrial methylated spirit

Administration route:

Oral

Units in package:

100 tablets

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Essential hypertension; oedematous disorders such as oedema and ascites of congestive cardiac failure, cirrhosis of the liver, nephrotic syndrome; diagnosis and treatment of primary hyperaldosteronism; 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: ALDACTONE, when used alone, is effective in lowering both systolic and diastolic blood pressure. ALDACTONE improves the hypotensive action of thiazide diuretics while at the same time reducing or preventing potassium loss due to the thiazide. ALDACTONE enhances the effectiveness of other antihypertensive agents such as beta blockers, vasodilators etc. Congestive Cardiac Failure: ALDACTONE, when used alone, is effective in the management of oedema and sodium retention associated with congestive cardiac failure. ALDACTONE 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 ALDACTONE does not produce hypokalaemia. When administered with a thiazide or other conventional diuretics ALDACTONE offsets hypokalaemia induced by these diuretics. The prevention of potassium loss is particularly important in the treatment of digitalized patients since digitalis intoxication may be precipitated if hypokalaemia is induced by conventional diuretic therapy. Hepatic Cirrhosis with Ascites and Oedema: ALDACTONE when used alone is frequently adequate for the relief of ascites and oedema associated with hepatic cirrhosis. ALDACTONE 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 pathologic process in the renal glomerulus, should probably be employed first, ALDACTONE either alone or in combination with a conventional diuretic is useful for inducing diuresis. Primary Hyperaldosteronism: ALDACTONE may be used to establish the diagnosis of primary hyperaldosteronism by therapeutic trial. ALDACTONE may also be used for the short term pre operative 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 the long term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Hirsutism in Females: ALDACTONE 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 Aldactone should be considered only after all other alternatives of non drug therapy have been explored. For women of child bearing age, see CONTRAINDICATIONS and PRECAUTIONS, Use in Pregnancy.

Product summary:

Visual Identification: Round, buff-coloured film-coated tablet engraved "SEARLE" over "39" on one side and plain on the reverse, with peppermint odour.; Container Type: Blister Pack; Container Material: Al laminated with PVC/paper; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1999-05-28

Patient Information leaflet

ALDACTONE
®
A
L
D
A
C
T
O
N
E
®
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 ALDACTONE?
Aldactone contains the active ingredient spironolactone. Aldactone 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 Aldactone? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ALDACTONE?
Do not use if you have ever had an allergic reaction to Aldactone 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
Aldactone? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Aldactone 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 ALDACTONE?
Daily doses of Aldactone in adults can range from 25 mg to 400 mg.
Depending on the dose and your condition, Aldactone 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 Aldactone every day or in repeating
cycles with a break in between.
Doses of Aldactone 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 Aldactone?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ALDACTONE?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using Aldactone.
•
If you are about to have any blood tests, tell your doctor that you
are taking Aldactone.
•
Tell your doctor if you are taking other types of medicines to treat
high blood pressure or to prevent blo

Summary of Product characteristics

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AUSTRALIAN
PRODUCT
INFORMATION
–
ALDACTONE
® (SPIRONOLACTONE)
1.
NAME OF THE MEDICINE
Spironolactone
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The 25 mg ALDACTONE tablets contain 25 mg spironolactone.
The 100 mg ALDACTONE tablets contain 100 mg spironolactone.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
25 mg ALDACTONE tablets: 8.7 mm in diameter, round, biconvex, buff
coloured, peppermint
flavoured, film coated, stamped SEARLE over 39 on one side and
unmarked on the other.
100 mg ALDACTONE tablets: 11.2 mm in diameter, round, biconvex, buff
coloured,
peppermint flavoured, film coated, stamped SEARLE over 134 on one side
and unmarked on
the other.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ESSENTIAL HYPERTENSION
ALDACTONE, when used alone, is effective in lowering both systolic and
diastolic blood
pressure. ALDACTONE improves the hypotensive action of thiazide
diuretics while at the
same time reducing or preventing potassium loss due to the thiazide.
ALDACTONE enhances
the effectiveness of other antihypertensive agents such as beta
blockers, vasodilators, etc.
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Page 2 of 12
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.
OEDEMATOUS DISORDERS, SUCH AS OEDEMA AND ASCITES OF CONGESTIVE CARDIAC
FAILURE, CIRRHOSIS
OF THE LIVER, NEPHROTIC SYNDROME.
CONGESTIVE CARDIAC FAILURE
ALDACTONE, when used alone, is effective in the management of oedema
and sodium
retention
associated
with
congestive
cardiac
failure.
ALDACTONE
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