SPIRACTIN 100 spironolactone 100mg tablets

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

spironolactone, Quantity: 100 mg

Mevcut itibaren:

Alphapharm Pty Ltd

Farmasötik formu:

Tablet, uncoated

Kompozisyon:

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

Uygulama yolu:

Oral

Paketteki üniteler:

100 tablets

Reçete türü:

(S4) Prescription Only Medicine

Terapötik endikasyonlar:

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

Ürün özeti:

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

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

1993-10-14

Bilgilendirme broşürü

SPIRACTIN
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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

Ürün özellikleri

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