ALDACTONE TAB 100MG 100

Category: Prescription Drug

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ALDACTONE is used:

• To treat essential hypertension (high blood pressure with an unknown cause)
• To treat oedematous disorders (swelling with fluid), including congestive cardiac failure
• For the diagnosis and treatment of primary aldosteronism (a hormone disorder causing fluid retention)
• As add-on therapy in malignant hypertension (a very serious form of high blood pressure)
• Where there is a low amount of potassium (a mineral) in the blood caused by another diuretic (fluid-removing medicine)

ALDACTONE improves the blood pressure lowering action of thiazide diuretics while at the same time reducing or preventing potassium loss due to these medicines.

• For the prevention of low amounts of potassium in the blood in patients taking digitalis (a type of heart drug)
• For the treatment of hirsutism (excess body hair in women)

ALDACTONE acts by working against a hormone called aldosterone. Too much aldosterone causes increased amounts of sodium (a mineral) and water to be retained by the kidneys, while too much potassium is removed from the body. ALDACTONE works against the effects of aldosterone.

ALDACTONE acts by removing excess fluid and by lowering blood pressure. It may be given alone or with other diuretics (fluid-removing medicines). It improves the effectiveness of other medicines used to lower blood pressure.

ALDACTONE also has a moderate ability to act against male sex hormones (anti-androgenic effect). Because of this, ALDACTONE is effective in the treatment of female hirsutism (excess body hair). It reduces hair growth, thickness and hair colour. Increased urine flow is unlikely to be a problem when ALDACTONE is used to treat hirsutism. This is because aldosterone levels are not normally high in patients with hirsutism.

• The safety of ALDACTONE for the treatment of hirsutism in women of child-bearing age has not been established by specific studies.
• Your doctor may recommend combined use with oral contraceptives to provide both regular menstrual cycles and adequate contraception.
• Your doctor, however, may prescribe ALDACTONE for another purpose.

Ask your doctor if you have any questions about why ALDACTONE has been prescribed for you.

• There is no evidence that ALDACTONE is addictive.

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

Your doctor or pharmacist will tell you how many tablets you will need to take each day. This depends on your condition and whether or not you are taking any other medicines.

How much to take

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.

Follow your doctor`s instructions exactly regarding the dose you should take and how often you should take it.

• Doses of ALDACTONE in children are measured according to body weight and will be calculated by your doctor.

If you forget to take it

If you forget to take ALDACTONE, do not try to make up for missed doses by taking more than one dose at a time.

• If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much ALDACTONE.

• Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep telephone numbers for these places handy.

• Overdose may cause nausea and vomiting. Sometimes, drowsiness, mental confusion, rash, diarrhoea or dehydration may occur.

ALDACTONE 25 mg tablets are round, biconvex, buff coloured, peppermint flavoured, film coated, stamped SEARLE over 39 on one side and unmarked on the other side. The tablets are available in blister packs of 100 tablets.

ALDACTONE 100 mg tablets are round, biconvex, buff coloured, peppermint flavoured, film coated, stamped SEARLE over 134 on one side and unmarked on the other side. The tablets are available in blister packs of 100 tablets.

Identification

ALDACTONE tablets can be identified by the Australian Registration number that appears on the carton.

• 25 mg tablets: AUST R 68953.
• 100 mg tablets: AUST R 68954.

Ingredients

The active ingredient in ALDACTONE tablets is spironolactone. ALDACTONE 25 mg tablets contain 25 mg spironolactone and ALDACTONE 100 mg tablets contain 100 mg spironolactone.

The tablets also contain:

• calcium sulfate
• maize starch
• povidone
• magnesium stearate
• hypromellose
• macrogol 400
• peppermint flavour
• Opaspray yellow