SUMMARY CMI

Aldactone^®

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?

For more information, see Section 5. What should I know while using Aldactone? in the full CMI.

6. Are there any side effects?

Some common side effects include cramping, diarrhoea, nausea, vomiting, drowsiness, lethargy, generally feeling unwell, skin rash, itchiness, peeling skin, skin redness, fever, sore throat, unusual hair loss or thinning or excessive hair growth.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

Aldactone^® (al-dak-tone)

Active ingredient(s): spironolactone (spur-ron-o-lack-tone)

Consumer Medicine Information (CMI)

This leaflet provides important information about using Aldactone. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Aldactone.

Where to find information in this leaflet:

1. Why am I using Aldactone?
2. What should I know before I use Aldactone?
3. What if I am taking other medicines?
4. How do I use Aldactone?
5. What should I know while using Aldactone?
6. Are there any side effects?
7. Product details

1. Why am I using Aldactone?

Aldactone contains the active ingredient spironolactone. 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 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 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.

2. What should I know before I use Aldactone?

Warnings

Do not use Aldactone if:

1. you are allergic to spironolactone, or any of the ingredients listed at the end of this leaflet.

Always check the ingredients to make sure you can use this medicine.

2. you are pregnant or think you might be pregnant

Aldactone should not be used during pregnancy due to possible effects on the developing baby (fetus).

3. you are breast feeding

The drug may appear in the breast milk and be passed to the infant.

4. you have severe kidney disease or are not passing urine
5. you have hyperkalaemia (high levels of potassium in the blood)
6. you have Addison's disease (a condition where the adrenal glands do not work properly).
7. you are taking eplerenone, a potassium sparing diuretic used to treat heart failure or high blood pressure
8. the expiry date printed on the pack has passed or if the packaging is torn or shows signs of tampering.

Check with your doctor if you:

• have any other medical conditions
• take any medicines for any other condition, including:
  - potassium supplements
  - potassium containing salt substitutes
  - potassium sparing diuretics
  - other medicines for high blood pressure.
• are allergic to any other medicines, foods, preservatives or dyes.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Women of child-bearing age

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.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Aldactone and affect how it works, including:

• other medicines used to treat high blood pressure
• diuretics, which are fluid removing medicines also known as water tablets
• digoxin, a medicine used to treat heart conditions
• medicines to prevent blood clots
• potassium supplements or potassium sparing diuretics
• dietary salt substitutes as many of these contain potassium
• cholestyramine, a medicine used to lower cholesterol levels in the blood
• ammonium chloride, which is contained in some cough and cold medicines
• aspirin
• non-steroidal anti-inflammatory medicines (NSAIDS) or other medicines which are used to relieve pain, swelling and other symptoms of inflammation, including arthritis
• regional or general anaesthetics
• abiraterone treatment in prostate cancer patients.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Aldactone.

4. How do I use Aldactone?

How much to take

• daily doses of Aldactone in adults can range from 25 mg to 400 mg
• doses of Aldactone in children are measured according to body weight and will be calculated by your doctor
• follow the instructions provided and use Aldactone until your doctor tells you to stop.

When to take Aldactone

• 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.

If you forget to use Aldactone

Aldactone should be used regularly at the same time each day.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you use too much Aldactone

If you think that you have used too much Aldactone, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

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

5. What should I know while using Aldactone?

Things you should do

• Take Aldactone exactly as your doctor has prescribed
• If you are about to have any blood tests tell your doctor that you are taking Aldactone
  Aldactone may interfere with the results of some tests.
• Tell your doctor if you are taking other types of medicines to treat high blood pressure
• Tell your doctor if you are taking medicines to prevent blood clots
• Tell your doctor if you become pregnant while you are taking Aldactone
  If it is possible for you to become pregnant, you should use adequate contraception while you are taking Aldactone
  Examples of adequate contraception are oral contraceptives ("the Pill") or intra-uterine devices (IUDs).
• Stop taking Aldactone if you become pregnant or you think you may be pregnant
• Go to your doctor regularly for a check-up.
  Your doctor may do blood tests to check your sodium and potassium levels and see how your kidneys are working.
  Your doctor may do the blood test weekly at the start of your treatment, monthly for the first 3 months of treatment then quarterly for a year, and then every 6 months when increasing your dose.
  You may need to stop taking Aldactone if your blood is high in potassium or if your kidneys are not working properly.

Call your doctor straight away if you:

• become pregnant while you are taking Aldactone.

Remind any doctor or dentist you visit that you are using Aldactone. This is especially important if you are going to receive an anaesthetic agent while being treated with Aldactone.

Things you should not do

• Do not stop using this medicine suddenly.
• Do not take potassium supplements or use salt substitutes that contain potassium
• Do not consume a diet rich in potassium
  Dried fruit, bananas and oranges are some foods that contain high amounts of potassium. Consuming some of these foods is usually safe but do not consume excessive amounts.
  If you are taking Aldactone, too much potassium can cause serious problems, such as disturbances to the heart rhythm.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Aldactone affects you.

Aldactone may cause drowsiness or dizziness in some people and may affect alertness.

Looking after your medicine

Keep Aldactone in a cool dry place where the temperature stays below 30°C.

Follow the instructions on the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Do not use this medicine after the expiry date.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Common side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Aldactone contains

Do not take this medicine if you are allergic to any of these ingredients.

What Aldactone looks like

Aldactone 25 mg - round, biconvex, buff coloured, peppermint flavoured, film coated tablets; stamped SEARLE over 39 on one side and unmarked on the other side.
AUST R 68953

Aldactone 100 mg - round, biconvex, buff coloured, peppermint flavoured, film coated tablets; stamped SEARLE over 134 on one side and unmarked on the other side.
AUST R 68954

The tablets are available in blister packs of 100 tablets.

Who distributes Aldactone

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizermedicalinformation.com.au

This leaflet was prepared in July 2022.

® Registered Trademark

© Pfizer Australia Pty Ltd 2022

Published by MIMS September 2022

1 Name of 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.

Oedematous disorders, such as oedema and ascites of congestive cardiac failure, cirrhosis of the liver, nephrotic syndrome.

Congestive cardiac failure.

Hepatic cirrhosis with ascites and oedema.

Nephrotic syndrome.

Diagnosis and treatment of primary hyperaldosteronism.

Hirsutism.

4.2 Dose and Method of Administration

Dosage.

Adults.

Congestive cardiac failure.

Cirrhosis.

Nephrotic syndrome.

Long test.

Short test.

Children and adolescents.

Oedema.

4.3 Contraindications

Acute renal insufficiency, significant impairment of renal function, anuria.
Addison's disease or other conditions associated with hyperkalaemia (see Section 4.4 Special Warnings and Precautions for Use).
Hyperkalaemia.
Pregnancy.
Hypersensitivity to spironolactone.
Concomitant use of eplerenone.

4.4 Special Warnings and Precautions for Use

Concomitant use of spironolactone with angiotensin converting enzyme (ACE) inhibitors, nonsteroidal anti-inflammatory drugs, angiotensin II antagonists, aldosterone blockers, heparin, low molecular weight heparin, other drugs or conditions known to cause hyperkalaemia, potassium supplements, a diet rich in potassium, including salt substitutes containing potassium, or other potassium sparing agents is not recommended as it may lead to severe hyperkalaemia.
Hyperkalaemia may be fatal in patients with severe heart failure (New York Heart Association [NYHA] class III-IV). Potassium and creatinine levels should be closely monitored 1 week after initiation or monthly for the first 3 months, then quarterly for a year, and then every 6 months when increasing the dose of spironolactone. Concomitant use of spironolactone and other potassium sparing diuretics in patients with severe heart failure should be avoided. If serum potassium is > 3.5 mEq/L, oral potassium supplements should be avoided. Treatment with spironolactone should be discontinued or interrupted in patients with serum potassium > 5 mEq/L or with serum creatinine > 4 mg/dL.
Periodic estimation of serum electrolytes is desirable due to the possibility of hyperkalaemia, hyponatraemia and possible transient blood urea nitrogen (BUN) elevation especially in the elderly and/or patients with pre-existing impaired renal or hepatic function, in whom the risk/ benefit ratio should always be weighed.
Reversible hyperchloraemic metabolic acidosis, usually in association with hyperkalaemia, has been reported to occur in some patients with decompensated hepatic cirrhosis, even in the presence of normal renal function.
The safety of Aldactone for the treatment of hirsutism in women of childbearing age has not been established by specific long-term clinical trials. Epidemiological studies are also inadequate to establish the safety of long-term use in this population.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concomitant use of drugs known to cause hyperkalaemia with spironolactone may result in severe hyperkalaemia (see Section 4.4 Special Warnings and Precautions for Use).
Hyperkalaemia has been associated with the use of indomethacin or ACE inhibitors in combination with potassium sparing diuretics.
Spironolactone reduces the vascular responsiveness to noradrenaline. Therefore caution should be exercised in the management of patients subjected to regional or general anaesthesia while they are being treated with Aldactone.
As carbenoxolone may cause sodium retention and thus decrease the effectiveness of spironolactone, concurrent use of the two agents should be avoided.
Spironolactone has been shown to increase the half-life of digoxin. This may result in increased serum digoxin levels and subsequent digitalis toxicity. It may be necessary to reduce the digoxin dose when spironolactone is administered, and the patient should be carefully monitored to avoid over- or under-digitalisation.
Spironolactone may have an additive effect when given concomitantly with other diuretics and antihypertensive agents. The dose of such drugs may need to be reduced when spironolactone is added to the treatment regimen.
Nonsteroidal anti-inflammatory drugs such as aspirin, indomethacin, and mefenamic acid may attenuate the natriuretic efficacy of diuretics due to inhibition of intrarenal synthesis of prostaglandins and have been shown to attenuate the diuretic effect of spironolactone.
Spironolactone enhances the metabolism of antipyrine.
Hyperkalaemic metabolic acidosis has been reported in patients given spironolactone concurrently with ammonium chloride or cholestyramine.
Spironolactone binds to the androgen receptor and may increase prostate-specific antigen (PSA) levels in abiraterone-treated prostate cancer patients.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Somnolence and dizziness have been reported to occur in some patients. Caution is advised when driving or operating machinery until the response to initial treatment has been determined.

4.8 Adverse Effects (Undesirable Effects)

Gynaecomastia may develop in association with the use of spironolactone, and physicians should be alert to its possible onset. The development of gynaecomastia appears to be related to both dosage level and duration of therapy and is normally reversible when Aldactone is discontinued. In rare instances some breast enlargement may persist.
Other adverse reactions that have been reported in association with Aldactone are: gastrointestinal symptoms, including cramping, diarrhoea, nausea, vomiting, gastric bleeding, ulceration and gastritis; drowsiness, lethargy, headache, maculopapular or erythematous cutaneous eruptions, urticaria, mental confusion, drug fever, ataxia, inability to achieve or maintain erection, irregular menses or amenorrhoea, postmenopausal bleeding, malaise, benign breast neoplasm, breast pain, leucopenia (including agranulocytosis), thrombocytopenia, abnormal hepatic function, electrolyte disturbances, hyperkalaemia, leg cramps, dizziness, changes in libido, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), alopecia, hypertrichosis, pruritus, rash, and acute renal failure.
Carcinoma of the breast has been reported in patients taking spironolactone, but a cause and effect relationship has not been established.

Reporting suspected adverse effects.

4.9 Overdose

Symptoms.

Treatments.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Calcium sulfate dihydrate, maize starch, povidone, magnesium stearate, hypromellose, macrogol 400, Felcofix peppermint flavour 961149/701213, Opaspray yellow M-1-6032B.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

The 25 mg and 100 mg tablets are available as blister packs of 100 tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (S4).

Summary Table of Changes