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.
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.
3. What if I am taking other medicines?
Some medicines may interfere with SPIRACTIN and affect how it works.
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?
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Things you should do
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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 clots.
Tell your doctor immediately if you become pregnant while you are taking SPIRACTIN.
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Things you should not do
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Do not stop using this medicine suddenly.
Do not take with potassium sparing diuretics.
Do not take potassium supplements or use salt substitutes that contain potassium.
Do not consume a diet rich in potassium.
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Driving or using machines
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Do not drive or operate machinery until you know how SPIRACTIN affects you.
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Looking after your medicine
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Keep SPIRACTIN in a cool dry place where the temperature stays below 30°C.
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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.
Active ingredient:
spironolactone
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using SPIRACTIN. 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 SPIRACTIN.
Where to find information in this leaflet:
1. Why am I using SPIRACTIN?
SPIRACTIN contains the active ingredient spironolactone. SPIRACTIN 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. SPIRACTIN works against the effects
of aldosterone and helps to maintain normal levels of potassium in the blood by retaining
potassium in the body.
SPIRACTIN is a fluid tablet or diuretic. It helps reduce the amount of excess fluid
in the body by increasing the amount of urine produced. This also helps to lower 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.
SPIRACTIN 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)
SPIRACTIN 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 facial or body hair in women).
All women produce small amounts of the male sex hormone, testosterone. Women with
excess facial or body hair tend to be especially sensitive to the action of testosterone
on hair growth. SPIRACTIN has a moderate ability to act against testosterone (anti-androgenic
effect). Because of this, SPIRACTIN 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 SPIRACTIN is used to treat hirsutism. This is
because aldosterone levels are not normally high in patients with hirsutism.
There is no evidence that SPIRACTIN is addictive.
2. What should I know before I use SPIRACTIN?
Warnings
Do not use SPIRACTIN if:
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.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
you are pregnant or think you might be pregnant
SPIRACTIN should not be used during pregnancy due to possible effects on the developing
baby (foetus).
you are breast feeding.
The drug may appear in the breast milk and be passed to the infant.
you have severe kidney disease or are not passing urine.
you have hyperkalaemia (high levels of potassium in the blood).
you have Addison's disease (a condition where the adrenal glands do not work properly).
you are taking eplerenone, a potassium sparing diuretic used to treat heart failure
or high blood pressure.
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:
are allergic to any other medicines, foods, preservatives or dyes.
have of have had any of the following medical conditions.
liver problems
kidney problems
severe heart failure.
take any medicines for any other conditions, including:
potassium supplements
potassium containing salt substitutes
potassium sparing diuretics
other medicines for high blood pressure.
Tell your doctor if you plan to have surgery.
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 SPIRACTIN 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 SPIRACTIN and affect how it works, including:
other medicines used to treat high blood pressure including ACE inhibitors
diuretics, which are fluid removing medicines also known as water tablets
digoxin, a medicine used to treat heart conditions
medicines to prevent blood clots including aspirin
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
non-steroidal anti-inflammatory medicines (NSAIDS) or other medicines which are used
to relieve pain, swelling and other symptoms of inflammation, including arthritis
(e.g. aspirin, indometacin or mefenamic acid)
carbenoxolone, a medicine used to treat mouth ulcers
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 SPIRACTIN.
4. How do I use SPIRACTIN?
How much to take
daily doses of SPIRACTIN in adults can range from 25 mg to 400 mg
doses of SPIRACTIN in children are measured according to body weight and will be calculated
by your doctor
follow the instructions provided and use SPIRACTIN until your doctor tells you to
stop.
When to take SPIRACTIN
depending on the dose and your condition, SPIRACTIN may be taken once a day or divided
into separate doses
take SPIRACTIN with or immediately after food
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.
If you forget to use SPIRACTIN
SPIRACTIN 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.
Otherwise, take it as soon as you remember, and then go back to taking your medicine
as you would normally.
Do not take a double dose to make up for the dose you missed.
If you use too much SPIRACTIN
If you think that you have used too much SPIRACTIN, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26); New Zealand telephone 0800 POISON or 0800 764 766
for advice, 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 SPIRACTIN?
Things you should do
Take SPIRACTIN exactly as your doctor has prescribed.
If you are about to have any blood tests tell your doctor that you are taking SPIRACTIN.
SPIRACTIN 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 immediately if you become pregnant while you are taking SPIRACTIN.
If it is possible for you to become pregnant, you should use adequate contraception
while you are taking SPIRACTIN.
Examples of adequate contraception are oral contraceptives ("the Pill") or intra-uterine
devices (IUDs).
Stop taking SPIRACTIN 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 SPIRACTIN 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 SPIRACTIN.
Remind any doctor or dentist you visit that you are using SPIRACTIN. This is especially
important if you are going to receive an anaesthetic agent while being treated with
SPIRACTIN.
Things you should not do
Do not stop taking your medicine or lower the dose without checking with your doctor.
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 SPIRACTIN, 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 SPIRACTIN
affects you.
SPIRACTIN may cause drowsiness or dizziness in some people and may affect alertness.
Lifestyle measures that help reduce heart disease risk
By following these simple measures, you can further reduce the risk from heart disease.
Quit smoking and avoid second-hand smoke.
Limit alcohol intake.
Enjoy healthy eating by:
eating plenty of vegetables and fruit;
reducing your saturated fat intake (eat less fatty meats, full fat dairy products,
butter, coconut and palm oils, most take-away foods, commercially-baked products).
Be active. Progress, over time, to at least 30 minutes of moderate-intensity physical
activity on 5 or more days each week. Can be accumulated in shorter bouts of 10 minutes
duration. If you have been prescribed anti-angina medicine, carry it with you when
being physically active.
Maintain a healthy weight.
Discuss your lifestyle and lifestyle plans with your doctor.
For more information and tools to improve your heart health, call Heartline, the Heart
Foundation's national telephone information service, on 1300 36 27 87 (local call
cost).
Know warning signs of heart attack and what to do:
Tightness, fullness, pressure, squeezing, heaviness or pain in your chest, neck, jaw,
throat, shoulders, arms or back.
You may also have difficulty breathing, or have a cold sweat or feel dizzy or light
headed or feel like vomiting (or actually vomit).
If you have heart attack warning signs that are severe, get worse or last for 10 minutes
even if they are mild, call triple zero (000). Every minute counts.
Looking after your medicine
Keep your tablets in the bottle until it is time to take them.
Keep SPIRACTIN in a cool dry place where the temperature stays below 30°C.
Follow the instructions in the label 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.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
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.
Do not use this medicine after the expiry date or if the packaging is torn or shows
signs of tampering.
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
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Common side effects
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What to do
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Stomach cramps or diarrhoea
nausea or vomiting
headache
drowsiness, lethargy or generally feeling unwell
skin rash, itchiness, hives
unsteadiness when walking
leg cramps
peeling skin or skin redness
fever or sore throat
unusual hair loss or thinning
excessive hair growth
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Speak to your doctor or pharmacist if you have any of these common side effects and
they worry you.
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Serious side effects
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Serious side effects
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What to do
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frequent infection such as fever, severe chills, sore throat or mouth ulcers
A few cases of agranulocytosis (lack of white blood cells) have been reported in patients
taking SPIRACTIN.
breast enlargement
Breast enlargement may occur in men taking SPIRACTIN. This normally goes away when
SPIRACTIN is stopped. In rare instances some breast enlargement may persist.
breast lumps
Breast lumps and breast cancer have been reported in patients taking SPIRACTIN although
SPIRACTIN has not been shown to cause breast cancer.
breast pain
irregular periods or no periods
post-menopausal bleeding
change in sex drive
impotence (inability to achieve or maintain an erection)
bleeding or bruising more easily than normal.
unsteadiness when walking
leg cramps
headache
mental confusion or dizziness
shortness of breath and swelling of the legs from fluid build
May be due to hyperkalaemia (high levels of potassium in the blood) that is very serious
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The serious side effects may require medical attention.
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Very 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
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 SPIRACTIN contains
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Active ingredient
(main ingredient)
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SPIRACTIN 25 tablets contain 25 mg spironolactone
SPIRACTIN 100 tablets contain 100 mg spironolactone
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Other ingredients
(inactive ingredients)
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lactose monohydrate
microcrystalline cellulose
maize starch
sodium starch glycollate
purified talc
magnesium stearate
polysorbate 80
povidone
quinoline yellow aluminium lake erythrosine aluminium lake sunset yellow FCF aluminium
lake peppermint oil
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Potential allergens
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trace quantities of sulfites
trace quantities of galactose
sugars as lactose
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Do not take this medicine if you are allergic to any of these ingredients.
What SPIRACTIN looks like
SPIRACTIN 25 is 7mm pale orange, normal convex, peppermint flavoured tablet marked
"SP" breakline "1" on one side, " alpha" symbol on the reverse. (AUST R 46689).
SPIRACTIN 100 is 11mm pale orange, normal convex, peppermint flavoured tablet marked
"SP" breakline "2" on one side, "alpha" symbol on the reverse (AUST R 46691).
Who distributes SPIRACTIN
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in April 2023.
SPIRACTIN is a Viatris company trade mark
SPIRACTIN_cmi\Apr23/00