contains the active ingredient spironolactone
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common questions about SPIRONOLACTONE VIATRIS.
It does not contain all of the available information. It does not take the place of
talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking
SPIRONOLACTONE VIATRIS against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with your medicine. You may need to read it again.
What SPIRONOLACTONE VIATRIS is used for
SPIRONOLACTONE VIATRIS is used:
to treat essential hypertension (high blood pressure with an unknown cause)
to treat oedematous disorders (swelling with fluid), including congestive cardiac
to help bring potassium levels in the blood back to normal when the levels become
to treat hyperaldosteronism (a hormone disorder causing fluid retention)
as add on therapy in malignant hypertension (a very serious form of high blood pressure)
treat excess facial or body hair in women.
Ask your doctor if you have any questions about why this medicine has been prescribed
Your doctor may have prescribed it for another reason.
This medicine is available only with a doctor's prescription.
There is no evidence that SPIRONOLACTONE VIATRIS is addictive.
How SPIRONOLACTONE VIATRIS works
In fluid build-up and high blood pressure
SPIRONOLACTONE VIATRIS 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.
In hyperaldosteronism and low potassium levels in the blood
In hyperaldosteronism, the adrenal glands produce too much of a hormone called aldosterone.
SPIRONOLACTONE VIATRIS works by stopping the effects of aldosterone.
By stopping the effects of aldosterone, SPIRONOLACTONE VIATRIS also helps to maintain
normal levels of potassium in the blood by retaining potassium in the body.
In women with excess hair
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. SPIRONOLACTONE VIATRIS reduces the growth of hair by stopping the
effects of testosterone. Increased urine flow is unlikely to be a problem when SPIRONOLACTONE
VIATRIS is used to treat hirsutism. This is because aldosterone levels are not normally
high in patients with hirsutism.
Before you take SPIRONOLACTONE VIATRIS
When you must not take it
Do not take SPIRONOLACTONE VIATRIS if you are allergic to any medicine containing
spironolactone or any of the ingredients listed at the end of this leaflet.
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.
Do not take SPIRONOLACTONE VIATRIS if you have any of the following medical conditions:
high potassium levels in your blood (hyperkalaemia)
severe kidney disease or not passing urine.
Addison's disease, a condition where the adrenal glands do not work properly.
The safety of SPIRONOLACTONE VIATRIS 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.
Do not take this medicine if you are pregnant or think you might be pregnant.
SPIRONOLACTONE VIATRIS can affect your developing baby if you take it during pregnancy.
Do not take this medicine if you are breastfeeding.
SPIRONOLACTONE VIATRIS passes into breast milk and may affect your baby.
Do not take this medicine after the expiry date printed on the pack or if the pack
or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal. If you
are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, dyes or preservatives.
Tell your doctor if you have or have had any of the following medical conditions:
severe heart failure.
Tell your doctor if you plan to become pregnant or breastfeed.
Tell your doctor if you plan to have surgery.
If you have not told your doctor about any of the above, tell him/her before you start
taking SPIRONOLACTONE VIATRIS .
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any
that you buy with or without a prescription from a pharmacy, supermarket or health
Some medicines and SPIRONOLACTONE VIATRIS may interfere with each other. These include:
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
potassium supplements or potassium-containing salt substitutes
colestyramine, a medicine used to lower cholesterol levels in the blood
ammonium chloride, which is contained in some cough and cold medicines
medicines to prevent blood clots, including aspirin
non-steroidal anti-inflammatory drugs (NSAIDs), or other medicines 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.
These medicines may be affected by SPIRONOLACTONE VIATRIS or may affect how well it
works. You may need different amounts of your medicines, or you may need to take different
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking SPIRONOLACTONE VIATRIS .
How to take SPIRONOLACTONE VIATRIS
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the bottle, ask your doctor or pharmacist
How much to take
Your doctor will tell you how many tablets you need to take each day. Daily doses
of SPIRONOLACTONE VIATRIS in adults can range from 25mg to 400mg. This depends on
your condition and whether or not you are taking other medicines.
Doses of SPIRONOLACTONE VIATRIS in children are measured according to body weight
and will be calculated by your doctor.
Follow your doctor's instructions exactly regarding the dose you should take and how
often you should take it.
How to take it
Swallow the tablets with a glass of water.
When to take it
Depending on the dose and your condition, SPIRONOLACTONE VIATRIS may be taken once
a day or divided into separate doses.
Take SPIRONOLACTONE VIATRIS with or immediately after food.
How long to take it for
Continue taking your medicine for as long as your doctor tells you to.
The length of treatment will depend on your condition. SPIRONOLACTONE VIATRIS is usually
taken long term.
If you forget to take it
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 that you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13
11 26) for advice, or go to Accident and Emergency at the nearest hospital if you
think you or anyone else may have taken too much SPIRONOLACTONE VIATRIS. Do this even
if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too much SPIRONOLACTONE VIATRIS , you may feel drowsy, weak, confused
or sick, vomit, have diarrhoea or pins and needles of the hands or feet.
While you are taking SPIRONOLACTONE VIATRIS
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking SPIRONOLACTONE VIATRIS.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
This is especially important if you are going to receive an anaesthetic agent while
being treated with SPIRONOLACTONE VIATRIS. If you become pregnant while taking this
medicine, tell your doctor immediately.
If it is possible for you to become pregnant, you should use adequate contraception
while you are taking SPIRONOLACTONE VIATRIS. Examples of adequate contraception are
oral contraceptives ("the Pill") or intra-uterine devices (IUDs). Stop taking SPIRONOLACTONE
VIATRIS if you become pregnant or you think you may be pregnant.
If you are about to have any blood tests, tell your doctor that you are taking this
It may interfere with the results of some tests.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may ask you to have blood tests to check your sodium and potassium levels
and see how your kidneys are working.
Things you must not do
Do not take SPIRONOLACTONE VIATRIS to treat any other complaints unless your doctor
tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
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 SPIRONOLACTONE VIATRIS, too much potassium can cause serious problems,
such as disturbances to the heart rhythm.
Things to be careful of
Be careful driving or operating machinery until you know how SPIRONOLACTONE VIATRIS
This medicine may cause drowsiness or dizziness in some people. If you have any of
these, do not drive, operate machinery or do anything else that could be dangerous.
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
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.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking SPIRONOLACTONE VIATRIS.
Like other medicines, SPIRONOLACTONE VIATRIS may cause unwanted side effects in some
people. Sometimes they are serious, most of the time they are not. You may need medical
attention if you get some of the side effects.
Do not be alarmed by the following list of side effects.
You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
vomiting, feeling sick (nausea)
stomach cramps or pain
drowsiness, lethargy or generally feeling unwell
skin rash, itchiness, hives
unsteadiness when walking
hair loss or thinning
excessive hair growth
menstrual problems in women
change in sex drive
impotence (inability to get or maintain an erection in men)
breast enlargement in men. This normally goes away when SPIRONOLACTONE VIATRIS is
stopped. In rare instances some breast enlargement may persist.
Tell your doctor as soon as possible if you notice any of the following:
mental confusion or dizziness
frequent infection such as fever, severe chills, sore throat or mouth ulcers
bleeding or bruising more easily than normal.
breast lumps and breast cancer have been reported in patients taking SPIRONOLACTONE
VIATRIS although SPIRONOLACTONE VIATRIS has not been shown to cause breast cancer.
The above list includes serious side effects that may require medical attention.
If any of the following happen, tell your doctor immediately or go to Accident and
Emergency at your nearest hospital:
yellow skin and eyes (jaundice). SPIRONOLACTONE VIATRIS can cause impairment of liver
stomach bleeding, ulcers or gastritis (inflammation of the stomach)
vomiting blood or material that looks like coffee grounds, bleeding from the back
passage, black sticky bowel motions (stools) or bloody diarrhoea
irregular heartbeat, tingling sensation, paralysis or difficulty in breathing, which
may be symptoms of raised potassium levels in your blood
The above list includes very serious side effects. You may need urgent medical attention
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some patients.
After taking SPIRONOLACTONE VIATRIS
Keep your tablets in the bottle until it is time to take them.
If you take the tablets out of the bottle they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 30°C.
Do not store SPIRONOLACTONE VIATRIS or any other medicine in the bathroom or near
a sink. Do not leave it in the car or on a window sill.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
If your doctor tells you to stop taking this medicine, or the expiry date has passed,
ask your pharmacist what to do with any medicine that is left over.
What it looks like
SPIRONOLACTONE VIATRIS comes in two strengths of tablets:
SPIRONOLACTONE VIATRIS 25 - round, pale orange, peppermint flavoured tablet, marked
SP/1 and a Greek alpha symbol
SPIRONOLACTONE VIATRIS 100 - round, pale orange, peppermint flavoured tablet, marked
SP/2 and a Greek alpha symbol.
Each bottle contains 100 tablets.
The active ingredient in SPIRONOLACTONE VIATRIS is spironolactone
each SPIRONOLACTONE VIATRIS 25 tablet contains 25 mg of spironolactone
each SPIRONOLACTONE VIATRIS 100 tablet contains 100 mg of spironolactone.
The tablets also contain the following inactive ingredients:
sodium starch glycollate
sunset yellow FCF
SPIRONOLACTONE VIATRIS contains sugars as lactose and trace quantities of galactose
SPIRONOLACTONE VIATRIS is made in Australia by:
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 November 2021.
Australian registration numbers:
SPIRONOLACTONE VIATRIS 25: AUST R 338091
SPIRONOLACTONE VIATRIS 100: AUST R 338092