perindopril (pronounced per-in-do-pril)
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about PREXUM. It does not contain all the
available information. It does not take the place of talking to your doctor, pharmacist
or nurse. If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet.
All medicines have risks and benefits. Your doctor has weighed the risks of taking
PREXUM against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor, pharmacist or
nurse. Keep this leaflet with the medicine.
You may need to read it again.
WHAT PREXUM IS
The name of your medicine is PREXUM. The medicine contains the active ingredient perindopril
arginine. Perindopril belongs to a group of medicines called angiotensin converting
enzyme (ACE) inhibitors.
WHAT PREXUM IS USED FOR
PREXUM is available only with a doctor's prescription.
PREXUM lowers high blood pressure, a condition which doctors call hypertension.
Everyone has blood pressure. This pressure helps get your blood all around the body.
Your blood pressure may be different at different times of the day, depending on how
busy or worried you are. You have high blood pressure when your blood pressure stays
higher than is needed, even when you are calm or relaxed.
There are usually no symptoms of high blood pressure. The only way of knowing that
you have it is to have your blood pressure checked on a regular basis. If high blood
pressure is not treated it can lead to serious health problems. You may feel fine
and have no symptoms, but eventually it can cause stroke, heart disease and kidney
failure. PREXUM helps lower your blood pressure.
You may be prescribed PREXUM for heart failure. Heart failure means that the heart
muscle cannot pump blood strongly enough to supply all the blood needed throughout
the body. Heart failure is not the same as heart attack and does not mean that the
heart stops working.
Some people develop heart failure after having had a heart attack. However there are
also other causes of heart failure.
Heart failure may start off with no symptoms, but as the condition progresses, you
may feel short of breath or may get tired easily after light physical activity such
as walking. You may wake up short of breath at night. Fluid may collect in different
parts of the body, often first noticed as swollen ankles and feet. In severe heart
failure, symptoms may occur even at rest.
PREXUM helps to treat heart failure. If you follow your doctor's advice, your ability
to perform daily activities may improve. You may breath more easily, feel less tired,
and have less swelling.
You may also have been prescribed PREXUM if you have coronary artery disease. Coronary
artery disease is narrowing of the vessels carrying blood to the heart. In patients
with coronary artery disease, PREXUM has been shown to reduce some of the risks, including
BEFORE YOU TAKE PREXUM
There are some people who shouldn't take PREXUM. Please read the list below. If you
think any of these situations apply to you or you have any questions, please consult
Do not take PREXUM if:
You are allergic to perindopril, any other ACE inhibitor or any of the ingredients
listed at the end of this leaflet.
You have experienced symptoms such as wheezing, swelling of the face, tongue, lips
or throat, intense itching or severe skin rashes with previous ACE inhibitor treatment
or if you or a member of your family have had these symptoms either spontaneously
or, in response to another medicine in the past (a rare condition called angioedema).
You are pregnant or trying to become pregnant.
You are breastfeeding or plan to breast-feed.
You undergo treatments where your blood is treated outside of the body (also known
as extracorporeal treatments) that may increase your risk of allergic reactions, treatments
renal dialysis or haemofiltration using polyacrylonitrile membranes
low-density lipoprotein (LDL) apheresis, a technique where LDL is 'filtered' out of
the blood, using dextran sulphate.
You are treated with a blood pressure lowering medicine containing aliskiren and have
diabetes or impaired kidney function.
You have kidney problems where the blood supply to your kidneys is reduced (renal
You are treated with sacubitril/ valsartan a medicine used to treat long-term heart
failure (see also 'Tell Your Doctor Straight Away' and 'Taking Other Medicines' sections).
The packaging is damaged or shows sign of tampering.
The expiry date (EXP) on the pack has passed.
Tell your doctor straight away if:
You are pregnant or become pregnant while taking PREXUM, as it may cause serious harm
to your baby.
You are undergoing desensitisation treatment, or have had an allergic reaction during
previous desensitisation treatment (e.g. treatments using bee, wasp or ant venom).
You are undergoing, or you are intending to undergo, treatments where your blood is
treated outside of the body (also known as extracorporeal treatments).
You are to undergo anaesthesia and/or surgery.
You have recently suffered from diarrhoea or vomiting or are dehydrated.
You are on a salt restricted diet or use salt substitutes which contain potassium.
You have an intolerance to some sugars as PREXUM contains lactose.
You are taking lithium (used to treat mania or depression).
You are taking any of the following medicines used to treat high blood pressure:
an 'angiotensin II receptor blocker' (also known as ARBs or sartans - for example
valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney
sacubitril (available as fixed-dose combination with another medicine valsartan),
used to treat long-term heart failure.
You have any other health problems, including:
kidney disease, or if you are on renal dialysis
aortic stenosis (narrowing of the main blood vessel leading from the heart)
high or low levels of potassium, or other problems with salt balance
low blood pressure
heart disease, including hypertrophic cardiomyopathy (heart muscle disease)
systemic lupus erythematous or scleroderma (a disease affecting the skin, joints and
are of African origin since you may have a higher risk of angioedema and this medicine
is less effective in lowering your blood pressure
have abnormally increased levels of a hormone called aldosterone in your blood (primary
If you think any of these situations apply to you, or you have any doubts or questions
about taking PREXUM consult your doctor or pharmacist.
Taking other medicines
Taking PREXUM may change the effect of some medicines, and some medicines may affect
how well PREXUM works. You may need different amounts of your medication or to take
different medicines. The medicines that may interact with PREXUM include the following:
Some medications used to treat high blood pressure (including angiotensin receptor
blockers), aliskiren (see also 'Do Not Take PREXUM If' and 'Tell Your Doctor Straight
Away' sections), diuretics (sometimes called 'fluid' or 'water' tablets because they
increase the amount of urine passed each day)
Some treatments where your blood is treated outside of the body, also known as extracorporeal
treatments (see also 'Do Not Take PREXUM If' and 'Tell Your Doctor Straight Away'
Some antibiotics and medicines used to treat infections
Some anti-inflammatory drugs (including high dose aspirin, ibuprofen) for pain relief
Medicines used to treat mood swings and some types of depression (lithium, tricyclic
Potassium-sparing diuretics, sources of potassium, like potassium tablet and salt
substitutes containing potassium, other drugs which can increase potassium in your
body (such as heparin and co-trimoxazole also known as trimethoprim/sulfamethoxazole)
Immunosuppressants (medicines which reduces the activity of the body's natural defences)
Vasodilators including nitrates
Medicines used to treat diabetes (tablets and insulin)
Medicines which may affect the blood cells, such as allopurinol, procainamide
Baclofen (a medicine used to treat muscle stiffness in diseases such as multiple sclerosis)
Medicines used for the treatment of low blood pressure, shock or asthma (e.g. ephedrine,
noradrenaline or adrenaline)
Gold salts, especially with intravenous administration (used to treat symptoms of
Medicines which may increase the risk of angioedema (a severe allergic reaction) such
Mammalian target of rapamycin (mTOR) inhibitors used to avoid rejection of transplanted
organs (e.g. temsirolimus, sirolimus, everolimus)
Sacubitril (available as fixed-dose combination with valsartan), used to treat long-term
heart failure (see also 'Do Not Take PREXUM If' and 'Tell Your Doctor Straight Away'
It is a good idea to remind your doctor of all other medicines you take. Your doctor
or pharmacist has more information on medicines to be careful with or avoid while
For older people or children
PREXUM can generally be used safely by elderly people. However reduced kidney function
is often found in elderly people and in this case, the starting dose should always
be 2.5 mg.
PREXUM is not recommended for children.
HOW TO TAKE PREXUM
The dose of PREXUM you may need each day will be decided and adjusted by your doctor.
This will normally be 2.5 mg (PREXUM 2.5), 5 mg (PREXUM 5) or 10 mg (PREXUM 10) once
daily for high blood pressure and for people with coronary artery disease or 2.5 mg
(PREXUM 2.5) to 5 mg (PREXUM 5) once daily for heart failure.
Swallow your tablet(s) with water, preferably in the morning before a meal.
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 it as you would normally.
Do not take a double dose to make up for the dose that you missed.
How long to take it
PREXUM helps control your blood pressure, or heart failure or coronary artery disease
but does not cure it. Continue taking the tablets for as long as your doctor tells
If you take too much
Taking too much PREXUM (an overdose) may cause low blood pressure (also known as hypotension).
The most likely effect in case of overdose is low blood pressure which can make you
feel dizzy or faint. If this happens, lying down with the legs elevated can help.
Other effects like sickness, cramps, sleepiness, confusion, kidney problems, salt
and water disturbances are possible. You may require urgent medical attention.
If you think that you or anyone else may have taken too much PREXUM then act immediately:
Telephone your doctor or the Poisons Information Centre (13 11 26 in Australia), or
go to the Accident and Emergency department at your nearest hospital. Do this even
if there are no signs of discomfort or poisoning.
WHILE YOU ARE TAKING PREXUM
Things you must do
Take PREXUM exactly as your doctor has prescribed. Otherwise you may not get the benefits
from treatment. Tell all doctors, dentists and pharmacists who are involved with your
treatment that you are taking PREXUM.
Make sure you drink enough water during exercise and hot weather especially if you
sweat a lot. This will help you avoid any dizziness or light-headedness caused by
a sudden drop in blood pressure.
Tell your doctor straight away if you have excessive vomiting or diarrhoea while taking
Things you must not do
Do not give PREXUM to anyone else, even if they have the same condition as you.
Do not use PREXUM to treat other complaints unless your doctor tells you to.
Do not stop taking PREXUM or change the dosage, without checking with your doctor.
Do not stop taking your tablets because you are feeling better, unless advised by
Things to be careful of
Take care when driving or operating machinery until you know how PREXUM affects you.
Dizziness or weakness due to low blood pressure may occur in certain patients. If
you have any of these symptoms do not drive or operate machinery.
If you do not feel well while you are taking PREXUM then tell your doctor or pharmacist
as soon as possible.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not.
PREXUM helps most people with high blood pressure, heart failure or coronary artery
disease, but it may have unwanted side effects in a few people. While these side effects
when they occur are usually mild they can be serious.
Angioedema (a severe allergic reaction) has been reported in patients treated with
ACE inhibitors, including PREXUM. This may occur at any time during treatment. If
you develop such symptoms described below you should tell your doctor immediately
or go to the Accident and Emergency department at your nearest hospital. These side
effects are extremely rare but can become serious:
Swelling of your extremities (limbs, hands or feet), lips, face, mouth, tongue or
A fast and irregular heart beat
Purple spots with occasional blisters on the front of your arms and legs and/or around
your neck and ears (a rare condition known as Stevens-Johnson Syndrome)
Difficulty in breathing
Severe blisters, skin rash, itching, erythema multiforme or other allergic reactions.
Talk to your doctor or pharmacist or nurse if you notice any of the following side
Common (may affect up to 1 in 10 people) side effects can include:
Cough, often described as dry and irritating, shortness of breath, discomfort on exertion
Headache, dizziness, vertigo, pins and needles
Changes in the rhythm or rate of the heart beat, fast or irregular heart beat
Feeling tired, lethargic or weak
Tinnitus (persistent noise in the ears), vision disturbances
Hypotension, flushing, impaired peripheral circulation, vasculitis, nose bleeds
Nausea, vomiting, taste disturbances, indigestion, diarrhoea, constipation, stomach
pain or discomfort
Rash, pruritus (itching).
Uncommon (may affect up to 1 in 100 people) side effects can include:
High levels in the blood of potassium, urea and/or creatine, low sodium levels in
Mood disturbance, sleep disturbances (difficulty sleeping, abnormal dreams), feeling
sleepy or drowsy, fainting
Difficulty breathing or wheezing
Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in
swallowing or breathing
Increased sensitivity of the skin to sun, skin rash or inflammation of the skin often
including blisters that weep and become crusted
Increase in some white blood cells
Fever or high temperature
Decreased blood sugar levels
Aching muscles, muscle tenderness or weakness, not caused by exercise
Generally feeling unwell
Rare (may affect up to 1 in 1,000 people) side effects can include:
Elevation of bilirubin levels in the blood, increases in liver enzymes.
Worsening of psoriasis
Very rare (may affect up to 1 in 10,000 people) side effects can include:
Inflammation of the pancreas (pancreatitis)
Runny or blocked nose, sneezing, facial pressure or pain
Red, often itchy spots, similar to the rash of measles, which starts on the limbs
and sometimes on the face and the rest of the body
Swelling of hands, ankles or feet
Bleeding or bruising more easily than normal caused by a low blood platelet count,
frequent infections such as fever, severe chills, sore throat or mouth ulcers caused
by a lack of white blood cells, pancytopenia (a rare type of anaemia)
Illnesses resulting from a lack of red blood cells
Stroke, myocardial infarction, angina pectoris (a feeling of tightness, pressure or
heaviness in the chest)
Changes in the rhythm or rate of the heart beat
Confusion, depression or hallucinations
Concentrated urine (dark in colour), feel or are sick, have muscle cramps, confusion
and fits which may be due to inappropriate anti-diuretic hormone (ADH) secretion.
If you have these symptoms contact your doctor as soon as possible.
Consult your doctor, pharmacist or nurse if you experience any of these or notice
anything else that is making you feel unwell.
Do not be alarmed by this list of possible side effects. You may not experience any
of them. Other uncommon side effects have been reported and you should ask your doctor,
pharmacist or nurse if you want to know more.
AFTER TAKING PREXUM
Heat and dampness can destroy some medicines. Keep your tablets in the pack until
it is time to take them. Keep them in a cool, dry place where it stays below 30°C.
Do not store medicines in a bathroom or near a sink. Do not leave them in a car or
on a windowsill. Keep them where children cannot reach them. Keep the container tightly
If your doctor tells you to stop taking PREXUM, or the tablets have passed their expiry
date, return any leftover tablets to your pharmacist for disposal.
WHAT PREXUM LOOKS LIKE
PREXUM 2.5 are white round convex film-coated tablets containing 2.5 mg of perindopril
PREXUM 5 are light-green rod-shaped film-coated tablets engraved with a Servier logo
on one face and scored on both edges containing 5 mg of perindopril arginine.
PREXUM 10 are green round biconvex film-coated tablets with a Servier logo on one
face and a heart on the other face containing 10 mg of perindopril arginine.
Thirty (30) tablets are supplied in a white bottle containing desiccants and equipped
with a white child-resistant screw-on cap.
Each tablet of PREXUM 2.5 contains 2.5 mg of perindopril arginine as the active ingredient
and a number of inactive ingredients.
Each tablet of PREXUM 5 contains 5 mg of perindopril arginine as the active ingredient
and a number of inactive ingredients.
Each tablet of PREXUM 10 contains 10 mg of perindopril arginine as the active ingredient
and a number of inactive ingredients.
All tablet doses include lactose monohydrate, magnesium stearate, maltodextrin, hydrophobic
colloidal anhydrous silica, sodium starch glycollate (type A), macrogol 6000. All
tablet coatings include glycerol, hypromellose and titanium dioxide.
The inactive ingredient specific to:
PREXUM 5 is: premix for light-green colour coating [chlorophyllin-copper complex]
PREXUM 10 is: premix for green colour coating [chlorophyllin-copper complex]
PREXUM is registered on the Australian Register of Therapeutic Goods.
Australian Register Number:
PREXUM 2.5: AUST R 194884
PREXUM 5: AUST R 194885
PREXUM 10: AUST R 194886
PREXUM is a product discovered by Servier Research International.
It is distributed in Australia by:
Servier Laboratories (Aust.) Pty Ltd
8 Cato Street
Hawthorn Victoria 3122
Phone: 1800 153 590
This document was last revised in July 2018