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APO-Perindopril Arginine
Perindopril Arginine
Consumer Medicine Information
For a copy of a large print leaflet, Ph: 1800 195 055
Some people develop heart failure
Ask your doctor if you have any
What is in this leaflet questions about why this medicine after having had a heart attack.
has been prescribed for you. However, there are also other causes
This leaflet answers some common Your doctor may have prescribed it of heart failure.
questions about this medicine. It does for another reason. Heart failure may start off with no
not contain all the available
This medicine is available only with symptoms, but as the condition
information. It does not take the
a doctor's prescription. progresses, you may feel short of
place of talking to your doctor or
breath or may get tired easily after
pharmacist.
High Blood Pressure light physical activity such as
All medicines have risks and walking. You may wake up short of
benefits. Your doctor has weighed Everyone has blood pressure. This
breath at night. Fluid may collect in
the risks of you taking this medicine pressure helps get your blood all
different parts of the body, often first
against the benefits they expect it around the body. Your blood
noticed as swollen ankles and feet. In
will have for you. pressure may be different at different
severe heart failure, symptoms may
times of the day, depending on how
If you have any concerns about occur even at rest.
busy or worried you are. You have
taking this medicine, ask your
high blood pressure when your blood Perindopril arginine helps to treat
doctor or pharmacist.
pressure stays higher than is needed, heart failure. If you follow your
Keep this leaflet with the medicine. doctor's advice, your ability to
even when you are calm or relaxed.
You may need to read it again. perform daily activities may
There are usually no symptoms of
high blood pressure. The only way of improve. You may breathe more
knowing that you have it is to have easily, feel less tired, and have less
your blood pressure checked on a swelling.
What this medicine is regular basis. If high blood pressure
used for is not treated it can lead to serious Coronary Artery Disease
health problems. You may feel fine You may also have been prescribed
The name of your medicine is APO-
and have no symptoms, but perindopril arginine if you have
Perindopril Arginine tablets.
eventually it can cause stroke, heart coronary artery disease. Coronary
It contains the active ingredient disease and kidney failure. artery disease is narrowing of the
perindopril arginine.
Perindopril arginine helps lower your vessels carrying blood to the heart. In
Perindopril belongs to a group of blood pressure. patients with coronary artery disease,
medicines called angiotensin perindopril arginine has been shown
converting enzyme (ACE) inhibitors. Heart Failure to reduce some of the risks, including
It is used to treat high blood pressure, heart attacks.
Heart failure means that the heart
heart failure or coronary artery muscle cannot pump blood strongly Ask your doctor if you have any
disease. enough to supply all the blood questions about why this medicine
needed throughout the body. Heart has been prescribed for you. Your
failure is not the same as heart attack doctor may have prescribed this
and does not mean that the heart medicine for another reason.
stops working.
APO-Perindopril Arginine
Published by MIMS August 2021 1Before you take this • You are treated with sacubitril/ • You have any other health
medicine valsartan, a medicine used to problems, including:
treat long term heart failure, as - Kidney disease, or if you are on
There are some people who should the risk of angioedema (rapid renal dialysis.
not take perindopril arginine. Please swelling under the skin in an - Aortic stenosis (narrowing of
read the list below. If you think any area such as the throat) is the main blood vessel leading
of these situations apply to you or increased (see sections ‘Before from the heart).
you have any questions, please you start to take it’ and ‘Taking - Liver disease.
consult your doctor. Other Medicines’. - High or low levels of potassium,
• The packaging is damaged or or other problems with salt
When you must not take it shows sign of tampering. balance.
• The expiry date (EXP) on the - Diabetes.
• You are allergic to perindopril, - Low blood pressure.
any other ACE inhibitor or any pack has passed.
- Heart disease, including
of the ingredients listed at the hypertrophic cardiomyopathy
end of this leaflet. Before you start to take it
(heart muscle disease).
• You have experienced Tell your doctor immediately if: - Systemic lupus erythematous or
symptoms such as wheezing, • You are pregnant or become scleroderma (a disease affecting
swelling of the face, tongue, lips pregnant while taking perindopril the skin, joints and kidneys).
or throat, intense itching or arginine, as it may cause serious - Are of African origin, since you
severe skin rashes with harm to your baby. may have a higher risk of
previous ACE inhibitor • You are undergoing angioedema and this medicine is
treatment or if you or a desensitisation treatment, or have less effective in lowering your
member of your family have had an allergic reaction during blood pressure.
had these symptoms either previous desensitisation treatment - Have abnormally increased
spontaneously or, in response to (e.g. treatments using bee, wasp levels of a hormone called
another medicine in the past (a or ant venom). aldosterone in your blood
rare condition called (primary aldosteronism).
• You are undergoing, or you are
angiodema). If you think any of these situations
intending to undergo, treatments
• You are pregnant or trying to where your blood is treated apply to you, or you have any
become pregnant. outside the body (also known as doubts, or questions about taking
• You are breastfeeding or plan extracorporeal treatments). perindopril arginine, consult your
to breastfeed. doctor or pharmacist.
• You are to undergo anaesthesia
• You undergo treatments where and/or surgery. Taking other medicines
your blood is treated outside of • You have recently suffered from
the body (also known as diarrhoea or vomiting or are Tell your doctor or pharmacist if
extracorporeal treatments) that you are taking any other
dehydrated.
may increase your risk of medicines, including any that you
• You are on a salt restricted diet or get without a prescription from
allergic reactions, treatments
use salt substitutes which contain your pharmacy, supermarket or
such as:
potassium. health food shop.
- Renal dialysis or
haemofiltration using • You are taking lithium (used to Taking perindopril arginine may
polyacrylonitrile membranes. treat mania or depression). change the effect of some medicines,
- Low-density lipoprotein • You are taking any of the and some medicines may affect how
(LDL) apheresis, a technique following medicines used to treat well perindopril arginine works. You
where LDL is ‘filtered’ out of high blood pressure: may need different amounts of your
the blood, using dextran sulfate. - An ‘angiotensin II receptor medication or to take different
• You are treated with a blood blocker’ (also known as ARBs or medicines. The medicines that may
pressure lowering medicine sartans – e.g. valsartan, interact with perindopril arginine
containing aliskiren and have telmisartan, irbesartan), in include the following:
diabetes or impaired kidney particular if you have diabetes- • Some medications used to treat
function. related kidney problems.
high blood pressure (including
- Aliskiren.
• You have kidney problems angiotensin receptor blockers),
- Sacubitril (available as fixed- aliskiren (see sections ‘Before
where the blood supply to your
dose combinations with another
kidney is reduced (renal artery you take this medicine’ - ‘When
medicine valsartan), used to treat
stenosis). you must not take this medicine’
long term heart failure.
APO-Perindopril Arginine
Published by MIMS August 2021 2and ‘Before you start to take it’ - • Gold salts, especially with How much to take
‘Tell your doctor immediately intravenous administration (used
Your doctor will tell you how much
if’), diuretics (sometimes called to treat symptoms of rheumatoid
of this medicine you should take.
‘fluid’ or ‘water’ tablets because arthritis).
This will depend on your condition
they increase the amount of urine • Medicines which may increase
and whether you are taking any other
passed each day). the risk of angioedema (a severe
medicines.
• Some treatments where your allergic reaction) such as:
blood is treated outside of the - Mammalian target of rapamycin Do not stop taking your medicine or
body, also known as (mTOR) inhibitors used to avoid change your dosage without first
extracorporeal treatments (see rejection of transplanted organs checking with your doctor.
sections ‘Before you take this (e.g. temsirolimus, sirolimus, The dose of perindopril arginine you
medicine’ - ‘When you must not everolimus). may need each day will be decided
take this medicine’ and ‘Before - Sacubitril (available as fixed- and adjusted by your doctor. This
you start to take it’ - ‘Tell your dose combination with valsartan), will normally be 2.5 mg, 5 mg or 10
doctor immediately if’). used to treat long term heart mg once daily for high blood
• Some antibiotics and medicines failure treatments (see sections pressure and for people with
used to treat infections. ‘Before you take this medicine’ - coronary artery disease or 2.5 mg to
• Some anti-inflammatory ‘When you must not take this 5 mg once daily for heart failure.
medicines (including high dose medicine’ and ‘Before you start
aspirin, ibuprofen) for pain relief. to take it’ - ‘Tell your doctor How to take it
immediately if’).
• Medicines used to treat mood Swallow your tablet(s) with a glass
- gliptins used to treat diabetes of water.
swings and some types of
(e.g. linagliptin, saxagliptin,
depression (lithium, tricyclic
sitagliptin, vildagliptin, When to take it
antidepressants, antipsychotics).
alogliptin).
• Potassium-sparing diuretics, Take it at about the same time
It is a good idea to remind your
sources of potassium, like each day, preferably in the
doctor of all other medicines you
potassium tablet and salt morning before a meal.
take. Your doctor and pharmacist
substitutes containing potassium, have more information on Taking your medicine at the same
other medicines which can medicines to be careful with or time each day will have the best
increase potassium in your body avoid while taking this medicine. effect. It will also help you remember
(such as heparin, a medicine used when to take it.
to thin blood to prevent clots and For the Elderly or Children
co-trimoxazole also known as How long to take it
trimethoprim/sulfamethoxazole Perindopril arginine can generally be
used safely by the elderly. However, Continue taking your medicine for
for infections caused by bacteria; as long as your doctor tells you.
and ciclosporin, an reduced kidney function is often
found in the elderly and in this case, This medicine helps to control your
immunosuppressant medicine
the starting dose should always be condition but does not cure it. It is
used to prevent organ transplant
2.5 mg. important to keep taking your
rejection).
Perindopril arginine is not medicine even if you feel well.
• Immunosuppressants (medicines
which reduce the activity of the recommended for children. Continue taking your medicine
until you finish the pack.
body’s natural defences).
• Vasodilators including nitrates. If you forget to take it
• Medicines used to treat diabetes How to take this
(tablets and insulin). If it is almost time to take your
medicine next dose, skip the dose you missed
• Medicines which may affect the and take your next dose when you
blood cells, such as allopurinol, Follow all directions given to you are meant to.
procainamide. by your doctor or pharmacist
Otherwise, take it as soon as you
• Baclofen (a medicine used to treat carefully.
remember, and then go back to
muscle stiffness in diseases such They may differ from the
taking your medicine as you would
as multiple sclerosis). information contained in this leaflet. normally.
• Medicines used for the treatment If you do not understand the Do not take a double dose to make
of low blood pressure, shock or directions, ask your doctor or up for the dose that you missed.
asthma (e.g. ephedrine, pharmacist for help. This may increase the chance of
noradrenaline or adrenaline).
APO-Perindopril Arginine
Published by MIMS August 2021 3you getting an unwanted side If you are going to have surgery, failure or coronary artery disease, but
effect. tell the surgeon or anaesthetist that it may have unwanted side effects in
If you are not sure what to do, ask you are taking this medicine. a few people. All medicines can have
your doctor or pharmacist. It may affect other medicines used side effects. Sometimes they are
during surgery. serious, most of the time they are not.
If you have trouble remembering
to take your medicine, ask your If you become pregnant or start to You may need medical attention if
pharmacist for some hints. breastfeed while taking this you get some of the side effects.
medicine, tell your doctor Do not be alarmed by the following
If you take too much immediately. lists of side effects. You may not
(overdose) If you are about to have any blood experience any of them.
tests, tell your doctor that you are
Immediately telephone your doctor Ask your doctor or pharmacist to
taking this medicine.
or the Poisons Information Centre answer any questions you may
It may interfere with the results of have.
(telephone 13 11 26) for advice or
some tests.
go to Accident and Emergency at Angiodema (a severe allergic
the nearest hospital, if you think Keep all your doctor's reaction) has been reported in
that you or anyone else may have appointments so that your progress patients treated with ACE
taken too much of this medicine. can be checked. inhibitors, including perindopril
Do this even if there are no signs of Your doctor may do some tests from arginine.
discomfort or poisoning. time to time to make sure the This may occur at any time during
You may need urgent medical medicine is working and to prevent treatment. If you develop such
attention. unwanted side effects. symptoms described below, you
If you take too much your blood should tell your doctor
Things you must not do immediately or go to the Accident
pressure may fall (also known as
and Emergency Department at
hypotension), which can make you Do not take this medicine to treat
your nearest hospital. These side
feel dizzy or faint. If this happens, any other complaints unless your
effects are extremely rare but can
lying down with the legs elevated can doctor tells you to.
be serious:
help. Other effects like sickness, Do not give your medicine to
anyone else, even if they have the • Swelling of your extremities
cramps, sleepiness, confusion, kidney
same condition as you. (limbs, hands or feet), lips, face,
problems, salt and water disturbances
mouth, tongue or throat.
are possible. You may require urgent Do not stop taking your medicine
medical attention. or change the dosage without • A fast and irregular heartbeat.
checking with your doctor. • Purple spots with occasional
Do not stop taking your medicine blisters on the front of your arms
because you are feeling better, and legs and/or around your neck
While you are using this unless advised by your doctor. and ears (a rare condition known
medicine as Stevens-Johnson Syndrome).
Things to be careful of • Difficulty in breathing.
Things you must do Be careful driving or operating • Severe blisters, skin rash, itching,
machinery until you know how this erythema multiforme or other
If you are about to be started on
any new medicine, remind your medicine affects you. allergic reactions.
doctor and pharmacist that you Dizziness or weakness due to low Talk to your doctor or pharmacist
are taking this medicine. blood pressure may occur in if you notice any of the following
certain patients. If you have any of side effects:
Make sure you drink enough water
during exercise and hot weather these symptoms do not drive or Common (may affect up to 1 in 10
especially if you sweat a lot. This operate machinery. people) side effects can include:
will help you avoid dizziness or • Cough, often described as dry and
light-headedness caused by a irritating, shortness of breath,
sudden drop in blood pressure.
discomfort on exertion.
Tell your doctor immediately if Side effects
• Headache, dizziness, vertigo, pins
you have excessive vomiting or
Tell your doctor or pharmacist as and needles.
diarrhoea while taking this
soon as possible if you do not feel • Changes in the rhythm or rate of
medicine.
well while you are taking this heartbeat, fast or irregular
Tell any other doctors, dentists, medicine. heartbeat.
and pharmacists who treat you
that you are taking this medicine. This medicine helps most people • Feeling tired, lethargic or weak.
with high blood pressure, heart
APO-Perindopril Arginine
Published by MIMS August 2021 4• Tinnitus (persistent noise in the Very rare (may affect up to 1 in uncommon side effects have been
ear), vision disturbances. 10,000 people) side effects can reported and you should ask your
• Hypotension, flushing, impaired include: doctor or pharmacist if you want to
peripheral circulation, vasculitis, • Hepatitis. know more.
nose bleeds. • Inflammation of the pancreas
• Nausea, vomiting, taste (pancreatitis).
disturbances, indigestion, • Eosinophilic pneumonia.
diarrhoea, constipation, stomach • Runny or blocked nose, sneezing,
Storage and Disposal
pain or discomfort. facial pressure or pain.
• Muscle cramps. Storage
• Red, often itchy spots, similar to
• Rash, pruritus (itching). the rash of measles, which starts Keep your tablets in the pack until
Uncommon (may affect up to 1 in on the limbs and sometimes on it is time to take them.
100 people) side effects can the face and the rest of the body. If you take the tablets out of the pack
include: • Joint pain. they may not keep well.
• High levels in the blood of • Swelling of hands, ankles or feet. Keep your medicine in a cool dry
potassium, urea and/or creatine, place where the temperature stays
• Bleeding or bruising more easily
low sodium levels in the blood. below 25°C.
than normal caused by a low
• Mood disturbances, sleep blood platelet count, frequent Do not store this medicine or any
disturbances (difficulty sleeping, other medicine in the bathroom or
infections such as fever, severe
near a sink. Do not leave it on a
abnormal dreams), feeling sleepy chills, sore throat or mouth ulcers
window sill or in the car.
or drowsy, fainting. caused by a lack of white blood
Heat and dampness can destroy some
• Difficulty in breathing or cells, pancytopenia (a rare type of
medicines.
wheezing. anaemia).
Keep it where children cannot
• Dry mouth. • Illnesses resulting from a lack of
reach it.
• Swelling of the face, lips, mouth, red blood cells.
A locked cupboard at least one-and-
tongue or throat which may cause • Stroke, myocardial infarction, a-half metres above the ground is a
difficulty in swallowing or angina pectoris (a feeling of good place to store medicines.
breathing. tightness, pressure or heaviness in
• Excessive sweating. the chest). Disposal
• Increased sensitivity of the skin to • Changes in the rhythm or rate of
If your doctor tells you to stop
sun, skin rash or inflammation of the heartbeat.
taking this medicine or the expiry
the skin often including blisters • Confusion, depression or date has passed, ask your
that weep and become crusted. hallucinations. pharmacist what to do with any
• Increase in some white blood Not known (frequency cannot be medicine that is left over.
cells. estimated from the data available):
• Erectile dysfunction. • Discolouration, numbness and
• Fever or high temperature. pain in fingers or toes (Raynaud’s
phenomenon). Product description
• Chest pain.
• Kidney problems. Other:
What APO-Perindopril
• Decreased blood sugar levels. Concentrated urine (dark in colour),
Arginine looks like
• Aching muscles, muscle feel or are sick, have muscle cramps,
tenderness or weakness, not confusion and fits which may be due 2.5 mg Tablets
caused by exercise. to inappropriate anti-diuretic White coloured, round shaped,
hormone (ADH) secretion can occur biconvex, film coated tablets, with
• Generally feeling unwell.
with ACE inhibitors. If you have engraved "APO" on one side and
• Falls. "2.5" on the other side.
these symptoms contact your doctor
Rare (may affect up to 1 in 1,000 as soon as possible. It is available in blister pack of 30 or
people) side effects can include:
Consult your doctor or pharmacist 100 tablets and bottle pack of 30 or
• Elevation of bilirubin levels in the if you experience any of these or 100 tablets
blood, increased liver enzymes. notice anything else that is making
5 mg Tablets
• Worsening of psoriasis. you feel unwell.
Light green coloured, capsule-
• Kidney disease. Do not be alarmed by this list of
shaped, biconvex, film coated tablets,
possible side effects. You may not
• Problems with production or
experience of them. Other
passing of urine.
APO-Perindopril Arginine
Published by MIMS August 2021 5with notch and engraved "APO" on Supplier
one side and "P 5" on the other side.
This medicine is supplied in
It is available in blister pack of 30 or Australia by:
100 tablets and bottle pack of 30 or
Apotex Pty Ltd
100 tablets
16 Giffnock Avenue
10 mg Tablets Macquarie Park NSW 2113
Green coloured, round shaped, Tel: (02) 8877 8333
biconvex, film coated tablets, with Web: www1.apotex.com/au
engrave "APO" on one side and "P
APO and APOTEX are registered
10" on the other side.
trade marks of Apotex Inc.
It is available in blister pack of 30 or
This leaflet was prepared in July
100 tablets and bottle pack of 30 or
2021.
100 tablets.
APO-Perindopril Arginine 2.5 mg
tablet (blister pack): AUST R
184819.
APO- Perindopril Arginine 2.5 mg
tablet (bottle): AUST R 184808.
APO-Perindopril Arginine 5 mg
tablet (blister pack): AUST R
184814.
APO- Perindopril Arginine 5 mg
tablet (bottle): AUST R 184806.
APO-Perindopril Arginine 10 mg
tablet (blister pack): AUST R
184809.
APO- Perindopril Arginine 10 mg
tablet (bottle): AUST R 184812.
Ingredients
Each tablet contains 2.5 mg, 5 mg or
10 mg of perindopril arginine as the
active ingredient.
This medicine also contains the
following:
• Isomalt
• Colloidal anhydrous silica
• Magnesium stearate
• Hypromellose
• Hydroxypropyl cellulose
• Macrogol 8000
• Titanium dioxide
5 mg and 10 mg tablets contain
brilliant blue FCF aluminium lake
and iron oxide yellow.
This medicine does not contain
lactose, sucrose, gluten, tartrazine or
any other azo dyes.
APO-Perindopril Arginine
Published by MIMS August 2021 6You can also read
