perindopril (pronounced per-in-do-pril) and indapamide (pronounced in-dap-a-mide)
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons
living in Australia. This page contains answers to some common
. It does
not contain all the information that is known about
. It does not take the
place of talking to your doctor or pharmacist. All medicines have risks
and benefits. Your doctor has weighed the risk of you using this medicine
against the benefits he/she expects it will have for you. If you have
any concerns about using this medicine, ask your doctor or pharmacist.
Bookmark or print this page, you may need to read it again.
WHAT COVERSYL PLUS IS
The name of your medicine is COVERSYL PLUS. The medicine contains the active ingredients perindopril arginine and indapamide
hemihydrate. Perindopril belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors. Indapamide
belongs to a group of medicines called diuretics (a type of "water" tablet).
WHAT COVERSYL PLUS IS USED FOR
You have been prescribed COVERSYL PLUS for high blood pressure.
COVERSYL PLUS is available only with a doctor's prescription.
There is no evidence that COVERSYL PLUS is addictive.
Why COVERSYL PLUS is used for high blood pressure
Everyone has blood pressure. This pressure helps to circulate blood all around the body. Your blood pressure may be different
at different times of the day, depending on how busy or stressed you are. You have high blood pressure (also known as hypertension)
when your blood pressure stays higher than is needed, even when you are calm and relaxed.
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.
COVERSYL PLUS helps to lower your blood pressure.
Ask your doctor if you have any questions about why COVERSYL PLUS has been prescribed for you.
BEFORE YOU TAKE COVERSYL PLUS
There are some people who should not take COVERSYL PLUS. Please read the lists below. If you think any of these situations
apply to you, or you have any questions, please consult your doctor or pharmacist.
Do not take COVERSYL PLUS if:
You are allergic to perindopril, indapamide, or any of the other ingredients of COVERSYL PLUS listed at the end of this leaflet.
You are allergic to sulphonamide (sulpha) antibiotics, or to thiazide diuretics (a type of "fluid" or "water" tablet).
You are allergic to another angiotensin converting enzyme (ACE) inhibitor.
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 such as:
renal dialysis or haemofiltration using polyacrylonitrile membranes.
low-density lipoprotein (LDL) apheresis, a technique where LDL is 'filtered' out of a patient's blood, using dextran sulphate.
You are treated with a blood pressure lowering medicine containing aliskiren and have diabetes or impaired kidney function
You have narrowing of the blood vessels to one or both kidneys.
You are suffering from decreases in the amount, or absence of, urine produced by the kidney
You have narrowing of the main blood vessel leading from the heart and/or heart valve.
If you have low blood potassium
If you have severe liver disease or suffer from a condition called hepatic encephalopathy (degenerative disease of the brain
that occurs as a result of liver disease)
You have experienced serious swelling of the face, tongue, lips or throat either suddenly or in response to another medicine
in the past (a rare allergic condition known as angio-oedema).
The packaging is damaged or shows signs of tampering, or the tablets do not look quite right.
The expiry date (EXP) on the pack has passed.
Tell your doctor straight away if:
You are pregnant or become pregnant while taking COVERSYL PLUS, as it may cause serious harm to your unborn baby.
You have a severe allergic reaction with swelling of the face, lips, mouth, tongue or throat which may cause difficulty in
swallowing or breathing (angioedema). This may occur at any time during treatment. If you develop such symptoms, you should
stop taking COVERSYL PLUS and see a doctor immediately (see also 'SIDE EFFECTS' section).
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 undergoing anaesthesia and/or surgery.
You are undergoing a medical test that requires injection of an iodinated contrast agent (a substance that makes organs like
the kidney or stomach visible on an X-ray)
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 COVERSYL PLUS contains lactose.
You are of African origin since you may have a higher risk of angioedema and this medicine is less effective in lowering your
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 problems,
You have any other health problems, including:
Kidney disease or if you are on renal dialysis.
High or low levels of potassium, sodium, or other problems with salt balance.
Hardening of the arteries
Hyperparathyroidism (overactive parathyroid gland).
Photosensitivity reactions (increased sensitivity of the skin to sun)
Systemic lupus erythematosus or scleroderma (a disease affecting the skin, joints and kidneys)
Changes in your vision, increased pressure or pain in one or both of your eyes while taking COVERSYL PLUS. This could be a
sign that you are developing glaucoma. You should discontinue COVERSYL PLUS treatment and seek medical attention.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy,
supermarket or health food shop.
Taking COVERSYL PLUS may change the effect of some medicines, and some medicines may affect how well COVERSYL PLUS works.
You may need different amounts of your medication or to take different medicines. The medicines that may interact with COVERSYL
PLUS include the following:
Some medications used to treat high blood pressure (including angiotensin receptor blockers), aliskiren (see also 'Do Not
Take COVERSYL PLUS 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 COVERSYL PLUS If' and 'Tell Your Doctor Straight Away' sections)
Some antibiotic and medicines used to treat infections (e.g. trimethoprim, moxifloxacin).
Amphotericin B by injection (to treat severe fungal disease)
Tetracosactide (to treat Crohn's disease)
Some anti-inflammatory medicines (including high dose aspirin, ibuprofen) for pain relief.
Some anaesthetic medicines
Some steroid medicines.
Medicines used to treat mood swings and some types of depression (lithium, tricyclic antidepressants, antipsychotics).
Potassium-sparing diuretics (e.g. spironolactone, triamterene), sources of potassium, like potassium tablet and salt substitutes
Heparin (used to thin blood).
Some drugs used to treat cancer or to suppress the immune system.
Vasodilators including nitrates.
Medicines used to treat diabetes (e.g. metformin, gliptins and insulin).
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 rheumatoid arthritis).
Medicines which may affect the blood cells, such as allopurinol, procainamide.
Mammalian target of rapamycin (mTOR) inhibitors used to avoid rejection of transplanted organs (e.g. temsirolimus, sirolimus,
Iodinated contrast agent used in certain medical tests
Methadone (a medicine used to treat severe pain or opioid addiction)
Medicines used for heart rhythm problems (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol).
Digoxin or other cardiac glycosides (for the treatment of heart problems).
Stimulant laxatives (e.g. senna).
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking COVERSYL PLUS.
For older people or children
Elderly people can generally use COVERSYL PLUS safely. However, some older people have reduced kidney function - in which
case additional care may be required.
COVERSYL PLUS is not recommended for use in children and adolescents.
HOW TO TAKE COVERSYL PLUS
Follow all directions given to you by your doctor and pharmacist carefully.
If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
Your doctor will select a dose when they prescribe COVERSYL PLUS for you. The usual dose is one tablet once daily.
Swallow your tablet(s) with water, preferably in the morning.
How long to take COVERSYL PLUS for
COVERSYL PLUS can help to control your blood pressure but cannot cure this condition. COVERSYL PLUS treatment is usually for
life - so you should keep taking the tablets regularly unless advised otherwise by your doctor.
If you forget to take COVERSYL PLUS
If your next usual dose is less than 6 hours away, just leave out the dose that you missed. Take the next dose at the usual
time and continue as normal.
If your next dose is more than 6 hours away, take the dose you have missed as soon as you realise. Then take the next dose
at the usual time and continue as normal.
Do not try to make up for missed doses by taking more than one dose at a time.
If you take too much COVERSYL PLUS
Taking too much COVERSYL PLUS (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. If this happens, lying down
with the legs elevated can help.
Other effects like, nausea, vomiting, cramps, sleepiness, confusion changes in the amount of urine produced by the kidney
are possible. You may require urgent medical attention.
If you think that you or anyone else may have taken too much COVERSYL PLUS then act immediately:
Telephone your doctor or the Poisons Information Centre (13 11 26 in Australia; 03 474 7000 in New Zealand), 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 COVERSYL PLUS
Things you must do
Take COVERSYL PLUS 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 COVERSYL PLUS.
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 COVERSYL PLUS
Things you must not do
Do not give this medicine to anyone else, even they have the same condition as you.
Do not use COVERSYL PLUS to treat any other complaints unless your doctor tells you to.
Do not stop taking COVERSYL PLUS or change the dose, without checking with your doctor.
Things to be careful of
Be careful when driving or operating machinery until you know how COVERSYL PLUS affects you.
You may feel light-headed or dizzy when you begin to take COVERSYL PLUS. This is because your blood pressure is falling. If
you have these symptoms when standing up or getting out of bed then getting up more slowly can help. This allows your body
to get used to the change in position and blood pressure.
If you have these symptoms and they don't get better in a short time then talk to your doctor.
If you do not feel well while you are taking COVERSYL PLUS 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.
COVERSYL PLUS helps most people with high blood pressure, but it may sometimes have unwanted side effects in a few people.
While these side effects when they occur are usually mild they can be serious.
Stop taking COVERSYL PLUS and see a doctor immediately, if you experience any of the following side effects that can be serious
Dizziness becoming severe or fainting induced by low blood pressure.
Difficulty breathing or wheezing, tightening of the chest. (Uncommon).
Angioedema (a severe allergic reaction) has been reported in patients treated with ACE inhibitors, including COVERSYL PLUS.
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 throat. (Uncommon).
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). (Very rare).
Painful red areas, developing large blisters and peeling of layers of skin. This is accompanied by fever and chills (a condition
known as Toxic Epidermal Necrolysis or TEN). (Very rare).
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 (a condition known as Erythema Multiforme). (Very rare).
Stroke (signs include weakness of arms or legs or problems speaking). (Very rare).
Heart disorders such as a fast and irregular heart beat, heart attack, angina pectoris (a feeling of tightness, pressure or
heaviness in the chest). (Very rare).
Inflammation of the pancreas (Pancreatitis). (Very rare).
Liver disease (Hepatitis) characterised by yellowing of the skin or eyes (jaundice). (Very rare).
Life-threatening irregular heart beat (Torsades de pointes). (Frequency not known).
Disease of the brain caused by liver illness (Hepatic encephalopathy) (Frequency not known).
The above side effects are categorised into the following frequencies:
Common - may affect up to 1 in 10 people
Uncommon - may affect up to 1 in 100 people
Rare - may affect up to 1 in 1,000 people
Very rare - may affect up to 1 in 10,000 people
Not known - frequency cannot be estimated from the data available
Talk to your doctor or pharmacist or nurse if you notice any of the following side effects, some of which are usually only
identified after blood tests:
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.
Feeling tired or weak.
Tinnitus (persistent noise in the ears), vertigo, vision impairment.
Low blood pressure (and related effects), flushing, impaired peripheral circulation, vasculitis
Nausea, vomiting, taste disturbances, indigestion, diarrhoea, constipation, stomach pain or discomfort.
Muscle tenderness or weakness.
Rash, pruritus (itching), red raised skin rash
Hypersensitivity reactions, mainly skin reactions, in patients with allergies and asthmatic reactions
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 (salt) levels in the blood.
Altered mood, sleep disorder (difficulty sleeping, abnormal dreams), feeling sleepy or drowsy, fainting.
Bronchitis, upper respiratory tract infection
Increased sensitivity of the skin to sun, skin rash or inflammation of the skin often including blisters that weep and become
Pemphigoid - a skin disease usually affecting older people
Increase in some white blood cells.
Erectile dysfunction, libido disorder
Fever or high temperature.
Fast heart beat
Palpitations (awareness of your heartbeat).
Abnormal ECG heart tracing
Abnormal kidney function.
Polyuria - increased urination
Cystitis - an infection of the bladder.
Decreased blood sugar levels.
Worsening of pre-existing Lupus Erythematosus
Aching muscles, not caused by exercise, Joint pain
Generally feeling unwell or lethargic.
Vasculitis (inflammation of blood cells)
Impaired peripheral circulation
Syncope - fainting not associated with seizures or trauma.
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.
Elevated calcium levels in the blood
Worsening of psoriasis
Very rare (may affect up to 1 in 10,000 people) side effects can include:
Abnormal liver function
Runny or blocked nose, sneezing, facial pressure or pain.
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
Changes in the rhythm or rate of the heart beat.
Confusion, depression or hallucinations.
Not known (frequency cannot be estimated from the data available):
Myopia, blurred vision
Low potassium levels
Blood glucose increased
Blood uric acid increased
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 COVERSYL PLUS
Keep your COVERSYL PLUS tablets where children cannot reach them. A locked cupboard at least one-and-a-half metres above the
ground is a good place to store medicines.
Keep your tablets in the pack until it is time to take them. COVERSYL PLUS will not keep as well outside its container.
Heat and dampness can destroy some medicines. Keep them in a cool, dry place where the temperature 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.
If your doctor tells you to stop taking COVERSYL PLUS, or the tablets have passed their expiry date, return any leftover tablets
to your pharmacist for disposal.
WHAT COVERSYL PLUS LOOKS LIKE
COVERSYL PLUS LD 2.5MG/0.625MG tablets are white, rod shaped tablets with a score line.
COVERSYL PLUS 5MG/1.25MG tablets are white and rod shaped.
COVERSYL PLUS LD 2.5MG/0.625MG and COVERSYL PLUS 5MG/1.25MG are supplied in quantities of thirty (30) tablets in a white bottle
containing desiccants in sachet form and equipped with a red child-resistant screw-on cap.
Each tablet of COVERSYL PLUS LD 2.5MG/0.625MG contains 2.5mg of perindopril arginine and 0.625mg of indapamide hemihydrate
as active ingredients.
Each tablet of COVERSYL PLUS 5MG/1.25MG contains 5mg of perindopril arginine and 1.25mg of indapamide hemihydrate as active
The inactive ingredients in COVERSYL PLUS LD 2.5MG/0.625MG and COVERSYL PLUS 5MG/1.25MG tablets contain lactose monohydrate,
magnesium stearate, colloidal anhydrous silica, maltodextrin, sodium starch glycollate type A, macrogol 6000, glycerol, hypromellose,
The tablets are gluten free.
Manufacturer and Sponsor
COVERSYL® PLUS are products discovered by Servier Research International.
It is distributed in Australia by:
Servier Laboratories (Australia) Pty Ltd
ABN 54 004 838 500
8 Cato Street
Hawthorn, Victoria 3122
COVERSYL® PLUS LD 2.5MG/0.625MG is registered on the Australian Register of Therapeutic Goods.
Australian Register Number: AUST R 124552
COVERSYL® PLUS 5MG/1.25MG is registered on the Australian Register of Therapeutic Goods.
Australian Register Number: AUST R 124553
This leaflet was last revised in