2. What should I know before I take PERISYL COMBI?
Do not take if you have ever had an allergic reaction to perindopril erbumine, indapamide
hemihydrate 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. For more information, see Section
2. What should I know before I take PERISYL COMBI? in the full CMI.
3. What if I am taking other medicines?
4. How do I take PERISYL COMBI?
Your doctor will select a dose when they prescribe PERISYL COMBI for you. The usual
dose is one tablet once daily.
Swallow your tablet with water, preferably in the morning.
5. What should I know while taking PERISYL COMBI?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are taking PERISYL COMBI.
If you become pregnant or start to breastfeed while taking this medicine, tell your
doctor immediately.
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 immediately if you notice any serious side effects, especially severe
nausea or vomiting or stomach pain.
|
|
Things you should not do
|
Do not take PERISYL COMBI to treat any other complaints unless your doctor tells you
to.
Do not give PERISYL COMBI to anyone else, even if they have the same condition as
you.
Do not stop taking PERISYL COMBI or change the dosage without checking with your doctor.
|
|
Driving or using machines
|
Take care when driving or operating machinery until you know how this medicine 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.
|
|
Looking after your medicine
|
Store in a cool, dry place below 25°C.
Keep your tablets in the pack until it is time to take them.
|
6. Are there any side effects?
Less serious side effects: nausea, vomiting, diarrhoea, constipation, dry mouth, cough, low blood pressure, muscle
spasms, muscle tenderness or weakness, headache, dizziness, vertigo, pins and needles,
altered mood, sleep disorder, rash, nosebleeds, generally feeling unwell.
Serious side effects: concentrated urine, chest pain, palpitations, bleeding or bruising more easily than
normal, frequent infections, depression, anxiety, confusion, decrease in vision or
pain in your eyes.
Very serious side effects:, severe dizziness or fainting, difficulty breathing or wheezing, tightening of the
chest, severe allergic reaction, swelling of your extremities, large blisters on skin.
This is not a complete list of side effects. For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
perindopril erbumine and indapamide hemihydrate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking PERISYL COMBI. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking PERISYL COMBI.
Where to find information in this leaflet:
1. Why am I taking PERISYL COMBI?
PERISYL COMBI contains the active ingredient perindopril erbumine 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).
You have been prescribed PERISYL COMBI for high blood pressure.
PERISYL COMBI is used to treat 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.
PERISYL COMBI helps to lower your blood pressure.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
There is no evidence that PERISYL COMBI is addictive.
2. What should I know before I take PERISYL COMBI?
Warnings
Do not take PERISYL COMBI if:
you are allergic to perindopril, indapamide, or any of the ingredients listed at the
end of this leaflet.
Always check the ingredients to make sure you can take this medicine.
you are allergic to sulfonamide (sulfa) antibiotics, or to thiazide diuretics (a type
of 'fluid' or 'water' tablet).
you are allergic to another angiotensin converting enzyme (ACE) inhibitor.
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 sulfate.
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
artery stenosis).
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.
you have low blood potassium.
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
angioedema).
you are treated with sacubitril/valsartan a medicine used to treat long-term heart
failure as the risk of angioedema (rapid swelling under the skin in an area such as
the throat) is increased (see also subheading 'Tell Your Doctor Straight Away' and
Section
3. What if I am taking other medicines?).
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:
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 PERISYL COMBI and see a doctor immediately (See additional information under
Section
6. Are there any side effects).
are undergoing desensitisation treatment, or have had an allergic reaction during
previous desensitisation treatment (e.g. treatments using bee, wasp or ant venom).
are undergoing, or you are intending to undergo, treatments where your blood is treated
outside of the body (also known as extracorporeal treatments).
are undergoing anaesthesia and/or surgery.
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).
have recently suffered from diarrhoea or vomiting, or are dehydrated.
are on a salt restricted diet or use salt substitutes which contain potassium.
have an intolerance to some sugars as PERISYL COMBI contains lactose.
are of African origin since you may have a higher risk of angioedema and this medicine
is less effective in lowering your blood pressure.
are taking lithium (used to treat mania or depression).
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
sacubitril (available as fixed dose combination with another medicine valsartan),
used to treat long-term heart failure
aliskiren.
have any other health problems, including:
kidney disease or if you are on renal dialysis
liver disease
high or low levels of potassium, sodium, or other problems with salt balance
diabetes
gout
heart disease
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)
abnormally increased levels of a hormone called aldosterone in your blood (primary
aldosteronism)
if you experience a decrease in vision or eye pain. These could be symptoms of fluid
accumulation in the vascular layer of the eye or an increase of pressure in your eye
and can happen within hours to a week of taking PERISYL COMBI. This can lead to permanent
vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy,
you can be at higher risk of developing this.
muscle disorders including muscle pain, tenderness, weakness or cramps.
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
Do not take PERISYL COMBI if you are pregnant or trying to become pregnant.
Do not take PERISYL COMBI if you are breastfeeding or plan to breastfeed.
Tell your doctor straight away if you are pregnant or become pregnant while taking
PERISYL COMBI, as it may cause serious harm to your unborn baby.
For older people and children
Elderly people can generally use PERISYL COMBI safely. However, some older people
have reduced kidney function - in which case additional care may be required.
PERISYL COMBI is not recommended for use in children and adolescents.
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.
Taking PERISYL COMBI may change the effect of some medicines and some medicines may
affect how well PERISYL COMBI works. You may need different amounts of your medication
or to take different medicines.
Some medicines may interfere with PERISYL COMBI and affect how it works. These include:
Some steroid medicines
Diuretics (sometimes called 'fluid' or 'water' tablets because they increase the amount
of urine passed each day, e.g. amiloride, spironolactone, triamterene)
Medicines used for heart rhythm problems (e.g. quinidine, hydroquinidine, disopyramide,
amiodarone, sotalol, flecainide)
Some antibiotic and medicines used to treat infections (e.g. trimethoprim, moxifloxacin)
Medicines used to treat fungal disease [e.g. amphotericin B (amphotericin)] by injection,
fluconazole)
Tetracosactide (tetracosactrin) (to treat Crohn's disease)
Some anti-inflammatory medicines (including high dose aspirin, ibuprofen) for pain
relief
Some anaesthetic medicines.
Medicines used to treat mental illnesses such as some medicines for epilepsy, anxiety,
schizophrenia and some other antidepressants (e.g. lithium, tricyclic antidepressants,
antipsychotics drugs, neuroleptics such as: droperidol, haloperidol, chlorpromazine,
trifluoperazine, amisulpride, sulpiride, psychoanaleptics).
Antiparasitic medicines used to treat certain types of malaria (e.g. chloroquine).
Pentamidine (a medicine used to treat certain types of pneumonia).
Antihistamines used to treat allergic reactions, such as hay fever.
Medicines used to treat nausea and vomiting (e.g. ondansetron, domperidone).
Medicines used to treat gastrointestinal problems (e.g. cisapride, papaverine).
Potassium-sparing diuretics (e.g. spironolactone, triamterene), sources of potassium,
like potassium tablet and salt substitutes containing potassium, other drugs which
can increase potassium in your body (such as heparin, a medicine used to thin blood
to prevent clots; co-trimoxazole also known as trimethoprim/sulfamethoxazole for infections
caused by bacteria; and ciclosporin, an immunosuppressant medicine used to prevent
organ transplant rejection)
Medicines used to treat cancer (e.g vandetanib, oxaliplatin) or to suppress the immune
system (e.g. ciclosporin, tacrolimus).
Non-steroidal anti-inflammatory drugs for pain relief (e.g. ibuprofen) or high doses
of aspirin.
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 (epinephrine)]
Gold salts, especially with intravenous administration (used to treat symptoms of
rheumatoid arthritis)
Medicines which may affect the blood cells, such as allopurinol, procainamide
Medicines which may increase the risk of angioedema (a severe allergic reaction) such
as
Mammalian target of rapamycin (mTOR) inhibitors used to avoid rejection of transplanted
organs (e.g. temsirolimus, sirolimus, everolimus)
gliptins used to treat diabetes (e.g. linagliptin, saxagliptin, sitagliptin, vildagliptin,
alogliptin).
Iodinated contrast agent used in certain medical tests
Methadone (a medicine used to treat severe pain or opioid addiction)
Digoxin or other cardiac glycosides (for the treatment of heart problems)
Calcium supplements
Stimulant laxatives (e.g. senna).
Medicines used to treat bacterial infections (e.g. moxifloxacin, ciprofloxacin, clarithromycin
Allopurinol (a medicine used to treat gout).
Cilostazol (used to treat cramp - like pain in the legs when you walk).
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect PERISYL COMBI.
4. How do I take PERISYL COMBI?
How much to take
Follow all directions given to you by your doctor or 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 PERISYL COMBI for you. The usual
dose is one tablet once daily.
When to take PERISYL COMBI
Swallow your tablet with water, preferably in the morning.
How long to take PERISYL COMBI for
PERISYL COMBI can help to control your blood pressure but cannot cure this condition.
PERISYL COMBI treatment is usually for life - so you should keep taking the tablets
regularly unless advised otherwise by your doctor.
If you forget to take PERISYL COMBI
PERISYL COMBI should be taken regularly at the same time each day.
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 take a double dose to make up for the dose you missed.
If you take too much PERISYL COMBI
If you think that you or anyone else has taken too much PERISYL COMBI, urgent medical
attention may be required.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) 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.
Taking too much PERISYL COMBI (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.
5. What should I know while taking PERISYL COMBI?
Things you should do
Take PERISYL COMBI 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 PERISYL COMBI.
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.
Call your doctor straight away if you:
have excessive vomiting or diarrhea while taking PERISYL COMBI.
Things you should not do
Do not take PERISYL COMBI to treat any other complaints unless your doctor tells you
to.
Do not give PERISYL COMBI to anyone else, even if they have the same condition as
you.
Do not stop taking PERISYL COMBI or change the dosage without checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how PERISYL
COMBI affects you.
You may feel light-headed or dizzy when you begin to take PERISYL COMBI. 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.
Looking after your medicine
Keep your tablets in the pack until it is time to take them. If you take them out
of the pack they may not keep well.
Store below 25°C.
Follow the instructions on the carton 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 take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
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.
Less serious side effects
Very serious side effects
Tell your doctor, nurse 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.
Changes may occur in your laboratory parameters (blood tests) and your doctor may
need to give you blood tests to check your condition. The following changes in laboratory
tests may occur: low potassium in the blood, low sodium in the blood (that may lead
to dehydration and low blood pressure), increase in uric acid (a substance which may
cause or worsen gout), increase in blood glucose levels in diabetic patients, increased
levels of liver enzymes.
If you are about to have any blood tests, tell your doctor that you are taking PERISYL
COMBI. It may interfere with the results of some tests. Your doctor may do some tests
from time to time to make sure the medicine is working and to prevent unwanted side
effects.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
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 PERISYL COMBI contains
|
Active ingredient
(main ingredient)
|
4 mg of perindopril erbumine
1.25 mg of indapamide hemihydrate
|
|
Other ingredients
(inactive ingredients)
|
colloidal anhydrous silica
sodium bicarbonate
lactose
microcrystalline cellulose
magnesium stearate
|
|
Potential allergens
|
lactose
|
Do not take this medicine if you are allergic to any of these ingredients.
What PERISYL COMBI looks like
PERISYL COMBI is a white, capsule shaped, biconvex tablet debossed with “PTI” on one
side of the tablet and “M2” on the other side. (AUST R 179752).
Available in blister packs of 30 tablets.
Who distributes PERISYL COMBI
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 2025.
PERISYL® is a Viatris company trade mark
PERISYL COMBI_cmi\Nov25/00