SUMMARY CMI
APO-PERINDOPRIL/INDAPAMIDE 4/1.25
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about taking this medicine, speak to your doctor or pharmacist.
1. Why am I taking APO-PERINDOPRIL/INDAPAMIDE 4/1.25?
APO-PERINDOPRIL/INDAPAMIDE 4/1.25 contains the active ingredients perindopril erbumine and indapamide hemihydrate. APO-PERINDOPRIL/INDAPAMIDE 4/1.25 is used to treat high blood pressure (also known as hypertension).
For more information, see Section 1. Why am I taking APO-PERINDOPRIL/INDAPAMIDE 4/1.25? in the full CMI.
2. What should I know before I take APO-PERINDOPRIL/INDAPAMIDE 4/1.25?
Do not take if you have ever had an allergic reaction to perindopril erbumine or 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 APO-PERINDOPRIL/INDAPAMIDE 4/1.25? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with perindopril erbumine and indapamide hemihydrate and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
4. How do I take APO-PERINDOPRIL/INDAPAMIDE 4/1.25?
- Swallow tablet(s) with a glass of water. Do not crush or chew the tablets.
More instructions can be found in Section 4. How do I take APO-PERINDOPRIL/INDAPAMIDE 4/1.25? in the full CMI.
5. What should I know while taking APO-PERINDOPRIL/INDAPAMIDE 4/1.25?
Things you should do |
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Things you should not do |
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Driving or using machines |
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Drinking alcohol |
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Looking after your medicine |
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For more information, see Section 5. What should I know while taking APO-PERINDOPRIL/INDAPAMIDE 4/1.25? in the full CMI.
6. Are there any side effects?
There are a number of side effects associated with APO-PERINDOPRIL/INDAPAMIDE 4/1.25. It is important to be aware of them so that you can identify any symptoms if they occur.
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.
FULL CMI
APO-PERINDOPRIL/INDAPAMIDE 4/1.25
Active ingredient(s): perindopril erbumine and indapamide hemihydrate
Consumer Medicine Information (CMI)
This leaflet provides important information about taking APO-PERINDOPRIL/INDAPAMIDE 4/1.25. 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 APO-PERINDOPRIL/INDAPAMIDE 4/1.25.
Where to find information in this leaflet:
1. Why am I taking APO-PERINDOPRIL/INDAPAMIDE 4/1.25?
2. What should I know before I take APO-PERINDOPRIL/INDAPAMIDE 4/1.25?
3. What if I am taking other medicines?
4. How do I take APO-PERINDOPRIL/INDAPAMIDE 4/1.25?
5. What should I know while taking APO-PERINDOPRIL/INDAPAMIDE 4/1.25?
6. Are there any side effects?
7. Product details
1. Why am I taking APO-PERINDOPRIL/INDAPAMIDE 4/1.25?
APO-PERINDOPRIL/INDAPAMIDE 4/1.25 contains the active ingredients perindopril erbumine and indapamide hemihydrate.
APO-PERINDOPRIL/INDAPAMIDE 4/1.25 is used to treat high blood pressure (also known as hypertension).
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 (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.
APO-PERINDOPRIL/INDAPAMIDE 4/1.25 helps to lower your blood pressure.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed this medicine for another reason.
There is no evidence that this medicine is addictive.
2. What should I know before I take APO-PERINDOPRIL/INDAPAMIDE 4/1.25?
Warnings
Do not take APO-PERINDOPRIL/INDAPAMIDE 4/1.25 if:
- You are allergic to perindopril erbumine or indapamide hemihydrate, or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine. - Sulphonamide (sulfa) antibiotics, thiazide diuretics (a type of "fluid" or "water" tablet).
- Any other angiotensin converting enzyme (ACE) inhibitor.
- You experience symptoms of an allergic reaction:
- 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. - 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 intolerant or allergic to lactose. This medicine contains lactose.
- You have or have had any of the following medical conditions:
- Severe heart failure which is not being treated.
- Low potassium levels (hypokalaemia).
- Severe liver problems or hepatic encephalopathy (degenerative disease of the brain that occurs as a result of liver disease).
- Trouble urinating (i.e. little or no urine).
- Severe kidney problems or if you are on dialysis.
- Renal artery stenosis (a problem with the blood vessels to one or both kidneys).
- Narrowing of the main blood vessel leading from the heart and/or heart valve. - 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 the blood, using dextran sulfate. - You are taking other medicines which have the possible side effect of a heart problem called torsades de pointes, including:
- Some medicines used to treat abnormal heart rhythms (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol or flecainide).
- Some medicines used to treat mental illnesses (e.g. trifluoperazine, amisulpride, sulpiride, droperidol or haloperidol).
- Other medicines such as diphemanil, erythromycin IV, pentamidine or moxifloxacin.
- Sacubitril/valsartan combinations, 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. - You are treated with a blood pressure lowering medicine containing aliskiren and have diabetes or impaired kidney function.
- You are pregnant or trying to become pregnant. This medicine may affect your developing baby if you take it during pregnancy.
- You are breastfeeding or intend to breastfeed. This medicine may pass into human breast milk.
- 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 have allergies to any other medicines, foods, preservatives or dyes.
- You have or have had any of the following medical conditions:
- Kidney disease or you are on renal dialysis.
- Liver disease.
- Heart or blood vessel disease.
- Hyperparathyroidism (overactive parathyroid gland).
- Photosensitivity reactions (increased sensitivity of the skin to sun).
- Diabetes.
- Gout.
- Systemic lupus erythematosus (a disease affecting the skin, joints and kidneys).
- High or low levels of potassium, low levels of sodium or chlorine, or high levels of uric acid.
- You are on a salt restricted diet or use salt substitutes which contain potassium.
- 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 a medical test that requires injection of an iodinated contrast agent (a substance that makes organs like kidney or stomach visible on an X-ray).
- You have recently suffered from diarrhoea or vomiting or are dehydrated.
- You are undergoing de-sensitisation treatment or have had an allergic reaction during previous desensitisation treatment (e.g. treatments using bee, wasp or ant venom).
- Abnormally increased levels of a hormone called aldosterone in your blood (primary aldosteronism).
- Muscle disorders including muscle pain, tenderness, weakness or cramps. - 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 APO-PERINDOPRIL/INDAPAMIDE 4/1.25. 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.
- You are of African origin since you may have a higher risk of angioedema and this medicine is less effective in lowering your blood pressure.
- You are undergoing anaesthesia and/or surgery.
- 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.
- Sacubitril (available as fixed-dose combination with another medicine valsartan), used to treat long-term heart failure.
- Aliskiren. - You are pregnant or plan to become pregnant or are breastfeeding. Do not take this medicine whilst pregnant or breastfeeding.
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 this medicine if you are pregnant or plan to become pregnant.
Do not take this medicine if you are breastfeeding or plan to breastfeed.
It is important to tell your doctor if you are pregnant or intend to become pregnant, or if you are breastfeeding or intend to breastfeed.
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.
Some medicines may interfere with APO-PERINDOPRIL/INDAPAMIDE 4/1.25 and affect how it works. These include:
- Some medicines used to treat high blood pressure (including angiotensin receptor blockers), aliskiren, diuretics (sometimes called "fluid" or "water" tablets because they increase the amount of urine passed each day, e.g. amiloride, spironolactone, triamterene)) or medicines used to treat heart failure (e.g. sacubitril/valsartan or digoxin or other cardiac glycosides).
- Some anti-inflammatory medicines (including high dose aspirin and ibuprofen) for pain relief.
It is especially important to tell your doctor when taking blood pressure, water and/or heart tablets together with anti-inflammatory medicines.
- Some medicines used to treat gout (e.g. allopurinol).
- Some medicines used to treat cancer (e.g. vandetanib, oxaliplatin or anagrelide), or to suppress the immune system, such as after organ transplants (e.g. ciclosporin, tacrolimus).
- Baclofen, a muscle relaxant.
- Some antibiotics used to treat infections (e.g. trimethoprim, ciprofloxacin or moxifloxacin).
- Some anti-fungal medications used to treat fungal infections (e.g. fluconazole or amphotericin B by injection).
- Medicines such as lithium and tricyclic antidepressants (e.g. imipramine, citalopram or escitalopram) for treating depression and mood disorders.
- Medicines used for treating psychiatric disorders.
- Donepezil, used in Alzheimer's disease.
- Medicines which increase blood potassium levels, such as potassium-sparing diuretics, potassium tablets, salt substitutes containing potassium, or other medicines which can increase potassium in your body (e.g. 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 which decrease blood potassium levels such as steroids, tetracosactide and certain types of laxatives (e.g. senna).
- Antiparasitic medicines used to treat certain types of malaria (e.g. chloroquine).
- Pentamidine, 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 or domperidone).
- Medicines which have the possible side effect of a heart problem called torsades de pointes, including: some medicines used to treat abnormal heart rhythms (e.g. disopyramide, amiodarone, sotalol or flecainide); some medicines used to treat mental illnesses (e.g. trifluoperazine, amisulpride, sulpiride, droperidol, haloperidol); other medicines such as diphemanil, erythromycin IV, pentamidine, moxifloxacin.
- Metformin, insulin or gliptins (e.g. sitagliptin, linagliptin, saxagliptin, vildagliptin, alogliptin), medicines used to treat diabetes.
- 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).
- Calcium supplements.
- Injections containing iodine used to diagnose certain medical conditions.
- Alcohol or strong painkillers (e.g. methadone).
- Medicines which make your heartbeat faster or increase your blood pressure, such as decongestants (in cold & flu remedies).
- Medicines used during operations (e.g. anaesthetics).
- Cilostazol (used to treat cramp-like pain in the legs when you walk).
- 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).
- Sacubitril (available as fixed-dose combination with valsartan), used to treat long-term heart failure.
- Gliptins used to treat diabetes (e.g. linagliptin, saxagliptin, sitagliptin, vildagliptin, alogliptin). - Vasodilators including nitrates.
These medicines may be affected by APO-PERINDOPRIL/INDAPAMIDE 4/1.25 or may affect how well it works.
If you are taking any of these, you may need a different dose, or you may need to take different medicines.
Other medicines not listed above may also interfere with APO-PERINDOPRIL/INDAPAMIDE 4/1.25.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
4. How do I take APO-PERINDOPRIL/INDAPAMIDE 4/1.25?
How much to take
Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.
When to take APO-PERINDOPRIL/INDAPAMIDE 4/1.25
Take it at about the same time each day, preferably in the morning before breakfast. Taking it at the same time each day will have the best effect and will also help you remember when to take it.
How to take APO-PERINDOPRIL/INDAPAMIDE 4/1.25
Swallow your tablet(s) with a glass of water. Do not crush or chew the tablets.
If you forget to take APO-PERINDOPRIL/INDAPAMIDE 4/1.25
If your next planned dose is less than 6 hours away, leave out the dose that you missed. Take the next dose at the usual time and continue as normal.
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 missed doses.
This may increase the chance of you experiencing side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.
How long to take it
APO-PERINDOPRIL/INDAPAMIDE 4/1.25 can help to control your blood pressure but cannot cure this condition.
APO-PERINDOPRIL/INDAPAMIDE 4/1.25 treatment is usually for life, so you should keep taking your medicine for as long as your doctor tells you.
Make sure you have enough to last over weekends and holidays.
If you take too much APO-PERINDOPRIL/INDAPAMIDE 4/1.25
If you think that you have taken too much APO-PERINDOPRIL/INDAPAMIDE 4/1.25, you may need urgent medical attention.
You should immediately:
- phone the Poisons Information Centre
(by calling 13 11 26), 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.
If you take too much APO-PERINDOPRIL/INDAPAMIDE 4/1.25, your blood pressure may drop (hypotension) or you may be sick, feel confused, or have kidney problems or changes in the salt and water content of your body or muscle cramps.
5. What should I know while taking APO-PERINDOPRIL/INDAPAMIDE 4/1.25?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.
If you become pregnant or start to breastfeed while taking this medicine, tell your doctor immediately.
If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.
Keep all your doctor's appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.
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:
- Notice any serious side effects, especially severe nausea or vomiting or stomach pain.
Remind any doctor, dentist or pharmacist you visit that you are taking APO-PERINDOPRIL INDAPAMIDE 4/1.25.
Things you should not do
- Do not take this medicine 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 you.
- Do not stop taking your medicine or change the dosage without checking with your doctor.
Driving or using machines
Be careful 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.
Drinking alcohol
Tell your doctor if you drink alcohol.
Be careful when drinking alcohol while you are taking this medicine. Dizziness or light-headedness may be worse if you drink alcohol.
Things to be careful of
You may feel light-headed or dizzy when you begin to take this medicine. 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 do not get better in a short time, then talk to your doctor.
APO-PERINDOPRIL/INDAPAMIDE 4/1.25 contains a drug substance which may give a positive result in doping tests.
Looking after your medicine
Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack they may not keep well.
Follow the instructions on the carton on how to take care of your medicine properly.
Keep your medicine in a cool dry place where the temperature will stay below 25°C. Do not store it:
- in the bathroom or near a sink, or
- in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
When to discard your medicine
Do not take this medicine after the expiry date.
Getting rid of any unwanted medicine
If your doctor tells you to stop taking APO-PERINDOPRIL/INDAPAMIDE 4/1.25, or the tablets have passed their expiry date, return any leftover tablets to your pharmacist for disposal.
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.
APO-PERINDOPRIL/INDAPAMIDE 4/1.25 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.
Less serious side effects
Less serious side effects | What to do |
| Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
Serious side effects | What to do |
| STOP TAKING THIS MEDICINE. Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. |
Tell your doctor 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.
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 APO-PERINDOPRIL/INDAPAMIDE 4/1.25 contains
Active ingredient (main ingredient) |
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Other ingredients (inactive ingredients) |
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Potential allergens |
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This medicine is free from gluten, sucrose, tartrazine and other azo dyes.
Do not take this medicine if you are allergic to any of these ingredients.
What APO-PERINDOPRIL/INDAPAMIDE 4/1.25 looks like
White, capsule-shaped, biconvex tablets engraved "4/1.25" on one side and "APO" on the other side.
AUST R 127122.
Available in blister packs of 30 tablets.
Who distributes APO-PERINDOPRIL/INDAPAMIDE 4/1.25
Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel St
Cremorne VIC 3121
www.arrotex.com.au
This leaflet was prepared in November 2024.
Published by MIMS February 2025