PREXUM COMBI LD 2.5/0.625; PREXUM COMBI 5/1.25 perindopril (pronounced per-in-do-pril) and indapamide (pronounced in-dap-a-mide) Consumer Medicine Information

WHAT IS IN THIS WHAT PREXUM BEFORE YOU TAKE LEAFLET COMBI IS USED FOR PREXUM COMBI

This leaflet answers some common You have been prescribed There are some people who should questions about PREXUM COMBI. PREXUM COMBI for high not take PREXUM COMBI. Please It does not contain all the available pressure. read the lists below. If you think any information about this medicine. PREXUM COMBI is available only of these situations apply to you, or Reading this leaflet does not take the with a doctor's prescription. you have any questions, please place of talking to your doctor or consult your doctor or pharmacist. pharmacist. There is no evidence that PREXUM COMBI is addictive. All medicines have risks and Do not take PREXUM COMBI if: benefits. Your doctor has weighed Why PREXUM COMBI is the risks of you taking PREXUM used for high blood • You are allergic to perindopril, COMBI against the expected benefits pressure indapamide, or any of the other for you. ingredients of PREXUM Everyone has blood pressure. This If you have any concerns about COMBI listed at the end of this pressure helps to circulate blood all taking this medicine, ask your leaflet. around the body. Your blood doctor or pharmacist. pressure may be different at different • You are allergic to Keep this leaflet with the medicine. times of the day, depending on how (sulfa) , or to thiazide You may need to read it again. busy or stressed you are. You have (a type of 'fluid' or high blood pressure (also known as 'water' tablet). hypertension) when your blood • You are allergic to another pressure stays higher than is needed, angiotensin converting enzyme WHAT PREXUM even when you are calm and relaxed. (ACE) inhibitor. COMBI IS If high blood pressure is not treated it • You are pregnant or trying to can lead to serious health problems. become pregnant. The name of your medicine is You may feel fine and have no • You are breastfeeding or plan PREXUM COMBI. The medicine symptoms, but eventually it can to breast-feed. contains the active ingredients cause stroke, heart disease and • You undergo treatments where perindopril arginine and indapamide kidney failure. hemihydrate. Perindopril belongs to a your blood is treated outside of PREXUM COMBI helps to lower group of medicines called the body (also known as your blood pressure. angiotensin converting enzyme extracorporeal treatments) that (ACE) inhibitors. Indapamide Ask your doctor if you have any may increase your risk of belongs to a group of medicines questions about why PREXUM allergic reactions, treatments called diuretics (a type of "water" COMBI has been prescribed for such as: tablet). you. - renal dialysis or haemofiltration using polyacrylonitrile membranes

PREXUM® COMBI 1 - low-density lipoprotein Tell your doctor straight • You are taking any of the (LDL) apheresis, a away if: following medicines used to treat technique where LDL is high blood pressure: • You are pregnant or become 'filtered' out of a patient's pregnant while taking PREXUM - an 'angiotensin II receptor blood, using dextran sulfate. COMBI, as it may cause serious blocker' (also known as ARBs • You are treated with a blood harm to your unborn baby. or sartans - for example pressure lowering medicine valsartan, telmisartan, • You have a severe allergic containing aliskiren and have irbesartan), in particular if you reaction with swelling of the face, diabetes or impaired kidney have diabetes-related kidney lips, mouth, tongue or throat function. problems which may cause difficulty in • You have kidney problems swallowing or breathing - sacubitril (available as fixed- where the blood supply to your (angioedema). This may occur at dose combination with kidneys is reduced (renal artery any time during treatment. If you another medicine valsartan), stenosis). develop such symptoms, you used to treat long-term heart • You are suffering from should stop taking PREXUM failure decreases in the amount, or COMBI and see a doctor - aliskiren. absence of, urine produced by immediately (see also 'SIDE • You have any other health the kidney. EFFECTS' section). problems, including: • You have narrowing of the • You are undergoing - Kidney disease or if you are main blood vessel leading from desensitisation treatment, or have on renal dialysis the heart and/or heart valve. had an allergic reaction during - Liver disease • If you have low blood previous desensitisation treatment - High or low levels of potassium. (e.g. treatments using bee, wasp or ant venom). potassium, sodium, or other • If you have severe liver disease problems with salt balance or suffer from a condition • You are undergoing, or you are - Diabetes called hepatic encephalopathy intending to undergo, treatments (degenerative disease of the where your blood is treated - Gout outside of the body (also known brain that occurs as a result of - Heart disease liver disease). as extracorporeal treatments). - Hardening of the arteries • You have experienced serious • You are undergoing anaesthesia - Hyperparathyroidism swelling of the face, tongue, lips and/or surgery. (overactive parathyroid gland) or throat either suddenly or in • You are undergoing a medical response to another medicine in test that requires injection of an - Photosensitivity reactions the past (a rare allergic iodinated (a (increased sensitivity of the condition known as substance that makes organs like skin to sun) angioedema). the kidney or stomach visible on - Systemic lupus erythematosus • You are treated with sacubitril/ an X-ray) or scleroderma (a disease valsartan a medicine used to • You have recently suffered from affecting the skin, and treat long-term heart failure as diarrhoea or vomiting, or are kidneys) the risk of angioedema (rapid dehydrated. - Abnormally increased levels swelling under the skin in an • You are on a salt restricted diet or of a hormone called area such as the throat) is use salt substitutes which contain aldosterone in your blood increased (see also 'Tell Your potassium. (primary aldosteronism) Doctor Straight Away' and • You have an intolerance to some - If you experience a decrease 'Taking Other Medicines' sugars as PREXUM COMBI in vision or eye pain. These sections). contains lactose. could be symptoms of fluid • The packaging is damaged or accumulation in the vascular • You are of African origin since shows signs of tampering, or layer of the eye or an increase you may have a higher risk of the tablets do not look quite of pressure in your eye and angioedema and this medicine is right. can happen within hours to a less effective in lowering your week of taking PREXUM • The expiry date (EXP) on the blood pressure. pack has passed. COMBI. This can lead to • You are taking lithium (used to permanent vision loss, if not treat mania or depression). treated. If you earlier have had

PREXUM® COMBI 2 a penicillin or sulfonamide • Tetracosactide (tetracosactrin) (to ibuprofen) or high doses of allergy, you can be at higher treat Crohn's disease) aspirin. risk of developing this. • Some anti-inflammatory • Vasodilators including nitrates - Muscle disorders including medicines (including high dose • Medicines used to treat diabetes muscle pain, tenderness, aspirin, ibuprofen) for pain relief (e.g. metformin, gliptins and weakness or cramps. • Some anaesthetic medicines. insulin)

Taking other medicines • Medicines used to treat mental • Baclofen (a medicine used to treat illnesses such as some medicines muscle stiffness in diseases such Tell your doctor if you are taking any for epilepsy, anxiety, as multiple sclerosis) other medicines, including medicines schizophrenia and some other • Medicines used for the treatment that you buy without a prescription (e.g. lithium, of low blood pressure, shock or from a pharmacy, supermarket or tricyclic antidepressants, asthma (e.g. ephedrine, health food shop. , neuroleptics noradrenaline or adrenaline Taking PREXUM COMBI may such as: droperidol, haloperidol, (epinephrine)) change the effect of some medicines, chlorpromazine, trifluoperazine, • Gold salts, especially with and some medicines may affect how amisulpride, sulpiride, intravenous administration (used well PREXUM COMBI works. You psychoanaleptics). to treat symptoms of rheumatoid may need different amounts of your • Antiparasitic medicines used to arthritis) or to take different treat certain types of malaria (e.g. medicines. The medicines that may ). • Medicines which may affect the interact with PREXUM COMBI blood cells, such as allopurinol, • (a medicine used to include the following: procainamide treat certain types of pneumonia). • Some steroid medicines • Medicines which may increase • Antihistamines used to treat the risk of angioedema (a severe • Diuretics (sometimes called 'fluid' allergic reactions, such as hay allergic reaction) such as or 'water' tablets because they fever. increase the amount of urine - Mammalian target of • Medicines used to treat nausea passed each day, e.g. amiloride, rapamycin (mTOR) inhibitors and vomiting (e.g. ondansetron, spironolactone, triamterene) used to avoid rejection of domperidone). transplanted organs (e.g. • Medicines used for heart rhythm • Medicines used to treat gastro- temsirolimus, sirolimus, problems (e.g. , intestinal problems (e.g. everolimus) hydroquinidine, disopyramide, cisapride, papaverine). amiodarone, sotalol, flecainide) - Sacubitril (available as fixed- • Potassium-sparing diuretics (e.g. dose combination with • Some used to treat spironolactone, triamterene), valsartan), used to treat long- high blood pressure (including sources of potassium, like term heart failure (see also angiotensin converting enzyme potassium tablet and salt 'Do Not Take PREXUM (ACE) inhibitors, angiotensin substitutes containing potassium, COMBI If' and 'Tell Your receptor blockers), aliskiren (see other drugs which can increase Doctor Straight Away' also 'Do Not Take PREXUM potassium in your body (such as sections). COMBI If' and 'Tell Your Doctor heparin, a medicine used to thin Straight Away' sections) - gliptins used to treat diabetes blood to prevent clots; co- (e.g. linagliptin, saxagliptin, • Some treatments where your trimoxazole also known as sitagliptin, vildagliptin, blood is treated outside of the trimethoprim/sulfamethoxazole alogliptin). body, also known as for caused by ; extracorporeal treatments (see and ciclosporin, an - also 'Do Not Take PREXUM immunosuppressant medicine • Iodinated contrast agent used in COMBI If' and 'Tell Your Doctor used to prevent organ transplant certain medical tests Straight Away' sections) rejection) • Methadone (a medicine used to • Some and medicines • Medicines used to treat cancer treat severe pain or opioid used to treat infections (e.g. (e.g vandetanib, oxaliplatin) or to addiction) trimethoprim, moxifloxacin) suppress the (e.g. • Digoxin or other cardiac • Medicines used to treat fungal ciclosporin, tacrolimus). glycosides (for the treatment of disease (e.g. • Non-steroidal anti-inflammatory heart problems) (amphotericin) by injection, drugs for pain relief (e.g. • Calcium supplements fluconazole)

PREXUM® COMBI 3 • (e.g. senna). If you forget to take WHILE YOU ARE • Medicines used to treat bacterial PREXUM COMBI TAKING PREXUM infections (e.g. moxifloxacin, • If your next usual dose is less COMBI ciprofloxacin, clarithromycin than 6 hours away, just leave out • Allopurinol (a medicine used to the dose that you missed. Take Things you must do treat gout). the next dose at the usual time and continue as normal. Take PREXUM COMBI exactly as • Cilostazol (used to treat cramp - your doctor has prescribed. like pain in the legs when you • If your next dose is more than 6 Otherwise you may not get the walk). hours away, take the dose you benefits from treatment. Tell all Your doctor or pharmacist has more have missed as soon as you doctors, dentists and pharmacists information on medicines to be realise. Then take the next dose at who are involved with your treatment careful with or avoid while taking the usual time and continue as that you are taking PREXUM PREXUM COMBI. normal. COMBI. Do not try to make up for missed Make sure you drink enough water For older people or children doses by taking more than one dose during exercise and hot weather at a time. Elderly people can generally use especially if you sweat a lot. This PREXUM COMBI safely. However, will help you avoid any dizziness or If you take too much some older people have reduced light-headedness caused by a sudden kidney function - in which case PREXUM COMBI drop in blood pressure. additional care may be required. Taking too much PREXUM COMBI Tell your doctor straight away if you PREXUM COMBI is not (an overdose) may cause low blood have excessive vomiting or diarrhoea recommended for use in children pressure (also known as while taking PREXUM COMBI and adolescents. hypotension). The most likely effect in case of Things you must not do overdose is low blood pressure Do not give this medicine to anyone which can make you feel dizzy. If else, even they have the same HOW TO TAKE this happens, lying down with the condition as you. legs elevated can help. PREXUM COMBI Do not use PREXUM COMBI to Other effects like, nausea, vomiting, treat any other complaints unless Follow all directions given to you cramps, sleepiness, confusion your doctor tells you to. by your doctor and pharmacist changes in the amount of urine Do not stop taking PREXUM carefully. produced by the kidney are possible. COMBI or change the dose, without If you do not understand the You may require urgent medical checking with your doctor. instructions on the label, ask your attention. doctor or pharmacist for help. If you think that you or anyone Things to be careful of Your doctor will select a dose when else may have taken too much they prescribe PREXUM COMBI for PREXUM COMBI then act Be careful when driving or you. The usual dose is one tablet immediately: operating machinery until you know how PREXUM COMBI once daily. Telephone your doctor or the Poisons affects you. Swallow your tablet(s) with water, Information Centre (13 11 26 in You may feel light-headed or dizzy preferably in the morning. Australia; 03 474 7000 in New Zealand), or go to the Accident and when you begin to take PREXUM How long to take PREXUM Emergency department at your COMBI. This is because your blood pressure is falling. If you have these COMBI for nearest hospital. Do this even if there are no signs of discomfort or symptoms when standing up or PREXUM COMBI can help to poisoning. getting out of bed then getting up control your blood pressure but more slowly can help. This allows cannot cure this condition. PREXUM your body to get used to the change COMBI treatment is usually for life - in position and blood pressure. so you should keep taking the tablets If you have these symptoms and regularly unless advised otherwise by they don't get better in a short time your doctor. then talk to your doctor.

PREXUM® COMBI 4 SIDE EFFECTS • Red, often itchy spots, similar to Common (may affect up to 1 in 10 the rash of measles, which starts people) side effects can include: If you do not feel well while you on the limbs and sometimes on • Cough, often described as dry and are taking PREXUM COMBI then the face and the rest of the body irritating, shortness of breath, tell your doctor or pharmacist as (a condition known as Erythema discomfort on exertion Multiforme). (Very rare) soon as possible. • Nosebleeds All medicines can have side effects. • Stroke (signs include weakness of arms or legs or problems • Headache, dizziness, vertigo, pins Sometimes they are serious, most of and needles the time they are not. speaking). (Very rare) • Feeling tired or weak PREXUM COMBI helps most • Heart disorders such as a fast and people with high blood pressure, but irregular heartbeat, heart attack, • Tinnitus (persistent noise in the it may sometimes have unwanted angina pectoris (a feeling of ears), vertigo, vision impairment side effects in a few people. While tightness, pressure or heaviness in • Low blood pressure (and related these side effects when they occur the chest). (Very rare) effects), flushing, impaired are usually mild they can be serious. • Inflammation of the pancreas peripheral circulation, vasculitis Stop taking PREXUM COMBI (Pancreatitis). (Very rare) • Nausea, vomiting, taste and see a doctor immediately, if • Liver disease (Hepatitis) disturbances, indigestion, you experience any of the following characterised by yellowing of the diarrhoea, constipation, stomach side effects that can be serious: skin or eyes (jaundice). (Very pain or discomfort • Dizziness becoming severe or rare) • Dry mouth fainting induced by low blood • Life-threatening irregular • Decreased appetite pressure heartbeat (Torsades de pointes). • Muscle spasms • Difficulty breathing or wheezing, (Frequency not known) • Muscle tenderness or weakness tightening of the chest. • Disease of the brain caused by (Uncommon) liver illness (Hepatic • Rash, pruritus (itching), red raised skin rash • Angioedema (a severe allergic encephalopathy) (Frequency not reaction) has been reported in known). • Hypersensitivity reactions, patients treated with ACE • Muscle spasms, tenderness, pain mainly skin reactions, in patients inhibitors, including PREXUM or weakness and particularly, if at with allergies and asthmatic COMBI. This may occur at any the same time, you feel unwell or reactions. time during treatment. If you have a high temperature it may be Uncommon (may affect up to 1 in develop such symptoms described caused by an abnormal muscle 100 people) side effects can below you should tell your doctor breakdown (frequency not include: immediately or go to the Accident known). • High levels in the blood of and Emergency department at The above side effects are potassium, urea and/or creatine your nearest hospital. These side categorised into the following • Low sodium (salt) levels in the effects are extremely rare but can frequencies: become serious. Swelling of your blood Common - may affect up to 1 in extremities (limbs, hands or feet), • Altered mood, sleep disorder 10 people lips, face, mouth, tongue or (difficulty sleeping, abnormal throat. (Uncommon) Uncommon - may affect up to 1 dreams), feeling sleepy or • Purple spots with occasional in 100 people drowsy, fainting. blisters on the front of your arms Rare - may affect up to 1 in 1,000 • Anxiety and legs and/or around your neck people • Bronchitis, upper respiratory tract and ears (a rare condition known Very rare - may affect up to 1 in as Stevens-Johnson Syndrome). 10,000 people (Very rare) • Back pain Not known - frequency cannot be • Gastrointestinal inflammation • Painful red areas, developing estimated from the data available large blisters and peeling of • Excessive sweating. Talk to your doctor or pharmacist or layers of skin. This is nurse if you notice any of the • Increased sensitivity of the skin to accompanied by fever and chills following side effects, some of which sun, skin rash or inflammation of (a condition known as Toxic are usually only identified after blood the skin often including blisters Epidermal Necrolysis or TEN). tests: that weep and become crusted (Very rare)

PREXUM® COMBI 5 • Pemphigoid - a skin disease blood count, frequent you blood tests to check your usually affecting older people infections such as fever, severe condition. The following changes in • Increase in some white blood chills, sore throat or mouth ulcers laboratory tests may occur low cells caused by a lack of white blood potassium in the blood, low sodium cells, pancytopenia (a rare type of in the blood (that may lead to • Erectile dysfunction, libido anaemia) dehydration and low blood pressure), disorder • Illnesses resulting from a lack of increase in uric acid (a substance • Fever or high temperature red blood cells which may cause or worsen gout), • Chest pain increase in blood glucose levels in • Changes in the rhythm or rate of diabetic patients, increased levels of • Fast heartbeat the heartbeat liver enzymes. • Palpitations (awareness of your • Confusion, depression or heartbeat) hallucinations. • Abnormal ECG heart tracing Not known (frequency cannot be • Abnormal kidney function estimated from the data available): AFTER TAKING PREXUM COMBI • Polyuria - increased urination • Myopia, blurred vision • Low blood levels of potassium, • Cystitis - an infection of the Storage bladder magnesium or chloride Keep your PREXUM COMBI • Decreased blood sugar levels • Blood glucose increased tablets where children cannot • Blood uric acid increased. • Worsening of pre-existing Lupus reach them. A locked cupboard at Erythematosus • Discolouration, numbness and least one-and-a-half metres above • Aching muscles, not caused by pain in fingers or toes (Raynaud’s the ground is a good place to store exercise, pain phenomenon). medicines. • Generally feeling unwell or • Decrease in vision or pain in your Keep your tablets in the pack until it lethargic eyes due to high pressure is time to take them. PREXUM (possible signs of fluid • Falls COMBI will not keep as well outside accumulation in the vascular its container. • Vasculitis (inflammation of blood layer of the eye or acute angle - Heat and dampness can destroy cells) closure glaucoma). some medicines. Keep them in a • Impaired peripheral circulation Other: cool, dry place where the • Syncope - fainting not associated Concentrated urine (dark in colour), temperature stays below 30°C. Do with seizures or trauma. feel or are sick, have muscle cramps, not store medicines in a bathroom • Kidney failure confusion and fits which may be due or near a sink. Do not leave them to inappropriate anti- in a car or on a windowsill. • Problems with production or hormone (ADH) secretion can occur passing of urine. with ACE inhibitors.. If you have Disposal Rare (may affect up to 1 in 1,000 these symptoms contact your doctor If your doctor tells you to stop taking people) side effects can include: as soon as possible. PREXUM COMBI, or the tablets • Elevation of bilirubin levels in the Consult your doctor, pharmacist have passed their expiry date, return blood, increases in liver enzymes or nurse if you experience any of any leftover tablets to your • Elevated calcium levels in the these or notice anything else that is pharmacist for disposal. blood making you feel unwell. • Worsening of . Most of these side effects are mild when they occur. Do not be alarmed Very rare (may affect up to 1 in by this list of possible side effects. WHAT PREXUM 10,000 people) side effects can You may not experience any of them. include: COMBI LOOKS LIKE Other uncommon side effects have • Abnormal liver function been reported and you should ask PREXUM COMBI LD 2.5/0.625 • Eosinophilic pneumonia your doctor, pharmacist or nurse if tablets are white, rod shaped tablets with a score line. • Runny or blocked nose, sneezing, you want to know more. facial pressure or pain Changes may occur in your PREXUM COMBI 5/1.25 tablets are white and rod shaped. • Bleeding or bruising more easily laboratory parameters (blood tests) than normal caused by a low and your doctor may need to give

PREXUM® COMBI 6 PREXUM COMBI LD 2.5/0.625 and PREXUM COMBI 5/1.25 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.

Ingredients Each tablet of PREXUM COMBI LD 2.5/0.625 contains 2.5 mg of perindopril arginine and 0.625 mg of indapamide hemihydrate as active ingredients. Each tablet of PREXUM COMBI 5/1.25 contains 5 mg of perindopril arginine and 1.25 mg of indapamide hemihydrate as active ingredients. The inactive ingredients in PREXUM COMBI LD 2.5/0.625 and PREXUM COMBI 5/1.25 tablets contain lactose monohydrate, magnesium stearate, hydrophobic colloidal silica anhydrous, maltodextrin, sodium starch glycollate type A, macrogol 6000, glycerol, hypromellose, titanium dioxide. The tablets are gluten free.

Manufacturer and Sponsor PREXUM COMBI are products discovered by Servier Research International which are distributed in Australia by: Servier Laboratories (Aust.) Pty Ltd 8 Cato Street Hawthorn, Victoria 3122 Australia

PREXUM COMBI LD 2.5/0.625 and PREXUM COMBI 5/1.25 are registered on the Australian Register of Therapeutic Goods. Australian Register Numbers: PREXUM® COMBI LD 2.5/0.625: AUST R 279405 PREXUM® COMBI 5/1.25: AUST R 194917 This leaflet was last revised in March 2021

PREXUM® COMBI 7