PERINDOPRIL AND INDAPAMIDE-GH 4/1.25
(perindopril erbumine and indapamide hemihydrate) tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Perindopril and Indapamide-GH 4/1.25 mg tablets. It does not contain all the available information about this medicine. Reading this leaflet does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Perindopril and Indapamide-GH 4/1.25 mg tablets against the expected benefits for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What Perindopril and Indapamide-GH 4/1.25 is used for
The name of your medicine is Perindopril and Indapamide-GH 4/1.25 mg tablets. The medicine contains the active ingredients 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 chlorosulphamoyl diuretics.
You have been prescribed Perindopril and Indapamide-GH 4/1.25 mg tablets for high blood pressure.
Perindopril and Indapamide-GH 4/1.25 mg tablets are available only with a doctor's prescription.
There is no evidence that Perindopril and Indapamide-GH 4/1.25 mg tablets are addictive.
Why Perindopril and Indapamide-GH 4/1.25 mg tablets 4/1.25 mg 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.
Perindopril and Indapamide-GH 4/1.25 mg tablets help to lower your blood pressure.
Ask your doctor if you have any questions about why Perindopril and Indapamide-GH 4/1.25 mg tablets has been prescribed for you.
Before you take Perindopril and Indapamide-GH 4/1.25
There are some people who should not take Perindopril and Indapamide-GH 4/1.25 mg tablets. 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 Perindopril and Indapamide-GH 4/1.25 mg tablets if:
- you are allergic to perindopril, indapamide, or any of the other ingredients of Perindopril and Indapamide-GH 4/1.25 mg tablets 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 breastfeed.
- you undergo treatments where your blood pressure 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 (LPL) 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 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 angio-oedema).
- you are treated with sacubitril/valsartan a medicine used to treat long-term heart failure (see also 'Tell Your Doctor Straight Away' and 'Taking Other Medicines' sections).
- 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.
Before you start to take it
Tell your doctor straight away if:
- you are pregnant or become pregnant while taking Perindopril and Indapamide-GH 4/1.25 mg tablets, 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 Perindopril and Indapamide-GH 4/1.25 mg tablets 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 (eg. 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 Perindopril and Indapamide-GH 4/1.25 mg 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 blood pressure.
- you are taking lithium (used to treat mania or depression).
- 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;
- you 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.
– 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).
– Changes in your vision, increased pressure or pain in one or both of your eyes while taking Perindopril and Indapamide-GH 4/1.25 mg tablets. This could be a sign that you are developing glaucoma. You should discontinue Perindopril and Indapamide-GH 4/1.25 mg tablets 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 Perindopril and Indapamide-GH 4/1.25 mg tablets may change the effect of some medicines, and some medicines may affect how well Perindopril and Indapamide-GH 4/1.25 mg tablets work. You may need different amounts of your medication or to take different medicines. The medicines that may interact with Perindopril and Indapamide-GH 4/1.25 mg tablets include the following:
- Some anaesthetic medicines.
- Some medications used to treat high blood pressure (including angiotensin receptor blockers), aliskiren (see also “Do not take Perindopril and Indapamide-GH 4/1.25 mg tablets if” and “Tell you 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 Perindopril and Indapamide-GH 4/1.25 mg tablets if” and “Tell you doctor straight away” sections).
- Some antibiotic and medicines used to treat infections (eg. 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 steroid medicines.
- Medicines used to treat mood swings and some types of depression (lithium, tricyclic antidepressants, antipsychotics).
- Potassium-sparing diuretics (eg. 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 and cotrimoxazole also known as trimethoprim/ sulfamethoxazole).
- Some drugs used to treat cancer or to suppress the immune system.
- Vasodilators including nitrates.
- Medicines used to treat diabetes (eg. 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 (eg. 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.
- 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 (eg. temsirolimus, sirolimus, everolimus).
– Sacubitril (available as fixed-dose combination with valsartan), used to treat long-term heart failure (see also 'Do Not Take Perindopril and Indapamide-GH 4/1.25 mg tablets if' and 'Tell Your Doctor Straight Away' sections).
– 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 (eg. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol).
– Digoxin or other cardiac glycosides (for the treatment of heart problems).
– Calcium supplements.
– Stimulant laxatives (eg. senna).
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking Perindopril and Indapamide-GH 4/1.25 mg tablets.
For older people or children
- Elderly people can generally use Perindopril and Indapamide-GH 4/1.25 mg tablets safely. However, some older people have reduced kidney function – in which case additional care may be required.
- Perindopril and Indapamide-GH 4/1.25 mg tablet is not recommended for use in children and adolescents.
How to take Perindopril and Indapamide-GH 4/1.25
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 Perindopril and Indapamide-GH 4/1.25 mg tablets for you. The usual dose is one tablet once daily.
How to take it
Swallow your tablet(s) with water, preferably in the morning.
How long to take it
Perindopril and Indapamide-GH 4/1.25 mg tablets can help to control your blood pressure, but cannot cure this condition. Perindopril and Indapamide-GH 4/1.25 mg tablets treatment is usually for life -so you should keep taking the tablets regularly unless advised otherwise by your doctor.
If you forget to take it
- 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 (overdose)
Taking too much Perindopril and Indapamide -GH 4/1.25 mg tablets (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 Perindopril and Indapamide-GH 4/1.25 mg tablets then act immediately: Telephone your doctor or the Poisons Information Centre (13 11 26 in Australia; 0800 764 766 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 Perindopril and Indapamide-GH 4/1.25
Things you must do
Take Perindopril and Indapamide-GH 4/1.25 mg tablets 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 Perindopril and Indapamide-GH 4/1.25 mg tablets.
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 Perindopril and Indapamide-GH 4/1.25 mg tablets.
Things you must not do
Do not give this medicine to anyone else, even if they have the same condition as you. Do not use Perindopril and Indapamide-GH 4/1.25 mg tablets to treat any other complaints unless your doctor tells you to.
Do not stop taking Perindopril and Indapamide-GH 4/1.25 mg tablets 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 Perindopril and Indapamide-GH 4/1.25 mg tablets affects you. You may feel light-headed or dizzy when you begin to take Perindopril and Indapamide-GH 4/1.25 mg tablets. 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 Perindopril and Indapamide-GH 4/1.25 mg
tablets 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.
Perindopril and Indapamide-GH 4/1.25 mg tablets help most people with high blood pressure, but it may sometimes have unwanted side effects in few people. While these side effects when they occur are usually mild they can be serious.
Stop taking Perindopril and Indapamide-GH 4/1.25 mg tablets 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 Perindopril and Indapamide-GH 4/1.25 mg tablets. 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 heartbeat, 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.
- Dry mouth.
- Decreased appetite.
- Muscle spasms.
- 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.
- Back pain.
- Gastrointestinal inflammation.
- Excessive sweating.
- Increased sensitivity of the skin to sun, skin rash or inflammation of the skin often including blisters that weep and become crusted.
- Pemphigoid – a skin disease usually affecting older people.
- Increase in some white blood cells.
- Erectile dysfunction, libido disorder.
- Fever or high temperature.
- Chest pain.
- Fast heartbeat.
- 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.
- Kidney failure.
- Eosinophilic pneumonia.
- 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 heartbeat.
- 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.
Concentrated urine (dark in colour), feel or are sick, have muscle cramps, confusion and fits which may be due to inappropriate anti-diuretic hormone (ADH) secretion can occur with ACE inhibitors. If you have these symptoms contact your doctor as soon as possible.
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 Perindopril and Indapamide-GH 4/1.25
Keep your Perindopril and Indapamide-GH 4/1.25 mg 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. Perindopril and Indapamide-GH 4/1.25 mg tablets will not keep as well outside its blister packaging.
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 Perindopril and Indapamide-GH 4/1.25 mg tablets, or the tablets have passed their expiry date, return any leftover tablets to your pharmacist for disposal.
What it looks like
Perindopril erbumine and Indapamide hemihydrate tablets 4 mg/1.25 mg are white
to off-white; capsule shaped uncoated tablets, plain on both sides containing Perindopril erbumine Ph Eur 4.0 mg and Indapamide Ph Eur 1.22 mg equal to Indapamide hemihydrate 1.25mg.
Perindopril and Indapamide-GH 4/1.25 mg tablets come in a blister strip. Each box contains 30 tablets.
Each tablet of Perindopril and Indapamide-GH 4/1.25 mg tablets contains 4 mg of perindopril erbumine and 1.25 mg of indapamide hemihydrate.
- microcrystalline cellulose;
- lactose monohydrate;
- magnesium stearate; and
- silica dimethyl salicylate.
Australian Registration Numbers
Perindopril and Indapamide-GH 4/1.25 mg tablets:
AUST R 147149.
Generic Health Pty Ltd
Suite 2, Level 2
19-23 Prospect Street
Box Hill, VIC, 3128
Telephone: +61 3 9809 7900
This leaflet was prepared in August 2019.
Published by MIMS November 2019