Contains the active ingredients, Perindopril (per-in-do-pril) and Indapamide (ind-ap-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 questions about . 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 perindopril/ indapamide 4/1.25 is used for
The name of your medicine is Chemmart Perindopril/ Indapamide 4/1.25.
It contains the active ingredients, perindopril erbumine and indapamide hemihydrate.
It 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.
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 it for another reason.
This medicine is available only with a doctor's prescription.
There is no evidence that this medicine is addictive.
Use in children
There is not enough information to recommend the use of this medicine in children.
Before you take perindopril/ indapamide 4/1.25
When you must not take it
Do not take this medicine if you are allergic to or have had an allergic reaction to:
Perindopril or indapamide or any of the ingredients listed at the end of this leaflet
sulphonamide (sulpha) antibiotics, or thiazide diuretics (a type of "fluid" or "water" tablet).
any other angiotensin converting enzyme (ACE) inhibitor
Symptoms of an allergic reaction may include: shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; muscle pain or tenderness or joint pain; or rash, itching or hives on the skin.
Do not take this medicine if you are pregnant or trying to become pregnant.
Perindopril/ indapamide 4/1.25 may affect your developing baby if you take it during pregnancy.
Do not take this medicine if you are breast-feeding or intend to breast-feed.
It is not known if Perindopril/ indapamide 4/1.25 passes into human breast milk.
Do not take this medicine if you have any of the following conditions:
severe heart failure which is not being treated.
low potassium levels (hypokalaemia)
severe liver problems
trouble urinating (i.e. little or no urine)
severe kidney problems
renal artery stenosis (a problem with the blood vessels to one or both kidneys)
hepatic encephalopathy
Do not take this medicine if you are taking other medicines which have the possible side effect of a heart problem called torsades de pointes (medicines such as erythromycin, given by injection, astemizole, terfenadine or pentamidine).
Do not take this medicine if you undergo renal dialysis using polyacrylonitrile membranes.
Do not take this medicine if you have experienced 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).
Do not take this medicine if you are intolerant or allergic to lactose.
This medicine contains lactose
Do not take this medicine after the expiry date (EXP) printed on the pack.
If you take this medicine after the expiry date has passed, it may not work as well.
Do not take this medicine if the packaging is torn, shows signs of tampering or if it does not look quite right.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if:
1. You have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes.
2. You have or have had any medical conditions, especially the following:
kidney disease
liver disease
heart or blood vessel disease
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. If you have a salt imbalance you may feel thirsty, weak, drowsy, restless, sick, or have weak or cramped muscles, or have changes in your heart rate or rhythm. You may also have gout due to high uric acid levels
you have, or have had an allergic reaction during previous, low-density lipoprotein (LDL) apheresis, a technique where LDL is 'filtered' out of a patient's blood, using dextran sulphate
you have recently suffered from diarrhoea or vomiting
you are undergoing de-sensitisation treatment or have had an allergic reaction during previous desensitization treatment (e.g. treatments using bee, wasp or ant venom).
you are to undergo anaesthetic and/or surgery.
3. You are pregnant or breast-feeding or you plan to become pregnant or breast-feed.
If you have not told your doctor about any of the above, tell them before you start taking this medicine.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and perindopril/ indapamide 4/1.25 may interfere with each other. These include:
some drugs used to treat gout (e.g. allopurinol)
some drugs used to treat cancer or to suppress the immune system (such as after organ transplants, e.g. cyclosporin)
baclofen, a muscle relaxant
some antibiotic drugs
medicines such as lithium and tricyclic antidepressants (e.g. imipramine) for treating depression and mood disorders
medicines used for treating psychiatric disorders
some anti-inflammatory drugs such as non-steroidal anti-inflammatory drugs (including aspirin)
medicines which increase blood potassium levels, such as potassium-sparing diuretics, sources of potassium, like potassium tablets and salt substitutes containing potassium
medicines which decrease blood potassium levels such as steroids, tetracosactide and certain types of laxative
some medications used to treat high blood pressure (including diuretics -sometimes called "fluid" or "water" tablets)
some medicines used to treat fast or irregular heartbeats, and other heart conditions (procainamide, quinidine, disopyramide, amiodarone, sotalol, digoxin)
certain medicines which have a possible side effect of affecting the heart, e.g. pentamidine, astemizole, terfenadine and erythromycin IV (see also " When you must not take it")
It is especially important to tell your doctor when taking blood pressure, water and/or heart tablets together with anti-inflammatory drugs
medicines used to treat diabetes (tablets and insulin)
gold injections used for treating arthritis
calcium supplements
injections containing iodine used to diagnose certain medical conditions
taking strong painkillers, barbiturates or blood pressure tablets or drinking alcohol whilst taking this medicine may cause your blood pressure to drop too much and you may feel faint or pass out.
medicines which make your heart beat faster or your blood pressure go up, such as decongestants (in cold remedies) or adrenaline
drugs (anaesthetics) used during operations.
These medicines may be affected by perindopril/ indapamide 4/1.25 or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist can tell you if you are taking any of these medicines. They may also have more information on medicines to be careful with or avoid while taking perindopril/ indapamide 4/1.25.
Other interactions not listed above may also occur.
How to take this medicine
Follow all directions given to you by your doctor or pharmacist carefully.
They may be different to the information in this leaflet.
If you do not understand any written instructions, ask your doctor or pharmacist for help.
How much to take
Your doctor or pharmacist will tell you how many tablets you will need to take. This depends on your condition and whether or not you are taking any other medicines.
Some older people have reduced kidney function. The usual starting dose in the elderly should always be one tablet of a perindopril 2 mg / indapamide 0.625 mg fixed dose combination product daily.
The usual adult dose of perindopril/indapamide 4/1.25 is one tablet daily.
How to take it
Swallow your tablet(s) with a glass of water.
Do not crush or chew the tablets.
When to take it
Take it at about the same time each day, preferably in the morning before breakfast.
Taking your medicine at the same time each day will have the best effect. It will also help you remember when to take it.
How long to take it for
Perindopril/ indapamide 4/1.25 can help to control your blood pressure or heart failure, but cannot cure these conditions. 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 forget to take it
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 the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 for Australia) for advice, or go to the Accident and Emergency Department at the nearest hospital, if you think that you or anyone else may have taken too much perindopril/ indapamide 4/1.25.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too much 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.
While you are taking perindopril/ indapamide 4/1.25.
Things you must do
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking perindopril/ indapamide 4/1.25.
Tell your doctor immediately if you become pregnant.
If you are about to have any blood tests, tell your doctor that you are taking this medicine.
Go to your doctor regularly for a check-up.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent 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-headeness 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.
(See "Side effects of perindopril /indapamide 4/1.25" below for a full list of possible side effects).
Things you must not do
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not take your medicine to treat any other complaints unless your doctor or pharmacist tells you to.
Do not stop taking your medicine, or change the dosage, without checking with your doctor.
Things to be careful of
Be careful while driving or operating machinery until you know how perindopril/ indapamide 4/1.25 affects you.
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 don't get better in a short time then talk to your doctor.
Side effects of perindopril/ indapamide 4/1.25
All medicines may have some unwanted side effects. Sometimes they are serious, but most of the time, they are not.
Your doctor has weighed the risks of using this medicine against the benefits they expect it will have for you.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking perindopril/ indapamide 4/1.25.
Ask your doctor or pharmacist to answer any questions you may have.
Following is a list of possible side effects. Do not be alarmed by this list. You may not experience any of them.
If any of the following happen, stop taking your medicine and either tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
swelling of your lips, face, mouth, tongue or throat.
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).
severe blisters, widespread skin rash, itching, skin reaction which makes the skin look scalded, or other skin reactions
a fast, slow or irregular heart beat.
angina or chest pain, loss of consciousness
sudden weakness or numbness of the face, arms or legs, especially on one side, slurred speech
liver problems, yellow skin or eyes
not passing any urine
feeling breathless or having problems breathing, chest infection such as bronchitis or pneumonia
severe pains in the stomach or upper stomach
feeling or being very sick
These are very serious side effects. You may need urgent medical attention or hospitalisation.
Tell your doctor as soon as possible if you notice any of the following:
sweating
feeling depressed, anxious, confused or hearing or seeing things that are not there
sexual problems
kidney problems (i.e. cystitis, cloudy urine or problems urinating or urinating too much)
sunburn following only a small exposure to the sun; fine, broken blood vessels below the skin, skin reaction which makes the skin look scalded.
infections such as chest or throat infections, fever, severe chills or mouth ulcers
itching blood vessels
These may be serious side effects. You may need medical attention.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
a dry cough
headache, dizziness, drowsiness, giddiness, numbness, tingling or pins and needles
tinnitus (pain or ringing in the ears), problems with your eyesight
hypotension (low blood pressure), palpitations, poor circulation in your hands and feet
dry mouth, strange taste sensations, loss of appetite, flushing, constipation, diarrhoea
feeling tired or weak or as if you have less energy
feeling uncomfortable after eating, indigestion, feeling or being sick,
rash, itching, pimples on the skin
nose bleed, blocked nose
muscle cramps, weak legs
back or joint pain
altered mood, problems when sleeping or getting to sleep, or strange dreams
These side effects are usually mild when they occur.
Other side effects not listed above may occur in some patients.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
After taking this medicine
Storage
Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool, dry place where the temperature will stay below 25 degrees C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink.
Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor or pharmacist tells you to stop taking this medicine or it has passed its expiry date, ask your pharmacist what to do with any medicine that is left over.
Where to go for further information
Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.
Product description
What Chemmart Perindopril/ Indapamide 4/1.25 looks like
Chemmart Perindopril/ Indapamide 4/1.25:
White, capsule-shaped, biconvex tablets, engraved "4/1.25" on one side and "Apo" on the other side.
Ingredients
Each tablet contains 4mg perindopril erbumine and 1.25mg indapamide hemihydrate as the active ingredients.
It also contains the following inactive ingredients:
anhydrous lactose
magnesium stearate
This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.
Australian Registration Numbers
Chemmart Perindopril/ Indapamide 4/1.25 tablets:
Blister packs of 30
AUST R 127120
Sponsor
Apotex Pty Ltd
66 Waterloo Road
North Ryde NSW 2113
Australia
Distributor
Symbion Pharmacy Services Pty Ltd
48-58 Overseas Drive
Noble Park North VIC 3174
Australia
Chemmart is a registered trade mark of Symbion Pharmacy Services Pty Ltd.
This leaflet was prepared in:
December 2008
