Idaprex Combi

perindopril (pronounced per-in-do-pril) and indapamide (pronounced in-dap-a-mide)
Consumer Medicine Information
 

 

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about IDAPREX COMBI 4/1.25. 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 IDAPREX COMBI 4/1.25 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 IDAPREX COMBI 4/1.25 IS

The name of your medicine is IDAPREX COMBI 4/1.25. 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.

WHAT IDAPREX COMBI 4/1.25 IS USED FOR

You have been prescribed IDAPREX COMBI 4/1.25 for high blood pressure.
IDAPREX COMBI 4/1.25 is available only with a doctor's prescription.
There is no evidence that IDAPREX COMBI 4/1.25 is addictive.

Why IDAPREX COMBI 4/1.25 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.
IDAPREX COMBI 4/1.25 helps to lower your blood pressure.
Ask your doctor if you have any questions about why IDAPREX COMBI 4/1.25 has been prescribed for you.

BEFORE YOU TAKE IDAPREX COMBI 4/1.25

There are some people who should not take IDAPREX COMBI 4/1.25. 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 IDAPREX COMBI 4/1.25 if:

You are allergic to perindopril, indapamide, or any of the other ingredients of IDAPREX COMBI 4/1.25 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 breast-feed.
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 sulphate.
You are treated with a blood pressure lowering medicine containing aliskiren and have diabetes or impaired kidney function
You have narrowing of the blood vessels to one or both kidneys.
You have narrowing of the main blood vessel leading from the heart and/or heart valve.
If you have low blood potassium
If 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).
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 are pregnant or become pregnant while taking IDAPREX COMBI 4/1.25, as it may cause serious harm to your unborn baby.
You are undergoing desensitisation treatment, or have had an allergic reaction during previous desensitisation treatment (e.g. 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 have recently suffered from diarrhoea or vomiting.
You are on a salt restricted diet or use salt substitutes which contain potassium.
You have an intolerance to some sugars as IDAPREX COMBI 4/1.25 contains lactose.
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,
aliskiren.
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.
Diabetes.
Gout.
Heart disease.
Systemic lupus erythematosus or scleroderma (a disease affecting the skin, joints and kidneys)
Are of African origin since you may have a higher risk of angioedema and this medicine is less effective in lowering your blood pressure.
Primary hyperaldosteronism

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 IDAPREX COMBI 4/1.25 may change the effect of some medicines, and some medicines may affect how well IDAPREX COMBI 4/1.25 works. You may need different amounts of your medication or to take different medicines. The medicines that may interact with IDAPREX COMBI 4/1.25 include the following:
Some medications used to treat high blood pressure (including angiotensin receptor blockers), aliskiren (see also 'Do Not Take IDAPREX COMBI 4/1.25 If' and 'Tell Your 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 IDAPREX COMBI 4/1.25 If' and 'Tell Your Doctor Straight Away' sections)
Some antibiotic and medicines used to treat infections.
Some anti-inflammatory medicines (including high dose aspirin, ibuprofen) for pain relief.
Some anaesthetic medicines
Some steroid medicines.
Medicines used to treat mood swings and some types of depression (lithium, tricyclic antidepressants, antipsychotics).
Potassium-sparing diuretics, sources of potassium, like potassium tablet and salt substitutes containing potassium.
Heparin (used to thin blood).
Some drugs used to treat cancer or to suppress the immune system.
Vasodilators including nitrates.
Medicines used to treat diabetes (tablets 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).
Gold salts, especially with intravenous administration (used to treat symptoms of rheumatoid arthritis).
Medicines which may affect the blood cells, such as allopurinol, procainamide.
Mammalian target of rapamycin (mTOR) inhibitors used to avoid rejection of transplanted organs (e.g. temsirolimus, sirolimus, everolimus)
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking IDAPREX COMBI 4/1.25.

For older people or children

Elderly people can generally use IDAPREX COMBI 4/1.25 safely. However, some older people have reduced kidney function - in which case additional care may be required.
IDAPREX COMBI 4/1.25 is not recommended for use in children.

HOW TO TAKE IDAPREX COMBI 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 IDAPREX COMBI 4/1.25 for you. The usual dose is one tablet once daily.
Swallow your tablet(s) with water, preferably in the morning.

How long to take IDAPREX COMBI 4/1.25 for

IDAPREX COMBI 4/1.25 can help to control your blood pressure but cannot cure this condition. IDAPREX COMBI 4/1.25 treatment is usually for life - so you should keep taking the tablets regularly unless advised otherwise by your doctor.

If you forget to take IDAPREX COMBI 4/1.25

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 IDAPREX COMBI 4/1.25

Taking too much IDAPREX COMBI 4/1.25 (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 or faint. If this happens, lying down with the legs elevated can help.
Other effects like sickness, cramps, sleepiness, confusion, kidney problems, salt and water disturbances are possible. You may require urgent medical attention.
If you think that you or anyone else may have taken too much IDAPREX COMBI 4/1.25 then act immediately:
Telephone your doctor or the Poisons Information Centre (13 11 26 in Australia; 03 474 7000 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 IDAPREX COMBI 4/1.25

Things you must do

Take IDAPREX COMBI 4/1.25 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 IDAPREX COMBI 4/1.25.
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 IDAPREX COMBI 4/1.25

Things you must not do

Do not give this medicine to anyone else, even they have the same condition as you.
Do not use IDAPREX COMBI 4/1.25 to treat any other complaints unless your doctor tells you to.
Do not stop taking IDAPREX COMBI 4/1.25 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 IDAPREX COMBI 4/1.25 affects you.
You may feel light-headed or dizzy when you begin to take IDAPREX COMBI 4/1.25. 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

If you do not feel well while you are taking IDAPREX COMBI 4/1.25 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.
IDAPREX COMBI 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.
Angioedema (a severe allergic reaction) has been reported in patients treated with ACE inhibitors, including IDAPREX COMBI 4/1.25. 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.
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).
Painful red areas, developing large blisters and peeling of layers of skin. This is accompanied by fever and chills,
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.
Difficulty breathing
A fast and irregular heart - beat.
 
Talk to your doctor or pharmacist or nurse if you notice any of the following side effects:
Some of the side effects 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.
Nosebleeds
Headache, dizziness, vertigo, pins and needles.
Changes in the rhythm or rate of the heart - beat, fast or irregular heart - beat.
Feeling tired, lethargic or weak.
Tinnitus (persistent noise in the ears), 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.
Fatigue
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.
Anxiety
Difficulty breathing or wheezing, bronchitis, upper respiratory tract infection
Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing.
Swelling of hands, ankles or feet
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 heart beat
Abnormal ECG heart tracing
Abnormal kidney function.
Polyuria - increased urination
Cystitis - an infection of the bladder.
Decreased blood sugar levels.
Aggravation of pre-existing Lupus Erythematosus
Aching muscles, not caused by exercise, Joint pain
Generally feeling unwell.
Falls.
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:
Liver disease (Hepatitis), abnormal liver function
Inflammation of the pancreas (Pancreatitis).
Kidney failure
Eosinophilic pneumonia.
Runny or blocked nose, sneezing, facial pressure or pain.
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.
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).
Painful red areas, developing large blisters and peeling of layers of skin. This is accompanied by fever and chills,
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
Stroke, myocardial infarction, angina pectoris (a feeling of tightness, pressure or heaviness in the chest).
Changes in the rhythm or rate of the heart beat.
Confusion, depression or hallucinations.
Not known (frequency cannot be estimated from the data available):
Myopia, blurred vision
Low potassium levels
Life-threatening irregular heart beat (Torsades de pointes)
Blood glucose increased
Blood uric acid increased
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 IDAPREX COMBI 4/1.25

Storage

Keep your IDAPREX COMBI 4/1.25 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. IDAPREX COMBI 4/1.25 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.

Disposal

If your doctor tells you to stop taking IDAPREX COMBI 4/1.25, or the tablets have passed their expiry date, return any leftover tablets to your pharmacist for disposal.

WHAT IDAPREX COMBI 4/1.25 LOOKS LIKE

IDAPREX COMBI 4/1.25 tablets are white and rod shaped.
The tablets come in a blister strip. Each box contains 30 tablets.

Ingredients

Each tablet of IDAPREX COMBI 4/1.25 contains 4mg of perindopril erbumine and 1.25mg of indapamide hemihydrate as active ingredients.
The inactive ingredients in IDAPREX COMBI 4/1.25 tablets include microcrystalline cellulose, lactose, magnesium stearate, and hydrophobic colloidal silica.
The tablets are gluten free.

Manufacturer and Sponsor

IDAPREX COMBI 4/1.25 is a product discovered by Servier Research International.
It is distributed in Australia by:
Sandoz Pty Ltd
54 Waterloo Road,
Macquarie Park 2113, NSW, Australia
IDAPREX COMBI 4/1.25 is registered on the Australian Register of Therapeutic Goods.
Australian Register Number: AUST R 94527
This leaflet was last revised in August 2016