BTC Perindopril

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Perindopril erbumine
Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about perindopril. It does not contain all the available information about this medicine. It 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 this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may want to read it again.

What this medicine is used for

Perindopril is used to treat high blood pressure (also known as hypertension), heart failure or coronary artery disease.
Perindopril belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors.

High blood pressure

Perindopril helps to lower your blood pressure. Everyone has blood pressure, which 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 worried you are. You have high blood pressure when your blood pressure stays higher than is needed, even when you are relaxed. There are usually no symptoms of high blood pressure. The only way of knowing that you have it is to have your blood pressure checked on a regular basis. Untreated high blood pressure can lead to serious health problems, such as stroke, heart disease and kidney failure.

Heart failure

Perindopril helps to treat heart failure. Heart failure means that the heart muscle is not pumping blood strongly enough to circulate blood around the body properly. Heart failure is not the same as a heart attack and does not mean that the heart stops working. Heart failure may start off with no symptoms, but as the condition progresses, you may feel short of breath or get tired easily after light physical activity such as walking. Fluid may accumulate in the body, such as swollen ankles and feet. In severe heart failure, symptoms like breathlessness may occur even at rest. If you follow your doctor's advice, your ability to perform daily activities may improve. You may breathe more easily, feel less tired and have less swelling.

Coronary artery disease

Coronary artery disease is the narrowing of the vessels carrying blood to the heart. Perindopril has been shown to reduce some risks of coronary artery disease, including heart attacks.
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.
This medicine is available only with a doctor's prescription.
This medicine is not addictive.
There is not enough information to recommend the use of this medicine should not be used in children.

Before you take this medicine

When you must not take it

Do not take this medicine if you have an allergy to:
perindopril
any of the ingredients listed at the end of this leaflet.
Some of the 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
rash, itching or hives on the skin.
Do not take this medicine if you have or have had any of the following medical conditions:
diabetes or kidney impairment and are taking aliskiren to treat high blood pressure
undergoing renal dialysis using polyacrylonitrile membranes
unilateral or bilateral renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
swelling of the face, tongue, lips or throat, either suddenly or in response to another ACE inhibitor medicine (a rare allergic condition known as angioedema)
intolerance or allergy to lactose (this medicine contains lactose).
Do not take this medicine if you are taking a combined medicine called sacubitril/valsartan.
Do not take this medicine if you are pregnant or plan to become pregnant.
Perindopril may affect your developing baby if you take it during pregnancy.
Do not take this medicine if you are breastfeeding.
It is not known if perindopril passes into human breast milk.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
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 you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
narrowing of the main blood vessel leading from the heart
kidney or liver problems
heart disease
diabetes
high or low levels of potassium, sodium or other problems with salt balance
on a salt restricted diet or use salt substitutes containing potassium
you are undergoing, 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
recent diarrhoea or vomiting
you are undergoing de-sensitisation treatment or have had an allergic reaction during previous desensitisation treatment (e.g. bee, wasp or ant venom).
Tell your doctor if you also take an angiotensin II receptor blocker (e.g. valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems.
Tell your doctor 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.
Tell your doctor if you are planning to have surgery, dental treatment or an anaesthetic.
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 if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interact with perindopril. These include:
some antibiotics to treat infection
some anti-inflammatory drugs for pain relief (e.g. ibuprofen)
medicines used to treat mood disorders (e.g. lithium, tricyclic antidepressants, antipsychotics)
potassium-sparing diuretics, potassium tablets, salt substitutes containing potassium
heparin, used to thin the blood
immunosuppressants, medicines which reduce the activity of the body's natural defences
some medications used to treat high blood pressure (e.g. diuretics), a fast or irregular heartbeat and other heart conditions
vasodilators (e.g. nitrates)
medicines used to treat diabetes
gold injections, used for arthritis.
These medicines may be affected by this medicine 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 have more information on medicines to be careful with or avoid while taking this medicine.
Other medicines not listed above may also interact with perindopril.

How to take this medicine

Follow all directions given to you by your doctor carefully.
They may differ to the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much to take

Your doctor will tell you how much of this medicine you should take. This will depend on your condition, such as elderly people or severe kidney failure, and whether you are taking any other medicines.
High blood pressure, coronary artery disease
The usual starting dose is 4 mg once daily. This may be increased by your doctor up to 8 mg once daily.
Heart failure
The usual starting dose is 2 mg once daily. This may be increased by your doctor up to 4 mg once daily.

How to take it

Swallow your tablet whole with a glass of water.

When to take it

Take it at about the same time each day, preferably in the morning before a meal.
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

Continue taking your medicine for as long as your doctor tells you.
Perindopril can help control your condition, but cannot cure it. It is important to keep taking your medicine even if you feel well.
Make sure you have enough to last over weekends and holidays.

If you forget to take it

If it is almost time to take your next dose, skip the dose you missed and take your next dose when you are meant to.
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.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much of this medicine. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too much perindopril, your blood pressure may fall (also known as hypotension), which can make you feel dizzy or faint.

While you are taking this medicine

Things you must 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 are treating you that you take this medicine.
If you become pregnant while taking this medicine, tell your doctor immediately.
Tell your doctor if you are about to have any blood tests.
Tell your doctor if you are going to have surgery or an anaesthetic or are going into hospital.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.

Things you must not do

Do not give this medicine to anyone else, even if they have the same condition as you.
Do not take your medicine to treat any other complaint unless your doctor tells you to.
Do not stop taking your medicine or change the dosage without first checking with your doctor.

Things to be careful of

Be careful while driving or operating machinery until you know how perindopril 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 or do anything else that could be dangerous.

Side effects

Tell your doctor and pharmacist as soon as possible if you do not feel well while you are taking perindopril.
This medicine helps most people, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following:
dry irritating cough, shortness of breath, discomfort on exertion
headache, dizziness, vertigo, pins and needles
feeling tired or lethargic
tinnitus (persistent noise in the ears), vision disturbances
nausea, vomiting, taste disturbances, indigestion, diarrhoea, constipation or abdominal pain
muscle cramps
rash, pruritus (itching)
decreased blood sugar levels.
The above list includes the more common side effects of your medicine.
Tell your doctor as soon as possible if you notice any of the following:
hypotension, flushing, impaired peripheral circulation, nose bleeds, fainting
problems urinating, blood in urine, tiredness (signs of kidney problems)
yellowing of the skin and/or eyes (signs of liver problems)
bleeding or bruising more easily than normal (may be caused by a low blood platelet count).
These may be serious side effects and you may need medical attention.
If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to Accident and Emergency at your nearest hospital:
shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin, severe blisters (signs of an allergic reaction)
purple spots with occasional blisters on the front of your arms, legs, around your neck and ears (Stevens-Johnson Syndrome)
changes in the rhythm or rate of the heartbeat
fast or irregular heartbeat
fever, chest pain, shortness of breath, feeling unwell (signs of eosinophilic pneumonia)
feeling of tightness, pressure or heaviness in the chest (signs of myocardial infarction, angina)
frequent infections, fever, severe chills, sore throat or mouth ulcers (may be caused by a lack of white blood cells)
stroke.
These are very serious side effects and you may need urgent medical attention or hospitalisation.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may occur in some patients.

Storage and disposal

Storage

Keep your medicine in the pack until it is time to take it.
If you take your medicine out of the pack it may not keep well.
Keep your medicine in a cool, dry place where the temperature stays below 25°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 this medicine 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 tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine left over.

Product Description

What it looks like

2 mg tablets: light pink to pink-coloured capsule-shaped tablets debossed with ‘P’ and ‘9’ on either side of the score line on one side and deep break-line on other side.
Blister packs of 30 tablets AUST R 304693.
4 mg tablets: white to off-white capsule-shaped tablets debossed with ‘P’ and ‘9’ on either side of the score line on one side and deep break-line on other side.
Blister packs of 30 tablets. AUST R 304694.
8 mg tablets: white to off-white capsule-shaped tablets debossed with ‘P’ and ‘6’ on either side of the break-line on one side and break-line on other side.
Blister packs of 30 tablets AUST R 304695.
* Not all strengths may be available.

Ingredients

Each tablet contains 2 mg, 4 mg or 8 mg perindopril erbumine as the active ingredient.
It also contains the following:
lactose monohydrate
magnesium stearate
microcrystalline cellulose
colloidal anhydrous silica
Additionally, the 2mg tablet contains iron oxide red as colourant.
This medicine does not contain gluten, sucrose, tartrazine or any other azo dyes.

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
This leaflet was last revised in:
January 2019.