Indopril

Contains the active ingredient Perindopril (per-in-do-pril) erbumine

Consumer Medicine Information

What is in this leaflet

Read this leaflet carefully before taking your medicine. Ask your doctor or pharmacist if you do not understand anything or are worried about taking your medicine.

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.

The information in this leaflet was last updated on the date listed on the last page. Some more recent information on your medicine may be available. Speak to your pharmacist or doctor to obtain the most up-to-date information.

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.

Keep this leaflet with the medicine. You may want to read it again.

What Perindopril is used for

The name of your medicine is Indopril

It contains the active ingredient perindopril erbumine.

Perindopril belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors.

It is used to treat high blood pressure, heart failure or stable coronary artery disease.

This medicine is available only with a doctor’s prescription.

There is no evidence that this medicine is addictive.

Use in children

This medicine is not recommended for use in children.

Why it 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 helps to lower your blood pressure.

Why it is used for 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 has stopped working. Some people may develop heart failure after having a heart attack, but there are a number of other causes of heart failure.

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 different parts of the body, often first noticed as swollen ankles and feet. You may also wake up short of breath at night. In severe heart failure, symptoms like breathlessness may occur even at rest.

Perindopril helps to treat heart failure. 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.

Why it is used for Coronary Artery Disease

You may have been perindopril if you have coronary artery disease. Coronary artery disease is narrowing of the vessels carrying blood to the heart. In patients with coronary artery disease, perindopril has been shown to reduce some of the risks, 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 perindopril for another reason.

Before you take Perindopril

When you must not take it

There are some people who should not take Perindopril.

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 this medicine if you have had an allergic reaction to perindopril or any of the ingredients listed at the end of this leaflet.

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. Perindopril may affect your developing baby if you take it during pregnancy.

Do not take this medicine if you are breast-feeding. It is not known if perindopril passes into human breast milk.

Do not take this medicine if you undergo renal dialysis using polyacrylonitrile membranes.

Do not take this medicine if you have renal artery stenosis (a problem with the blood vessels to one or both kidneys).

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.

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 disease
• Diabetes
• High or low levels of potassium, sodium or other problems with salt balance
• 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.
• 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 anaesthesia and/or surgery

3. 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 if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines and perindopril may interfere with each other. These include:

• Some antibiotic drugs.
• Some anti-inflammatory drugs.
• Lithium medications (used to treat mood swings and some types of depression).
• Potassium-sparing diuretics, sources of potassium, like potassium tablet and salt substitutes containing potassium.
• Some medications used to treat high blood pressure (including diuretics (sometimes called "fluid" or "water" tablets) a fast or irregular heartbeat, and other heart conditions (It is especially important to tell your doctor when taking blood pressure, water and/or heart tablets together with anti-inflammatory drugs and perindopril)
• Medicines used to treat diabetes (tablets and insulin)
• Gold injections used for treating arthritis
• Medicines which make your heart beat faster or your blood pressure go up, such as decongestants (in cold remedies) or adrenaline.

These medicines may be affected by perindopril 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.

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.

The usual dose of perindopril:

• For high blood pressure is up to 8 mg once daily.
• For heart failure is up to 4 mg once daily.
• For coronary artery disease is up to 8 mg once daily.

Elderly people can generally use perindopril safely. However, some older people have reduced kidney function- in which case the starting dose of perindopril should be 2 mg once daily. A less frequent dose may be used with serious kidney failure.

How to take it

Swallow your tablet(s) with a glass of water.

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 can help to control your blood pressure or heart failure, but cannot cure these conditions. Perindopril 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, 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 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.

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 fall (also known as hypotension).

While you are taking Perindopril

Things you must do

Tell any other doctors, dentists, and pharmacists who are treating you that you are taking perindopril.

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.

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 affects you.

Side effects of Perindopril

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.

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.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

• A dry cough, feeling breathless
• Headache, dizziness, feeling giddy, numbness 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, flushing, constipation, diarrhoea
• Feeling tired or weak or as if you have less energy, feeling uncomfortable after physical exertion
• Feeling uncomfortable after eating, feeling or being sick, or having stomach pain
• Rash, itching, pimples on the skin, inflamed blood vessels
• Nose bleed, blocked nose
• Muscle cramps
• Altered mood, problems when sleeping or getting to sleep, or strange dreams

These side effects are usually mild when they occur.

Tell your doctor as soon as possible if you notice any of the following:

• Sweating
• Feeling depressed, confused or hearing or seeing things that are not there
• Sexual problems
• Kidney problems (i.e. problems urinating)
• Liver problems, yellow skin or eyes
• Severe pains in the stomach or upper stomach

These may be serious side effects. You may need medical attention. Most of these side effects are rare.

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).
• A fast and irregular heart beat.
• Severe blisters, widespread skin rash, itching or other allergic reactions
• Angina or chest pain, loss of consciousness
• Sudden weakness or numbness of the face, arms or legs, especially on one side, slurred speech
• Problems breathing, pneumonia

These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

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 them. If you take the tablets out of their original packaging they may not keep well.

Keep your medicine in a cool, dry place where the temperature will stay 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 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 Indopril looks like

Indopril 2 mg tablets are white, round, biconvex tablets, engraved “APO” on one side and “PE2” on the reverse.

Indopril 4 mg tablets are white, capsule shaped, biconvex tablets, scored and engraved “PE” bisect “4” on one side, and “APO” on the reverse.

Indopril 8 mg tablets are white, capsule shaped, biconvex tablets, scored and engraved “PE” bisect “8” on one side, and “APO” on the reverse.

Ingredients

Each tablet contains 2 mg, 4 mg or 8 mg perindopril erbumine as the active ingredient.

It also contains the following inactive ingredients:

• Lactose anhydrous
• Magnesium stearate

This medicine is gluten-free, sucrose-free, tartrazine-free and other azo dyes-free.

Australian Registration Numbers

Indopril 2 mg tablets
Blister packs of 30 tablets.
AUST R Number 121625

Indopril 4 mg tablets
Blister packs of 30 tablets.
AUST R Number 121626

Indopril 8 mg tablets
Blister packs of 30 tablets.
AUST R Number 121627

Sponsor

Apotex Pty Ltd
ABN 52 096 916 148
66 Waterloo Road
North Ryde NSW 2113
Australia

This leaflet was prepared in:
November 2008

Published by MIMS/myDr March 2009

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