Contains the active ingredient, clopidogrel
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons
living in Australia. This page contains answers to some common
. 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 clopidogrel is used for
The name of your medicine is APO- Clopidogrel. It contains the active ingredient, clopidogrel.
It is used to prevent blood clots forming in hardened blood vessels (a process known as atherothrombosis) which can lead to
events such as stroke, heart attack or death.
How it works
Clopidogrel belongs to a group of medicine called anti-platelet medicines.
Platelets are very small blood cells which clump together during blood clotting. By preventing this clumping, anti-platelet
medicines reduce the chances of blood clots forming (a process called thrombosis).
You may have been prescribed clopidogrel to help prevent blood clots forming and to reduce the risk of stroke, heart attack
or death because:
you have previously suffered a heart attack, stroke or have a condition known as peripheral arterial disease (leg pain on
walking or at rest).
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed clopidogrel 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 clopidogrel
When you must not take it
Do not take this medicine if you have had an allergic reaction to clopidogrel 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
Do not take this medicine if you have any of the following:
a medical condition that is causing bleeding such as a stomach ulcer or bleeding within your head
severe liver disease
Do not take this medicine if you are breast-feeding.
Clopidogrel passes into breast milk and, therefore, there is the possibility that the breast-fed baby may be affected
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 or pharmacist.
Before you start to take it
Tell your doctor if:
You have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes.
You have or have had any medical conditions, especially the following:
bleeding disorders or blood clotting problems
any illness or disability that was caused by bleeding, for example impaired sight or vision because of bleeding within eye
recent serious injury
recent surgery (including dental surgery)
any form of liver disease
a genetic condition which means that a certain enzyme (CYP2C19) in your liver works differently.
You plan to become pregnant or breast-feed.
Your doctor will discuss the possible risks and benefits of taking clopidogrel during pregnancy. As discussed above, breast-feeding
is not recommended whilst taking this medicine.
You are planning to have an operation (including dental surgery) in the next two weeks.
Your doctor will decide whether or not you need to stop clopidogrel prior to surgery.
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 clopidogrel may interfere with each other. These include:
medicines used to treat or prevent blood clots, for example: aspirin, heparins, warfarin and ticlopidine. There may also be
non-steroidal anti-inflammatory drugs (NSAIDs) medicines used to treat arthritis, period pain, inflammation, aches and pain
phenytoin, a medicine used to treat epilepsy
tolbutamide, a medicine used to treat diabetes
tamoxifen, a medicine used to treat breast cancer
fluvastatin, a medicine used to lower cholesterol
medicines which may affect the liver enzyme in your body which makes clopidogrel work. Examples include omeprazole and lansoprazole
(used to treat stomach problems); letrozole and bicalutamide (used to treat certain cancers), and fluvoxamine (used to treat
depression). These may stop clopidogrel working properly. There may also be others.
These medicines may be affected by clopidogrel 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 clopidogrel.
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 clopidogrel is one 75 mg tablet daily.
Your clopidogrel tablets are provided in a calendar pack which is designed to remind you when to take this medication.
To do this, take your first dose from the position marked "First Day ". On the following day take the first tablet which is
labelled with the appropriate day. When you have taken all doses in this pack, take your next prescription in the same way.
How to take it
Swallow the tablet 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.
Taking your medicine at the same time each day will have the best effect. It will also help you remember when to take it.
It does not matter if you take it before, with or after food.
How long to take it for
Continue 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 it is almost time for 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 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 clopidogrel.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too much clopidogrel, you may experience excessive bleeding (see Side Effects section).
While you are taking clopidogrel
Things you must do
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking clopidogrel.
It may increase the risk of bleeding during an operation or some dental work. Therefore, treatment may need to be stopped
before surgery. Your doctor will decide whether to stop clopidogrel and if so, how long before surgery or dental work.
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 and have any blood tests promptly if your doctor orders them.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.
Tell your doctor if you decide to breast-feed your baby. Your doctor may want to discuss this and change your medicine.
Remind your doctor that you are taking clopidogrel if you are about to start on any new medicine.
Ask your doctor whether there are any activities you should avoid while taking clopidogrel, for example certain sports.
Sometimes after an injury, bleeding may occur inside your body without you knowing about it.
Tell your doctor immediately if you are injured while taking clopidogrel.
It may take longer than usual to stop bleeding while you are taking it.
Tell your doctor immediately if you notice any of the following:
abnormal bruising or bleeding
abnormal nose bleeds
bloody or black bowel motions
red or purple blotches on your skin
swelling of the face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing (see also "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 clopidogrel affects you.
As with other medicines, clopidogrel may cause faintness or dizziness in some people. Make sure you know how you react to
the medicine before you drive a car or operate machinery, or do anything else that could be dangerous if you are faint or
dizzy. If this occurs, do not drive. If you drink alcohol, faintness or dizziness may be worse.
Side effects of clopidogrel
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 clopidogrel.
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:
pain or stiffness in the joints
things taste different.
The above list includes the more common side effects. Mostly, these are mild.
Tell your doctor immediately if you notice any of the following:
(Note: if you take both clopidogrel and aspirin, the risk of side effects related to bleeding may be increased)
bloody or black bowel motions
diarrhoea with blood, mucus, stomach pain and fever
abdominal or stomach pain
vomiting of blood or vomit that looks like coffee grounds
coughing up blood
blood in the urine
unusually heavy bleeding or oozing from cuts or wounds
bleeding (including nose bleeds) or bruising more easily than normal
unusually heavy or unexpected menstrual bleeding
nausea or vomiting
headache (severe and continuing)
faintness or dizziness
light-headedness or blurred vision
confusion or hallucinations
fever or other signs of infection, such as a sore throat
chills, sweating or clammy skin
fever, muscle weakness, loss of appetite and fatigue
anaemia (being tired and looking pale)
red or purple spots visible through your skin
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:
Symptoms of an allergic reaction such as:
shortness of breath, tight chest, wheezing or difficulty breathing
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, or swelling of
other parts of the body
muscle pain or tenderness or joint pain
rash, itching or hives on the skin, or inflamed, cracking or red skin.
Symptoms of severe liver effects such as:
yellowing of the skin or the whites of the eyes, pale stools and dark urine with vomiting and stomach pain
Other side effects such as:
blood in the eyes
numbness (paralysis) or problem with co-ordination
slurred speech or other difficulty in speaking
These are very serious side effects. You may need urgent medical attention or hospitalisation.
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
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°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.
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.
What APO-Clopidogrel looks like
APO-Clopidogrel 75 mg is a reddish brown, round biconvex film-coated tablets, imprinted "APO" on one side and "CL" over "75"
on the other side.
Bottles of 28 and 500 tablets.
Not all strengths, pack types and/or pack sizes may be available.
Each tablet contains 75 mg of clopidogrel.
It also contains the following inactive ingredients:
colloidal anhydrous silica
iron oxide red.
This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.
Australian Registration Numbers
APO-Clopidogrel 75 mg tablets (bottle): AUST R 129642
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park, NSW 2113
Apotex Pty Ltd is the licensee of the registered trademarks APO and APOTEX from the registered proprietor, Apotex Inc.
This leaflet was prepared in June 2012