APO-Clopidogrel Aspirin (clopidogrel and aspirin) Drug / Medicine Information

APO-Clopidogrel Aspirin (clopidogrel and aspirin) Drug / Medicine Information

clopidogrel (as clopidogrel hydrogen sulfate) and aspirin

Consumer Medicine Information

What is in this leaflet

Read this leaflet carefully before taking your medicine.

This leaflet answers some common questions about Clopidogrel/Aspirin. It does not
contain all the available information. 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 using
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 your medicine. You may want to read it again.

What this medicine is used for

The name of your medicine is APO-Clopidogrel/Aspirin. It contains the active ingredients
clopidogrel (as clopidogrel hydrogen sulfate) and aspirin.

Clopidogrel/Aspirin 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.

Clopidogrel/Aspirin belongs to a group of medicines 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/aspirin to help prevent blood clots forming
and to reduce the risk of heart attack, stroke or death, because you have suffered
a severe type of chest pain called unstable angina or have had a heart attack.

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.

There is no evidence that this medicine is addictive.

Before you take this medicine

When you must not take it

Do not take this medicine if you have an allergy to:

any medicine containing clopidogrel or aspirin

any other similar medicines such as salicylates or anti-inflammatories (NSAIDs)

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 or other parts of the body

rash, itching or hives on the skin

Do not take this medicine if you are pregnant.

Do not take clopidogrel/aspirin during the third trimester of pregnancy.

It is not known whether clopidogrel/aspirin may affect your developing baby if you
take it during the first two trimesters of pregnancy. Your doctor can discuss with
you the risks and benefits involved.

Do not take this medicine if you are breast-feeding.

Clopidogrel/Aspirin may pass into breast milk and there is a possibility that your
baby may be affected.

Do not take this medicine if you have or have had any of the following medical conditions:

a medical condition that causes bleeding such as a haemophilia, stomach ulcers or
bleeding within your head or bowels

erosive gastritis

severe liver or kidney disease

asthma with rhinitis and/or nasal polyps

mastocytosis.

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:

bleeding disorders or blood clotting problems

any illness or disability that was caused by bleeding, e.g. impaired sight or vision
because of bleeding within the eye

stroke

recent serious injury

recent surgery (including dental surgery)

liver or kidney disease

stomach ulcers or other problems with your digestive system

inherited diseases causing galactose intolerance or glucose-galactose malabsorption

Lapp lactase deficiency

Glucose-6-phosphate dehydrogenase (G6PD) deficiency

gout

asthma or allergies

allergies to other anti-platelet medicines (such as ticlopidine or prasugrel)

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.

Do not take this medicine whilst in the third trimester of pregnancy. Your doctor
can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell them before you start
taking this medicine.

Your doctor may advise you to go for tests to determine if this medicine will adequately
work for you, as some patients may not convert this medicine to its active form.

These patients may not get the same benefit from clopidogrel/aspirin as other patients.
Based on the test results, your doctor may consider alternative treatments for you.

Taking other medicines

Tell your doctor or pharmacist 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 and this one may interfere with each other. These include:

aspirin and other salicylates – this medicine already contains aspirin; taking additional
aspirin is not recommended unless advised by your doctor

clopidogrel – this medicine already contains clopidogrel; taking additional clopidogrel
is not recommended unless advised by your doctor

other medicines used to prevent blood clots, such as heparins and warfarin

thrombolytic agents, medicines used to break down blood clots

non-steroidal anti- inflammatory drugs (NSAIDs), medicines used to treat arthritis,
period pain, aches and pains, such as ibuprofen

steroids, including hydrocortisone

uricosuric medicines, which may be used to treat gout, such as probenecid

methotrexate, used to treat cancer or arthritis

bupropion, fluoxetine, fluvoxamine and moclobemide, medicines used to treat depression

omeprazole, esomeprazole, lansoprazole and pantoprazole, medicines known as proton
pump inhibitors used to prevent gastric reflux

nicorandil, used to treat chest pain (angina)

tenofovir, an antiretroviral medicine

varicella vaccine

acetazolamide, used to treat glaucoma

cimetidine, used to treat stomach ulcers

phenytoin, diazepam, carbamazepine, oxcarbazepine and valproic acid, medicines used
to treat epilepsy

repaglinide, tolbutamide and chlorpropamide, medicines used to treat diabetes

tamoxifen and paclitaxel, medicines used to treat breast cancer

fluvastatin, used to lower cholesterol

voriconazole and fluconazole, medicines used to treat fungal infections

ciprofloxacin and chloramphenicol, antibiotic medicines

levothyroxine, used to treat low thyroid activity

spironolactone, a diuretic medicine

ACE inhibitors or angiotensin receptor antagonists plus a thiazide diuretic – these
medicines are used to treat high blood pressure, and in some cases may be used together
to treat other cardiovascular diseases

opioids, medicines for strong pain relief, such as morphine

These medicines may be affected by clopidogrel/aspirin 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.

Alcohol consumption

The consumption of alcohol may affect how well this medicine works. It may increase
blood loss and stomach irritation. Please ask your doctor for more information.

How to take this medicine

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the directions, ask your doctor or pharmacist for help.

How much to take

The usual dose of clopidogrel/aspirin is one tablet daily.

You may receive a starting dose of 300 mg clopidogrel plus an aspirin tablet. Long
term treatment is continued with one clopidogrel/aspirin tablet daily.

Should your doctor require you to take higher doses of aspirin you will be switched
to separate tablets and no longer take clopidogrel/aspirin.

How to take it

Swallow the tablet whole with a glass of water.

When to take it

Take clopidogrel/aspirin during or immediately after a meal.

Take your medicine at about the same time each day.

Taking it 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.

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 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 (telephone 13
11 26) for advice or go to Accident and Emergency at the 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.

While you are taking this medicine

Things you must do

Keep all your doctor’s appointments so that your progress can be checked.

Take this medicine exactly as your doctor has prescribed and have any blood tests
ordered by your doctor promptly.

Your doctor may do some tests from time to time to make sure the medicine is working
and to prevent unwanted side effects.

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 treat you that you are taking
this medicine.

If you are going to have surgery (including dental procedures), tell the surgeon or
anaesthetist that you are taking this medicine.

This medicine may increase the risk of bleeding during an operation or dental procedure.
Therefore, treatment may need to be stopped before surgery. Your doctor will decide
whether to stop this medicine, and for how long.

If you become pregnant or start to breastfeed while taking this medicine, tell your
doctor immediately.

If you are about to have any blood tests, tell your doctor that you are taking this
medicine.

It may interfere with the results of some tests.

Tell your doctor if you are injured while taking this medicine.

It may take longer than usual to stop bleeding while you are taking clopidogrel/aspirin.

Sometimes after an injury, bleeding may occur inside your body without you knowing
about it.

Ask your doctor whether there are any activities you should avoid while taking clopidogrel/aspirin,
for example certain sports.

Things you must not do

Do not take this medicine to treat any other complaints unless your doctor tells you
to.

Do not give your medicine to anyone else, even if they have the same condition as
you.

Do not stop taking your medicine or lower the dosage without checking with your doctor.

Things to be careful of

Be careful when driving or operating machinery until you know how this medicine affects
you.

As with other medicines, clopidogrel/aspirin may cause faintness or dizziness in some
people. If you drink alcohol, faintness or dizziness may be worse.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking this medicine.

All medicines can have side effects. Sometimes they are serious but most of the time
they are not.

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 if you notice any of the following and they worry you:

diarrhoea

itching

pain or stiffness in the joints

ringing in the ears

taste disturbances

trembling

flushing

a fast, pounding heart beat

If any of the following happen, tell your doctor immediately or go to Accident and
Emergency at your nearest hospital:

bloody or black tar-like bowel motions

diarrhoea with blood, mucus, stomach pain and fever

abdominal or stomach pain

heartburn

vomiting of blood or vomit that looks like coffee grounds

coughing up blood

blood in the urine

blood in the eyes

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

breast enlargement in men

numbness (paralysis) or problems with co-ordination

nausea or vomiting

faintness or dizziness

light-headedness or blurred vision

slurred speech or other difficulty in speaking

headache (severe and continuing)

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

muscle pain

weight loss

anaemia (being tired and looking pale)

red or purple spots visible through your skin

itching, inflamed, cracking or red skin

tightness of the chest

yellowing of the skin or the whites of the eyes, pale stools and dark urine with vomiting
and stomach pain

oedema (build-up of fluid in the body that can cause swelling)

low-blood sugar levels, sweating, fainting, light-headedness, weakness and fatigue
– these are the symptoms of insulin autoimmune syndrome

symptoms of an allergic reaction including cough, 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

The above list includes very serious side effects. 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 also occur in some people.

Storage and disposal

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°C
and protected from moisture.

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 that is left over.

Product description

What it looks like

75mg/75mg tablets

Yellow, oval, biconvex coated tablet. Engraved “75-75” on one side, “APO” on the other
side. AUST R 201680. AUST R 201684.

Available in blister packs of 2, 4, 7, 14, 28, 30, 50, 56, and 84 tablets or bottles
of 280 tablets.

75mg/100mg tablets

Light pink, oval biconvex coated tablets, engraved “APO” on one side, “75-100” on
the other side.

AUST R 190326. AUST R 190325.

Available in blister packs of 2, 4, 7, 14, 28, 30, 50, 56, 84, 98, 100, 112, 280 tablets
or bottles of 280 tablets.

* Not all strengths, pack types and/or pack sizes may be available.

Ingredients

Each tablet contains 75mg of clopidogrel (as clopidogrel hydrogen sulfate) and 75mg
or 100mg of aspirin as the active ingredients.

It also contains the following inactive ingredients:

lactose

methylcellulose

crospovidone

colloidal anhydrous silica

zinc stearate

microcrystalline cellulose

maize starch

iron oxide yellow

hypromellose

hyprolose

macrogol 8000

titanium dioxide

iron oxide red (75/100mg strength only)

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

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park, NSW 2113

Australia

Tel: (02) 8877 8333

Web: www1.apotex.com/au

APO and APOTEX are registered trademarks of Apotex Inc.

This leaflet was last updated in

December 2019.

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