APO-Clopidogrel Aspirin

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

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 75/75 or APO-Clopidogrel/Aspirin 75/100 It contains the active ingredients clopidogrel (as clopidogrel hydrogen sulfate) and aspirin.
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.
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 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.

How it works

This medicine 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).
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 are pregnant.
Clopidogrel/Aspirin may affect your developing baby if you take it during pregnancy.
You are breast-feeding.
Clopidogrel/Aspirin may pass into human breast milk.
You have or have had any of the following:
a medical condition that causes bleeding such as a haemophilia, stomach ulcer or bleeding within your head or bowel
erosive gastritis
severe liver or kidney disease
asthma with rhinitis and/or nasal polyps
mastocytosis.
The expiry date (EXP) printed on the pack has passed.
The packaging is torn, shows signs of tampering or it does not look quite right.
You are hypersensitive to or have had an allergic reaction to clopidogrel, aspirin, salicylates, anti-inflammatories (NSAIDs) or any of the ingredients listed at the end of this leaflet.
Do not take this medicine to treat any other complaint unless your doctor says it is safe. Do not give this medicine to anyone else.
This medicine is not recommended for children as its safety and effectiveness has not been established.

Before you start to take it

Before you start taking this medicine, 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:

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 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, glucose-galactose malabsorption
Lapp lactase deficiency
Glucose-6-phosphate dehydrogenase (G6PD) deficiency
gout
asthma or allergies
allergic to other anti-platelet medicines such as ticlopidine, prasugrel.

3. You are currently pregnant, or you plan to become pregnant. Do not take this medicine whilst in the third trimester of pregnancy. Your doctor will discuss the possible risks and benefits when this medicine is taken during pregnancy.

4. You are currently breast-feeding or you plan to breast-feed. Do not take this medicine whilst breast-feeding.

5. You are planning to have surgery, including dental surgery, or an anaesthetic in the next two weeks. Your doctor will decide whether you need to stop this medicine prior to surgery.

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

Taking other medicines

Tell your doctor or pharmacist if are taking, or are planning to take, any other medicines. This includes any medicines you buy without a prescription, vitamins and supplements that are available from your pharmacy, supermarket or health food shop.
Some medicines may interact with Clopidogrel/Aspirin. These include:
aspirin and other salicylates
clopidogrel
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, a medicine 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, a medicine used to treat glaucoma
cimetidine, a medicine used to treat stomach ulcers
phenytoin, diazepam, carbamazepine, oxcarbazepine and valproic acid, medicines used to treat epilepsy
tolbutamide and chlorpropamide, medicines used to treat diabetes
tamoxifen and paclitaxel, a medicine used to treat breast cancer
fluvastatin, a medicine used to lower cholesterol
voriconazole and fluconazole, medicines used to treat fungal infections
ciprofloxacin and chloramphenicol, antibiotic medicines
levothyroxine, a medicine 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.
If you are taking any of these you may need a different dose or you may need to take different medicines.
Other medicines not listed above may also interact with Clopidogrel/Aspirin.
Your doctor will have more information on medicines to avoid or be careful of while taking Clopidogrel/Aspirin.

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 carefully all directions given to you by your doctor or pharmacist. Their instructions may be different to the information in this leaflet.

How much to take

Clopidogrel/Aspirin is to be used under medical supervision only.
Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.
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.
Do not stop taking your medicine or change your dosage without first checking with your doctor.

How to take it

You should swallow the tablet with a glass of water.

When to take it

Take Clopidogrel/Aspirin during or immediately after a meal.
Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and 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.
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 missed dose and take your next dose at the usual time. 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 to help you remember.

If you take too much (overdose)

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your nearest hospital.
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

Take Clopidogrel/Aspirin exactly as your doctor has prescribed and have any blood tests ordered by your doctor promptly.
Tell your doctor that you are taking this medicine if:
you are about to be started on any new medicine
you are pregnant or are planning to become pregnant
you are breast-feeding or are planning to breast-feed
you are about to have any blood tests
you are going to have surgery or an anaesthetic or are going into hospital. 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 are injured while taking Clopidogrel/Aspirin.
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.
Sometimes after an injury, bleeding may occur inside your body without you knowing about it.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Go to your doctor regularly for a check-up.

Things you must not do

Do not:
Give this medicine to anyone else, even if their symptoms seem similar to yours
Take your medicine to treat any other condition unless your doctor or pharmacist tells you to
Stop taking your medicine, or change the dosage, without first 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 as soon as possible if you do not feel well while you are taking Clopidogrel/Aspirin or if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Tell your doctor if you notice any of the following.
This list includes the more common side effects. Mostly, these are mild:
diarrhoea
itching
pain or stiffness in the joints
ringing in the ears
things taste different.
Tell your doctor as soon as possible if you notice any of the following.
These may be serious side effects. You may need medical attention. Most of these side effects are rare.
blood or black bowel motions
diarrhoea with blood, mucus, stomach pain and fever
abdominal pain 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
rash or hives
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, wheezing, coughing or difficulty breathing
yellowing of the skin or the whites of the eyes, pale stools and dark urine with vomiting and stomach pain
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing.
These could be more serious side effects and you may need urgent medical attention.
Other side effects not listed above may also occur in some people. Tell your doctor if you notice any other effects.

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 or pharmacist tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What APO- Clopidogrel/Aspirin 75/75 looks like

75mg/75mg tablets: Yellow, oval, biconvex coated tablet. Engraved "75-75" on one side, "APO" on the other side.

What APO-Clopidogrel/Aspirin 75/100 looks like

75mg/100mg tablets: Light pink, oval biconvex coated tablets, engraved "APO" on one side, "75-100" on the other side
* Not all strengths, pack types and/or pack sizes may be available.

Ingredients

Each APO Clopidogrel/Aspirin 75/75 - tablet contains 75mg of Clopidogrel (as clopidogrel hydrogen sulfate) and 75mg Aspirin as the active ingredients.
Each APO-Clopidogrel/Aspirin 75/100 tablet contains 75mg of Clopidogrel (as clopidogrel hydrogen sulfate) and 100mg 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 (Clopidogrel/Aspirin 75/100 only)
This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.

Australian Registration Numbers

APO-Clopidogrel/Aspirin 75/75 tablets (blisters of 2, 4, 7, 14, 28, 30, 50, 56, 84): AUST R 201680.
APO-Clopidogrel/Aspirin 75/75 tablets (bottles of 280): AUST R 201684.
APO-Clopidogrel/Aspirin 75/100 tablets (blisters of 2, 4, 7, 14, 28, 30, 50, 56, 84, 98, 100, 112, 280): AUST R 190326.
APO-Clopidogrel/Aspirin 75/100 tablets (bottles of 280): AUST R 190325.

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park, NSW 2113
Australia
 
Apotex Pty Ltd is the licensee of the registered trademarks APO and APOTEX from the registered proprietor, Apotex Inc.
 
This leaflet was last updated in:
January 2019.