Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using Clopidogrel Winthrop Plus Aspirin?
Clopidogrel Winthrop Plus Aspirin contains the active ingredient clopidogrel and aspirin.
Clopidogrel Winthrop Plus 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. For more information, see Section
1. Why am I using Clopidogrel Winthrop Plus Aspirin? in the full CMI.
2. What should I know before I use Clopidogrel Winthrop Plus Aspirin?
Do not use if you have ever had an allergic reaction to Clopidogrel Winthrop Plus
Aspirin or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section
2. What should I know before I use Clopidogrel Winthrop Plus Aspirin? in the full CMI.
3. What if I am taking other medicines?
4. How do I use Clopidogrel Winthrop Plus Aspirin?
5. What should I know while using Clopidogrel Winthrop Plus Aspirin?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Clopidogrel
Winthrop Plus Aspirin
Tell your doctor immediately if you are injured while taking Clopidogrel Winthrop
Plus Aspirin
Tell your doctor that you are taking Clopidogrel Winthrop Plus Aspirin if you are
about to start on any new medicine.
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Things you should not do
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Do not use Clopidogrel Winthrop Plus Aspirin during pregnancy or if you are breast
feeding or intend to breast feed.
Do not stop using this Clopidogrel Winthrop Plus Aspirin suddenly or if you have a
medical condition that is causing bleeding such as a haemophilia, stomach ulcer or
bleeding within your head or bowel.
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Driving or using machines
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Clopidogrel Winthrop Plus Aspirin may cause faintness or dizziness in some people.
Make sure you know how you react to Clopidogrel Winthrop Plus Aspirin 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.
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Drinking alcohol
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The consumption of alcohol may affect how well Clopidogrel Winthrop Plus Aspirin works;
it may increase blood loss and stomach irritation. Please ask your doctor for more
information.
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Looking after your medicine
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Keep Clopidogrel Winthrop Plus Aspirin in a cool, dry place where the temperature
stays below 25°C.
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6. Are there any side effects?
Like other medicines Clopidogrel Winthrop Plus Aspirin can cause some side effects.
Most are likely to be minor and temporary. However, some may be serious and need medical
attention. There are a number of side effects associated with this medicine. It is
important to be aware of them so that you can identify any symptoms if they occur.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredients:
Clopidogrel (clop-id-o(h)-grel) and Aspirin (as-per-in)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Clopidogrel Winthrop Plus
Aspirin. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Clopidogrel Winthrop Plus Aspirin.
Where to find information in this leaflet:
1. Why am I using Clopidogrel Winthrop Plus Aspirin?
Clopidogrel Winthrop Plus Aspirin contains the active ingredient clopidogrel and
aspirin. Clopidogrel Winthrop Plus 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).
Clopidogrel Winthrop Plus 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.
You may have been prescribed Clopidogrel Winthrop Plus 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.
Your doctor may have prescribed this medicine for another use. If you want more information,
ask your doctor.
Clopidogrel Winthrop Plus Aspirin is only available on a doctor's prescription.
2. What should I know before I use Clopidogrel Winthrop Plus Aspirin?
Warnings
Do not use Clopidogrel Winthrop Plus Aspirin if:
you are allergic to clopidogrel, aspirin, salicylates, anti-inflammatories (Non-Steroidal
Anti-Inflammatory Drugs) or any of the ingredients listed under 'Product Description'
at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
you have a medical condition that is causing bleeding such as a haemophilia, stomach
ulcer or bleeding within your head or bowel.
you suffer from severe liver disease.
you have asthma, rhinitis or nasal polyps.
the packaging shows signs of tampering.
the expiry date on the pack has passed. If you use this product after the expiry date
has passed, it may not work.
Do not take Clopidogrel Winthrop Plus Aspirin to treat any other complaint unless
your doctor says it is safe. Do not give this medicine to anyone else.
Check with your doctor if you:
you have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes
take any medicines for any other condition
have any other 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
recent serious injury
recent surgery (including dental surgery)
any form of liver disease
any recent history of stroke
any form of kidney disease
history of 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 antiplatelet medicines (such as ticlopidine, prasugrel)
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 Winthrop Plus
Aspirin prior to surgery
If you have not told your doctor about any of the above, tell him/her before you start
taking Clopidogrel Winthrop Plus Aspirin.
Some patients may not convert Clopidogrel Winthrop Plus Aspirin to its active form
as well as other patients. These patients may not get the same benefit from Clopidogrel
Winthrop Plus Aspirin. Your doctor may advise you to go for tests to determine if
Clopidogrel Winthrop Plus Aspirin will adequately work for you. Based on the test
results, your doctor may change your dose of Clopidogrel Winthrop Plus Aspirin or
consider alternative treatments for you.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Do not use Clopidogrel Winthrop Plus Aspirin in the third trimester of pregnancy.
It is recommended not to take this medicine during first and second trimesters of
pregnancy. Taking clopidogrel plus aspirin may harm your unborn baby.
If you are pregnant or suspect that you are pregnant, you should tell your doctor
or your pharmacist before taking clopidogrel plus aspirin. If you become pregnant
while taking clopidogrel plus aspirin, consult your doctor immediately as it is recommended
not to take clopidogrel plus aspirin while you are pregnant.
Do not take Clopidogrel Winthrop Plus Aspirin if you are breast feeding or intend
to breast feed. Clopidogrel Winthrop Plus Aspirin passes into breast milk and, therefore, there is
the possibility that the breast fed baby may be affected.
Use in Children
Clopidogrel Winthrop Plus Aspirin is not recommended for children as its safety and
effectiveness in children have not been established.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with
Clopidogrel Winthrop Plus Aspirin and affect how it works. These include:
aspirin - Clopidogrel Winthrop Plus Aspirin already contains aspirin. Taking additional
aspirin is not recommended. Please check with your doctor first.
clopidogrel - Clopidogrel Winthrop Plus Aspirin already contains clopidogrel. Taking
additional clopidogrel is not recommended. Please check with your doctor first.
medicines that "thin the blood". The most common examples of these include heparins
and warfarin. There are others so please check with your doctor.
non-steroidal anti-inflammatory drugs (NSAIDs) - medicines used to treat arthritis,
period pain, aches and pains such as ibuprofen.
nicorandil - a medicine used to treat angina.
steroids e.g., hydrocortisone.
bupropion.
diazepam.
some gout medicines.
some antidepressant medicines.
antiretrovirals e.g tenofovir.
ciprofloxacin, chloramphenicol, fluconazole and voriconazole - medicines used to treat
infections.
varicella vaccine.
methotrexate - a medicine used to treat cancer or arthritis.
Acetazolamide - a medicine used to treat glaucoma.
carbamazepine, oxcarbazepine, phenytoin and valproic acid - medicines used to treat
epilepsy.
tolbutamide, repaglinide and chlorpropamide- medicines used to treat diabetes.
tamoxifen and paclitaxel medicines used to treat breast cancer.
levothyroxine - a medicine used to treat low thyroid activity.
fluvastatin - a medicine used to lower cholesterol.
ACE inhibitors or angiotensin receptor antagonists plus a thiazide diuretic. These
medicines are used to treat high blood pressure. In some cases the medicines may be
used together to treat other cardiovascular diseases
medicines used to prevent gastric reflux - proton pump inhibitors (e.g., omeprazole)
certain type of pain relief medicines called opiates.
rosuvastatin (used to lower your cholesterol level)
These medicines may be affected by Clopidogrel Winthrop Plus Aspirin or affect how
well Clopidogrel Winthrop Plus Aspirin works.
Your doctor may need to change the amount of your medicines, or you may need to take
different medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Clopidogrel Winthrop Plus Aspirin.
4. How do I use Clopidogrel Winthrop Plus Aspirin?
How much to take
Clopidogrel Winthrop Plus Aspirin is to be used under medical supervision only.
Your doctor will tell you how many tablets to take each day. Take Clopidogrel Winthrop
Plus Aspirin only as prescribed by your doctor and follow his or her directions carefully.
They may differ from the information contained in this leaflet.
The usual dose of Clopidogrel Winthrop Plus Aspirin is one tablet daily.
Clopidogrel Winthrop Plus Aspirin contains 75 mg clopidogrel and 100 mg aspirin
You may receive a starting dose of 300 mg clopidogrel, then one Clopidogrel Winthrop
Plus Aspirin tablet daily.
Take Clopidogrel Winthrop Plus Aspirin at about the same time each day. Taking your
tablet at the same time each day will have the best effect. It will also help you
to remember when to take it.
Should your doctor require you to take higher doses of aspirin you will be switched
to separate tablets and no longer take Clopidogrel Winthrop Plus Aspirin.
Follow the instructions provided and use Clopidogrel Winthrop Plus Aspirin until your
doctor tells you to stop.
When to take Clopidogrel Winthrop Plus Aspirin
Take Clopidogrel Winthrop Plus Aspirin during or immediately after a meal. You should
swallow the tablet with a glass of water.
You should take Clopidogrel Winthrop Plus Aspirin for as long as your doctor continues
to prescribe it.
If you forget to use Clopidogrel Winthrop Plus Aspirin
If you miss a dose, take it as soon as you remember. If it is almost time for your
next dose, skip the dose you missed and take your next dose when you are meant to.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
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 use too much Clopidogrel Winthrop Plus Aspirin
If you think that you have used too much Clopidogrel Winthrop Plus Aspirin, you may
need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Clopidogrel Winthrop Plus Aspirin?
Things you should do
take Clopidogrel Winthrop Plus Aspirin exactly as your doctor has prescribed, and
have any blood tests promptly if your doctor orders them.
tell your doctor if you become pregnant while taking Clopidogrel Winthrop Plus Aspirin.
tell your doctor if you decide to breastfeed your baby. Your doctor may want to discuss
this and change your medicine.
tell your doctor that you are taking Clopidogrel Winthrop Plus Aspirin if you are
about to start on any new medicine.
tell all your doctors, dentists, nurses and pharmacists that you are taking Clopidogrel
Winthrop Plus Aspirin. Clopidogrel Winthrop Plus Aspirin 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 Winthrop
Plus Aspirin and if so, how long before surgery or dental work.
ask your doctor whether there are any activities you should avoid while taking Clopidogrel
Winthrop Plus Aspirin, for example certain sports. Sometimes after an injury bleeding
may occur inside your body without you knowing about it.
Call your doctor straight away if you:
if you are injured while taking Clopidogrel Winthrop Plus Aspirin.
It may take longer than usual to stop bleeding while you are taking Clopidogrel Winthrop
Plus Aspirin.
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' section)
symptoms or signs of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
which may include flu-like symptoms and a rash with fever, enlarged lymph nodes and
increase in a type of white blood cell (eosinophilia). Other abnormal blood test results
may include (but are not limited to) increased levels of liver enzymes
Things you should not do
Do not stop using this medicine suddenly without telling your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Clopidogrel
Winthrop Plus Aspirin affects you.
Clopidogrel Winthrop Plus Aspirin may cause faintness or dizziness in some people.
Make sure you know how you react to Clopidogrel Winthrop Plus Aspirin 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.
Drinking alcohol
Tell your doctor if you drink alcohol.
The consumption of alcohol may affect how well Clopidogrel Winthrop Plus Aspirin works;
it may increase blood loss and stomach irritation. Please ask your doctor for more
information.
Looking after your medicine
Keep your tablets in the blister pack until it is time to take them.
If you take your tablets out of the box or blister pack they will not keep well.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place where the temperature stays below 25°C away from moisture,
heat or sunlight; for example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines. Do not leave Clopidogrel Winthrop Plus
Aspirin in the car on hot days.
Keep it where young children cannot reach it.
A locked cupboard at least one and a half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
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Serious side effects
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What to do
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Blood-related
anaemia (being tired and looking pale)
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
Allergic-reaction
tightness of the chest, wheezing, coughing or difficulty breathing
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in
swallowing or breathing
a severe reaction affecting the skin, blood and internal organs (DRESS)
Gut-related
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
nausea or vomiting
pale stools and dark urine with vomiting and stomach pain
General
weight loss
headache (severe and continuing)
loss of appetite and fatigue
slurred speech or other difficulty in speaking
heartburn
breast enlargement in men
fever or other signs of infection, such as a sore throat
muscle weakness
muscle pain
faintness or dizziness
light-headedness or blurred vision
buildup of fluid in the body that can cause swelling (oedema)
Skin-related
rash or hives
red or purple spots visible through your skin
itching, inflamed, cracking or red skin
yellowing of the skin or the whites of the eyes
chills, sweating or clammy skin
Nervous system-related
confusion or hallucinations
numbness (paralysis) or problems with co-ordination
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Clopidogrel Winthrop Plus Aspirin contains
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Active ingredient
(main ingredient)
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Clopidogrel Winthrop Plus Aspirin 75mg/100mg:
clopidogrel 75 mg, aspirin 100 mg
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Other ingredients
(inactive ingredients)
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mannitol
carnauba wax
macrogol 6000
microcrystalline cellulose
hydrogenated castor oil
hyprolose
maize starch
stearic acid
colloidal anhydrous silica
lactose monohydrate
OPADRY II complete film coating system 32K24375 Pink
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Do not take this medicine if you are allergic to any of these ingredients.
What Clopidogrel Winthrop Plus Aspirin looks like
Clopidogrel Winthrop Plus Aspirin is available as:
Clopidogrel Winthrop Plus Aspirin 75mg/100mg tablets: light pink, oval tablets with
'C75' on one side and 'A100' on the other.
AUST R 150470.
Supplied in a box containing 30 tablets.
Who distributes Clopidogrel Winthrop Plus Aspirin
Clopidogrel Winthrop Plus Aspirin is supplied in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Rd,
Macquarie Park NSW 2113
This leaflet was prepared in February 2023.
® Winthrop is a registered trademark of sanofi-aventis.
clopidogrel-winthrop-plus-aspirin-ccdsv23-24-cmiv15-03feb23