Clopidogrel Winthrop Plus Aspirin

What Clopidogrel Winthrop Plus Aspirin is used for

Clopidogrel Winthrop Plus Aspirin contains the medicines 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.

Before you take it

When you must not take it

You should not take 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.

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 or kidney disease.

you have asthma, rhinitis or nasal polyps.

you are breastfeeding or intend to breastfeed. Clopidogrel Winthrop Plus Aspirin passes into breast milk and, therefore, there is the possibility that the breastfed baby may be affected.

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.

Clopidogrel Winthrop Plus Aspirin is not recommended for children as its safety and effectiveness in children have not been established.

Before you start to take it

You must tell your doctor if:

you have allergies to:

any other medicines

any other substances, such as foods, preservatives or dyes

you are pregnant or intend to become pregnant. Your doctor will discuss the possible risks and benefits of taking Clopidogrel Winthrop Plus Aspirin during pregnancy.

you are breastfeeding. You must not breastfeed while taking Clopidogrel Winthrop Plus Aspirin.

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 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
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
gout
asthma or allergies
allergic to other antiplatelet medicines (such as ticlopidine, prasugrel)

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 consider alternative treatments for you.

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 store.

Some medicines and Clopidogrel Winthrop Plus Aspirin may interfere with each other. 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.

steroids e.g. Hydrocortisone.

bupropion.

diazepam.

some gout medicines.

methotrexate - a medicine used to treat cancer or arthritis.

phenytoin - a medicine used to treat epilepsy.

tolbutamide and chlorpropamide- a medicine used to treat diabetes.

tamoxifen - a medicine used to treat breast cancer.

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).

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.

If you are unsure about any medicine you are taking you should check with your doctor or pharmacist. They will have more information on medicines to be careful with or avoid while taking Clopidogrel Winthrop Plus Aspirin.

Alcohol Consumption

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.

How to take it

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 during or immediately after a meal. You should swallow the tablet with a glass of water.

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.

You should take Clopidogrel Winthrop Plus Aspirin for as long as your doctor continues to prescribe 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.

If you forget to take it

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 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), or go to the Emergency Department at your nearest hospital, if you think that you or anyone else may have taken too much Clopidogrel Winthrop Plus Aspirin. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking it

Things you must 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.

tell your doctor immediately 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.

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' section)

Do not suddenly stop taking Clopidogrel Winthrop Plus Aspirin without telling your doctor.

Things to be careful of

Be careful driving or operating machinery until you know how Clopidogrel Winthrop Plus Aspirin affects you.

As with other medicines, 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.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Clopidogrel Winthrop Plus Aspirin tablets.

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.

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
things taste different.

Tell your doctor immediately if you notice any of the following:

bloody or black 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
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 - you may need urgent medical attention.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

Do not be alarmed by this list of side effects. Most people do not experience any of them.

After taking it

Storage

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.

Keep Clopidogrel Winthrop Plus Aspirin in a cool, dry place where the temperature stays below 25°C.

Heat and dampness can destroy some medicines. Do not leave Clopidogrel Winthrop Plus Aspirin in the car on hot days.

Do not store Clopidogrel Winthrop Plus Aspirin or any other medication in the bathroom or near a sink.

Keep Clopidogrel Winthrop Plus Aspirin 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 Clopidogrel Winthrop Plus Aspirin, ask your pharmacist what to do with any tablets that are left over.

Product description

What it 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.

Clopidogrel Winthrop Plus Aspirin 75mg/75mg* tablets :yellow, oval tablets with 'C75' on one side and 'A75' on the other.

AUST R 150469.

Supplied in a box containing 2*, 4*, 7*, 14*, 28*, 30, 50*, 56*, 84*, 98*, 100*, 112* and 280* tablets

Active Ingredients:

Clopidogrel Winthrop Plus Aspirin 75mg/100mg: clopidogrel 75 mg, aspirin 100 mg

Clopidogrel Winthrop Plus Aspirin 75mg/75mg*: clopidogrel 75 mg, aspirin 75 mg

Other Ingredients:

mannitol

macrogol 6000

microcrystalline cellulose

hydrogenated castor oil

hydroxypropylcellulose

hypromellose

maize starch

stearic acid

colloidal anhydrous silica

lactose

titanium dioxide

glycerol triacetate

carnauba wax

red iron oxide (Clopidogrel Winthrop Plus Aspirin 75mg/100mg)

yellow iron oxide (Clopidogrel Winthrop Plus Aspirin 75mg/75mg)*

*Presentations currently not marketed

Manufacturer

Clopidogrel Winthrop Plus Aspirin is supplied in Australia by:

sanofi-aventis australia pty ltd

12-24 Talavera Road

Macquarie Park NSW 2113

Clopidogrel Winthrop Plus Aspirin is supplied in New Zealand by:

sanofi-aventis new zealand limited

Level 8, James & Wells Tower

56 Cawley Street

Ellerslie

Auckland

This leaflet was prepared on March 2013

Clopidogrel Winthrop Plus Aspirin is a registered trademark of sanofi-aventis.