Clopidogrel WinthropPlus Aspirin®

Clopidogrel (clop-id-o(h)-grel) and Aspirin (as-per-in)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some commonquestions about ClopidogrelWinthrop Plus Aspirin tablets.

It does not contain all the availableinformation. Some of the informationit contains may not apply to you.

It does not take the place of talking toyour doctor or pharmacist.

All medicines have benefits andrisks. In deciding to give youClopidogrel Winthrop Plus Aspirin,your doctor has weighed the risks ofyou taking Clopidogrel WinthropPlus Aspirin against the expectedbenefits it will have for you.

Always follow the instructions thatyour doctor and pharmacist give youabout Clopidogrel Winthrop PlusAspirin tablets.

If you have any concerns abouttaking this medicine, ask yourdoctor or pharmacist.

Please read this leaflet carefullybefore you start taking ClopidogrelWinthrop Plus Aspirin.

You may wish to keep it to readagain.

What ClopidogrelWinthrop Plus Aspirinis used for

Clopidogrel Winthrop Plus Aspirincontains the medicines clopidogreland aspirin. Clopidogrel WinthropPlus Aspirin belongs to a group ofmedicines called anti-plateletmedicines.

Platelets are very small blood cellswhich clump together during bloodclotting. By preventing thisclumping, anti-platelet medicinesreduce the chances of blood clotsforming (a process calledthrombosis).

Clopidogrel Winthrop Plus Aspirin isused to prevent blood clots formingin hardened blood vessels (a processknown as atherothrombosis) whichcan lead to events such as stroke,heart attack or death.

You may have been prescribedClopidogrel Winthrop Plus Aspirin tohelp prevent blood clots forming andto reduce the risk of heart attack,stroke or death, because you havesuffered a severe type of chest paincalled unstable angina, or had a heartattack.

Your doctor may have prescribed thismedicine for another use. If you wantmore information, ask your doctor.

Clopidogrel Winthrop Plus Aspirin isonly available on a doctor'sprescription.

Before you take it

When you must not take it

You should not take ClopidogrelWinthrop Plus Aspirin if:

• you are allergic to clopidogrel,aspirin, salicylates, anti-inflammatories (Non-SteroidalAnti-Inflammatory Drugs) orany of the ingredients listedunder 'Product Description' atthe end of this leaflet.

• you have a medical conditionthat is causing bleeding such asa haemophilia, stomach ulcer orbleeding within your head orbowel.

• you suffer from severe liver orkidney disease.

• you have asthma, rhinitis ornasal polyps.

• you are breastfeeding or intendto breastfeed. ClopidogrelWinthrop Plus Aspirin passesinto breast milk and, therefore,there is the possibility that thebreastfed baby may be affected.

• the packaging shows signs oftampering.

• the expiry date on the pack haspassed. If you use this productafter the expiry date haspassed, it may not work.

Do not take Clopidogrel WinthropPlus Aspirin to treat any othercomplaint unless your doctor saysit is safe. Do not give this medicineto anyone else.

Clopidogrel Winthrop Plus Aspirin isnot recommended for children as itssafety and effectiveness in childrenhave 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 asfoods, preservatives or dyes

• you are pregnant or intend tobecome pregnant. Your doctorwill discuss the possible risks

CLOPIDOGREL WINTHROP PLUS ASPIRIN® 1

and benefits of takingClopidogrel Winthrop PlusAspirin during pregnancy.

• you are breastfeeding. Youmust not breastfeed whiletaking Clopidogrel WinthropPlus Aspirin.

• you are planning to have anoperation (including dentalsurgery) in the next two weeks.Your doctor will decidewhether or not you need to stopClopidogrel Winthrop PlusAspirin prior to surgery.

• if you have or have had anymedical conditions, especiallythe following:

- bleeding disorders or bloodclotting problems

- any illness or disability that wascaused by bleeding, for exampleimpaired sight or vision becauseof bleeding within the eye

- recent serious injury

- recent surgery (including dentalsurgery)

- any form of liver disease

- any recent history of stroke

- any form of kidney disease

- history of stomach ulcers or otherproblems with your digestivesystem

- inherited diseases causinggalactose intolerance

- gout

- asthma or allergies

If you have not told your doctorabout any of the above, tell him/her before you start takingClopidogrel Winthrop PlusAspirin.

Some patients may not convertClopidogrel Winthrop Plus Aspirinto its active form as well as otherpatients. These patients may notget the same benefit fromClopidogrel Winthrop PlusAspirin. Your doctor may adviseyou to go for tests to determine ifClopidogrel Winthrop Plus Aspirinwill adequately work for you.Based on the test results, your

doctor may consider alternativetreatments for you.

Taking other medicines

Tell your doctor or pharmacist ifyou are taking any othermedicines, including any that youbuy without a prescription fromyour pharmacy, supermarket orhealth food store.

Some medicines and ClopidogrelWinthrop Plus Aspirin may interferewith each other. These include:

• aspirin - Clopidogrel WinthropPlus Aspirin already containsaspirin. Taking additionalaspirin is not recommended.Please check with your doctorfirst.

• clopidogrel - ClopidogrelWinthrop Plus Aspirin alreadycontains clopidogrel. Takingadditional clopidogrel is notrecommended. Please checkwith your doctor first.

• medicines that "thin theblood". The most commonexamples of these includeheparins and warfarin. Thereare others so please check withyour doctor.

• non-steroidal anti-inflammatory drugs (NSAIDs) -medicines used to treatarthritis, period pain, aches andpains.

• steroids e.g. Hydrocortisone.

• bupropion.

• diazepam.

• some gout medicines.

• methotrexate - a medicine usedto treat cancer or arthritis.

• phenytoin - a medicine used totreat epilepsy.

• tolbutamide andchlorpropamide- a medicineused to treat diabetes.

• tamoxifen - a medicine used totreat breast cancer.

• fluvastatin - a medicine used tolower cholesterol.

• ACE inhibitors or angiotensinreceptor antagonists plus athiazide diuretic. Thesemedicines are used to treat highblood pressure. In some casesthe medicines may be usedtogether to treat othercardiovascular diseases.

• medicines used to preventgastric reflux - proton pumpinhibitors (e.g. omeprazole).

These medicines may be affected byClopidogrel Winthrop Plus Aspirinor affect how well ClopidogrelWinthrop Plus Aspirin works.

Your doctor may need to change theamount of your medicines, or youmay need to take different medicines.

If you are unsure about anymedicine you are taking youshould check with your doctor orpharmacist. They will have moreinformation on medicines to becareful with or avoid while takingClopidogrel Winthrop PlusAspirin.

Alcohol Consumption

The consumption of alcohol mayaffect how well ClopidogrelWinthrop Plus Aspirin works; itmay increase blood loss andstomach irritation. Please ask yourdoctor for more information.

How to take it

How to take it

Clopidogrel Winthrop Plus Aspirinis to be used under medicalsupervision only.

Your doctor will tell you how manytablets to take each day. TakeClopidogrel Winthrop Plus Aspirinonly as prescribed by your doctorand follow his or her directionscarefully. They may differ from theinformation contained in thisleaflet.

The usual dose of ClopidogrelWinthrop Plus Aspirin is one tabletdaily.

CLOPIDOGREL WINTHROP PLUS ASPIRIN® 2

Clopidogrel Winthrop Plus Aspirincontains 75 mg clopidogrel and 100mg aspirin

You may receive a starting dose of300 mg clopidogrel, then oneClopidogrel Winthrop Plus Aspirintablet daily. Take ClopidogrelWinthrop Plus Aspirin during orimmediately after a meal. You shouldswallow the tablet with a glass ofwater.

Take Clopidogrel Winthrop PlusAspirin at about the same timeeach day. Taking your tablet at thesame time each day will have thebest effect. It will also help you toremember when to take it.

You should take ClopidogrelWinthrop Plus Aspirin for as long asyour doctor continues to prescribe it.

Should your doctor require you totake higher doses of aspirin you willbe switched to separate tablets and nolonger take Clopidogrel WinthropPlus Aspirin.

If you forget to take it

If you miss a dose, take it as soon asyou remember. If it is almost time foryour next dose, skip the dose youmissed and take your next dose whenyou are meant to.

If you are not sure what to do, askyour doctor or pharmacist.

If you have trouble remembering totake your medicine, ask yourpharmacist for some hints.

If you take too much(overdose)

Immediately telephone your doctoror the Poisons Information Centre(telephone 13 11 26), or go to theEmergency Department at yournearest hospital, if you think thatyou or anyone else may have takentoo much Clopidogrel WinthropPlus Aspirin. Do this even if thereare no signs of discomfort orpoisoning. You may need urgentmedical attention.

While you are taking it

Things you must do

• take Clopidogrel Winthrop PlusAspirin exactly as your doctorhas prescribed, and have anyblood tests promptly if yourdoctor orders them.

• tell your doctor if you becomepregnant while takingClopidogrel Winthrop PlusAspirin.

• tell your doctor if you decide tobreastfeed your baby. Yourdoctor may want to discuss thisand change your medicine.

• tell your doctor that you aretaking Clopidogrel WinthropPlus Aspirin if you are about tostart on any new medicine.

• tell all your doctors, dentists,nurses and pharmacists thatyou are taking ClopidogrelWinthrop Plus Aspirin.Clopidogrel Winthrop PlusAspirin may increase the risk ofbleeding during an operation orsome dental work. Therefore,treatment may need to bestopped before surgery. Yourdoctor will decide whether tostop Clopidogrel Winthrop PlusAspirin and if so, how longbefore surgery or dental work.

• ask your doctor whether thereare any activities you shouldavoid while taking ClopidogrelWinthrop Plus Aspirin, forexample certain sports.

Sometimes after an injurybleeding may occur inside yourbody without you knowing aboutit.

• tell your doctor immediately ifyou are injured while takingClopidogrel Winthrop PlusAspirin.

It may take longer than usual tostop bleeding while you aretaking Clopidogrel Winthrop PlusAspirin.

• tell your doctor immediately ifyou notice any of the following:

- abnormal bruising or bleeding

- abnormal nose bleeds

- bloody or black bowel motions

- red or purple blotches on yourskin

- swelling of the face, lips, mouth,tongue or throat which may causedifficulty swallowing or breathing(see also 'Side effects' section)

Do not suddenly stop takingClopidogrel Winthrop Plus Aspirinwithout telling your doctor.

Things to be careful of

Be careful driving or operatingmachinery until you know howClopidogrel Winthrop Plus Aspirinaffects you.

As with other medicines, ClopidogrelWinthrop Plus Aspirin may causefaintness or dizziness in some people.Make sure you know how you reactto Clopidogrel Winthrop Plus Aspirinbefore you drive a car or operatemachinery, or do anything else thatcould be dangerous if you are faint ordizzy. If this occurs, do not drive. Ifyou drink alcohol, faintness ordizziness may be worse.

Side effects

Tell your doctor or pharmacist assoon as possible if you do not feelwell while you are takingClopidogrel Winthrop Plus Aspirintablets.

Like other medicines ClopidogrelWinthrop Plus Aspirin can causesome side effects. Most are likely tobe minor and temporary. However,some may be serious and needmedical attention.

Ask your doctor or pharmacist toanswer any questions you mayhave.

Tell your doctor if you notice anyof the following and they worryyou:

• diarrhoea

• itching

CLOPIDOGREL WINTHROP PLUS ASPIRIN® 3

• pain or stiffness in the joints

• ringing in the ears

• things taste different.

Tell your doctor immediately ifyou 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 thatlooks like coffee grounds

• coughing up blood

• blood in the urine

• blood in the eyes

• unusually heavy bleeding oroozing from cuts or wounds

• bleeding (including nose bleeds)or bruising more easily thannormal

• unusually heavy or unexpectedmenstrual bleeding

• numbness (paralysis) or problemswith co-ordination

• nausea or vomiting

• faintness or dizziness

• light-headedness or blurred vision

• slurred speech or other difficultyin 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 ofappetite and fatigue

• muscle pain

• weight loss

• anaemia (being tired and lookingpale)

• red or purple spots visiblethrough your skin

• itching, inflamed, cracking or redskin

• tightness of the chest, wheezing,coughing or difficulty breathing

• yellowing of the skin or thewhites of the eyes, pale stools anddark urine with vomiting andstomach pain

• swelling of the face, lips, mouth,tongue or throat which may causedifficulty in swallowing orbreathing.

These could be more serious sideeffects - you may need urgentmedical attention.

Other side effects not listed abovemay also occur in some patients.Tell your doctor if you notice anyother effects.

Do not be alarmed by this list of sideeffects. Most people do notexperience any of them.

After taking it

Storage

Keep your tablets in the blisterpack until it is time to take them.

If you take your tablets out of the boxor blister pack they will not keepwell.

Keep Clopidogrel Winthrop PlusAspirin in a cool, dry place wherethe temperature stays below 25°C.

Heat and dampness can destroy somemedicines. Do not leave ClopidogrelWinthrop Plus Aspirin in the car onhot days.

Do not store Clopidogrel WinthropPlus Aspirin or any othermedication in the bathroom ornear a sink.

Keep Clopidogrel Winthrop PlusAspirin where children cannotreach it.

A locked cupboard at least one and ahalf metres above the ground is agood place to store medicines.

Disposal

If your doctor tells you to stop takingClopidogrel Winthrop Plus Aspirin,ask your pharmacist what to do withany tablets that are left over.

Product description

What it looks like

Clopidogrel Winthrop Plus Aspirin isavailable as:

Clopidogrel Winthrop Plus Aspirin75mg/100mg tablets: light pink, ovaltablets with 'C75' on one side and'A100' on the other.

AUST R 150470.

Clopidogrel Winthrop Plus Aspirin75mg/75mg* tablets :yellow, ovaltablets 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 Aspirin75mg/100mg: clopidogrel 75 mg,aspirin 100 mg

Clopidogrel Winthrop Plus Aspirin75mg/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 WinthropPlus Aspirin 75mg/100mg)

yellow iron oxide (ClopidogrelWinthrop Plus Aspirin 75mg/75mg)*

*Presentations currently notmarketed

CLOPIDOGREL WINTHROP PLUS ASPIRIN® 4

Manufacturer

Clopidogrel Winthrop Plus Aspirin issupplied in Australia by:

sanofi-aventis australia pty ltd

12-24 Talavera Road

Macquarie Park NSW 2113

Clopidogrel Winthrop Plus Aspirin issupplied in New Zealand by:

sanofi-aventis new zealand limited

Level 8, James & Wells Tower

56 Cawley Street

Ellerslie

Auckland

This leaflet was prepared on 19August 2011

Clopidogrel Winthrop Plus Aspirin isa registered trademark of sanofi-aventis.

CLOPIDOGREL WINTHROP PLUS ASPIRIN® 5