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This document is a consumer information leaflet for Clopidogrel Winthrop Plus Aspirin tablets. It describes what the medication is used for, which is to prevent blood clots from forming in hardened blood vessels and reduce the risk of heart attack, stroke or death. It provides information on when it should not be taken, such as if the patient is allergic to any ingredients or has a bleeding disorder. It also lists important factors to discuss with a doctor before taking the medication, such as other medical conditions or medications.
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- 1. Clopidogrel Winthrop Plus Aspirin® Clopidogrel (clop-id-o(h)-grel) and Aspirin (as-per-in) Consumer Medicine Information Platelets are very small blood cells • you have a medical condition What is in this leaflet which clump together during blood that is causing bleeding such as This leaflet answers some common clotting. By preventing this a haemophilia, stomach ulcer or questions about Clopidogrel clumping, anti-platelet medicines bleeding within your head or Winthrop Plus Aspirin tablets. reduce the chances of blood clots bowel. forming (a process called • you suffer from severe liver or It does not contain all the available thrombosis). kidney disease. information. Some of the information it contains may not apply to you. Clopidogrel Winthrop Plus Aspirin is • you have asthma, rhinitis or used to prevent blood clots forming nasal polyps. It does not take the place of talking to in hardened blood vessels (a process your doctor or pharmacist. • you are breastfeeding or intend known as atherothrombosis) which All medicines have benefits and can lead to events such as stroke, to breastfeed. Clopidogrel risks. In deciding to give you heart attack or death. Winthrop Plus Aspirin passes Clopidogrel Winthrop Plus Aspirin, into breast milk and, therefore, You may have been prescribed there is the possibility that the your doctor has weighed the risks of Clopidogrel Winthrop Plus Aspirin to breastfed baby may be affected. you taking Clopidogrel Winthrop help prevent blood clots forming and Plus Aspirin against the expected • the packaging shows signs of to reduce the risk of heart attack, benefits it will have for you. tampering. stroke or death, because you have Always follow the instructions that suffered a severe type of chest pain • the expiry date on the pack has your doctor and pharmacist give you called unstable angina, or had a heart passed. If you use this product about Clopidogrel Winthrop Plus attack. after the expiry date has Aspirin tablets. Your doctor may have prescribed this passed, it may not work. If you have any concerns about medicine for another use. If you want Do not take Clopidogrel Winthrop taking this medicine, ask your more information, ask your doctor. Plus Aspirin to treat any other doctor or pharmacist. Clopidogrel Winthrop Plus Aspirin is complaint unless your doctor says Please read this leaflet carefully only available on a doctor's it is safe. Do not give this medicine before you start taking Clopidogrel prescription. to anyone else. Winthrop Plus Aspirin. Clopidogrel Winthrop Plus Aspirin is You may wish to keep it to read not recommended for children as its again. safety and effectiveness in children Before you take it have not been established. Before you start to take it When you must not take it What Clopidogrel You should not take Clopidogrel You must tell your doctor if: Winthrop Plus Aspirin Winthrop Plus Aspirin if: • you have allergies to: is used for - any other medicines • you are allergic to clopidogrel, Clopidogrel Winthrop Plus Aspirin aspirin, salicylates, anti- - any other substances, such as contains the medicines clopidogrel inflammatories (Non-Steroidal foods, preservatives or dyes and aspirin. Clopidogrel Winthrop Anti-Inflammatory Drugs) or • you are pregnant or intend to Plus Aspirin belongs to a group of any of the ingredients listed become pregnant. Your doctor medicines called anti-platelet under 'Product Description' at will discuss the possible risks medicines. the end of this leaflet. CLOPIDOGREL WINTHROP PLUS ASPIRIN® 1
- 2. and benefits of taking doctor may consider alternative • ACE inhibitors or angiotensin Clopidogrel Winthrop Plus treatments for you. receptor antagonists plus a Aspirin during pregnancy. thiazide diuretic. These • you are breastfeeding. You Taking other medicines medicines are used to treat high must not breastfeed while blood pressure. In some cases Tell your doctor or pharmacist if taking Clopidogrel Winthrop the medicines may be used you are taking any other Plus Aspirin. together to treat other medicines, including any that you cardiovascular diseases. • you are planning to have an buy without a prescription from operation (including dental your pharmacy, supermarket or • medicines used to prevent surgery) in the next two weeks. health food store. gastric reflux - proton pump Your doctor will decide inhibitors (e.g. omeprazole). Some medicines and Clopidogrel whether or not you need to stop Winthrop Plus Aspirin may interfere These medicines may be affected by Clopidogrel Winthrop Plus with each other. These include: Clopidogrel Winthrop Plus Aspirin Aspirin prior to surgery. or affect how well Clopidogrel • aspirin - Clopidogrel Winthrop • if you have or have had any Winthrop Plus Aspirin works. Plus Aspirin already contains medical conditions, especially aspirin. Taking additional Your doctor may need to change the the following: aspirin is not recommended. amount of your medicines, or you - bleeding disorders or blood Please check with your doctor may need to take different medicines. clotting problems first. If you are unsure about any - any illness or disability that was • clopidogrel - Clopidogrel medicine you are taking you caused by bleeding, for example Winthrop Plus Aspirin already should check with your doctor or impaired sight or vision because contains clopidogrel. Taking pharmacist. They will have more of bleeding within the eye additional clopidogrel is not information on medicines to be recommended. Please check careful with or avoid while taking - recent serious injury with your doctor first. Clopidogrel Winthrop Plus - recent surgery (including dental Aspirin. • medicines that "thin the surgery) blood". The most common - any form of liver disease Alcohol Consumption examples of these include - any recent history of stroke heparins and warfarin. There The consumption of alcohol may - any form of kidney disease are others so please check with affect how well Clopidogrel your doctor. Winthrop Plus Aspirin works; it - history of stomach ulcers or other may increase blood loss and problems with your digestive • non-steroidal anti- inflammatory drugs (NSAIDs) - stomach irritation. Please ask your system doctor for more information. medicines used to treat - inherited diseases causing arthritis, period pain, aches and galactose intolerance pains. - gout • steroids e.g. Hydrocortisone. - asthma or allergies How to take it • bupropion. If you have not told your doctor • diazepam. How to take it about any of the above, tell him/ • some gout medicines. Clopidogrel Winthrop Plus Aspirin her before you start taking Clopidogrel Winthrop Plus • methotrexate - a medicine used is to be used under medical Aspirin. to treat cancer or arthritis. supervision only. Some patients may not convert • phenytoin - a medicine used to Your doctor will tell you how many Clopidogrel Winthrop Plus Aspirin treat epilepsy. tablets to take each day. Take to its active form as well as other • tolbutamide and Clopidogrel Winthrop Plus Aspirin patients. These patients may not chlorpropamide- a medicine only as prescribed by your doctor get the same benefit from used to treat diabetes. and follow his or her directions Clopidogrel Winthrop Plus carefully. They may differ from the • tamoxifen - a medicine used to Aspirin. Your doctor may advise information contained in this treat breast cancer. you to go for tests to determine if leaflet. Clopidogrel Winthrop Plus Aspirin • fluvastatin - a medicine used to The usual dose of Clopidogrel will adequately work for you. lower cholesterol. Winthrop Plus Aspirin is one tablet Based on the test results, your daily. CLOPIDOGREL WINTHROP PLUS ASPIRIN® 2
- 3. Clopidogrel Winthrop Plus Aspirin - abnormal bruising or bleeding While you are taking it contains 75 mg clopidogrel and 100 - abnormal nose bleeds mg aspirin Things you must do - bloody or black bowel motions You may receive a starting dose of • take Clopidogrel Winthrop Plus - red or purple blotches on your 300 mg clopidogrel, then one Aspirin exactly as your doctor skin Clopidogrel Winthrop Plus Aspirin tablet daily. Take Clopidogrel has prescribed, and have any - swelling of the face, lips, mouth, Winthrop Plus Aspirin during or blood tests promptly if your tongue or throat which may cause immediately after a meal. You should doctor orders them. difficulty swallowing or breathing swallow the tablet with a glass of • tell your doctor if you become (see also 'Side effects' section) water. pregnant while taking Do not suddenly stop taking Take Clopidogrel Winthrop Plus Clopidogrel Winthrop Plus Clopidogrel Winthrop Plus Aspirin Aspirin at about the same time Aspirin. without telling your doctor. each day. Taking your tablet at the • tell your doctor if you decide to same time each day will have the breastfeed your baby. Your Things to be careful of best effect. It will also help you to doctor may want to discuss this Be careful driving or operating remember when to take it. and change your medicine. machinery until you know how You should take Clopidogrel • tell your doctor that you are Clopidogrel Winthrop Plus Aspirin Winthrop Plus Aspirin for as long as taking Clopidogrel Winthrop affects you. your doctor continues to prescribe it. Plus Aspirin if you are about to As with other medicines, Clopidogrel Should your doctor require you to start on any new medicine. Winthrop Plus Aspirin may cause take higher doses of aspirin you will • tell all your doctors, dentists, faintness or dizziness in some people. be switched to separate tablets and no nurses and pharmacists that Make sure you know how you react longer take Clopidogrel Winthrop you are taking Clopidogrel to Clopidogrel Winthrop Plus Aspirin Plus Aspirin. Winthrop Plus Aspirin. before you drive a car or operate Clopidogrel Winthrop Plus machinery, or do anything else that If you forget to take it Aspirin may increase the risk of could be dangerous if you are faint or bleeding during an operation or dizzy. If this occurs, do not drive. If If you miss a dose, take it as soon as some dental work. Therefore, you drink alcohol, faintness or you remember. If it is almost time for treatment may need to be dizziness may be worse. your next dose, skip the dose you missed and take your next dose when stopped before surgery. Your you are meant to. doctor will decide whether to stop Clopidogrel Winthrop Plus If you are not sure what to do, ask your doctor or pharmacist. Aspirin and if so, how long Side effects before surgery or dental work. If you have trouble remembering to • ask your doctor whether there Tell your doctor or pharmacist as take your medicine, ask your are any activities you should soon as possible if you do not feel pharmacist for some hints. avoid while taking Clopidogrel well while you are taking Winthrop Plus Aspirin, for Clopidogrel Winthrop Plus Aspirin If you take too much example certain sports. tablets. (overdose) Like other medicines Clopidogrel Sometimes after an injury Immediately telephone your doctor bleeding may occur inside your Winthrop Plus Aspirin can cause or the Poisons Information Centre body without you knowing about some side effects. Most are likely to (telephone 13 11 26), or go to the it. be minor and temporary. However, Emergency Department at your some may be serious and need • tell your doctor immediately if nearest hospital, if you think that medical attention. you are injured while taking you or anyone else may have taken Ask your doctor or pharmacist to Clopidogrel Winthrop Plus too much Clopidogrel Winthrop answer any questions you may Aspirin. Plus Aspirin. Do this even if there have. are no signs of discomfort or It may take longer than usual to stop bleeding while you are Tell your doctor if you notice any poisoning. You may need urgent taking Clopidogrel Winthrop Plus of the following and they worry medical attention. Aspirin. you: • tell your doctor immediately if • diarrhoea you notice any of the following: • itching CLOPIDOGREL WINTHROP PLUS ASPIRIN® 3
- 4. • pain or stiffness in the joints • yellowing of the skin or the Product description • ringing in the ears whites of the eyes, pale stools and dark urine with vomiting and • things taste different. stomach pain What it looks like Tell your doctor immediately if • swelling of the face, lips, mouth, Clopidogrel Winthrop Plus Aspirin is you notice any of the following: tongue or throat which may cause available as: • bloody or black bowel motions difficulty in swallowing or Clopidogrel Winthrop Plus Aspirin • diarrhoea with blood, mucus, breathing. 75mg/100mg tablets: light pink, oval stomach pain and fever These could be more serious side tablets with 'C75' on one side and effects - you may need urgent 'A100' on the other. • abdominal or stomach pain medical attention. AUST R 150470. • heartburn Other side effects not listed above Clopidogrel Winthrop Plus Aspirin • vomiting of blood or vomit that may also occur in some patients. 75mg/75mg* tablets :yellow, oval looks like coffee grounds Tell your doctor if you notice any tablets with 'C75' on one side and • coughing up blood other effects. 'A75' on the other. • blood in the urine Do not be alarmed by this list of side AUST R 150469. • blood in the eyes effects. Most people do not Supplied in a box containing 2*, 4*, experience any of them. • unusually heavy bleeding or 7*, 14*, 28*, 30, 50*, 56*, 84*, 98*, oozing from cuts or wounds 100*, 112* and 280* tablets • bleeding (including nose bleeds) or bruising more easily than Active Ingredients: After taking it normal Clopidogrel Winthrop Plus Aspirin • unusually heavy or unexpected 75mg/100mg: clopidogrel 75 mg, Storage menstrual bleeding aspirin 100 mg Keep your tablets in the blister Clopidogrel Winthrop Plus Aspirin • numbness (paralysis) or problems pack until it is time to take them. 75mg/75mg*: clopidogrel 75 mg, with co-ordination If you take your tablets out of the box aspirin 75 mg • nausea or vomiting or blister pack they will not keep • faintness or dizziness well. Other Ingredients: • light-headedness or blurred vision Keep Clopidogrel Winthrop Plus mannitol • slurred speech or other difficulty Aspirin in a cool, dry place where macrogol 6000 in speaking the temperature stays below 25°C. microcrystalline cellulose • headache (severe and continuing) Heat and dampness can destroy some medicines. Do not leave Clopidogrel hydrogenated castor oil • confusion or hallucinations Winthrop Plus Aspirin in the car on hydroxypropylcellulose • fever or other signs of infection, hot days. hypromellose such as a sore throat Do not store Clopidogrel Winthrop maize starch • rash or hives Plus Aspirin or any other medication in the bathroom or stearic acid • chills, sweating or clammy skin near a sink. colloidal anhydrous silica • fever, muscle weakness, loss of appetite and fatigue Keep Clopidogrel Winthrop Plus lactose • muscle pain Aspirin where children cannot titanium dioxide reach it. • weight loss glycerol triacetate A locked cupboard at least one and a • anaemia (being tired and looking half metres above the ground is a carnauba wax pale) good place to store medicines. red iron oxide (Clopidogrel Winthrop • red or purple spots visible Plus Aspirin 75mg/100mg) through your skin Disposal yellow iron oxide (Clopidogrel • itching, inflamed, cracking or red If your doctor tells you to stop taking Winthrop Plus Aspirin 75mg/75mg)* skin Clopidogrel Winthrop Plus Aspirin, *Presentations currently not • tightness of the chest, wheezing, ask your pharmacist what to do with marketed coughing or difficulty breathing any tablets that are left over. CLOPIDOGREL WINTHROP PLUS ASPIRIN® 4
- 5. 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 19 August 2011 Clopidogrel Winthrop Plus Aspirin is a registered trademark of sanofi- aventis. CLOPIDOGREL WINTHROP PLUS ASPIRIN® 5