国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
clopidogrel hydrogen sulfate
Sanofi-Aventis Australia Pty Ltd
Registered
PLAVIX ® TABLETS P l a v i x ® T a b l e t s 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 PLAVIX? Plavix contains the active ingredient clopidogrel. Plavix 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 Plavix? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE PLAVIX? Do not use if you have ever had an allergic reaction to Plavix 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 Plavix? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Plavix and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE PLAVIX? • Take Plavix only as prescribed by your doctor and follow his or her directions carefully. More instructions can be found in Section 4. How do I use Plavix? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING PLAVIX? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Plavix. Plavix may increase the risk of bleeding during an operation or some dental work. • Tell your doctor immediately if you are injured while taking Plavix. It may take longer than usual to stop bleeding while you are taking Plavix. • Tell your doctor that you are taking Plavix if you are about to start on any new medicine. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly. • Do not take Plavix if you have a medical condition that is causing bleeding such as a stomach ulcer or bleeding within your head. DRIVING OR 阅读完整的文件
plavix-ccdsv29-piv21-25oct21 1 AUSTRALIAN PRODUCT INFORMATION – PLAVIX ® (CLOPIDOGREL HYDROGEN SULFATE) FILM COATED TABLET 1 NAME OF THE MEDICINE Clopidogrel hydrogen sulfate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Plavix 75 mg contains 97.875 mg of clopidogrel hydrogen sulfate which is the molar equivalent of 75 mg of clopidogrel base. Plavix 300 mg contains 391.5 mg of clopidogrel hydrogen sulfate which is the molar equivalent of 300 mg of clopidogrel base. Excipient with known effect: the coating contains lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM 75 mg film coated tablets - pink round slightly biconvex film coated tablets, engraved “75” on one side and “1171” on the other side. 300 mg film coated tablets - pink oblong film coated tablets, engraved “300” on one side and “1332” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease. ACUTE CORONARY SYNDROME Plavix is indicated in combination with aspirin for patients with: • Unstable angina or non-ST-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). Plavix is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularisation (surgical or PCI, with or without stent). • ST-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. In this population, Plavix has been shown to reduce the rate plavix-ccdsv29-piv21-25oct21 2 of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy. 4.2 DOSE AND METHOD OF ADMINISTRATION Clopidogrel should be taken once a day with or without food. AD 阅读完整的文件