Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
clopidogrel hydrogen sulfate, Quantity: 97.875 mg (Equivalent: clopidogrel, Qty 75 mg); aspirin, Quantity: 100 mg
Sanofi-Aventis Australia Pty Ltd
Aspirin,clopidogrel hydrogen sulfate
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; stearic acid; Carnauba Wax; hyprolose; colloidal anhydrous silica; maize starch; hydrogenated castor oil; macrogol 6000; mannitol; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red
Oral
30 tablets
(S4) Prescription Only Medicine
Duocover is a fixed-dose combination product intended as continuation of therapy in patients with acute coronary syndrome already initiated with separate clopidogrel and aspirin products: 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). Duocover 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, Duocover has been shown to reduce the rate 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.
Visual Identification: Light Pink, Oval, slightly biconvex, film-coated, engraved with "C75" on one side and "A100" on the other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2009-09-23
DUOCOVER ® _Clopidogrel (clop-id-o(h)-grel) and Aspirin (as-per-in)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DuoCover tablets. It does not contain all the available information. Some of the information it contains may not apply to you. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. In deciding to give you DuoCover, your doctor has weighed the risks of you taking DuoCover against the expected benefits it will have for you. Always follow the instructions that your doctor and pharmacist give you about DuoCover tablets. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Please read this leaflet carefully before you start taking DuoCover. You may wish to keep it to read again. WHAT DUOCOVER IS USED FOR DUOCOVER CONTAINS THE MEDICINES CLOPIDOGREL AND ASPIRIN. DUOCOVER 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). DuoCover 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 DuoCover 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. DuoCover is only available on a doctor's prescription. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT_ YOU SHOULD NOT TAKE DUOCOVER 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 Read the complete document
duocover-ccdsv27-ccds20-piv19-4aug20 1 AUSTRALIAN PRODUCT INFORMATION – DUOCOVER ® (CLOPIDOGREL (AS HYDROGEN SULFATE)/ ASPIRIN) FILM COATED TABLET 1 NAME OF THE MEDICINE Clopidogrel (as hydrogen sulfate) and aspirin. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Duocover 75mg/100mg containing clopidogrel 75 mg (as clopidogrel hydrogen sulfate) and aspirin 100 mg 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 Duocover 75mg/100mg tablets are light pink, oval, slightly biconvex, film-coated, engraved with “C75” on one side and “A100” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Duocover is a fixed-dose combination product. Duocover is intended as continuation of therapy in patients with acute coronary syndrome already initiated with separate clopidogrel and aspirin products: • 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). Duocover 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, Duocover has been shown to reduce the rate 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. duocover-ccdsv27-ccds20-piv19-4aug20 2 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS Duocover is given as a single tablet (75mg/100mg) once a day taken with adequate water. ACUTE CORONARY SYNDROME Duocover is used following an initial loading dose of 300 mg clopidogrel in combination with aspirin in patients with acute coronary syndrome: • Unstable angina or non-ST-elevation myocardial infarction: - Treatment should be initia Read the complete document