Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
rosuvastatin calcium, Quantity: 41.6 mg
Pharmacor Pty Ltd
Tablet, film coated
Excipient Ingredients: magnesium oxide; crospovidone; microcrystalline cellulose; lactose monohydrate; magnesium stearate; purified water; titanium dioxide; hypromellose; triacetin; iron oxide red
Oral
90, 30
(S4) Prescription Only Medicine
ROSUVACOR should be used as an adjunct to diet when the response to diet and exercise is inadequate.,Prevention of cardiovascular events ROSUVACOR is indicated for prevention of major cardiovascular events in men ?50 years old and women ?60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease). ROSUVACOR is indicated to: ? Reduce the risk of nonfatal myocardial infarction ? Reduce the risk of nonfatal stroke ? Reduce the risk of coronary artery revascularisation procedures.,In patients with hypercholesterolaemia ROSUVACOR is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). Prior to initiating therapy with ROSUVACOR, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.
Visual Identification: Pink color, oval shape, biconvex, film coated tablets debossed with R on one side and 40 on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2022-05-23
ROSUVACOR 1 ROSUVACOR 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 ROSUVACOR? ROSUVACOR film-coated tablets contains the active ingredient Rosuvastatin calcium. ROSUVACOR is used to lower high cholesterol levels. For more information, see Section 1. Why am I using ROSUVACOR? i n the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ROSUVACOR? Do not use if you have ever had an allergic reaction to ROSUVACOR 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 ROSUVACOR? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with ROSUVACOR and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? i n the full CMI. 4. HOW DO I USE ROSUVACOR? • The dose of ROSUVACOR is related to body weight for all patients. Your doctor will calculate the dose you need and tell you how many tablets to take each day. • Take ROSUVACOR once a day, every day, at about the same time each day with some water. More instructions can be found in Section 4. How do I use ROSUVACOR? i n the full CMI. 5. WHAT SHOULD I KNOW WHILE USING ROSUVACOR? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using ROSUVACOR. • Keep all of your doctor's appointments so that your progress can be checked. Your doctor will do regular tests (blood, urine or Magnetic Resonance Imaging (MRI)) to make sure the medicine is working and to prevent unwanted side effects. Your doctor will also use these tests to decide when you should stop taking ROSUVACOR. THINGS YOU SHOULD NOT DO • Do not give this medicine to anyone else, even if their condition seems similar to yours. • Do not use i Läs hela dokumentet
AUSTRALIAN PRODUCT INFORMATION ROSUVACOR (ROSUVASTATIN CALCIUM) 1. NAME OF THE MEDICINE Rosuvastatin calcium 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet of ROSUVACOR contains 10 mg, 20 mg and 40 mg of rosuvastatin (as calcium). Excipient with known effect: Sugars (as lactose). For the full list of excipients, see Section 6.1 List of excipients 3. PHARMACEUTICAL FORM ROSUVACOR 10 mg are pink color, circular, biconvex, film coated tablets debossed with “R” on one side and “10” on the other side. ROSUVACOR 20 mg are pink color, circular, biconvex, film coated tablets debossed with “R” on one side and “20” on the other side. ROSUVACOR 40 mg are pink color, oval shape, biconvex, film coated tablets debossed with “R” on one side and “40” on the other side 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS ROSUVACOR should be used as an adjunct to diet when the response to diet and exercise is inadequate. Prevention of cardiovascular events ROSUVACOR is indicated for prevention of major cardiovascular events in men ≥50 years old and women ≥60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease). ROSUVACOR is indicated to: • Reduce the risk of nonfatal myocardial infarction • Reduce the risk of nonfatal stroke • Reduce the risk of coronary artery revascularisation procedures. IN PATIENTS WITH HYPERCHOLESTEROLAEMIA ROSUVACOR is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). Prior to initiating therapy with ROSUVACOR, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. 4.2. DOSE AND METHOD OF ADMINISTRATION ROSUVACOR TABLETS ARE AVAILABLE ONLY IN A 10 MG, 20 MG AND 40 Läs hela dokumentet