Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
rosuvastatin calcium, Quantity: 10.4 mg
Pharmacor Pty Ltd
Tablet, film coated
Excipient Ingredients: purified water; crospovidone; magnesium stearate; magnesium oxide; lactose monohydrate; microcrystalline cellulose; titanium dioxide; hypromellose; triacetin; iron oxide red
Oral
90, 30
(S4) Prescription Only Medicine
CRESTABS should be used as an adjunct to diet when the response to diet and exercise is inadequate.,Prevention of cardiovascular events CRESTABS 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). CRESTABS 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 CRESTABS is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). Prior to initiating therapy with CRESTABS, 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, circular, biconvex, film coated tablets debossed with R on one side and 10 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
CRESTABS 1 CRESTABS 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 CRESTABS? CRESTABS film-coated tablets contains the active ingredient Rosuvastatin calcium. CRESTABS is used to lower high cholesterol levels. For more information, see Section 1. Why am I using CRESTABS? i n the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE CRESTABS? Do not use if you have ever had an allergic reaction to CRESTABS 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 CRESTABS? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with CRESTABS 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 CRESTABS? • The dose of CRESTABS 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 CRESTABS 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 CRESTABS? i n the full CMI. 5. WHAT SHOULD I KNOW WHILE USING CRESTABS? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using CRESTABS. • 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 CRESTABS. THINGS YOU SHOULD NOT DO • Do not give this medicine to anyone else, even if their condition seems similar to yours. • Do not use it to treat any ot Đọc toàn bộ tài liệu
AUSTRALIAN PRODUCT INFORMATION CRESTABS (ROSUVASTATIN CALCIUM) 1. NAME OF THE MEDICINE Rosuvastatin calcium 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet of CRESTABS 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 CRESTABS 10 mg are pink color, circular, biconvex, film coated tablets debossed with “R” on one side and “10” on the other side. CRESTABS 20 mg are pink color, circular, biconvex, film coated tablets debossed with “R” on one side and “20” on the other side. CRESTABS 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 CRESTABS should be used as an adjunct to diet when the response to diet and exercise is inadequate. Prevention of cardiovascular events CRESTABS 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). CRESTABS 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 CRESTABS is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). Prior to initiating therapy with CRESTABS, 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 CRESTABS TABLETS ARE AVAILABLE ONLY IN A 10 MG, 20 MG AND 40 MG STRENGT Đọc toàn bộ tài liệu