Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
rosuvastatin calcium, Quantity: 10.4 mg (Equivalent: rosuvastatin, Qty 10 mg)
Pharmacor Pty Ltd
Tablet
Excipient Ingredients: magnesium stearate; microcrystalline cellulose; lactose monohydrate; light magnesium oxide; crospovidone; titanium dioxide; hypromellose; triacetin; iron oxide red
Oral
60 tablets - 3 x 10 day calendar packs containing 30 x ezetimibe10 mg tablets and 30 x rosuvastatin (as calcium) 10 mg tablets, 20 tablets - 1 x 10 day calendar pack containing 10 x ezetimibe 10 mg tablets and 10 x rosuvastatin (as calcium) 10 mg tablets (starter pack)
(S4) Prescription Only Medicine
Primary HypercholesterolaemiaPHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients:,? not appropriately controlled with rosuvastatin or ezetimibe alone; or,? already treated with rosuvastatin and ezetimibe,Homozygous Familial Hypercholesterolaemia (HoFH),PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK is indicated for patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).
Visual Identification: Pink coloured, circular, biconvex, film coated tablets debossed with R on one side and 10 on the other side.; Container Type: Multiple containers; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2023-02-06
PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK Ver 01 1 CONSUMER MEDICINE INFORMATION (CMI) SUMMARY 1. WHY AM I USING PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK? 2. WHAT SHOULD I KNOW BEFORE I USE PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK? 3. WHAT IF I AM TAKING OTHER MEDICINES? 4. HOW DO I USE PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK? 5. WHAT SHOULD I KNOW WHILE USING PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK? 6. ARE THERE ANY SIDE EFFECTS? PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK contains the active ingredient ezetimibe and rosuvastatin calcium. PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE helps to lower cholesterol levels. It is used in people whose cholesterol levels are too high and when diet alone cannot lower these levels adequately. For more information, see Section 1. Why am I using PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK? in the full CMI. Do not use if you have ever had an allergic reaction to PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK 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 PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK? in the full CMI. Some medicines may interfere with PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK 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. Your doctor will tell you how much to take. This may depend on your age, your condition and whether or not you are taking any other medicines. More instructions can be found in Section 4. How do I use PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK? in the full CMI. THINGS YOU SHOULD DO Take PHARMACOR EZETIMIBE ROS Прочетете целия документ
PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK Ver: 01 1 AUSTRALIAN PRODUCT INFORMATION PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK (EZETIMIBE, ROSUVASTATIN) TABLETS 1 NAME OF THE MEDICINE Ezetimibe Rosuvastatin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PHARMACOR EZETIMIBE Each tablet of PHARMACOR EZETIMIBE for oral administration contains 10 mg ezetimibe. List of excipients with known effect: Contains sugar (as lactose). CRESTABS Each film-coated tablet of CRESTABS contains 10 mg, 20 mg or 40 mg rosuvastatin (as calcium). Excipients with known effect: Contains sugars as lactose. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM PHARMACOR EZETIMIBE CRESTABS PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK 10 mg + 10 mg PHARMACOR EZETIMIBE is White to off white capsule shaped, flat faced, beveled edge tablets, debossed with A25 on one side and plain on other side. CRESTABS 10 mg are pink color, circular, biconvex, film coated tablets debossed with “R” on one side and “10” on the other side. PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK 10 mg + 20 mg CRESTABS 20 mg are pink color, circular, biconvex, film coated tablets debossed with “R” on one side and “20” on the other side. PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK 10 mg + 40 mg CRESTABS 40 mg are pink color, oval shape, biconvex, film coated tablets debossed with “R” on one side and “40” on the other side. PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK Ver: 01 2 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PRIMARY HYPERCHOLESTEROLAEMIA PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: not appropriately controlled with rosuvastatin or ezetimibe alone; or already treated with rosuvastatin and ezetimibe HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA (HOFH) PHARMACOR EZETIMIBE ROSUVAS Прочетете целия документ