国家: 马来西亚
语言: 英文
来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ROSUVASTATIN CALCIUM
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
ROSUVASTATIN CALCIUM
2 x 14 Tablets
Recipharm Pharmaservices Private Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ ROSTAR FC TABLET Rosuvastatin Film Coated Tablet 10mg Rosuvastatin Film Coated Tablet 20mg 1 What is in this leaflet 1. What Rostar is used for 2. How Rostar works 3. Before you use Rostar 4. How to use Rostar 5. While you are using it 6. Side effects 7. Storage and Disposal of Rostar 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of Revision 12. Serial Number WHAT ROSTAR IS USED FOR You have been prescribed Rostar because you have a high cholesterol level. This means you are at risk from a heart attack or stroke. HOW ROSTAR WORKS Rostar is used to correct the levels of fatty substances in the blood called lipids, the most common of which is cholesterol. There are different types of cholesterol found in the blood ‘bad’ cholesterol (LDL-C) and ‘good’ cholesterol (HDL-C). • Rostar can reduce the ‘bad’ cholesterol and increase the ‘good’ cholesterol. • It works by helping to block your body’s production of ‘bad’ cholesterol. It is also improving your body’s ability to remove it from your blood. For most people, high cholesterol does not affect the way they feel because it does not produce any symptoms. However, if it is left untreated, fatty deposits can build up in the walls of your blood vessels causing them to narrow. Sometimes, these narrowed blood vessels can get blocked which can cut off the blood supply to the heart or brain leading to a heart attack or a stroke. By lowering your cholesterol levels, you reduce your risk of having a heart attack, a stroke or related health problems. You need to keep taking Rostar, even if it has got your cholesterol to the right level, because it prevents your cholesterol levels from creeping up again and causing buildup of fatty deposits. BEFORE YOU USE ROSTAR - _When you must not use it _ Do not take Rostar: • If you have ever had an allergic reaction to Rostar or similar medicines, or to any of its ingredients. Rostar contains lactose, which may cause a problem i 阅读完整的文件
Colour Document Category Pharmacode / QR Code / Others File Information Remarks RA Submission Artwork Internal Artwork Circulation Others : _____________________________________ Colours shown on this proof are to indicate correct colour separations. Artwork Type NPRA Approval Copy Previous Approved Artwork Approval Copy Artwork Draft Artwork : T - ROSTAR FILM COATED TABLET [FRONT] Product SAP No. : - : RAS/V1 Version : 13 Dec 2023 Date Pages No : 1 of 2 Font : Helvetica Condensed Regular ( Spacing - 8pt / Size - 7.5pt ) Dimension : 297mm(w) x 420mm(h) Label Description Standard W2 Width of thin code bar 0.35 mm X 2 Width of thick code bar 1.0 mm Y 2 Gap between code bar 0.65 mm Z2 Height of code bar 5.0 mm W2 X2 Y2 Z2 *Dimension stated here is final. Printer to follow Ai artwork design accordingly. Sign / Stamp Unit Box Outer Box Label Leaflet Fix-A-Form Others : __________________ Aluminium Foil Sachet Black 100% [ PLEASE TICK ] [ PLEASE TICK ] N/A ROSTAR FC TABLET recommended by guidelines. TABLE 1: CANADIAN RECOMMENDATIONS FOR TARGET LIPID VALUES BASED ON LEVEL OF RISK *Start medication and lifestyle change concomitantly if values are above target values **Start medication if target values are not achieved after 3 months of lifestyle modification ***Start medication if target values are not achieved after 6 months of lifestyle modification The following reductions in total cholesterol, LDL-C, TG, Total-C/HDL and increase in HDL-C have been observed in a dose-response study, and may serve as a guide to treatment of patients with mild to moderate hypercholesterolemia. TABLE 2: DOSE-RESPONSE IN PATIENTS WITH MILD TO MODERATE HYPERCHOLESTEROLEMIA (MEAN PERCENT CHANGE FROM BASELINE) _Dosage in patients with renal insufficiency_ The usual dose range applies in patients with mild to moderate renal impairment. For patients with severe renal impairment (CLcr <30mL/min/1.73 m 2 ) not on hemodialysis, dosing of Rosuvastatin should be started at 5 mg once daily and not exceed 10 mg once daily. _Dosage in patients with hep 阅读完整的文件