Riik: Malaisia
keel: inglise
Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ATORVASTATIN CALCIUM
PFIZER (MALAYSIA) SDN. BHD.
ATORVASTATIN CALCIUM
30Tablet Tablets; 100 Tablet Tablets
PFIZER PHARMACEUTICALS LLC
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ LIPITOR ® TABLET Crystalline atorvastatin calcium (10 mg, 20 mg, 40 mg or 80 mg) 1 PLD TITLE :LIPITOR ® PLD DATE :24 April 2019 COUNTRY :Malaysia REFERENCE DOCUMENT :10 mg, 20 mg, 40 mg and 80 mg Lipitor film-coated tablets of Malaysia LPD Information for the user dated 08 February 2018 REASON FOR CHANGE :To update PRH address Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ LIPITOR ® TABLET Crystalline atorvastatin calcium (10 mg, 20 mg, 40 mg or 80 mg) WHAT IS IN THIS LEAFLET 1. What LIPITOR is used for 2. How LIPITOR works 3. Before you use LIPITOR 4. How to use LIPITOR 5. While you are using it 6. Side effects 7. Storage and Disposal of LIPITOR 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT LIPITOR IS USED FOR LIPITOR belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. LIPITOR is used to lower lipids known as cholesterol [total cholesterol, low- density lipoprotein cholesterol (LDL-C)] and other fats (triglycerides) and to increase high density lipoprotein cholesterol (HDL-C) in the blood when a low fat diet and lifestyle changes on their own have failed. LIPITOR can lower the risk for heart attack, stroke, certain types of heart surgery, and chest pain in patients who have heart disease or risk factors for heart disease such as: Age, smoking, high blood pressure, low HDL-C, heart disease in the family. LIPITOR can lower the risk for heart attack or stroke in patients with diabetes and risk factors such as: Eye problems, kidney problems, smoking, or high blood pressure. Cholesterol: Everyone has cholesterol and triglycerides in their blood. They are types of blood fat needed by the body for many things, including building cell walls, making bile acids (which help to digest food) and certain hormones. However, too much cholesterol can be a problem. Your body makes cholesterol, but it also comes from fo Lugege kogu dokumenti
Pfizμb Confidμbntial 1 Lipit\br Tablets ® Crystalline At\b m 1.TRA DENAME(S )OFTH EMEDICIN ALPRODU CT LIPITOR 2.QUAL ITAT IVEAN D QUANTITATI VECOMP OSITION Ac tivμbIngrμb diμbnt:crystal linμbato rvastatin Thμbtablμbtsfororaladministrationcon taincrystallinμbatorvastati ncalcium μb:i valμb ntto10mg , 20 mg ,40 mg or80 mgatorva statin. 3.PHA RMACEUTICA LFO RM Atorvas tatin tab lμbts for ora ladministra tion conta in10 mg , 20 mg ,40 m g or80mgcrystalli nμb atorvastat in. 10 mg: Wh itμb6 round, film -coatμbd tablμb tsdμb!\bd “10” on onμb sidμb and “ATV” on thμb othμb sidμb. 20 mg: Wh itμb6 round, film -coatμbd tablμb tsdμb!\bd “20” on onμb sidμb and “ATV” on thμb othμb sidμb. 40 mg: Wh itμb6 round, film -coatμbd tabl μbtsdμb!\bd “40” on onμb sidμb and “ATV” on thμb othμb sidμb. 80 mg: Wh itμb6 round, film -coatμbd tablμb tsdμb!\bd “80” on onμb sidμb and “ATV” on thμb othμb sidμb. 4.CLI NICA LPARTICULA RS 4.1Ther apeut icindicati\bn s Atorvastatin is indicatμbd as an adjunct to diμbt for thμb trμba tmμbt of patiμbs with μb\bvatμbd total cholμb\brol (tot al-C), low dμb" lipoprotμbn cholμb\brol (LDL -C), apolipoprotμbn B (apo B), and trig lycμbr idμbs (TG) and to incrμb\b high dμb" lipoprotμb cholμbs tμb (HDL -C) in patiμbn ts with primary hypμb rcholμb\brolμb mia (hμb tμbz ygous familial and nonfa milial hypμb /o lμb\brolμb, combinμbd (mixμb ) hypμb \b mia (Fre dr\bn Typμb IIa and IIb), μb\bvatμbd sμbr um TG lμb\bls (Fredr\bc kson Typμb IV), and for patiμb with dysbμbp rotμb\b mia (Fredr\bn Ty pμb III) who do not rμbd adμb:\bly todiμb. Atorvastatin is also indicatμbd for thμb rμb t ion of total -C and LDL -C in patiμbs with ho moz ygous familial h ypμbrcholμb\brolμb. Prevent\bn of Card\b r D\be In adult patiμbs without clinically μbi dμbt cardiovascular disμb\b (CVD), bu Lugege kogu dokumenti