PATIENT INFORMATION. Rosuvastatin calcium tablets are used along with diet to:

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1 PATIENT INFORMATION Rsuvastatin Calcium (re-soo-va-stat-in KAL-see-um) Tablets Read this Patient Infrmatin carefully befre yu start taking rsuvastatin calcium tablets and each time yu get a refill. If yu have any questins abut rsuvastatin calcium tablets, ask yur dctr. Only yur dctr can determine if rsuvastatin calcium tablets are right fr yu. What are rsuvastatin calcium tablets? Rsuvastatin calcium tablets are a prescriptin medicine that cntains a chlesterl-lwering medicine called rsuvastatin calcium. Mst f the chlesterl in yur bld is made in the liver. Rsuvastatin calcium tablets wrk by reducing chlesterl in tw ways: Rsuvastatin calcium tablets blck an enzyme in the liver causing the liver t make less chlesterl, and rsuvastatin calcium tablets increase the uptake and breakdwn by the liver f chlesterl already in the bld. Rsuvastatin calcium tablets are used alng with diet t: lwer the level f yur bad chlesterl (LDL) increase the level f yur gd chlesterl (HDL) lwer the level f fat in yur bld (triglycerides) Rsuvastatin calcium tablets are used t treat: adults wh cannt cntrl their chlesterl levels by diet and exercise alne Pediatric use infrmatin fr patients 7 t 17 years f age is apprved fr AstraZeneca s CRESTOR (rsuvastatin calcium) tablets. Hwever, due t AstraZeneca s marketing exclusivity rights, this drug prduct is nt labeled with that pediatric infrmatin. It is nt knwn if rsuvastatin calcium tablets are safe and effective in peple wh have Fredricksn Type I and V dyslipidemias. Wh shuld nt take rsuvastatin calcium tablets? D nt take rsuvastatin calcium tablets if yu: are allergic t rsuvastatin calcium r any f the ingredients in rsuvastatin calcium tablets. See the end f this leaflet fr a cmplete list f ingredients in rsuvastatin calcium tablets. have liver prblems. are pregnant r think yu may be pregnant, r are planning t becme pregnant. Rsuvastatin calcium tablets may harm yur unbrn baby. If yu becme pregnant, stp taking rsuvastatin calcium tablets and call yur dctr right away. If yu are nt planning t becme pregnant yu shuld use effective birth cntrl (cntraceptin) while yu are taking rsuvastatin calcium tablets.

2 are breastfeeding. Medicines like rsuvastatin calcium tablets can pass int yur breast milk and may harm yur baby. What shuld I tell my dctr befre and while taking rsuvastatin calcium tablets? Tell yur dctr if yu: have unexplained muscle aches r weakness have r have had kidney prblems have r have had liver prblems drink mre than 2 glasses f alchl daily have thyrid prblems are 65 years f age r lder are f Asian descent are pregnant r think yu may be pregnant, r are planning t becme pregnant are breastfeeding Tell yur dctr abut all the medicines yu take, including prescriptin and ver-the-cunter medicines, vitamins, and herbal supplements. Talk t yur dctr befre yu start taking any new medicines. Taking rsuvastatin calcium tablets with certain ther medicines may affect each ther causing side effects. Rsuvastatin calcium tablets may affect the way ther medicines wrk, and ther medicines may affect hw rsuvastatin calcium tablets wrk. Especially tell yur dctr if yu take: cyclsprine (a medicine fr yur immune system) gemfibrzil (a fibric acid medicine fr lwering chlesterl) anti-viral medicines including HIV r hepatitis C prtease inhibitrs (such as lpinavir, ritnavir, fsamprenavir, tipranavir, atazanavir, r simeprevir) certain anti-fungal medicines (such as itracnazle, ketcnazle and flucnazle) cumarin anticagulants (medicines that prevent bld clts, such as warfarin) niacin r nictinic acid fibric acid derivatives (such as fenfibrate) clchicine (a medicine used t treat gut) Ask yur dctr r pharmacist fr a list f these medicines if yu are nt sure.

3 Knw all f the medicines yu take. Keep a list f them t shw yur dctr and pharmacist when yu get new medicine. Hw shuld I take rsuvastatin calcium tablets? Take rsuvastatin calcium tablets exactly as yur dctr tells yu t take it. Take rsuvastatin calcium tablets, by muth, 1 time each day. Swallw the tablet whle. Rsuvastatin calcium tablets can be taken at any time f day, with r withut fd. D nt change yur dse r stp rsuvastatin calcium tablets withut talking t yur dctr, even if yu are feeling well. Yur dctr may d bld tests t check yur chlesterl levels befre and during yur treatment with rsuvastatin calcium tablets. Yur dctr may change yur dse f rsuvastatin calcium tablets if needed. Yur dctr may start yu n a chlesterl lwering diet befre giving yu rsuvastatin calcium tablets. Stay n this diet when yu take rsuvastatin calcium tablets. Wait at least 2 hurs after taking rsuvastatin calcium tablets t take an antacid that cntains a cmbinatin f aluminum and magnesium hydrxide. If yu miss a dse f rsuvastatin calcium tablets, take it as sn as yu remember. Hwever, d nt take 2 dses f rsuvastatin calcium tablets within 12 hurs f each ther. If yu take t much rsuvastatin calcium tablets r verdse, call yur dctr r g t the nearest hspital emergency rm right away. What are the Pssible Side Effects f rsuvastatin calcium tablets? Rsuvastatin calcium tablets may cause serius side effects, including: Muscle pain, tenderness and weakness (mypathy). Muscle prblems, including muscle breakdwn, can be serius in sme peple and rarely cause kidney damage that can lead t death. Tell yur dctr right away if: yu have unexplained muscle pain, tenderness, r weakness, especially if yu have a fever r feel mre tired than usual, while yu take rsuvastatin calcium tablets. yu have muscle prblems that d nt g away even after yur dctr has tld yu t stp taking rsuvastatin calcium tablets. Yur dctr may d further tests t diagnse the cause f yur muscle prblems. Yur chances f getting muscle prblems are higher if yu: are taking certain ther medicines while yu take rsuvastatin calcium tablets are 65 years f age r lder have thyrid prblems (hypthyridism) that are nt cntrlled have kidney prblems

4 are taking higher dses f rsuvastatin calcium tablets Liver prblems. Yur dctr shuld d bld tests t check yur liver befre yu start taking rsuvastatin calcium tablets and if yu have symptms f liver prblems while yu take rsuvastatin calcium tablets. Call yur dctr right away if yu have any f the fllwing symptms f liver prblems: feel unusually tired r weak lss f appetite upper belly pain dark urine yellwing f yur skin r the whites f yur eyes The mst cmmn side effects may include: headache, muscle aches and pains, abdminal pain, weakness, and nausea. Additinal side effects that have been reprted with rsuvastatin calcium tablets include memry lss and cnfusin. Tell yur dctr if yu have any side effect that bthers yu r that des nt g away. These are nt all the pssible side effects f rsuvastatin calcium tablets. Fr mre infrmatin, ask yur dctr r pharmacist. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at FDA Hw shuld I stre rsuvastatin calcium tablets? Stre rsuvastatin calcium tablets at 20 t 25 C (68 t 77 F), excursins permitted t 15 t 30 C (59 t 86 F) [see USP Cntrlled Rm Temperature] and in a dry place. Safely thrw away medicine that is ut f date r n lnger needed. Keep rsuvastatin calcium tablets and all medicines ut f the reach f children. What are the Ingredients in rsuvastatin calcium tablets? Active Ingredient: rsuvastatin as rsuvastatin calcium Inactive Ingredients: crspvidne, hyprmellse, lactse mnhydrate, magnesium stearate, micrcrystalline cellulse, titanium dixide and triacetin. Additinally, the 5 mg tablets cntain ferric xide yellw and the 10 mg, 20 mg and 40 mg tablets cntain ferric xide red. General Infrmatin abut the safe and effective use f rsuvastatin calcium tablets

5 Medicines are smetimes prescribed fr purpses ther than thse listed in a Patient Infrmatin leaflet. D nt use rsuvastatin calcium tablets fr a cnditin fr which it was nt prescribed. D nt give rsuvastatin calcium tablets t ther peple, even if they have the same medical cnditin yu have. It may harm them. Yu can ask yur pharmacist r dctr fr infrmatin abut rsuvastatin calcium tablets that is written fr health prfessinals. Fr mre infrmatin, call Trademarks are the prperty f their respective wners. Manufactured by: TORRENT PHARMACEUTICALS LTD., Indrad , INDIA. Manufactured fr: TORRENT PHARMA INC., Basking Ridge, NJ Revised August 2017 This Patient Infrmatin has been apprved by the U.S. Fd and Drug Administratin.