MEDICATION GUIDE Pioglitazone and Metformin Hydrochloride (PYE o GLI ta zone and met FOR min HYE-droe- KLOR-ide)Tablets, USP

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1 MEDICATION GUIDE Piglitazne and Metfrmin Hydrchlride (PYE GLI ta zne and met FOR min HYE-dre- KLOR-ide)Tablets, USP Read this Medicatin Guide carefully befre yu start taking piglitazne and metfrmin hydrchlride tablets and each time yu get a refill. There may be new infrmatin. This infrmatin des nt take the place f talking with yur dctr abut yur medical cnditin r yur treatment. If yu have any questins abut piglitazne and metfrmin hydrchlride tablets, ask yur dctr r pharmacist. What is the mst imprtant infrmatin I shuld knw abut piglitazne and metfrmin hydrchlride tablets? Piglitazne and metfrmin hydrchlride tablets can cause serius side effects, including: new r wrse heart failure. Piglitazne, ne f the medicines in piglitazne and metfrmin hydrchlride tablets, can cause yur bdy t keep extra fluid (fluid retentin), which leads t swelling (edema) and weight gain. Extra bdy fluid can make sme heart prblems wrse r lead t heart failure. Heart failure means yur heart des nt pump bld well enugh. D nt take piglitazne and metfrmin hydrchlride tablets if yu have severe heart failure If yu have heart failure with symptms (such as shrtness f breath r swelling), even if these symptms are nt severe, piglitazne and metfrmin hydrchlride tablets may nt be right fr yu Call yur dctr right away if yu have any f the fllwing: swelling r fluid retentin, especially in the ankles r legs shrtness f breath r truble breathing, especially when yu lie dwn an unusually fast increase in weight unusual tiredness lactic acidsis. Metfrmin, ne f the medicines in piglitazne and metfrmin hydrchlride tablets, can cause a rare but serius cnditin called lactic acidsis (a buildup f an acid in the bld) that can cause death. Lactic acidsis is a medical emergency and must be treated in the hspital. Call yur dctr right away if yu have any f the fllwing symptms, which culd be signs f lactic acidsis: yu feel weak r tired yu have unusual (nt nrmal) muscle pain yu have stmach pains, nausea, r vmiting yu have truble breathing yu feel dizzy r lightheaded yu have a slw r irregular heartbeat Mst peple wh have had lactic acidsis with metfrmin have ther things that, cmbined with the metfrmin, led t the lactic acidsis. Tell yur dctr if yu have any f the fllwing, because yu have a higher chance fr getting lactic acidsis with piglitazne and metfrmin hydrchlride tablets if yu: have kidney prblems r yur kidneys are affected by certain x-ray tests that use injectable dye. Peple whse kidneys are nt wrking prperly shuld nt take piglitazne and metfrmin hydrchlride tablets have liver prblems

2 drink alchl very ften, r drink a lt f alchl in shrt-term "binge" drinking get dehydrated (lse a large amunt f bdy fluids). This can happen if yu are sick with a fever, vmiting, r diarrhea. Dehydratin can als happen when yu sweat a lt with activity r exercise and d nt drink enugh fluids have surgery have a heart attack, severe infectin, r strke are 80 years f age r lder and have nt had yur kidneys tested The best way t keep frm having a prblem with lactic acidsis frm metfrmin is t tell yur dctr if yu have any f the prblems in the list abve. Yur dctr may decide t stp yur piglitazne and metfrmin hydrchlride tablets fr a while if yu have any f these things. Piglitazne and metfrmin hydrchlride tablets can have ther serius side effects. See What are the pssible side effects f piglitazne and metfrmin hydrchlride tablets? What are piglitazne and metfrmin hydrchlride tablets? Piglitazne and metfrmin hydrchlride tablets cntains tw prescriptin diabetes medicines called piglitazne and metfrmin hydrchlride. Piglitazne and metfrmin hydrchlride tablets can be used with diet and exercise t imprve bld sugar (glucse) cntrl in adults with type 2 diabetes. Piglitazne and metfrmin hydrchlride tablets are nt fr peple with type 1 diabetes. Piglitazne and metfrmin hydrchlride tablets are nt fr peple with diabetic ketacidsis (increased ketnes in yur bld r urine). It is nt knwn if piglitazne and metfrmin hydrchlride tablets are safe and effective in children under the age f 18. Piglitazne and metfrmin hydrchlride tablets are nt recmmended fr use in children. Wh shuld nt take piglitazne and metfrmin hydrchlride tablets? See What is the mst imprtant infrmatin I shuld knw abut piglitazne and metfrmin hydrchlride tablets? D nt take piglitazne and metfrmin hydrchlride tablets if yu: have severe heart failure are allergic t piglitazne, metfrmin, r any f the ingredients in piglitazne and metfrmin hydrchlride tablets. See the end f this Medicatin Guide fr a cmplete list f ingredients in piglitazne and metfrmin hydrchlride tablets have kidneys which are nt wrking prperly have a cnditin called metablic acidsis, including diabetic ketacidsis. Diabetic ketacidsis shuld be treated with insulin Tell yur dctr befre taking piglitazne and metfrmin hydrchlride tablets if yu have any f these cnditins. What shuld I tell my dctr befre taking piglitazne and metfrmin hydrchlride tablets? Befre yu take piglitazne and metfrmin hydrchlride tablets, tell yur dctr if yu: have heart failure have kidney prblems are ging t have dye injected int a vein fr an x-ray, CAT scan, heart study, r ther type f scanning

3 will be underging a surgical prcedure drink a lt f alchl (all the time r shrt binge drinking) have type 1 ( juvenile ) diabetes r had diabetic ketacidsis have a type f diabetic eye disease that causes swelling in the back f the eye (macular edema) have liver prblems have r have had cancer f the bladder are pregnant r plan t becme pregnant. It is nt knwn if piglitazne and metfrmin hydrchlride tablets will harm yur unbrn baby. Talk t yur dctr if yu are pregnant r plan t becme pregnant abut the best way t cntrl yur bld glucse levels while pregnant are a premenpausal wman (befre the change f life ) wh des nt have perids regularly r at all. Piglitazne and metfrmin hydrchlride tablets may increase yur chance f becming pregnant. Talk t yur dctr abut birth cntrl chices while taking piglitazne and metfrmin hydrchlride tablets. Tell yur dctr right away if yu becme pregnant while taking piglitazne and metfrmin hydrchlride tablets are breastfeeding r plan t breastfeed. It is nt knwn if piglitazne and metfrmin hydrchlride passes int yur breast milk. Yu and yur dctr shuld decide if yu will take piglitazne and metfrmin hydrchlride tablets r breastfeed. Yu shuld nt d bth. Talk t yur dctr abut the best way t cntrl yur bld glucse levels while breastfeeding Tell yur dctr abut all the medicines yu take, including prescriptin and ver the cunter medicines, vitamins, and herbal supplements. Piglitazne and metfrmin hydrchlride tablets and sme f yur ther medicines can affect ech ther. Yu may need t have yur dse f piglitazne and metfrmin hydrchlride tablets r certain ther medicines changed. Knw the medicines yu take. Keep a list f yur medicines and shw it t yur dctr and pharmacist befre yu start a new medicine. They will tell yu if it is kay t take piglitazne and metfrmin hydrchlride tablets with ther medicines. Hw shuld I take piglitazne and metfrmin hydrchlride tablets? Take piglitazne and metfrmin hydrchlride tablets exactly as yur dctr tells yu t take it Yur dctr may need t change yur dse f piglitazne and metfrmin hydrchlride tablets. D nt change yur piglitazne and metfrmin hydrchlride tablets dse unless yur dctr tells yu t Piglitazne and metfrmin hydrchlride tablets may be prescribed alne r with ther diabetes medicines. This will depend n hw well yur bld sugar is cntrlled Take piglitazne and metfrmin hydrchlride tablets with meals t lwer yur chance f an upset stmach If yu miss a dse f piglitazne and metfrmin hydrchlride tablets, take yur next dse as prescribed unless yur dctr tells yu differently. D nt take tw dses at ne time the next day If yu take t much piglitazne and metfrmin hydrchlride tablets, call yur dctr r g t the nearest hspital emergency rm right away If yur bdy is under stress such as frm a fever, infectin, accident, r surgery, the dse f yur diabetes medicines may need t be changed. Call yur dctr right away Stay n yur diet and exercise prgrams and test yur bld sugar regularly while taking piglitazne and metfrmin hydrchlride tablets Yur dctr shuld d certain bld tests befre yu start and while yu take piglitazne and metfrmin hydrchlride tablets Yur dctr shuld als d hemglbin A1C testing t check hw well yur bld sugar is

4 cntrlled with piglitazne and metfrmin hydrchlride tablets Yur dctr shuld check yur eyes regularly while yu take piglitazne and metfrmin hydrchlride tablets What are the pssible side effects f piglitazne and metfrmin hydrchlride tablets? Piglitazne and metfrmin hydrchlride tablets may cause serius side effects, including: See What is the mst imprtant infrmatin I shuld knw abut piglitazne and metfrmin hydrchlride tablets? lw bld sugar (hypglycemia). This can happen if yu skip meals, if yu als use anther medicine that lwers bld sugar, r if yu have certain medical prblems. Lightheadedness, dizziness, shakiness, r hunger may happen if yur bld sugar is t lw. Call yur dctr if lw bld sugar levels are a prblem fr yu liver prblems. Call yur dctr right away if yu have: nausea r vmiting stmach pain unusual r unexplained tiredness lss f appetite dark urine yellwing f yur skin r the whites f yur eyes bladder cancer. There may be an increased chance f having bladder cancer when yu take piglitazne and metfrmin hydrchlride tablets. Yu shuld nt take piglitazne and metfrmin hydrchlride tablets if yu are receiving treatment fr bladder cancer. Tell yur dctr right away if yu have any f the fllwing symptms f bladder cancer: bld r a red clr in yur urine an increased need t urinate pain while yu urinate brken bnes (fractures). Usually in the hand, upper arm, r ft in wmen. Talk t yur dctr fr advice n hw t keep yur bnes healthy diabetic eye disease with swelling in the back f the eye (macular edema). Tell yur dctr right away if yu have any changes in yur visin. Yur dctr shuld check yur eyes regularly release f an egg frm an vary in a wman (vulatin) leading t pregnancy. Ovulatin may happen when premenpausal wmen wh d nt have regular mnthly perids take piglitazne and metfrmin hydrchlride tablets. This can increase yur chance f getting pregnant. lw red bld cell cunt (anemia). The mst cmmn side effects f piglitazne and metfrmin hydrchlride tablets include: cld-like symptms (upper respiratry tract infectin) swelling (edema) diarrhea headache increased weight Tell yur dctr if yu have any side effect that bthers yu r that des nt g away. These are nt all the side effects f piglitazne and metfrmin hydrchlride 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 piglitazne and metfrmin hydrchlride tablets? Stre piglitazne and metfrmin hydrchlride tablets at C (68-77 F); excursins permitted t C (59-86 F) [See USP Cntrlled Rm Temperature]. Keep piglitazne and metfrmin hydrchlride tablets in the riginal cntainer t prtect frm light

5 Keep the piglitazne and metfrmin hydrchlride tablets bttle tightly clsed and keep tablets dry Keep piglitazne and metfrmin hydrchlride tablets and all medicines ut f the reach f children. General infrmatin abut the safe and effective use f piglitazne and metfrmin hydrchlride tablets Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use piglitazne and metfrmin hydrchlride tablets fr a cnditin fr which it was nt prescribed. D nt give piglitazne and metfrmin hydrchlride tablets t ther peple, even if they have the same symptms yu have. It may harm them. This Medicatin Guide summarizes the mst imprtant infrmatin abut piglitazne and metfrmin hydrchlride tablets. If yu wuld like mre infrmatin, talk with yur dctr. Yu can ask yur dctr r pharmacist fr infrmatin abut piglitazne and metfrmin hydrchlride tablets that is written fr healthcare prfessinals. Fr mre infrmatin call What are the ingredients in piglitazne and metfrmin hydrchlride tablets? Active Ingredients: piglitazne hydrchlride, USP and metfrmin hydrchlride, USP Inactive Ingredients: crscarmellse sdium, hyprmellse, magnesium stearate, micrcrystalline cellulse, plyethylene glycl, pvidne, talc, and titanium dixide Trademarks are the prperty f their respective wners. This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. Licensed - United States Patents Ns. 5,965,584, 6,166,042, 6,166,043, and 6,172,090. Manufactured by: TORRENT PHARMACEUTICALS LTD., Indrad , Dist. Mehsana, INDIA. Fr: TORRENT PHARMA INC. 150 Allen Rad, Suite 102 Basking Ridge, NJ Revised Octber 2014