MEDICATION GUIDE Alogliptin and Metformin HCl Tablets

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1 Page 38 f 42 MEDICATION GUIDE Algliptin and Metfrmin HCl Tablets Read this Medicatin Guide carefully befre yu start taking algliptin and metfrmin HCl 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 treatment. If yu have any questins abut algliptin and metfrmin HCl tablets, ask yur dctr r pharmacist. What is the mst imprtant infrmatin I shuld knw abut algliptin and metfrmin HCl tablets? Algliptin and metfrmin HCl tablets can cause serius side effects, including: 1. Lactic Acidsis. Metfrmin, ne f the medicines in algliptin and metfrmin HCl 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 cld in yur hands r feet yu feel dizzy r lightheaded yu have a slw r irregular heartbeat yu feel very weak r tired yu have unusual (nt nrmal) muscle pain yu have truble breathing yu feel sleepy r drwsy yu have stmach pains, nausea r vmiting Mst peple wh have had lactic acidsis with metfrmin have ther things that, cmbined with 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 algliptin and metfrmin HCl tablets if yu: have severe kidney prblems r yur kidneys are affected by certain x-ray tests that use injectable dye have liver prblems 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 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 listed abve. Yu dctr may decide t stp algliptin and metfrmin HCl tablets fr a while if yu have any f these things. Algliptin and metfrmin HCl tablets can have ther serius side effects. See What are the pssible side effects f algliptin and metfrmin HCl tablets? 2. Inflammatin f the pancreas (pancreatitis). Algliptin, ne f the medicines in algliptin and metfrmin HCl tablets, may cause pancreatitis, which may be severe. Certain medical cnditins make yu mre likely t get pancreatitis.

2 Befre yu start taking algliptin and metfrmin HCl tablets: Tell yur dctr if yu have ever had: Page 39 f 42 pancreatitis kidney prblems liver prblems Stp taking algliptin and metfrmin HCl tablets and call yur dctr right away if yu have pain in yur stmach area (abdmen) that is severe and will nt g away. The pain may be felt ging frm yur abdmen thrugh t yur back. The pain may happen with r withut vmiting. These may be symptms f pancreatitis. 3. Heart failure: Befre yu start taking algliptin and metfrmin HCl tablets: Tell yur healthcare prvider if yu have ever had heart failure r have prblems with yur kidneys. Cntact yur healthcare prvider right away if yu have any f the fllwing symptms: increasing shrtness f breath an unusually fast increase swelling f feet, ankles, r legs r truble breathing especially in weight when lying dwn These may be symptms f heart failure. What are algliptin and metfrmin HCl tablets? Algliptin and metfrmin HCl tablets cntain 2 prescriptin diabetes medicines, algliptin (NESINA) and metfrmin hydrchlride. Algliptin and metfrmin HCl tablets are a prescriptin medicine used with diet and exercise t imprve bld sugar (glucse) cntrl in adults with type 2 diabetes. Algliptin and metfrmin HCl tablets are nt fr peple with type 1 diabetes. Algliptin and metfrmin HCl tablets are nt fr peple with diabetic ketacidsis (increased ketnes in bld r urine). It is nt knwn if algliptin and metfrmin HCl tablets are safe and effective in children under the age f 18. Wh shuld nt take algliptin and metfrmin HCl tablets? D nt take algliptin and metfrmin HCl tablets if yu: have severe kidney prblems have a cnditin called metablic acidsis r have had diabetic ketacidsis (increased ketnes in yur bld r urine) are ging t get an injectin f dye r cntrast agents fr an x-ray prcedure, algliptin and metfrmin HCl tablets may need t be stpped fr a shrt time. Talk t yur dctr abut when yu shuld stp algliptin and metfrmin HCl tablets and when yu shuld start algliptin and metfrmin HCl tablets again are allergic t algliptin r metfrmin r any f the ingredients in algliptin and metfrmin HCl tablets r have had a serius allergic (hypersensitivity) reactin t algliptin r metfrmin. See the end f this Medicatin Guide fr a cmplete list f the ingredients in algliptin and metfrmin HCl tablets Symptms f a serius allergic reactin t algliptin and metfrmin HCl tablets may include: swelling f yur face, lips, thrat and ther areas difficulty with swallwing r breathing n yur skin raised, red areas n yur skin (hives) skin rash, itching, flaking r peeling If yu have any f these symptms, stp taking algliptin and metfrmin HCl tablets and cntact yur dctr r g t the nearest hspital emergency rm right away. What shuld I tell my dctr befre and during treatment with algliptin and metfrmin HCl tablets?

3 Befre yu take algliptin and metfrmin HCl tablets, tell yur dctr if yu: have r have had inflammatin f yur pancreas (pancreatitis) have severe kidney r liver prblems Page 40 f 42 have heart prblems, including cngestive heart failure are ging t get an injectin f dye r cntrast agents fr an x-ray prcedure, algliptin and metfrmin HCl tablets may need t be stpped fr a shrt time. Talk t yur dctr abut when yu shuld stp algliptin and metfrmin HCl tablets and when yu shuld start algliptin and metfrmin HCl tablets again drink alchl very ften r drink a lt f alchl in shrt-term binge drinking have ther medical cnditins are pregnant r plan t becme pregnant. It is nt knwn if algliptin and metfrmin HCl tablets will harm yur unbrn baby. Talk with yur dctr abut the best way t cntrl yur bld sugar while yu are pregnant r if yu plan t becme pregnant are breastfeeding r plan t breastfeed. It is nt knwn whether algliptin and metfrmin HCl tablets pass int yur breast milk. Talk with yur dctr abut the best way t feed yur baby if yu are taking algliptin and metfrmin HCl tablets Tell yur dctr abut all the medicines yu take, including prescriptin and ver-the-cunter medicines, vitamins and herbal supplements. Knw the medicines yu take. Keep a list f them and shw it t yur dctr and pharmacist befre yu start any new medicine. Algliptin and metfrmin HCl tablets may affect the way ther medicines wrk, and ther medicines may affect hw algliptin and metfrmin HCl tablets wrk. Cntact yur dctr befre yu start r stp ther types f medicines. Hw shuld I take algliptin and metfrmin HCl tablets? Take algliptin and metfrmin HCl tablets exactly as yur dctr tells yu t take it. Take algliptin and metfrmin HCl tablets 2 times each day. Take algliptin and metfrmin HCl tablets with fd t lwer yur chances f having an upset stmach. D nt break r cut algliptin and metfrmin HCl tablets befre swallwing. Yur dctr may need t change yur dse f algliptin and metfrmin HCl tablets t cntrl yur bld glucse. D nt change yur dse unless tld t d s by yur dctr. If yu miss a dse, take it as sn as yu remember. If yu d nt remember until it is time fr yur next dse, skip the missed dse, and take the next dse at yur regular time. D nt take 2 dses f algliptin and metfrmin HCl tablets at the same time. If yu take t many algliptin and metfrmin HCl tablets, call yur dctr r g t the nearest hspital emergency rm right away. If yur bdy is under stress, such as frm 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 check yur bld sugar as yur dctr tells yu t. Yur dctr may d certain bld tests befre yu start algliptin and metfrmin HCl tablets and during treatment as needed. Yur dctr may ask yu t stp taking algliptin and metfrmin HCl tablets based n the results f yur bld tests due t hw well yur kidneys are wrking. Yur dctr will check yur diabetes with regular bld tests, including yur bld sugar levels and yur hemglbin A1C. What are the pssible side effects f algliptin and metfrmin HCl tablets?

4 Algliptin and metfrmin HCl tablets can cause serius side effects, including: Page 41 f 42 See What is the mst imprtant infrmatin I shuld knw abut algliptin and metfrmin HCl tablets? Allergic (hypersensitivity) reactins, such as: swelling f yur face, lips, thrat and ther difficulty swallwing r breathing areas n yur skin raised, red areas n yur skin (hives) skin rash, itching, flaking r peeling If yu have these symptms, stp taking algliptin and metfrmin HCl tablets and cntact yur dctr right away. Liver prblems. Call yur dctr right away if yu have unexplained symptms, such as: nausea r vmiting stmach pain unusual r unexplained tiredness lss f appetite dark urine yellwing f yur skin r the whites f yur eyes Lw bld sugar (hypglycemia). If yu take algliptin and metfrmin HCl tablets with anther medicine that can cause lw bld sugar, such as a sulfnylurea r insulin, yur risk f getting lw bld sugar is higher. The dse f yur sulfnylurea medicine r insulin may need t be lwered while yu take algliptin and metfrmin HCl tablets. If yu have symptms f lw bld sugar, yu shuld check yur bld sugar and treat if lw, and then call yur dctr. Signs and symptms f lw bld sugar may include: shaking r feeling jittery fast heartbeat hunger change in md dizziness sweating change in visin headache cnfusin Jint pain. Sme peple wh take medicines called DPP-4 inhibitrs, ne f the medicines in algliptin and metfrmin HCl tablets, may develp jint pain that can be severe. Call yur dctr if yu have severe jint pain. The mst cmmn side effects f algliptin and metfrmin HCl tablets include: cld-like symptms (upper respiratry tract infectin) stuffy r runny nse and sre thrat diarrhea increase in bld pressure headache back pain urinary tract infectin Taking algliptin and metfrmin HCl tablets with fd can help lessen the cmmn stmach side effects f metfrmin that usually happen at the beginning f treatment. If yu have unexplained stmach prblems, tell yur dctr. Stmach prblems that start later, during treatment, may be a sign f smething mre serius. 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 algliptin and metfrmin HCl 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

5 Hw shuld I stre algliptin and metfrmin HCl tablets? Page 42 f 42 Stre algliptin and metfrmin HCl tablets at rm temperature between 68 F t 77 F (20 C t 25 C). Keep the cntainer f algliptin and metfrmin HCl tablets tightly clsed. Keep algliptin and metfrmin HCl tablets and all medicines ut f the reach f children. General infrmatin abut the safe and effective use f algliptin and metfrmin HCl tablets Medicines are smetimes prescribed fr purpses ther than thse listed in the Medicatin Guide. D nt take algliptin and metfrmin HCl tablets fr a cnditin fr which it was nt prescribed. D nt give algliptin and metfrmin HCl tablets t ther peple, even if they have the same symptms yu have. They may harm them. This Medicatin Guide summarizes the mst imprtant infrmatin abut algliptin and metfrmin HCl tablets. If yu wuld like t knw mre infrmatin, talk with yur dctr. Yu can ask yur dctr r pharmacist fr infrmatin abut algliptin and metfrmin HCl tablets that is written fr health prfessinals. Fr mre infrmatin, g t r call TAKEDA-7 ( ). What are the ingredients in algliptin and metfrmin HCl tablets? Active ingredients: algliptin and metfrmin hydrchlride Inactive ingredients: mannitl, micrcrystalline cellulse, pvidne, crspvidne and magnesium stearate; the tablets are film-cated with hyprmellse 2910, talc, titanium dixide and ferric xide yellw. All trademarks are the prperty f their respective wners ALK334 R3 This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. 5/2016

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