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1 MEDICATION GUIDE GLYXAMBI (glik-sam-bee) (empagliflzin and linagliptin) Tablets Read this Medicatin Guide carefully befre yu start taking GLYXAMBI and each time yu get a refill. There may be new infrmatin. This infrmatin des nt take the place f talking t yur dctr abut yur medical cnditin r yur treatment. If yu have any questins abut GLYXAMBI, ask yur dctr r pharmacist. What is the mst imprtant infrmatin I shuld knw abut GLYXAMBI? Serius side effects can happen t peple taking GLYXAMBI, including: Inflammatin f the pancreas (pancreatitis) which may be severe and lead t death. Certain medical prblems make yu mre likely t get pancreatitis. Befre yu start taking GLYXAMBI, tell yur dctr if yu have ever had: inflammatin f yur pancreas (pancreatitis) stnes in yur gallbladder (gallstnes) a histry f alchlism high bld triglyceride levels Stp taking GLYXAMBI 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 t yur back. The pain may happen with r withut vmiting. These may be symptms f pancreatitis. Dehydratin. GLYXAMBI can cause sme peple t have dehydratin (the lss f bdy water and salt). Dehydratin may cause yu t feel dizzy, faint, light-headed, r weak, especially when yu stand up (rthstatic hyptensin). Yu may be at higher risk f dehydratin if yu: have lw bld pressure take medicines t lwer yur bld pressure, including diuretics (water pill) are n lw sdium (salt) diet have kidney prblems are 65 years f age r lder Vaginal yeast infectin. Wmen wh take GLYXAMBI may get vaginal yeast infectins. Symptms f a vaginal yeast infectin include: vaginal dr white r yellwish vaginal discharge (discharge may be lumpy r lk like cttage cheese) vaginal itching Yeast infectin f the penis (balanitis r balanpsthitis). Men wh take GLYXAMBI may get a yeast infectin f the skin arund the penis. Men wh are nt circumcised may have swelling f the penis that makes it difficult t pull back the skin arund the tip f the penis. Other symptms f yeast infectin f the penis include: redness, itching, r swelling f the penis rash f the penis ful smelling discharge frm the penis 24
2 pain in the skin arund penis Talk t yur dctr abut what t d if yu get symptms f a yeast infectin f the vagina r penis. Yur dctr may tell yu t use an ver-the-cunter antifungal medicine. Talk t yur dctr right away if yu use an ver-the-cunter antifungal medicine and yur symptms d nt g away. What is GLYXAMBI? GLYXAMBI is a prescriptin medicine that cntains 2 diabetes medicines, empagliflzin (JARDIANCE) and linagliptin (TRADJENTA). GLYXAMBI can be used alng with diet and exercise t lwer bld sugar in adults with type 2 diabetes when treatment with bth empagliflzin (JARDIANCE) and linagliptin (TRADJENTA) is apprpriate. GLYXAMBI is nt fr peple with type 1 diabetes. GLYXAMBI is nt fr peple with diabetic ketacidsis (increased ketnes in the bld r urine). If yu have had pancreatitis in the past, it is nt knwn if yu have a higher chance f getting pancreatitis while yu take GLYXAMBI. It is nt knwn if GLYXAMBI is safe and effective in children under 18 years f age. Wh shuld nt take GLYXAMBI? D nt take GLYXAMBI if yu: have severe kidney prblems r are n dialysis are allergic t linagliptin (TRADJENTA), empagliflzin (JARDIANCE) r any f the ingredients in GLYXAMBI. See the end f this Medicatin Guide fr a cmplete list f ingredients in GLYXAMBI. Symptms f a serius allergic reactin t GLYXAMBI may include: skin rash, itching, flaking r peeling raised red patches n yur skin (hives) swelling f yur face, lips, tngue and thrat that may cause difficulty in breathing r swallwing difficulty with swallwing r breathing If yu have any f these symptms, stp taking GLYXAMBI and tell yur dctr r g t the nearest hspital emergency rm right away. What shuld I tell my dctr befre taking GLYXAMBI? Befre yu take GLYXAMBI, tell yur dctr if yu: have kidney prblems have liver prblems have r have had inflammatin f yur pancreas (pancreatitis). have a histry f infectin f the vagina r penis have a histry f urinary tract infectin r prblems with urinatin have any ther medical cnditins. are pregnant r plan t becme pregnant. It is nt knwn if GLYXAMBI will harm yur unbrn baby. If yu are pregnant, talk with yur dctr abut the best way t cntrl yur bld 25
3 sugar while yu are pregnant. Tell yur dctr right away if yu becme pregnant during treatment with GLYXAMBI. are breastfeeding r plan t breastfeed. It is nt knwn if GLYXAMBI passes int yur breast milk. Talk with yur dctr abut the best way t feed yur baby if yu take GLYXAMBI. Tell yur dctr abut all the medicines yu take, including prescriptin and ver-thecunter medicines, vitamins, and herbal supplements. GLYXAMBI may affect the way ther medicines wrk, and ther medicines may affect hw GLYXAMBI wrks. Especially tell yur dctr if yu take: insulin r ther medicines that can lwer yur bld sugar diuretics (water pills) rifampin (Rifadin, Rimactane, Rifater, Rifamate )*, an antibitic that is used t treat tuberculsis Knw the medicines yu take. Keep a list f them t shw yur dctr and pharmacist when yu get a new medicine. Hw shuld I take GLYXAMBI? Take GLYXAMBI exactly as yur dctr tells yu t take it. Take GLYXAMBI 1 time each day in the mrning, with r withut fd. 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 g back t yur regular schedule. D nt take tw dses f GLYXAMBI at the same time. Yur dctr may tell yu t take GLYXAMBI alng with ther diabetes medicines. Lw bld sugar can happen mre ften when GLYXAMBI is taken with certain ther diabetes medicines. See What are the pssible side effects f GLYXAMBI? If yu take t much GLYXAMBI, call yur dctr r lcal pisn cntrl center r g t the nearest hspital emergency rm right away. When yur bdy is under sme types f stress, such as fever, trauma (such as a car accident), infectin, r surgery, the amunt f diabetes medicine that yu need may change. Tell yur dctr right away if yu have any f these cnditins and fllw yur dctr s instructins. Check yur bld sugar as yur dctr tells yu t. Stay n yur prescribed diet and exercise prgram while taking GLYXAMBI. Talk t yur dctr abut hw t prevent, recgnize and manage lw bld sugar (hypglycemia), high bld sugar (hyperglycemia), and cmplicatins f diabetes. Yur dctr will check yur diabetes with regular bld tests, including yur bld sugar levels and yur hemglbin A1C. When taking GLYXAMBI, yu may have sugar in yur urine, which will shw up n a urine test. What are the pssible side effects f GLYXAMBI? GLYXAMBI may cause serius side effects, including: See What is the mst imprtant infrmatin I shuld knw abut GLYXAMBI? 26
4 Lw bld sugar (hypglycemia). If yu take GLYXAMBI 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 GLYXAMBI. Signs and symptms f lw bld sugar may include: headache drwsiness weakness cnfusin irritability hunger fast heart beat sweating feeling jittery Urinary tract infectins are a cmmn side effect f GLYXAMBI but can smetimes be serius. Signs and symptms f a urinary tract infectin may include a burning feeling when passing urine, urine that lks cludy, pain in the pelvis, r back pain. Tell yur dctr if yu have any signs r symptms f a urinary tract infectin. Allergic (hypersensitivity) reactins. Serius allergic reactins can happen after yur first dse r up t 3 mnths after starting GLYXAMBI. Symptms may include: swelling f yur face, lips, thrat, and ther areas n yur skin difficulty with swallwing r breathing raised, red areas n yur skin (hives) skin rash, itching, flaking, r peeling If yu have these symptms, stp taking GLYXAMBI and tell yur dctr r g t the nearest hspital emergency rm right away. Kidney prblems, especially in peple 75 years f age and lder and peple wh already have kidney prblems Increased fats in yur bld (chlesterl) The mst cmmn side effects f GLYXAMBI include: stuffy r runny nse and sre thrat upper respiratry tract infectin 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 GLYXAMBI. 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 GLYXAMBI? Stre GLYXAMBI at rm temperature between 68 F t 77 F (20 C t 25 C). Keep GLYXAMBI and all medicines ut f the reach f children. 27
5 General infrmatin abut the safe and effective use f GLYXAMBI. Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use GLYXAMBI fr a cnditin fr which it was nt prescribed. D nt give GLYXAMBI t ther peple, even if they have the same symptms that yu have. It may harm them. This Medicatin Guide summarizes the mst imprtant infrmatin abut GLYXAMBI. If yu wuld like mre infrmatin, talk with yur dctr. Yu can ask yur pharmacist r dctr fr infrmatin abut GLYXAMBI that is written fr health prfessinals. Fr mre infrmatin, g t r scan the cde belw, r call Behringer Ingelheim Pharmaceuticals, Inc. at r (TTY) What are the ingredients in GLYXAMBI? Active ingredients: empagliflzin and linagliptin Inactive ingredients: mannitl, pregelatinized starch, crn starch, cpvidne, crspvidne, talc and magnesium stearate. The film cating cntains the fllwing inactive ingredients: hyprmellse, mannitl, talc, titanium dixide, plyethylene glycl. 10 mg/5 mg tablets als cntain yellw ferric xide. 25 mg/5 mg tablets als cntain red ferric xide. This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. Distributed by: Behringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT USA Marketed by: Behringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT USA and Eli Lilly and Cmpany Indianaplis, IN USA Issued: January 2015 Licensed frm: Behringer Ingelheim Internatinal GmbH Ingelheim, Germany The brands listed are trademarks f their respective wners and are nt trademarks f Behringer Ingelheim Pharmaceuticals, Inc. The makers f these brands are nt affiliated with and d nt endrse Behringer Ingelheim Pharmaceuticals, Inc., r its prducts. Cpyright 2015 Behringer Ingelheim Internatinal GmbH 28
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