MEDICATION GUIDE. (canagliflozin) Tablets

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1 MEDICATION GUIDE INVOKANA (in-v-kahn-uh) (canagliflzin) Tablets What is the mst imprtant infrmatin I shuld knw abut INVOKANA? INVOKANA can cause imprtant side effects, including: Dehydratin. INVOKANA can cause sme peple t have dehydratin (the lss f bdy water and salt). Dehydratin may cause yu t feel dizzy, faint, lightheaded, 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 INVOKANA 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 INVOKANA may get a yeast infectin f the skin arund the penis. Certain 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 36

2 ful smelling discharge frm the penis 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 suggest yu use an ver-the-cunter antifungal medicine. Talk t yur dctr right away if yu use an ver-the-cunter antifungal medicatin and yur symptms d nt g away. What is INVOKANA? INVOKANA is a prescriptin medicine used alng with diet and exercise t lwer bld sugar in adults with type 2 diabetes. INVOKANA is nt fr peple with type 1 diabetes. INVOKANA is nt fr peple with diabetic ketacidsis (increased ketnes in bld r urine). It is nt knwn if INVOKANA is safe and effective in children under 18 years f age. Wh shuld nt take INVOKANA? D nt take INVOKANA if yu: are allergic t canagliflzin r any f the ingredients in INVOKANA. See the end f this Medicatin Guide fr a list f ingredients in INVOKANA. Symptms f allergic reactin t INVOKANA may include: rash raised red patches n yur skin (hives) swelling f the face, lips, tngue, and thrat that may cause difficulty in breathing r swallwing have severe kidney prblems r are n dialysis. What shuld I tell my dctr befre taking INVOKANA? Befre yu take INVOKANA, tell yur dctr if yu: have kidney prblems have liver prblems 37

3 are n a lw sdium (salt) diet. Yur dctr may change yur diet r yur dse f INVOKANA. have ever had an allergic reactin t INVOKANA have ther medical cnditins are pregnant r plan t becme pregnant. It is nt knwn if INVOKANA will harm yur unbrn baby. If yu are pregnant, talk with yur dctr abut the best way t cntrl yur bld sugar while yu are pregnant. are breastfeeding r plan t breastfeed. It is nt knwn if INVOKANA passes int yur breast milk. Talk with yur dctr abut the best way t feed yur baby if yu are taking INVOKANA. Tell yur dctr abut all the medicines yu take, including prescriptin and nn-prescriptin medicines, vitamins, and herbal supplements. INVOKANA may affect the way ther medicines wrk, and ther medicines may affect hw INVOKANA wrks. Especially tell yur dctr if yu take: diuretics (water pills) rifampin (used t treat r prevent tuberculsis) phenytin r phenbarbital (used t cntrl seizures) ritnavir (Nrvir, Kaletra, Lpinavir )* (used t treat HIV infectin) digxin (Lanxin )* (used t treat heart prblems) Ask yur dctr r pharmacist fr a list f these medicines if yu are nt sure if yur medicine is listed abve. Knw the medicines yu take. Keep a list f them and shw it t yur dctr and pharmacist when yu get a new medicine. Hw shuld I take INVOKANA? Take INVOKANA by muth 1 time each day exactly as yur dctr tells yu t take it. Yur dctr will tell yu hw much INVOKANA t take and when t take it. Yur dctr may change yur dse if needed. It is best t take INVOKANA befre the first meal f the day. 38

4 Yur dctr may tell yu t take INVOKANA alng with ther diabetes medicines. Lw bld sugar can happen mre ften when INVOKANA is taken with certain ther diabetes medicines. See What are the pssible side effects f INVOKANA? If yu miss a dse, take it as sn as yu remember. If it is almst time fr yur next dse, skip the missed dse and take the medicine at the next regularly scheduled time. D nt take tw dses f INVOKANA at the same time. Talk t yur dctr if yu have questins abut a missed dse. If yu take t much INVOKANA, call yur dctr 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 yu need may change. Tell yur dctr right away if yu have any f these cnditins and fllw yur dctr s instructins. Stay n yur prescribed diet and exercise prgram while taking INVOKANA. Check yur bld sugar as yur dctr tells yu t. INVOKANA will cause yur urine t test psitive fr glucse. Yur dctr may d certain bld tests befre yu start INVOKANA and during treatment as needed. Yur dctr may change yur dse f INVOKANA based n the results f yur bld tests. 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 INVOKANA? INVOKANA may cause serius side effects including: See What is the mst imprtant infrmatin I shuld knw abut INVOKANA? kidney prblems a high amunt f ptassium in yur bld (hyperkalemia) 39

5 lw bld sugar (hypglycemia). If yu take INVOKANA 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 INVOKANA. Signs and symptms f lw bld sugar may include: headache irritability drwsiness hunger weakness fast heart-beat dizziness sweating cnfusin shaking r feeling jittery serius allergic reactin. If yu have any symptms f a serius allergic reactin, stp taking INVOKANA and call yur dctr right away r g t the nearest hspital emergency rm. See Wh shuld nt take INVOKANA?. Yur dctr may give yu a medicine fr yur allergic reactin and prescribe a different medicine fr yur diabetes. The mst cmmn side effects f INVOKANA include: vaginal yeast infectins and yeast infectins f the penis (See What is the mst imprtant infrmatin I shuld knw abut INVOKANA? ) urinary tract infectin changes in urinatin, including urgent need t urinate mre ften, in larger amunts, r at night 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 INVOKANA. 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 Yu may als reprt side effects t Janssen Pharmaceuticals, Inc. at Hw shuld I stre INVOKANA? Stre INVOKANA at rm temperature between 68 F t 77 F (20 C t 25 C). Keep INVOKANA and all medicines ut f the reach f children. 40

6 General infrmatin abut the safe and effective use f INVOKANA. Medicines are smetimes prescribed fr purpses ther than thse listed in the Medicatin Guide. D nt use INVOKANA fr a cnditin fr which it was nt prescribed. D nt give INVOKANA 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 INVOKANA. If yu wuld like mre infrmatin, talk with yur dctr. Yu can ask yur pharmacist r dctr fr infrmatin abut INVOKANA that is written fr healthcare prfessinals. Fr mre infrmatin abut INVOKANA, call r visit ur website at What are the ingredients f INVOKANA? Active ingredient: canagliflzin Inactive ingredients: crscarmellse sdium, hydrxyprpyl cellulse, lactse anhydrus, magnesium stearate, and micrcrystalline cellulse. In additin, the tablet cating cntains irn xide yellw E172 (100 mg tablet nly), macrgl/peg, plyvinyl alchl, talc, and titanium dixide. This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. * The brands listed are trademarks f their respective wners and are nt trademarks f Janssen Pharmaceuticals, Inc. Active ingredient made in Belgium. Manufactured fr: Janssen Pharmaceuticals, Inc. Titusville, NJ Manufactured by: Janssen Orth, LLC Gurab, PR Licensed frm Mitsubishi Tanabe Pharma Crpratin Date f apprval: March Janssen Pharmaceuticals, Inc. 41

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