IM­POR­TANT IN­FOR­MA­TION ABOUT FARXIGA (far-SEE-guh)

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Please read this summary care­fully and then ask your doc­tor about FARXIGA® (da­pagliflozin).

No ad­ver­tise­ment can pro­vide all the in­for­ma­tion needed to de­ter­mine if a drug is right for you or take the place of care­ful dis­cus­sions with your health­care provider. Only your health­care provider has the train­ing to weigh the risks and ben­e­fits of a pre­scrip­tion drug. What is the most im­por­tant in­for­ma­tion I should know about FARXIGA?

FARXIGA can cause se­ri­ous side ef­fects, in­clud­ing:

De­hy­dra­tion.

• FARXIGA can cause some peo­ple to be­come de­hy­drated (the loss of body wa­ter and salt). De­hy­dra­tion may cause you to feel dizzy, faint, light­headed, or weak, es­pe­cially when you stand up (or­tho­static hy­poten­sion). You may be at a higher risk of de­hy­dra­tion if you: have low blood pres­sure take medicines to lower your blood pres­sure, in­clud­ing wa­ter pills (di­uret­ics) are 65 years of age or older are on a low salt diet have kid­ney prob­lems

• Vag­i­nal yeast in­fec­tion. Women who take FARXIGA may get vag­i­nal yeast in­fec­tions. Symp­toms of a vag­i­nal yeast in­fec­tion in­clude: vag­i­nal odor white or yel­low­ish vag­i­nal dis­charge (dis­charge may be lumpy or look like cot­tage cheese) vag­i­nal itch­ing • Yeast in­fec­tion of the pe­nis (bal­ani­tis). Men who take FARXIGA may get a yeast in­fec­tion of the skin around the pe­nis. Cer­tain men who are not cir­cum­cised may have swelling of the pe­nis that makes it dif­fi­cult to pull back the skin around the tip of the pe­nis. Other symp­toms of yeast in­fec­tion of the pe­nis in­clude: red­ness, itch­ing, or swelling of the pe­nis rash of the pe­nis foul smelling dis­charge from the pe­nis pain in the skin around the pe­nis Talk to your health­care provider about what to do if you get symp­toms of a yeast in­fec­tion of the vagina or pe­nis. Your health­care provider may sug­gest you use an over-the-counter an­ti­fun­gal medicine. Talk to your health­care provider right away if you use an over-the­counter an­ti­fun­gal med­i­ca­tion and your symp­toms do not go away. • Blad­der can­cer. In stud­ies of FARXIGA in peo­ple with di­a­betes, blad­der can­cer oc­curred in a few more peo­ple who were tak­ing FARXIGA than in peo­ple who were tak­ing other di­a­betes med­i­ca­tions. There were too few cases to know if blad­der can­cer was re­lated to FARXIGA. You should not take FARXIGA if you have blad­der can­cer. Tell your health­care provider right away if you have any of the fol­low­ing symp­toms: blood or a red color in your urine pain while you uri­nate

What is FARXIGA?

FARXIGA is a pre­scrip­tion medicine used along with diet and ex­er­cise to lower blood sugar in adults with type 2 di­a­betes. FARXIGA is not for peo­ple with type 1 di­a­betes. FARXIGA is not for peo­ple with di­a­betic ke­toaci­do­sis (in­creased ke­tones in your blood or urine). It is not known if FARXIGA is safe and ef­fec­tive in chil­dren younger than 18 years of age.

Who should not take FARXIGA?

Do not take FARXIGA if you: • are al­ler­gic to da­pagliflozin or any of the in­gre­di­ents in FARXIGA. See the end of this Med­i­ca­tion Guide for a list of in­gre­di­ents in FARXIGA. Symp­toms of a se­ri­ous al­ler­gic re­ac­tion to FARXIGA may in­clude skin rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause dif­fi­culty in breath­ing or swal­low­ing. If you have any of these symp­toms, stop tak­ing FARXIGA and con­tact your health­care provider or go to the near­est hos­pi­tal emer­gency room right away. • have se­vere kid­ney prob­lems or are

on dial­y­sis.

What should I tell my health­care provider be­fore tak­ing FARXIGA?

Be­fore you take FARXIGA, tell your health­care provider if you: • have type 1 di­a­betes or have had di­a­betic

ke­toaci­do­sis. • have kid­ney prob­lems. • have liver prob­lems. • have a history of uri­nary tract in­fec­tions

or prob­lems uri­nat­ing. • have or have had blad­der can­cer. • are go­ing to have surgery. • are eat­ing less due to ill­ness, surgery or

a change in your diet. • have or have had prob­lems with your pan­creas, in­clud­ing pan­cre­ati­tis or surgery on your pan­creas • drink al­co­hol very of­ten, or drink a lot of

al­co­hol in the short term (“binge” drink­ing). • are preg­nant or plan to be­come preg­nant. FARXIGA may harm your un­born baby. If you are preg­nant or plan to be­come preg­nant, talk to your health­care provider about the best way to con­trol your blood sugar. • are breast­feed­ing or plan to breast­feed. It is not known if FARXIGA passes into your breast milk. Talk with your health­care provider about the best way to feed your baby if you are tak­ing FARXIGA. Tell your health­care provider about all the medicines you take, in­clud­ing pre­scrip­tion and over-the-counter medicines, vi­ta­mins, and herbal sup­ple­ments.

How should I take FARXIGA?

• Take FARXIGA ex­actly as your health­care

provider tells you to take it. • Do not change your dose of FARXIGA

with­out talk­ing to your health­care provider. • Take FARXIGA by mouth 1 time each day,

with or with­out food. • When your body is un­der some types of stress, such as fever, trauma (such as a car ac­ci­dent), in­fec­tion, or surgery, the amount of di­a­betes medicine you need may change. Tell your health­care provider right away if you have any of these con­di­tions and fol­low your health­care provider’s in­struc­tions. • Stay on your pre­scribed diet and ex­er­cise

pro­gram while tak­ing FARXIGA.

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