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E ):- *:-);< .--,16/ 7: 84)6 <7 *:-);< .--, < 1; 67< 367?6 1. JANUVIA will pass into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking JANUVIA. Tell your doctor about all the medicines you take, including 8:-;+:18<176 )6, 676 8:-;+:18<176 5-,1+16-; >1<)516; )6, 0-:*)4 supplements. Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine. How should I take JANUVIA? E $)3- %& <15- -)+0 ,)A -@)+<4A ); A7=: ,7+<7: <-44; A7= E (7= +)6 <)3- %& ?1<0 7: ?1<07=< .77, E (7=: ,7+<7: 5)A ,7 *477, <-;<; .:75 <15- <7 <15- <7 ;-- 07? well your kidneys are working. Your doctor may change your dose of JANUVIA based on the results of your blood tests. E (7=: ,7+<7: 5)A <-44 A7= <7 <)3- %& )476/ ?1<0 7<0-: diabetes medicines. Low blood sugar can happen more often when JANUVIA is taken with certain other diabetes medicines. See â&#x20AC;&#x153;What are the possible side effects of JANUVIA?â&#x20AC;?. E . A7= 51;; ) ,7;- <)3- 1< ); ;776 ); A7= :-5-5*-: . A7= do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take two doses of JANUVIA at the same time. E . A7= <)3- <77 5=+0 %& +)44 A7=: ,7+<7: 7: 47+)4 !71;76 Control Center right away. E '0-6 A7=: *7,A 1; =6,-: ;75- <A8-; 7. ;<:-;; ;=+0 ); .->-: trauma (such as a car accident), infection or surgery, the amount of diabetes medicine that you need may change. Tell your doctor right away if you have any of these conditions and follow your doctorâ&#x20AC;&#x2122;s instructions. E 0-+3 A7=: *477, ;=/): ); A7=: ,7+<7: <-44; A7= <7 E # <)A 76 A7=: 8:-;+:1*-, ,1-< )6, -@-:+1;- 8:7/:)5 ?014- <)316/ JANUVIA. E $)43 <7 A7=: ,7+<7: )*7=< 07? <7 8:->-6< :-+7/61B- )6, manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and problems you have because of your diabetes. E (7=: ,7+<7: ?144 +0-+3 A7=: ,1)*-<-; ?1<0 :-/=4): *477, <-;<; 16+4=,16/ A7=: *477, ;=/): 4->-4; )6, A7=: 0-57/47*16 What are the possible side effects of JANUVIA? Serious side effects have happened in people taking JANUVIA. E #-- â&#x20AC;&#x153;What is the most important information I should know about JANUVIA?â&#x20AC;?. E L ow blood sugar (hypoglycemia). If you take JANUVIA with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you use JANUVIA. Signs and symptoms of low blood sugar may include: E 0-),)+0- E 1::1<)*141<A E ,:7?;16-;; E 0=6/-: E ?-)36-;; E .);< 0-):< *-)< E ,1BB16-;; E ;?-)<16/ E +76.=;176 E .--416/ 21<<-:A E S erious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking JANUVIA and call your doctor right away. See â&#x20AC;&#x153;Who should not take JANUVIA?â&#x20AC;?. Your doctor may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes. E K idney problems, sometimes requiring dialysis
The most common side effects of JANUVIA include: E =88-: :-;81:)<7:A 16.-+<176 E ;<=..A 7: :=66A 67;- )6, ;7:- <0:7)< E 0-),)+0JANUVIA may have other side effects, including: E ;<75)+0 =8;-< )6, ,1)::0-) E ;?-4416/ 7. <0- 0)6,; 7: 4-/; ?0-6 %& 1; =;-, ?1<0 :7;1/41<)B76- >)6,1)ÂŽ "7;1/41<)B76- 1; )67<0-: <A8- 7. diabetes medicine. These are not all the possible side effects of JANUVIA. For more information, ask your doctor or pharmacist. Tell your doctor if you have any side effect that bothers you, is unusual or does not go away. Call your doctor for medical advice about side effects. You may :-87:< ;1,- -..-+<; <7 )<
How should I store JANUVIA? #<7:- %& )< F <7 F
F <7 F Keep JANUVIA and all medicines out of the reach of children. General information about the use of JANUVIA Medicines are sometimes prescribed for purposes that are not listed in Medication Guides. Do not use JANUVIA for a condition for which it was not prescribed. Do not give JANUVIA to other people, even if they have the same symptoms you have. It may harm them. $01; -,1+)<176 =1,- ;=55):1B-; <0- 57;< 1587:<)6< 16.7:5)<176 about JANUVIA. If you would like to know more information, talk with your doctor. You can ask your doctor or pharmacist for additional information about JANUVIA that is written for health professionals. 7: 57:- 16.7:5)<176 /7 <7 ??? %& +75 7: +)44
What are the ingredients in JANUVIA? Active ingredient: sitagliptin Inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, and sodium stearyl fumarate. The tablet ďŹ lm coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide. What is type 2 diabetes? Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. '0-6 <01; 0)88-6; ;=/): /4=+7;- *=14,; =8 16 <0- *477, $01; +)6 lead to serious medical problems. High blood sugar can be lowered by diet and exercise, and by certain medicines when necessary.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
%# !)<-6< 7; )6, The trademarks depicted herein are owned by their respective companies. 78A:1/0< H
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DIAB-1050517-0019 08/13
Terms and Conditions t 5IJT WPVDIFS JT WBMJE GPS GSFF EBZ USJBM TVQQMZ PG +"/67*" t -JNJU WPVDIFS QFS QBUJFOU GPS UIF EVSBUJPO PG UIF QSPHSBN t 7BMJE GPS UJNF VTF POMZ 'SFF USJBM PGGFS JT WBMJE POMZ GPS VQ UP UBCMFUT PG +"/67*" /P QVSDIBTF JT OFDFTTBSZ 3FmMMT BSF OPU SFRVJSFE t 5IJT WPVDIFS JT OPU USBOTGFSBCMF /P TVCTUJUVUJPOT BSF QFSNJUUFE $BOOPU CF DPNCJOFE XJUI BOZ PUIFS GSFF USJBM DPVQPO EJTDPVOU QSFTDSJQUJPO TBWJOHT DBSE PS PUIFS PGGFS t This voucher is not insurance. t :PV NVTU CF ZFBST PS PMEFS UP SFEFFN UIJT WPVDIFS 1BUJFOU QIBSNBDJTU BOE QSFTDSJCFS BHSFF OPU UP TFFL SFJNCVSTFNFOU GPS BMM PS BOZ QBSU PG UIF CFOFmU SFDFJWFE CZ UIF SFDJQJFOU UISPVHI UIJT PGGFS 5IF GSFF USJBM TVQQMZ PG +"/67*" DBOOPU CF VTFE UPXBSE BOZ PVU PG QPDLFU DPTUT VOEFS BOZ QMBO TVDI BT USVF PVU PG QPDLFU FYQFOTF <5S001> t 5IJT WPVDIFS DBO CF VTFE POMZ CZ FMJHJCMF 6OJUFE 4UBUFT SFTJEFOUT BU BOZ QBSUJDJQBUJOH FMJHJCMF SFUBJM QIBSNBDZ JO UIF 6OJUFE 4UBUFT 1SPEVDU NVTU PSJHJOBUF JO UIF 6OJUFE 4UBUFT t 5IJT WPVDIFS JT UIF QSPQFSUZ PG .FSDL BOE NVTU CF UVSOFE JO PO SFRVFTU t It is illegal to sell, purchase, trade, or counterfeit this voucher. Void if reproduced. Void where prohibited by law, taxed, or restricted. t .FSDL SFTFSWFT UIF SJHIU UP SFTDJOE SFWPLF PS BNFOE UIJT PGGFS BU BOZ UJNF XJUIPVU OPUJDF t %BUB SFMBUFE UP ZPVS SFEFNQUJPO PG UIJT WPVDIFS NBZ CF DPMMFDUFE BOBMZ[FE BOE TIBSFE XJUI .FSDL GPS NBSLFU SFTFBSDI BOE PUIFS QVSQPTFT SFMBUFE UP BTTFTTJOH WPVDIFS QSPHSBNT %BUB TIBSFE XJUI .FSDL XJMM CF BHHSFHBUFE BOE EF JEFOUJmFE NFBOJOH JU XJMM CF DPNCJOFE XJUI EBUB SFMBUFE UP PUIFS WPVDIFS SFEFNQUJPOT BOE XJMM OPU JEFOUJGZ ZPV t Expiration Date: 06/30/2014.
6 philadelphia Wednesday, November 20, 2013
Medication Guide JANUVIA ÂŽ (jah-NEW-vee-ah) (sitagliptin) Tablets Read this Medication Guide carefully before you start taking JANUVIA and each time you get a reďŹ ll. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about JANUVIA, ask your doctor or pharmacist. What is the most important information I should know about JANUVIA? Serious side effects can happen in people taking JANUVIA, including inďŹ&#x201A;ammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis. Before you start taking JANUVIA: Tell your doctor if you have ever had E 8)6+:-)<1<1; E ;<76-; 16 A7=: /)44*4),,-: /)44;<76-; E ) 01;<7:A 7. )4+70741;5 E 01/0 *477, <:1/4A+-:1,- 4->-4; E 31,6-A 8:7*4-5; Stop taking JANUVIA and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis. What is JANUVIA? E %& 1; ) 8:-;+:18<176 5-,1+16- =;-, )476/ ?1<0 ,1-< )6, exercise to lower blood sugar in adults with type 2 diabetes. E %& 1; 67< .7: 8-784- ?1<0 <A8- ,1)*-<-; E %& 1; 67< .7: 8-784- ?1<0 ,1)*-<1+ 3-<7)+1,7;1; 16+:-);-, ketones in your blood or urine). E . A7= 0)>- 0), 8)6+:-)<1<1; 16D )55)<176 7. <0- 8)6+:-); 16 the past, it is not known if you have a higher chance of getting pancreatitis while you take JANUVIA. E < 1; 67< 367?6 1. %& 1; ;).- )6, -..-+<1>- ?0-6 =;-, 16 +014,:-6 =6,-: A-):; 7. )/- Who should not take JANUVIA? Do not take JANUVIA if: E A7= ):- )44-:/1+ <7 )6A 7. <0- 16/:-,1-6<; 16 %& #-- <0- end of this Medication Guide for a complete list of ingredients in JANUVIA. Symptoms of a serious allergic reaction to JANUVIA may include: E :);0 E :)1;-, :-, 8)<+0-; 76 A7=: ;316 01>-; E ;?-4416/ 7. <0- .)+- 418; <76/=- )6, <0:7)< <0)< 5)A +)=;- difďŹ culty in breathing or swallowing What should I tell my doctor before taking JANUVIA? Before you take JANUVIA, tell your doctor if you: E 0)>- 7: 0)>- 0), 16D )55)<176 7. A7=: 8)6+:-); 8)6+:-)<1<1; E 0)>- 31,6-A 8:7*4-5; E 0)>- )6A 7<0-: 5-,1+)4 +76,1<176; E ):- 8:-/6)6< 7: 84)6 <7 *-+75- 8:-/6)6< < 1; 67< 367?6 1. JANUVIA will harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant. Pregnancy Registry: If you take JANUVIA at any time during your pregnancy, talk with your doctor about how you can join the JANUVIA pregnancy registry. The purpose of this registry is to collect information about the health of you and your baby. You +)6 -6:744 16 <01; :-/1;<:A *A +)4416/