Medication Guide JANUVIA® (jah-NEW-vee-ah) (sitagliptin) Tablets
Read this Medication Guide carefully before you start taking JANUVIA and each time you get a refill. 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 inflammation 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 t QBODSFBUJUJT t TUPOFT JO ZPVS HBMMCMBEEFS HBMMTUPOFT t B IJTUPSZ PG BMDPIPMJTN t IJHI CMPPE USJHMZDFSJEF MFWFMT t LJEOFZ QSPCMFNT
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?
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Who should not take JANUVIA? Do not take JANUVIA if:
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Symptoms of a serious allergic reaction to JANUVIA may include: t SBTI t SBJTFE SFE QBUDIFT PO ZPVS TLJO IJWFT t TXFMMJOH PG UIF GBDF MJQT UPOHVF BOE UISPBU UIBU NBZ DBVTF EJGmDVMUZ JO CSFBUIJOH PS TXBMMPXJOH
What should I tell my doctor before taking JANUVIA? Before you take JANUVIA, tell your doctor if you: t IBWF PS IBWF IBE JOnBNNBUJPO PG ZPVS QBODSFBT QBODSFBUJUJT t IBWF LJEOFZ QSPCMFNT t IBWF BOZ PUIFS NFEJDBM DPOEJUJPOT
t BSF QSFHOBOU PS QMBO UP CFDPNF QSFHOBOU *U JT OPU LOPXO JG +"/67*" XJMM IBSN ZPVS VOCPSO CBCZ 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 can enroll in this registry by calling
t BSF CSFBTU GFFEJOH PS QMBO UP CSFBTU GFFE *U JT OPU LOPXO JG +"/67*" XJMM QBTT JOUP ZPVS CSFBTU NJML 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, JODMVEJOH QSFTDSJQUJPO BOE OPO QSFTDSJQUJPO medicines, vitamins, and herbal 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? t 5BLF +"/67*" UJNF FBDI EBZ FYBDUMZ BT ZPVS EPDUPS UFMMT ZPV t :PV DBO UBLF +"/67*" XJUI PS XJUIPVU GPPE
t :PVS EPDUPS NBZ EP CMPPE UFTUT GSPN UJNF UP UJNF UP TFF IPX XFMM ZPVS LJEOFZT BSF XPSLJOH :PVS doctor may change your dose of JANUVIA based on the results of your blood tests.
t :PVS EPDUPS NBZ UFMM ZPV UP UBLF +"/67*" BMPOH XJUI PUIFS EJBCFUFT NFEJDJOFT -PX CMPPE TVHBS DBO happen more often when JANUVIA is taken with certain other diabetes medicines. See “What are the possible side effects of JANUVIA?”.
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t 8IFO ZPVS CPEZ JT VOEFS TPNF UZQFT PG TUSFTT TVDI BT GFWFS USBVNB TVDI BT B DBS BDDJEFOU 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 doctor’s instructions.
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What are the possible side effects of JANUVIA? Serious side effects have happened in people taking JANUVIA. t 4FF “What is the most important information I should know about JANUVIA?”.
t Low 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:
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t Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking JANUVIA and call your doctor right away. See “Who should not take JANUVIA?”. Your doctor may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.
t Kidney problems, sometimes requiring dialysis
The most common side effects of JANUVIA include: t VQQFS SFTQJSBUPSZ JOGFDUJPO t TUVGGZ PS SVOOZ OPTF BOE TPSF UISPBU t IFBEBDIF
JANUVIA may have other side effects, including: t TUPNBDI VQTFU BOE EJBSSIFB t TXFMMJOH PG UIF IBOET PS MFHT XIFO +"/67*" JT VTFE XJUI SPTJHMJUB[POF "WBOEJB®
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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. '%"
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How should I store JANUVIA? 4UPSF +"/67*" BU ¡' UP ¡'
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Keep JANUVIA and all medicines out of the reach of children. General information about the use of JANUVIA
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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 film coating contains the following JOBDUJWF JOHSFEJFOUT QPMZWJOZM BMDPIPM QPMZFUIZMFOF HMZDPM UBMD UJUBOJVN EJPYJEF SFE JSPO PYJEF BOE ZFMMPX JSPO PYJEF
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 CPEZ QSPEVDFT EPFT OPU XPSL BT XFMM BT JU TIPVME :PVS CPEZ DBO BMTP NBLF UPP NVDI TVHBS 8IFO UIJT happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems.
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