JANUVIA Tablets 50mg [Class 1 Drugs]

The most commonly reported adverse reactions include hypoglycemia and constipation. If any of these symptoms occur, consult with your doctor or pharmacist.

The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.

• breathing difficulty, hives, swelling around eyes and lips[anaphylactic reaction]
• fever, erythema, bloodshot eyes[Stevens-Johnson syndrome, dermatitis exfoliativa]
• chills, craving for food, tremor in limbs[hypoglycemia]
• loss of appetite, general malaise, yellowness in skin or conjunctiva[hepatic dysfunction, jaundice]
• decreased urine output, general edema, malaise[acute kidney injury]
• severe pain in the upper abdomen, back pain, nausea[acute pancreatitis]
• fever, dry cough, breathing difficulty[interstitial pneumonia]
• failure of passing stool, stomach ache, abdominal bloating[intestinal obstruction]
• pain of the limb muscle, stiffness, numbness[rhabdomyolysis]
• continuous bleeding, blue spot, subcutaneous bleeding[thrombopenia]
• blister, erosion, erythema[bullous pemphigoid]

The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

• Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
• For patients with normal renal function or mild renal dysfunction : In general, for adults, take 1 tablet (50 mg of sitagliptin) at a time, once a day. If the dose seems to be insufficient, it may be increased up to 2 tablets (100 mg) at a time, once a day, adequately monitoring the condition.
  For patients with moderate renal dysfunction : In general, for adults, take 25 mg of sitagliptin at a time, once a day. If the dose seems to be insufficient, it may be increased up to 1 tablet (50 mg) at a time, once a day, adequately monitoring the condition.
  For patients with severe or end stage renal dysfunction : In general, for adults, take 12.5 mg of sitagliptin at a time, once a day. If the dose seems to be insufficient, it may be increased up to 25 mg at a time, once a day, adequately monitoring the condition.
  This medicine contains 50 mg of sitagliptin per a tablet. In either case, strictly follow the instructions.
• If you miss a dose, take the missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. You should never take two doses at one time.
• If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
• Do not stop taking this medicine unless your doctor instructs you to do so.

• If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines or foods.
  If you have: ketosis, diabetic coma or precoma stage, type 1 diabetes, infection, injury, renal dysfunction, pituitary gland disorder, adrenal gland disorder, insufficient diet, a history of abdominal surgery or intestinal obstruction.
  If you are in pre/postoperative period or debilitated.
  If you exercise intensely or drink a lot of alcohol.
• If you are pregnant or breastfeeding.
• If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

• Keep out the reach of children. Store away from direct sunlight, heat and moisture.
• Discard the remainder. Do not store them.