くすりのしおり

Internal
Revised: 9/2018

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
GLACTIV Tablets 25mg
 Active ingredient:
Sitagliptin phosphate hydrate
 Dosage form:
pale reddish yellow tablet, major axis: 9.1 mm, minor axis: 3.8 mm, thickness: 2.5 mm
 Print on wrapping:
GLACTIV 25mg, グラクティブ25mg, 糖尿病用薬, ono660, 1日1回服用

Effects of this medicine

This medicine inhibits enzyme that degrades incretin, blood glucose stabilizing substance. It consequently enhances insulinotropic action and effect of lowering glucagon level in state of hyperglycemia to improve blood glucose control.
It is usually used to treat type 2 diabetes.

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
    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.)

Dosing schedule (How to take this medicine)

  • 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 2 tablets (50 mg of sitagliptin) at a time, once a day. If the dose seems to be insufficient, it may be increased up to 4 tablets (100 mg) at a time, once a day, adequately monitoring the condition.
    For patients with moderate renal dysfunction
    : In general, for adults, take 1 tablet (25 mg of sitagliptin) at a time, once a day. If the dose seems to be insufficient, it may be increased up to 2 tablets (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 1 tablet (25 mg) at a time, once a day, adequately monitoring the condition.
    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.

Precautions while taking this medicine

  • Strictly follow diet and exercise therapy instructed by your doctor.
  • The medicine may cause hypoglycemic symptoms. Pay attention when you work at heights, drive a car or operate dangerous machinery.
  • In case hypoglycemic symptoms occurs, take food or drink that contains enough amount of sugar (sugar, glucose, refreshing drink, etc.). If you are taking the medicine concomitantly with an α-glucosidase inhibitor (medicines which delay absorption of sugar), ingest glucose in case of any hypoglycemic symptoms occur.

Possible adverse reactions to this medicine

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.

Storage conditions and other information

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

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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