くすりのしおり

Internal
Revised: 6/2018

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 :
INISYNC Combination Tablets
 Active ingredient:
Alogliptin benzoate
Metformin hydrochloride
 Dosage form:
faint red oval tablets, major axis: 13.7 mm, minor axis: 8.7 mm, thickness: about 6.6 mm
 Print on wrapping:
(Face) イニシンク 糖尿病用薬, (Back)アログリプチン メトホルミン配合 イニシンク 317

Effects of this medicine

This medicine inhibits the enzyme (DPP-4) which catalyzes decomposition of incretin, a hormone acting to maintain constant blood glucose level, thereby stimulating insulin secretion when blood glucose levels are high. In addition, it suppresses glucose formation in the liver. These actions improve blood glucose control.
It is usually used to treat type 2 diabetes mellitus.

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 experienced lactic acidosis in the past; have renal disorder; are on dialysis; have liver disorder, a heart disease or a lung disease; are a heavy drinker; have gastrointestinal disorders such as diarrhea/vomiting, ketosis, diabetic coma or precoma, type 1 diabetes mellitus or infection; are in a pre- or post-operative state; have an injury, inadequate food intake, debility, pituitary abnormality or adrenal disorder; are doing strenuous physical exercise; have undergone a laparotomy or experienced bowel obstruction.
  • If you are pregnant, possibly 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))
  • In general, for adults, take 1 tablet at a time, once a day, right before or after meal. Strictly follow the instructions.
  • If you miss a dose, take the missed dose when you have a next meal. If it is almost time for the next dose, skip the missed dose and follow 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 the instructions on dietary/exercise therapy.
  • This medicine may cause palpitation, dizziness, shivering of limbs, etc. due to hypoglycemia. Pay close attention when working at heights or operating dangerous machinery such as driving a car.
  • When hypoglycemia symptoms occur, take an adequate amount of sugar (e.g., sugar, glucose, soft drinks). If you are taking this medicine concomitantly with an α-glucosidase inhibitor (medicines which delay absorption of sugar such as voglibose and acarbose), ingest glucose in case of any hypoglycemic symptoms.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include rash, itching, hives, nausea, vomiting, abdominal distension, abdominal pain, gastroenteritis, constipation, headache, dizziness/light headedness, numbness of limbs, malaise, nasopharyngitis, edema, palpitation, arthralgia, muscle pain, anemia, diarrhea, loss of appetite, indigestion, gastrointestinal disorder, increased flatus, dull headache, drowsiness, taste abnormality, diaphoresis, lassitude and a sense of hunger. 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.
  • nausea, diarrhea, malaise, muscle pain [lactic acidosis]
  • cold sweat, a sense of hunger, shivering of limbs [hypoglycemia]
  • persistent severe abdominal pain, vomiting [acute pancreatitis]
  • loss of appetite, yellowing of the skin and the white of eyes [liver disorder, jaundice]
  • fever, general malaise, rash on skin/in eyes/in mouth, red rash [muco-cutaneo-ocular syndrome, erythema multiform]
  • lassitude, muscle pain, brown urine [rhabdomyolysis]
  • constipation, abdominal distension, persistent abdominal pain, vomiting [intestinal obstruction]
  • fever, cough, respiratory distress [interstitial pneumonia]
  • blister, erosion, red rash [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 of reach of children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them. Seek advice of your pharmacy or medical institution about proper disposal of the unused medicines.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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