くすりのしおり

Internal
Published: 11/2018

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 :
Tradiance Combination Tablets BP
 Active ingredient:
Empagliflozin
Linagliptin
 Dosage form:
pale red tablet, perpendicular: 8.1 mm, thickness: 3.2 mm
 Print on wrapping:
Tradiance, 配合錠BP, トラディアンス, 朝食前又は朝食後に服用, BP, 糖尿病用薬, 25/5, リナグリプチン5mg, エンパグリフロジン25mg

Effects of this medicine

This medicine inhibits an enzyme that degrades incretin to enhance insulinotropic effect and glucagon release inhibitory effect when blood glucose level is high and thereby to improve blood glucose control. It also inhibits SGLT2, which reabsorbs glucose in the kidney, to increase excretion of glucose in the urine and decrease the blood glucose.
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 ketosis, diabetic coma or precoma, type 1 diabetes mellitus or infection.
    If you are in a pre- or post-operative state.
    If you have trauma, pituitary abnormality or adrenal disease.
    If you are unable to take enough meals/nutrient or are debilitating.
    If you are doing strenuous physical exercise or consuming large amounts of alcohol.
    If you have a history of abdominal surgery or intestinal obstruction.
  • 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))
  • In general, for adults, take 1 tablet at a time, once a day, before or after breakfast. Strictly follow the instructions.
  • If you miss a dose, skip the missed dose and follow your regular dosing schedule on the following day. 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 polyuria/frequent urination, resulting in decreased body fluid volume and causing dehydration. Try to take an appropriate amount of water. This medicine may cause weight loss. Take care in excessive weight loss.
  • This medicine may cause hypoglycemia symptoms. Pay close attention to performing dangerous operation such as working at height or driving a car.
    Take a sufficient amount of sugar (such as sugar, glucose or soft drink) when hypoglycemia symptoms occur. If you take this medicine with an α-glucosidase inhibitor, which delays the sugar absorption, and have an onset of hypoglycemia symptoms, take glucose.
  • Because of excessive glucose excreted with urine, this medicine may cause ketoacidosis (blood becomes acidic) without significant rise in blood glucose levels. If any of the following symptoms occur, consult with your doctor: nausea, vomit, loss of appetite, abdominal pain, excessive dry mouth, general malaise, breathing difficulty, decreased consciousness, etc. The following patients must take care because they may easily fall into ketoacidosis: patients with decreased insulin secretion, who reduced or stopped insulin formulation, who are subject to excessive carbohydrate intake restriction, who cannot eat, with infectious diseases or with dehydration.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include cystitis, constipation and frequent urination. 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.
  • lassitude, a sense of hunger, cold sweat [hypoglycemia]
  • dry mouth, polyuria/frequent urination, falling of blood pressure [dehydration]
  • nausea/vomit, decreased appetite, abdominal pain [ketoacidosis]
  • chill, fever, pain in the flank/back [pyelonephritis, sepsis]
  • severe constipation, abdominal distension, continuous abdominal pain [intestinal obstruction]
  • general malaise, loss of appetite, nausea [liver dysfunction]
  • blister, erosion, erythema [pemphigoid]
  • cough, respiratory distress, fever [interstitial pneumonia]
  • severe upper abdominal pain, lumbar/back pain, nausea [acute pancreatitis]
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 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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