くすりのしおり

Internal
Revised: 9/2017

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 :
Prazaxa Capsules 75mg
 Active ingredient:
Dabigatran etexilate methanesulfonate
 Dosage form:
pale blue opaque/yellowish white opaque capsule, length: approx. 18 mm, diameter: approx. 6 mm
 Print on wrapping:
(Face) Prazaxa 75mg, 抗凝固薬, プラザキサ75mg, R75, カプセルを開けて服用しない, 湿気に注意 (Back) プラザキサ 75mg, Boehringer Ingelheim, 湿気に注意, 他院,他科を受診する時は本剤を服用していることを必ず医師・歯科医師・薬剤師にお伝えください。

Effects of this medicine

This medicine inhibits thrombin to suppress blood clotting and prevents formation of blood clots.
It is usually used to prevent ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

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 renal disorder.
    If you are bleeding or prone to bleeding.
    If you have a spinal/epidural catheter.
  • 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 150 mg of dabigatran etexilate at a time, twice daily. The dosage may be reduced to 110 mg at a time, twice daily, if necessary. This preparation contains 75 mg of dabigatran etexilate in a capsule. Strictly follow the instructions.
  • Take this medicine with sufficient amount of water (about a glass of water) without opening the capsule.
  • If you miss a dose, take the missed dose as soon as possible on the same day. However, wait at least 6 hours to take the next dose. 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

  • Avoid taking any food containing St. John's wort, since it may diminish medicinal effects.
  • This medicine has an action to prevent bleeding from stopping. Avoid work/exercise which may lead to injury. If any of the following symptoms occur, consult with your doctor immediately. Be sure to inform your doctor that you are taking this medicine because there is a specific reversal agent for this medicine: prolonged nose/gum bleeding, bruise (internal hemorrhage), bloody urine or bloody stool (red/black stool), heartburn, nausea or upset stomach.
  • If you need to undergo a surgery or tooth extraction, consult with your doctor beforehand. If you need to be seen in another medical facility, tell the doctor, dentist or pharmacist that you are taking this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include indigestion, diarrhea, upper abdominal pain, nose bleeding, nausea, chest pain, subcutaneous bleeding and bloody urine. 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.
  • headache/abdominal pain, black stool/bloody stool/bloody urine, gum/subcutaneous bleeding [bleeding (gastrointestinal bleeding, intracranial hemorrhage, etc.)]
  • cough, respiratory distress, fever [interstitial pneumonia]
  • hives, facial swelling, respiratory distress [anaphylaxis]
  • general malaise, loss of appetite, yellowing of the skin and the white of eyes [acute hepatic failure, hepatic dysfunction, jaundice]
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.
  • Store this medicine in the original aluminum package as much as possible since it is susceptible to moisture.
  • Remove a capsule from the blister package just before taking this medicine.
  • 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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