くすりのしおり

Internal
Revised: 12/2017

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 :
RABEPRAZOLE Sodium Tablets 10mg "KAKEN"
 Active ingredient:
Sodium rabeprazole
 Dosage form:
pale yellow tablet, diameter: 6.7mm, thickness: 3.3mm
 Print on wrapping:
ラベプラゾールナトリウム錠10mg「科研」, RABEPRAZOLE SODIUM Tab.10mg 「KAKEN」, 10mg, KC80

Effects of this medicine

This medicine inhibits the mechanism of gastric acid secretion in gastric mucosal cells to suppress gastric acid secretion. It consequently results in rapid healing of gastric and duodenal ulcer, and relieves pain and heartburn attributed to reflux esophagitis.
It is usually used in the treatment of gastric ulcer, duodenal ulcer, reflux esophagitis, and non-erosive gastroesophageal reflux disease. It is also used for adjunctive medicine to eradicate Helicobacter pylori bacteria in the stomach in gastric ulcer, duodenal ulcer, gastric MALT lymphoma, idiopathic thrombocytopenic purpura, and after endoscopic therapy for early gastric cancer, and Helicobacter pylori gastritis with other antibacterial medicines.

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 liver problems.
  • 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 gastric ulcer and duodenal ulcer, anastomotic ulcer and Zollinger-Ellison syndrome: In general, for adults, take 1 tablet (10 mg of the active ingredient) at a time, once daily. However, the dosage may be increased up to 2 tablets (20 mg), once daily. Duration of taking the medicine is up to 8 weeks for gastric ulcer and anastomotic ulcer; 6 weeks for duodenal ulcer.
    For reflux esophagitis: (Treatment) In general, for adults, take 1 tablet (10 mg of the active ingredient) at a time, once daily. However, the dosage may be increased up to 2 tablets (20 mg), once daily. Duration of taking the medicine is up to 8 weeks. When proton pump inhibitor treatment is ineffective, take 1 tablet (10 mg) or 2 tablets (20 mg) at a time, twice daily for further 8 weeks. However, a dose of 2 tablets (20 mg) at a time, twice daily is only used in patients with severe mucosa injury. (Maintenance therapy) For reflux esophagitis which relapses several times, take 1 tablet (10 mg), once daily. When proton-pump inhibitor treatment is ineffective, take 1 tablet (10 mg) at a time, twice a day as maintenance therapy.
    For non-erosive gastroesophageal reflux disease: In general, for adults, take 1 tablet (10 mg of the active ingredient) at a time, once daily. Duration of taking the medicine is up to 4 weeks.
    For helping to eradicate Helicobacter pylori bacteria: In general, for adults, take 1 tablet (10 mg of the active ingredient) at a time, twice daily, for 7 days, concomitantly with amoxicillin hydrate and clarithromycin. If this treatment resulted in failure, take 1 tablet (10 mg) at a time, twice daily, for 7 days, concomitantly with amoxicillin hydrate and metronidazole.
    In any case, strictly follow the instructions.
  • Swallow the tablet without chewing or crushing.
  • If you miss a dose, take a dose as soon as possible when you remember that you missed a dose. However, 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

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include rash, hives, itching sensation, diarrhea, abdominal pain, abdominal bloating 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, dizziness [shock, anaphylaxis]
  • fever, anemia, gum bleeding, subcutaneous bleeding [pancytopenia, agranulocytosis, thrombocytopenia, hemolytic anemia]
  • nausea, vomiting, decreased appetite, yellowing in the skin or white of the eye [fulminant hepatitis, hepatic dysfunction, jaundice]
  • fever, widespread red rash, erosion in the eye, mouth or genitalia [toxic epidermal necrosis, Stevens-Johnson syndrome, erythema multiforme]
  • decreased urine output, edema, fever [acute renal failure, interstitial nephritis]
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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