くすりのしおり

Internal
Revised: 3/2014

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 Na TABLETS 10mg "OHARA"
 Active ingredient:
Rabeprazole sodium
 Dosage form:
pale yellow tablet, diameter 6.9 mm, thick 3.6 mm
 Print on wrapping:
(front) ラベプラゾールNa塩10mg「オーハラ」, 10mg, プロトンポンプ阻害剤, (back) Rabeprazole Na 10mg「OHARA」, ラベプラゾールNa塩「オーハラ」, 10mg, プロトンポンプ阻害剤

Effects of this medicine

This medicine inhibits an enzyme on the gastric parietal cell and suppresses the gastric-acid secretion.
It is usually used in the treatment of gastric ulcer, duodenal ulcer, reflux esophagitis and none-erosive gastroesophageal reflux disease. It is also used for adjunctive medicine to eliminate 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 hepatic disorder.
  • 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, 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 to 2 tablets (20 mg), once daily. The maximum duration of taking the medicine is 8 weeks for gastric ulcer and anastomotic ulcer, and 6 weeks for duodenal ulcer.
    For reflux esophagitis: In general, for adults, take 1 tablet (10 mg of the active ingredient) at a time, once daily. However, the dosage may be increased to 2 tablets (20 mg), once daily. The maximum duration of taking the medicine is 8 weeks. When proton inhibitor treatment is ineffective, take 1 tablet (10 mg) or 2 tablets (20 mg) twice daily for further 8 weeks. However, a dose of 20 mg twice daily is only used in patients with severe mucosal injury. For reflux esophagitis which relapses several times, take 1 tablet (10 mg), once daily.
    None-erosive gastroesophageal reflux disease: In general, for adults, take 1 tablet (10 mg of the active ingredient) at a time, once daily. The maximum duration of taking the medicine is 4 weeks.
    For adjunct of eliminate 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 and metronidazole.
    Strictly follow the instructions in any case.
  • This medicine is an enteric coated tablet. Swallow the tablet without chewing or crushing.
  • If you miss a dose, take a dose as soon as you remember. However, 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

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include constipation, diarrhea, rash, itch and hives. 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.
  • pallor of the face, respiratory distress, hives [shock, anaphylaxis]
  • general malaise, subcutaneous/submucosal bleeding, fever [pancytopenia, agranulocytosis, thrombocytopenia, hemolytic anemia]
  • general malaise, loss of appetite, yellowing in the skin or white of the eye [severe hepatitis, hepatic function disorder, jaundice]
  • fever, dry cough, respiratory distress [interstitial pneumonia]
  • widespread red rash, fever, mucosal erosion in the mouth or eye [toxic epidermal necrosis, Stevens-Johnson syndrome, erythema multiforme]
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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