くすりのしおり

Internal
Revised: 9/2013

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 "NP"
 Active ingredient:
Sodium rabeprazole
 Dosage form:
pale yellow tablet, diameter: 6.8 mm, thickness: 3.5 mm
 Print on wrapping:
(Face)ラベプラゾールナトリウム10mg「NP」, 10mg, ラベプラゾール,(Back)RABEPRAZOLE SODIUM 10mg「NP」, ラベプラゾール, 10mg, NP-010

Effects of this medicine

This medicine inhibits the enzymatic activity of proton pump in gastric mucosal cells to suppress acid secretion in the stomach.
It is usually used to treat gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux esophagitis, Zollinger-Ellison syndrome and non-erosive gastroesophageal reflux disease, and to help eradication of Helicobacter pylori with antibacterial agents in gastric ulcer, duodenal ulcer, gastric MALT lymphoma, idiopathic thrombocytopenic purpura, stomach after the endoscopic therapy of early gastric cancer and Helicobacter pylori gastritis.

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 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))
  • 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 a day. The dosage may be increased to 2 tablets (20 mg) at a time, once a day, according to the symptoms. Duration of taking this medicine is up to 8 weeks for gastric ulcer and anastomotic ulcer; 6 weeks for duodenal ulcer.
    Reflux esophagitis: In general, for adults, take 1 tablet (10 mg of the active ingredient) at a time, once a day. The dosage may be increased to 2 tablets (20 mg) at a time, once a day, according to the symptoms. Duration of taking this medicine is up to 8 weeks. If proton pump inhibitor treatment is ineffective, take 1 tablet (10 mg) or 2 tablets (20 mg) at a time, twice a day for further 8 weeks. However, a dose of 2 tablets (20 mg) at a time, twice a day is only used in patients with severe mucosa injury. For reflux esophagitis which relapses several times, take 1 tablet (10 mg) at a time, once a day.
    Non-erosive gastroesophageal reflux disease: In general, for adults, take 1 tablet (10 mg of the active ingredient) at a time, once a day. Duration of taking this medicine is up to 4 weeks.
    Helping to eradicate Helicobacter pylori: In general, for adults, take 1 tablet (10 mg of the active ingredient) at a time, twice a day, for 7 days, concomitantly with amoxicillin hydrate and clarithromycin. If this treatment resulted in failure, take 1 tablet (10 mg) at a time, twice a day, 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 the missed dose as soon as possible. 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, itch, diarrhea, loose stools, taste abnormality, abdominal pain, abdominal enlarged feeling 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.
  • facial pallor, cold sweat, respiratory distress [shock, anaphylactoid symptoms]
  • fever, anaemia, gingiva/ subcutaneous bleeding [pancytopenia, agranulocytosis, decrease in platelets, hemolytic anemia]
  • general malaise, loss of appetite, yellowing of the skin and the membrana mucosa [fulminant hepatitis, liver dysfunction, jaundice]
  • fever, dry cough, respiratory distress [interstitial pneumonia]
  • widespread erythema/blisters, fever, bloodshot eyes [toxic epidermal necrolysis, muco-cutaneo-ocular syndrome, erythema multiform]
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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