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 Na Tablets 10mg "SAWAI"
 Active ingredient:
Rabeprazole sodium
 Dosage form:
pale yellow tablet, diameter: 6.9 mm, thickness: 3.6 mm
 Print on wrapping:
ラベプラゾールNa 10mg「サワイ」, SW-RZ10, Rabeprazole Na 10mg「SAWAI」

Effects of this medicine

This medicine inhibits the terminal step in gastric acid secretion, called proton-pump, and suppresses the gastric acid secretion.
It is usually used to treat gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux esophagitis, Zollinger-Ellison syndrome and non-erosive gastroesophageal reflux disease, as well as to help the eradication of Helicobacter pylori in gastric ulcer, duodenal ulcer, gastric MALT lymphoma, idiopathic thrombocytopenic purpura, after endoscopic treatment for early-stage gastric cancer, and in Helicobacter pylori-associated 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))
  • 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 a day. You may also take 2 tablets (20 mg) at a time, once a day, according to your symptoms. The maximum duration of medication is 8 weeks for gastric ulcer and anastomotic ulcer, and 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 a day. You may also take 2 tablets (20 mg) at a time, once a day, according to your symptoms. The maximum duration of medication is 8 weeks. When 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. (Maintenance therapy) For maintenance therapy of repeatedly recurrent/relapsing reflux esophagitis, take 1 tablet (10 mg) at a time, once a day. When proton-pump inhibitor treatment is ineffective, take 1 tablet (10 mg) at a time, twice a day.
    For non-erosive gastroesophageal reflux disease: In general, for adults, take 1 tablet (10 mg of the active ingredient) at a time, once a day. The maximum duration of medication is 4 weeks.
    For helping to eradicate of 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.
  • Take this medicine without chewing or crushing because it is an enteric-coated tablet.
  • 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. 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, itch, hives, anemia, increased blood pressure, constipation, diarrhea, loose stool, taste abnormality, abdominal pain, abdominal bloating, nausea, stomatitis, glossitis, gastric distress, flatulence/flatus and headache. 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.
  • dizziness, respiratory distress, redness with generalized itching [shock, anaphylaxis]
  • general malaise, sore throat, bleeding tendency [pancytopenia, agranulocytosis, decreased platelets, hemolytic anemia]
  • general malaise, loss of appetite, yellow discoloration of the skin and the white of eyes [fulminant hepatitis, liver dysfunction, jaundice]
  • fever, cough, respiratory distress [interstitial pneumonia]
  • fever, redness and swelling of skin/mucosa with rash or blisters, conjunctival hyperemia [toxic epidermal necrolysis, mucocutaneous ocular 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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