くすりのしおり

Internal
Published: 12/2018

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 :
SODIUM RISEDRONATE TABLETS 17.5mg "NP"[Paget's disease of bone]
 Active ingredient:
Sodium risedronate hydrate
 Dosage form:
pale red tablet, major axis: 8.1 mm, minor axis: 4.6 mm
 Print on wrapping:
(Face)SODIUM RISEDRONATE TABLETS 17.5mg「NP」, リセドロン酸Na錠17.5mg「NP」, 週1回1錠のむ薬です, (Back)リセドロン酸Na錠17.5mg「NP」, のみ方, のみ忘れた時, 骨粗しょう症の薬

Effects of this medicine

This medicine suppresses the increase in abnormal bone metabolism by suppressing bone resorption by osteoclasts. This medicine suppresses the symptoms and progression of Paget's disease of bone, which cause bone thickening and deformity.
It is usually used for the treatment of Paget's disease of bone at a daily dose of 1 tablet for 8 weeks on consecutive days.

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 esophageal transitional disorder, hypocalcemia or renal dysfunction.
    If you are unable to stand or sit upright for more than 30 minutes when taking the medicine.
  • If you are pregnant, possibly 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 1 tablet (17.5 mg of the active ingredient) at a time, once a day for 8 weeks at the time of rising with a glass of water (about 180 mL), prior to consuming any beverage or food. Avoid lying down for at least 30 minutes after taking the medicine. Avoid drinking any beverages (including mineral water with the particularly high content of calcium, magnesium, etc.) other than water, and do not take any food or other medicines for at least 30 minutes after taking the medicine. Strictly follow the instructions.
  • This medicine may irritate your mouth and throat. Avoid chewing and sucking this medicine. Do not take this medicine before going to bed or while lying in bed.
  • If you miss a dose and take nothing to eat or drink by the time when you remembered, take the missed dose as soon as possible. If you miss a dose after taking something to eat and drink, skip the missed dose on the day. Take a dose at the time of rising on the next day. 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

  • Maintain your oral hygiene and avoid mouth infection as much as possible while taking this medicine. If you notice any trouble with your tooth or gum, discontinue the medicine and see your dentist or oral surgeon immediately.
  • Inform your dentist that you are taking the medicine when you receive dental treatment.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include stomach discomfort, constipation, upper abdominal pain, nausea, dyspepsia, itch, rash, anemia, dizziness, erythema, hives, dermatitis and angioedema. 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.
  • chest pain, stomachache, difficulty in swallowing, black stool [upper gastrointestinal tract disturbance]
  • general malaise, loss of appetite, yellowing of the skin and the white of eyes [liver dysfunction, jaundice]
  • jaw pain, swollen gum, loose tooth [jaw bone necrosis, jaw osteomyelitis]
  • pain of the thigh/inguinal region [atypical subtrochanteric and diaphyseal femoral fractures]
  • earache, running ears, jam-packed feeling of the ear [osteonecrosis of the external auditory canal]
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. Ask the pharmacist or medical institution how to discard them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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