くすりのしおり

Internal
Revised: 6/2016

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 :
Actonel Tablets 17.5 mg [Paget's disease of bone]
 Active ingredient:
Sodium risedronate hydrate
 Dosage form:
Salmon-pink tablet, major axis: approximately 8.1 mm, minor axis: approximately 4.6 mm, thickness: approximately 3.3 mm
 Print on wrapping:
(face)アクトネル錠17.5mg, 17.5mg
(back)アクトネル, Actonel, 17.5mg, AJ4

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 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, esophagitis, gastric ulcer, duodenal ulcer, hypocalcemia and renal disorder.
    If you cannot keep your upper body raised up for at least 30 minutes at the time of taking of the medicine.
  • If you are pregnan, 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 and while lying in bed.
  • If you take nothing to eat or drink by the time when you remembered that you missed a dose, take the missed dose as soon as possible. If you remembered that you missed a dose after you take 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 took 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

  • Abnormality in jaw bone may occur in receiving dental treatment such as tooth extraction while taking bisphosphonates including this medicine. You need to receive an adequate explanation about the following points from doctors or pharmacists:
    If possible, receive dental treatment such as tooth extraction prior to taking the medicine, after consultation with your doctor.
    Undergo an oral or dental checkup regularly while taking the medicine.
    Avoid any treatments such as tooth extraction while taking the medicine.
    Keep your mouth clean by brushing of teeth while taking the medicine.
    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, diarrhea, gastric discomfort, constipation , epigastric pain and edema (face, limbs). 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, abdominal pain, difficulty in swallowing, black stool [upper gastrointestinal disorder]
  • nausea, vomiting, loss of appetite, yellowing of the skin or whites of the eyes [hepatic dysfunction, jaundice]
  • pains in teeth, gingivae and jaw, gingival swelling/pus discharge, loose tooth [necrosis of the jaw bone, osteomyelitis of the jaw]
  • earache, running ears, jam-packed feeling of the ear [osteonecrosis of the external auditory canal ]
  • The pain of the thigh or an inguinal region [atypical subtrochanteric and diaphyseal femoral fractures]
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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