Manufacturer's name : Eisai Co., Ltd. |
620004865 |
Revised: 12/2010 |
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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 |
Printings on wrapping: |
アクトネル 17.5mg AJ4 |
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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, tell your doctor/pharmacist
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If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
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.
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If you are pregnant or breastfeeding.
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If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce the risk of drug interactions.)
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Dosage regimen (proper use of this medicine)
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Your dosage regimen is:(order of your doctor)
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General dosage regimen: For adults, take 1 tablet (17.5 mg of the active ingredient) 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 of your doctor/pharmacist.
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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.
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Missed dose: 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. DO NOT take a double dose to make up for the missed dose.
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Overdose: If you took too much of this medicine (more than ordered), check with your doctor/pharmacist.
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Others: Do not stop taking this medicine without the instructions of your doctor. In case of receiving the retreatment, start taking the medicine at least 2 months have elapsed from the last dose according to your physician’s instruction.
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Precautions while using this medicine
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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.
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Side effects of this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: diarrhea, gastric discomfort, constipation, epigastric pain and edema (of the face and four extremities),etc.In rare cases, symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur, stop taking your medicine and check with your doctor immediately.
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chest pain, abdominal pain, difficulty in swallowing,tarry stool[upper gastrointestinal disorder or bleeding]
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nausea, vomiting, loss of appetite,yellowing of the skin or whites of the eyes[hepatic dysfunction, jaundice]
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pains in teeth, gingivae and jaw, gingival swelling/pus discharge,loose tooth[necrosis of the jaw bone, osteomyelitis of the jaw]
Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any worrisome symptom. |
Storage and other information
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Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
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Discard the remainder. Do not store them. Ask the pharmacist how to discard them.
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For further information, ask your doctor/pharmacist. "Kanjamuke Iyakuhin Guide" and Japanese package insert information (for medical professionals) is available on the website of Pharmaceuticals and Medical Devices Agency. |