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The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
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Brand name :
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ALENDRONATE Tablets 35mg "Mylan"
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Active ingredient:
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Alendronate sodium hydrate
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Dosage form:
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white tablet, major axis 10.3mm, minor axis 5.6mm, thickness 3.8mm
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Print on wrapping:
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アレンドロン酸錠35mg「マイラン」, Alendronate Tab. 35mg “Mylan”, M127
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Effects of this medicine
This medicine is taken up by osteoclasts in bones, to reduce bone resorption and increase bone mass by suppressing the osteoclast activities, and consequently make bones resistant to fractures.
It is usually used in the treatment of osteoporosis.
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Before using this medicine, be sure to tell your doctor and pharmacist
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If you ever experienced any allergic reaction (itch, rash, etc.) to any medicine.
If you have difficulty in swallowing food or medicine.
If you are unable to sit up for at least 30 minutes.
If you are a patient with hypocalcemia.
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If you are pregnant or breastfeeding.
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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.)
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Dosing schedule (How to take this medicine)
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Your dosing schedule prescribed by your doctor is << to be written by a healthcare professional>>
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General dosage regimen: For adults, take 1 tablet(35mg of alendronate) at a time, with about 180mL of water, once weekly, first thing in the morning. Strictly follow the instructions of your doctor/pharmacist.
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Never take the medicine with other than water(e.g. mineral water of high calcium and magnesium content, tea, coffee, juice, milk, etc.). Never chew the medicine or dissolve it in a mouth.
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You should not drink and eat anything (except for water), and not take other medicine for 30 minutes after taking this medicine. However you should not lay down for 30 minutes, and keep your body sitting up until you finish the first meal in a day. Do not take the medicine at bedtime or before rising.
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If you do not take the food/drink(except for water)/other medicine in a day, and you missed a dose, take a dose as soon as possible(the dosage regimen is same as usual). When you missed a dose after eating/drinking something, skip the missed dose and take a dose on the next morning. And continue your regular dosing schedule(Morning on the specified day of the week) for next time. DO NOT take double doses to make up for the missed dose.
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If you took too much of the medicine (more than ordered), check with your doctor/pharmacist.
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Do not stop taking the medicine without the instructions of your doctor.
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Precautions while taking this medicine
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Keep the mouth clean.
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If you receive the dental treatment such as tooth extraction or implants, tell the dentist or oral surgeon about your taking this medicine.
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Try to ingest calcium through food.
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If you take supplements(e.g. calcium, vitamin D), check with your doctor/pharmacist in advance.
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Possible adverse effects of this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: nausea, constipation, diarrhea, gastric pain, epigastralgia, gastritis, gastric discomfort, loss of appetite, anemia, headache, etc.
The symptoms described below are rarely seen as initial symptoms of the adverse effects indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
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difficulty in swallowing, swallowing pain, chest(back side of the bone) pain[esophageal disorder, intraoral disorder]
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epigastric pain, abdominal pain, abdominal discomfort[gastric disorder, duodenal disorder]
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fever, redness or erosion in mucosa, erythema[toxic epidermal necrolysis, Stevens-Johnson syndrome]
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jaw pain/swelling/numbness, loose tooth, swelling of the gum[jaw bone necrosis, jaw osteomyelitis]
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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.
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Storage conditions 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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Do not store the remainder and ask your pharmacist how to discard it.
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