Download Drug Information Sheet("Kusuri-no-Shiori") Internal Published: 01

Drug Information Sheet("Kusuri-no-Shiori")
Internal
Published: 01/2014
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:ALENDRONATE Tablets 35mg "AMEL"
Active ingredient:Alendronate sodium hydrate
Dosage form:white tablet, major axis: 10.3mm, minor axis: 5.6mm, thickness: 3.7mm
Print on wrapping:アレンドロン酸錠 35mg「アメル」
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 for the treatment of osteoporosis.
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 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.
・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>>
・In general, for adults, take 1 tablet (35mg of alendronate) at a time, with about 180mL of water, once weekly, first
thing in the morning (before a meal). Strictly follow the instructions.
・You fix on the day of the week to take, please take on the morning of the same day of the week every week.
・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.
・You should not drink and eat anything (except for water), and not take other medicine for 30 minutes after taking
this medicine. 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.
・If you miss a dose, take 1 tablet on the next morning of the notice day (the dosage regimen is same as usual). And
continue your regular dosing schedule (Morning on the specified day of the week) for next time. You should never
take two doses at one time.
・If you accidentally take a dose for two days in a row or take double doses, you should do cessation of the medicine
at the next scheduled day, you take a dose according to schedule after the next scheduled day. If you feel unusual,
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
・Keep the mouth clean.
・If you receive the dental treatment such as tooth extraction or implants, tell the dentist or oral surgeon about your
taking this medicine.
・Try to ingest calcium through food.
・If you take supplements (e.g. calcium, vitamin D), check with your doctor or pharmacist in advance.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include nausea, constipation, diarrhea, gastric pain, gastritis, gastric
discomfort, loss of appetite, anemia 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.
・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]
・fever, mucosal redness/erosion, erythema [toxic epidermal necrolysis, Stevens-Johnson syndrome]
・jaw pain/swelling/numbness, loose tooth, swelling of the gum [jaw bone necrosis, jaw osteomyelitis]
・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.
・Do not store the remainder and consult your pharmacy or medical institution how to discard it.
For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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