くすりのしおり

Internal
Revised: 3/2012

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 :
ALENDRONIC ACID TABLETS 5mg "TOWA"
 Active ingredient:
Alendronate sodium hydrate
 Dosage form:
white tablet, diameter: 7.0 mm, thickness: 3.0 mm
 Print on wrapping:
Tw160, アレンドロン酸 5 mg 「トーワ」, 5 mg, 骨粗鬆症の薬

Effects of this medicine

This medicine is taken up by osteoclasts in the bone and suppresses osteoclastic activity, thereby suppressing bone resorption, increasing bone mass and preventing bones from becoming easily fractured.
It is usually used to treat 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 swallowing food or medicine, or hypocalcemia.
    If you cannot keep your body in an upright position for more than 30 minutes.
  • 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 (5 mg as alendronate) at a time with a glass of water (approximately 180 mL), once a day when you wake up every morning (before breakfast). Do not lie down, and avoid eating, drinking fluids other than water and taking other medicines for at least 30 minutes after taking this medicine. Strictly follow the instructions.
  • This medicine may cause ulcers in the mouth or throat. Do not chew this medicine or dissolve it in the mouth.
  • Do not take this medicine with drinks other than water (never take this medicine with mineral water particularly high in calcium/magnesium content, tea, coffee, juice, milk, etc.)
  • If you miss a dose and have not had anything to eat/drink (except water), take the missed dose as soon as possible (the dosage regimen is the same as usual). However, if you have had something to eat/drink, skip the missed dose and follow your dosing schedule from the next day. You should not take two doses at one time.
  • If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist. Do not force yourself to throw up the medicine. Never lie down, and keep your body in an upright position. If it is seconds after taking more than the prescribed dose, drink milk. If you notice any abnormality, 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 while taking this medicine.
  • When you receive dental treatment such as tooth extraction or implant, tell your dentist or oral surgeon that you are taking this medicine.
  • Try to ingest calcium through meals, etc.
  • Consult with your doctor or pharmacist before taking supplements containing calcium or vitamin D.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, constipation, diarrhea, gastric pain, gastric inflammation, gastric distress, 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 swallowing, pain on swallowing, chest (backside of the breastbone) pain [esophageal/intraoral disorder]
  • epigastric pain, abdominal pain, stomach discomfort [gastric/duodenal disorder]
  • high fever/general malaise, lip erosion/bloodshot eyes/sore throat, red rash/bulla in wide area of skin [toxic epidermal necrolysis/mucocutaneous ocular syndrome]
  • jaw pain/swelling/numbness, loose tooth [jaw bone necrosis/jaw osteomyelitis]
  • pain in the thigh or inguinal region [atypical subtrochanteric and proximal femoral shaft 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 your pharmacy on how to discard the remainder.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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