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ALENDRONATE Tablets 5mg "TAIYO"£¨¥¢¥ì¥ó¥É¥í¥óËáåV5mg¡¸¥¿¥¤¥è©`¡¹£©
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Internal
Revised: 11/2012

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse 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.
Brand name :
ALENDRONATE Tablets 5mg "TAIYO"
¡¡Active ingredient:
Alendronate sodium hydrate
¡¡Dosage form:
white tablet, diameter: 8.0 mm, thickness: 3.0 mm
¡¡Print on wrapping:
t903

Effects of this medicine

This medicine is taken up via surface of a bone into osteoclasts and induces apoptosis of osteoclasts by its inhibitory action of meva lonate metabolic pathway in the cells, and consequently reduces bone resorption.
It is usually used in 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 such as esophageal stenosis or achalasia.
    If you are unable to remain sitting up or standing up at least for 30 minutes.
    If you have: 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 (5 mg of alendronate sodium) at a time, once daily, with approx. 180 mL of water at the time of awakening.
    You should not lie down, drink and eat anything (except for water), and not take other medicine at least for 30 minutes after taking this medicine. Strictly follow the instructions.
  • Take this medicine with water only. Never take this medicine with other than water (should not take with mineral water of high calcium and magnesium content). If you take this medicine with any food or other drink, absorption of this meidicine may deteriorate.
  • Never chew this medicine or dissolve it in a mouth since it may cause ulcer in the mouth or throat.
  • Never take this medicine before going to bed or before getting up.
  • If you miss a dose, take a dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and follow your regular dosing schedule. You should never take two doses at one time.
  • If you accidentally take 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

  • You should try to ingest calcium through food.
  •  

Possible adverse effects of this medicine

The most commonly reported adverse reactions include nausea, constipation, diarrhea, gastric pain, gastritis, gastric discomfort, dyspepsia, 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 effects indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
  • hematemesis, melena, anemia [esophageal disorder, oral disorder, gastric ulcer, duodenal ulcer]
  • general malaise, loss of appetite, yellowing in skin and white of eyes [hepatic dysfunction, jaundice]
  • convulsion, tetany (muscle weakness. muscle decline), numbness [hypocalcemia]
  • high fever, conjunctival hyperemia, lip erosion or genital erosion [oculomucocutaneous syndrome, toxic epidermal necrolysis]
  • swelling, pain or pus discharge of muscle, loosen tooth, exteriorization of dentary bone [jaw necrolysis, jaw osteomyelitis]
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 how to discard them.
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