くすりのしおり

Internal
Revised: 6/2016

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 5mg "SAWAI"
 Active ingredient:
Alendronate sodium hydrate
 Dosage form:
white tablet, diameter: 8.0 mm, thickness: 3.1 mm
 Print on wrapping:
アレンドロン酸錠5mg「サワイ」, 骨粗しょう症の薬, Alendronate5mg「SAWAI」

Effects of this medicine

This medicine suppresses bone resorption by inhibiting osteoclastic functions, thereby increasing bone density and making bones resistant to fractures.
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 disorders that delay passage through the esophagus [esophageal stenosis, achalasia (achalasia of esophagus), etc.], hypocalcemia.
  • If you cannot keep your body in an upright position or stand 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 of alendronate) at a time with approximately 180 mL of water, once a day at the time of awakening in the morning. Avoid lying down, eating/drinking (except water) and taking other medicines for at least 30 minutes after taking this medicine. Strictly follow the instructions.
  • Do not take this medicine with drinks other than water (including mineral water high in calcium/magnesium content), foods or other medicines.
  • This medicine may cause ulcer in your mouth or throat, do not chew this medicine or dissolve it in the mouth.
  • If you miss a dose and have not had anything to eat/drink by the time when you remember that you missed a dose, take the missed dose as soon as possible. However, if you have had something to eat/drink, do not take the missed dose on that day. Take a dose at the time of awakening on the next day. 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

  • Try to ingest enough calcium through meals, etc.
  • Consult with your doctor, and receive dental checkup before starting this medicine if needed. If possible, have your dental treatment, such as tooth extraction, completed before taking this medicine.
  • Maintain your oral hygiene by brushing your teeth and receive dental checkup regularly while taking this medicine.
  • When you visit a dentist, tell the dentist that you are taking this medicine and try to avoid treatments such as tooth extraction as much as possible.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, gastric pain/epigastric pain, gastric distress/stomach heaviness/stomach discomfort and abnormality in liver function. 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.
  • swallowing difficulty, pain on swallowing, vomiting of blood [esophageal/intraoral disorder, gastric/duodenal disorder]
  • general malaise, loss of appetite, yellow discoloration of the skin and the white of eyes [liver dysfunction, jaundice]
  • fever, redness and swelling of skin/mucosa with rash or blisters, conjunctival hyperemia [toxic epidermal necrolysis, mucocutaneous ocular syndrome]
  • jaw pain, loose teeth, gum swelling [jaw bone necrosis/jaw osteomyelitis ]
  • otitis externa, ear discharge (otorrhea), ear pain [osteonecrosis of the external ear canal]
  • 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 or medical institution 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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