くすりのしおり

Internal
Published: 12/2013

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 :
ALFACALCIDOL Capsules 1mcg "SAWAI"
 Active ingredient:
Alfacalcidol
 Dosage form:
faint yellow clear capsule, major axis: 9.1 mm, minor axis: 5.9 mm
 Print on wrapping:
アルファカルシドール1μg「サワイ」, SW-947, Alfacalcidol 1μg「SAWAI」

Effects of this medicine

This medicine prevents weakening of bones and improves bone diseases due to lack of vitamin D by promoting calcium absorption in the small intestine and kidney, promoting bone formation through direct effects on bone cells and suppressing secretion of parathyroid hormone in the blood.
It is usually used to treat osteoporosis and improve hypocalcemia, tetany, bone pain, bone lesion, etc., associated with abnormal vitamin D metabolism in patients with chronic renal failure, hypoparathyroidism and vitamin D-resistant rickets/osteomalacia.

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 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))
  • For osteoporosis : In general, for adults, take 0.5 to 1.0 mcg of the active ingredient at a time, once a day. In general, for children, take 0.01 to 0.03 mcg per kilogram of body weight at a time, once a day.
    For chronic renal failure: In general, for adults, take 0.5 to 1.0 mcg of the active ingredient at a time, once a day. In general, for children, take 0.05 to 0.1 mcg of the active ingredient per kilogram of body weight at a time, once a day.
    For hypoparathyroidism and other diseases associated with abnormal vitamin D metabolism: In general, for adults, take 1.0 to 4.0 mcg of the active ingredient at a time, once a day. In general, for children, take 0.05 to 0.1 mcg per kilogram of body weight at a time, once a day.
    In any case, the dosage may be adjusted according to the disease or age or symptoms. This medicine contains 1 mcg of the active ingredient in a capsule. Strictly follow the instructions.
  • If you miss a dose, take the missed dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose. 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

  • Consult with your doctor if you are taking over-the-counter medicines or dietary supplements containing a large amount of calcium or vitamin D. You may become more susceptible to adverse reactions.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include loss of appetite, nausea, diarrhea, constipation, gastric pain, decreased renal function, itch and conjunctival hyperemia. 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.
  • decreased urine output, edema, headache [acute renal failure]
  • general malaise, loss of appetite, yellow discoloration of the skin and the white of eyes [liver dysfunction, jaundice]
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 light, 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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