くすりのしおり

Internal
Revised: 5/2007

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 :
ALFAROL Capsule 0.5μg
 Active ingredient:
Alfacalcidol
 Dosage form:
opaque yellow capsule (φ: 5.6mm)
 Print on wrapping:
アルファロール0.5

Effects of this medicine

This hepatically-metabolized medicine turns into activated vitamin D3 and promotes digestive tract absorption of calcium. It is usually used to treat osteoporosis as well as to improve bone disease and other symptoms caused by lack of vitamin D.

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
  • 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))
  • General dosage regimen: Your dosage of this medicine is adjusted under a fully controlled condition of serum calcium level.
    To treat chronic renal failure and osteoporosis: For adults, take 0.5-1.0μg of the active ingredient once a day. It should be adjusted according to your disease, age and symptoms.
    To treat hypoparathyroidism and other disease caused by vitamin D metabolism abnormality: For adults, take 1.0-4.0μg of the active ingredient once a day. It should be adjusted according to your disease, age, symptoms and pattern of disease.
    For children: In the case of osteoporosis, take 0.01-0.03 μg/kg of the active ingredient once a day. In the case of other diseases, take 0.05-0.1μg/kg of the active ingredient once a day. It should be adjusted according to your disease and symptoms.
    1 capsule contains 0.5μg of the active ingredient. Strictly follow the instructions of your doctor in any case.
  • Skip the missed dose and continue your regular dosing schedule. DO NOT take a double dose to make up for the missed dose.
  • If you took too much of this medicine (more than ordered), check with your doctor/pharmacist.
  • Do not stop taking this medicine without the instructions of your doctor.

Precautions while taking this medicine

  • If you take a large amount of calcium or vitamin D contained in OTC medicine or food while taking this medicine, you may have a higher risk of side effects. Check with your doctor about it beforehand.

Possible adverse reactions to this medicine

Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: pruritus, loss of appetite, nausea, diarrhea, stomachache.
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 urinary volume, largely increased urinary volume, urinary retention, difficult urination, swollen body/legs/eyes, lassitude, easy fatigability, redden eyes, symptoms of hypercalcemia such as itch and irritation  [acute renal failure]
  • yellowness in the skin and/or the white of the eye, lassitude [hepatic 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

  • In the case of PTP (press-through package), keep out of the reach of children. Store in a covered container, at room temperature (1-30℃). Keep away from light and moisture.
  • If you are handed in capsules out from the bottle, do not open the bag of medicine and take them out except dosing. Keep out of the reach of children, and store away from direct sunlight.
  • Discard the remainder. Do not store them. Ask the pharmacist how to discard.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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