くすりのしおり

Internal
Revised: 4/2016

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 :
FULSTAN Tab. 0.3
 Active ingredient:
Falecalcitriol
 Dosage form:
white tablet with split line, diameter : approx. 7 mm, thickness : approx. 3.5 mm
 Print on wrapping:
フルスタン錠0.3μg, 213, FULSTAN0.3

Effects of this medicine

This medicine improves bone disease and symptoms caused by shortage of vitamin D, etc. It also prompts calcium absorption to supply lacked calcium and prevents bone-thinning.
It is usually used to treat secondary hyperparathyroidism under maintenance dialysis, hypoparathyroidism, rickets or 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 have hyperphosphatemia.
  • 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 treatment of secondary hyperparathyroidism under maintenance dialysis: In general, for adults, take 1 tablet (0.3 mcg of the active ingredient) at a time, once a day. The dosage should be adjusted according to the age or symptoms. Strictly follow the instructions.
    For hypoparathyroidism, rickets or osteomalacia: In general, for adults, take 1 to 3 tablets (0.3 to 0.9 mcg of the active ingredient) at a time, once a day. The dosage should be adjusted according to the age, symptoms or disease type. Strictly follow the instructions.
  • If you miss a dose, take the missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and continue 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

  • 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 adverse reactions. Check with your doctor about it beforehand.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include hypercalcemia and itch. 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.
  • thirstiness, increased output of urine, nausea [hypercalcemia]
  • severe pain in abdomen to back or lower back, hematuria, fever  [kidney stones, ureteral stone]
  • yellowness in skin or conjunctiva, malaise, loss of appetite  [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

  • Keep out the reach of children. Store away from light, heat and moisture.
  • Discard the remainder. Do not store them. Ask the pharmacist or healthcare facility how to discard them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.