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Alfacalcidol Tablets 0.25mcg - AMEL - Kusuri-no-Shiori (Drug Information Sheet)

This document provides information about Alfacalcidol Tablets 0.25mcg including its active ingredient, dosage forms, effects, dosing schedule, precautions, possible adverse reactions and storage conditions. It is used to improve symptoms associated with abnormal vitamin D metabolism and to treat osteoporosis. Patients should follow dosing instructions and see a doctor if any concerning symptoms arise.

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108 views2 pages

Alfacalcidol Tablets 0.25mcg - AMEL - Kusuri-no-Shiori (Drug Information Sheet)

This document provides information about Alfacalcidol Tablets 0.25mcg including its active ingredient, dosage forms, effects, dosing schedule, precautions, possible adverse reactions and storage conditions. It is used to improve symptoms associated with abnormal vitamin D metabolism and to treat osteoporosis. Patients should follow dosing instructions and see a doctor if any concerning symptoms arise.

Uploaded by

qa officer
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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4/3/24, 11:03 AM Alfacalcidol Tablets 0.

25mcg "AMEL" | Kusuri-no-Shiori(Drug Information Sheet)

Kusuri-no-Shiori
(Drug Information Sheet)

Information for people using this medication


Brand name

Alfacalcidol Tablets 0.25mcg "AMEL"


KYOWA PHARMACEUTICAL INDUSTRY CO., LTD

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.

Internal Published: 02/2024

Active ingredient: Alfacalcidol


Dosage form: white tablet, diameter: approx. 6.1mm, thickness: approx. 2.2mm
Imprint or print on wrapping: （face）アルファカルシドール0.25μg「アメル」 , KW171,（back）
Alfacalcidol 0.25μg≪AMEL≫, アルファカルシドール0.25μg「アメル」

Effects of this medicine


This medicine becomes active vitamin D3 in the liver and acts on the intestine and bone, etc., to promote intestinal calcium
absorption, dissolve bone minerals and form bones.
It is usually used to improve various symptoms (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, and to treat
osteoporosis.

The following patients may need to be careful when 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 or foods.
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, and for children, take 0.01 to 0.03 mcg/kg of the active ingredient at
a time, once a day. The dosage may be adjusted according to age or symptoms.
For chronic renal failure: In general, for adults, take 0.5 to 1.0 mcg, and for children, take 0.05 to 0.1 mcg/kg of the active
ingredient at a time, once a day. The dosage may be adjusted according to age/symptoms.
For hypoparathyroidism, vitamin D-resistant rickets/osteomalacia: In general, for adults, take 1.0 to 4.0 mcg, and for children, take
0.05 to 0.1 mcg/kg of the active ingredient at a time, once a day. The dosage may be adjusted according to the disease, age,
symptoms or type of disease.
This preparation contains 0.25 mcg of the active ingredient in a tablet. In any case, 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 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.

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4/3/24, 11:03 AM Alfacalcidol Tablets 0.25mcg "AMEL" | Kusuri-no-Shiori(Drug Information Sheet)

Precautions while taking this medicine


Do not take any over-the-counter medicines or dietary supplements containing a large amount of calcium or vitamin D without
consulting your doctor. Excessive intake of calcium and vitamin D would be of concern.
For healthcare professional use only

Possible adverse reactions to this medicine


The most commonly reported adverse reactions include itch, nausea, loss of appetite, diarrhea, constipation, gastric pain,
conjunctival hyperemia and rash. 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, general malaise [acute renal failure]


general malaise, loss of appetite, yellowness in the skin or whites of the eye [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 in a light shielding condition, away from heat and moisture.
Discard the remainder. Do not store them. Consult your pharmacy or medical institution about how to discard them.

For healthcare professional use only

Day Month Year

For further information, talk to your doctor or pharmacist.

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