Drug Information Sheet ("Kusuri-no-Shiori")
613110001
Revised: 05/2007
Information is based on approvals granted in Japan. In some cases, the approved details may vary in countries
other than Japan.
In deciding to use a medicine, the risk (side effects) of taking the medicine must be weighed against the benefit
(effects) it will do. The patient's cooperation is indispensable here.
Brand name： ALFAROL Capsule 0.25μg
Active ingredient： Alfacalcidol
Dosage form： transparent brown capsule (φ: 5.6mm)
Printings on wrapping： アルファロール 0.25
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, tell your doctor/pharmacist
・ If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
・ If you are pregnant or breastfeeding.
・ If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce
the risk of drug interactions.)
Dosage regimen (proper use of this medicine)
・ Your dosage regimen is:≪
:order of your doctor≫
・ 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 0.25μg of the active ingredient. Strictly follow the instructions of your doctor in
any case.
・ Missed dose: Skip the missed dose and continue your regular dosing schedule. DO NOT take a
double dose to make up for the missed dose.
・ Overdose: If you took too much of this medicine (more than ordered), check with your
doctor/pharmacist.
・ Others: Do not stop taking this medicine without the instructions of your doctor.
Precautions while using 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.
Side effects of 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.
Symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur,
stop taking your medicine and check with 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］
Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any
worrisome symptom.
Continued on next page.
ALFAROL Capsule 0.25μg
Storage 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 doctor use only: Day
Month
Year
For further information, ask your doctor/pharmacist. Japanese package insert information (for medical
professionals) is available on the website of Pharmaceuticals and Medical Devices Agency.
Drug Information Sheet ("Kusuri-no-Shiori")
613110002
Revised: 05/2007
Information is based on approvals granted in Japan. In some cases, the approved details may vary in countries
other than Japan.
In deciding to use a medicine, the risk (side effects) of taking the medicine must be weighed against the benefit
(effects) it will do. The patient's cooperation is indispensable here.
Brand name： ALFAROL Capsule 0.5μg
Active ingredient： Alfacalcidol
Dosage form： opaque yellow capsule (φ: 5.6mm)
Printings 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, tell your doctor/pharmacist
・ If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
・ If you are pregnant or breastfeeding.
・ If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce
the risk of drug interactions.)
Dosage regimen (proper use of this medicine)
・ Your dosage regimen is:≪
:order of your doctor≫
・ 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.
・ Missed dose: Skip the missed dose and continue your regular dosing schedule. DO NOT take a
double dose to make up for the missed dose.
・ Overdose: If you took too much of this medicine (more than ordered), check with your
doctor/pharmacist.
・ Others: Do not stop taking this medicine without the instructions of your doctor.
Precautions while using 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.
Side effects of 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.
Symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur,
stop taking your medicine and check with 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］
Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any
worrisome symptom.
Continued on next page.
ALFAROL Capsule 0.5μg
Storage 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 doctor use only: Day
Month
Year
For further information, ask your doctor/pharmacist. Japanese package insert information (for medical
professionals) is available on the website of Pharmaceuticals and Medical Devices Agency.
Drug Information Sheet ("Kusuri-no-Shiori")
613110003
Revised: 05/2007
Information is based on approvals granted in Japan. In some cases, the approved details may vary in countries
other than Japan.
In deciding to use a medicine, the risk (side effects) of taking the medicine must be weighed against the benefit
(effects) it will do. The patient's cooperation is indispensable here.
Brand name： ALFAROL Capsule 1μg
Active ingredient： Alfacalcidol
Dosage form： opaque yellowish white capsule (φ: 5.6mm)
Printings on wrapping： アルファロール 1
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, tell your doctor/pharmacist
・ If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
・ If you are pregnant or breastfeeding.
・ If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce
the risk of drug interactions.)
Dosage regimen (proper use of this medicine)
・ Your dosage regimen is:≪
:order of your doctor≫
・ 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 1μg of the active ingredient. Strictly follow the instructions of your doctor in any
case.
・ Missed dose: Skip the missed dose and continue your regular dosing schedule. DO NOT take a
double dose to make up for the missed dose.
・ Overdose: If you took too much of this medicine (more than ordered), check with your
doctor/pharmacist.
・ Others: Do not stop taking this medicine without the instructions of your doctor.
Precautions while using 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.
Side effects of 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.
Symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur,
stop taking your medicine and check with 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］
Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any
worrisome symptom.
Continued on next page.
ALFAROL Capsule 1μg
Storage 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 doctor use only: Day
Month
Year
For further information, ask your doctor/pharmacist. Japanese package insert information (for medical
professionals) is available on the website of Pharmaceuticals and Medical Devices Agency.