One-Alpha Capsules 0.25 microgram

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ALFACALCIDOL

Available from:

Cheplapharm Arzneimittel GmbH Ziegelhof 24 17489 Greifswald , Germany

ATC code:

A11CC03

INN (International Name):

ALFACALCIDOL 0.25 µg

Pharmaceutical form:

SOFT CAPSULE

Composition:

ALFACALCIDOL 0.25 µg

Prescription type:

POM

Therapeutic area:

VITAMINS

Authorization status:

Authorised

Authorization date:

2006-08-10

Patient Information leaflet

1
_Version 4, 02/2016 _
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ONE-ALPHA
® 0.25 MICROGRAM CAPSULES
Alfacalcidol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What One-Alpha
®
is and what it is used for
2.
What you need to know before you use One-Alpha
®
3.
How to take One-Alpha
®
4.
Possible side effects
5.
How to store One-Alpha
®
6.
Contents of the pack and other information
1.
WHAT ONE-ALPHA
® IS AND WHAT IT IS USED FOR
One-Alpha
®
capsules are indicated for the treatment of diseases caused by
disturbances in the calcium
- phosphate metabolism as a consequence of reduced endogenous
1α-hydroxylation of vitamin D3
such as:
Renal osteodystrophy and secondary
hyperparathyroidism.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ONE-ALPHA
®
DO NOT TAKE ONE-ALPHA
®
:
-
if you are allergic (hypersensitive) to alfacalcidol or any of the
other ingredients of One-
Alpha
®
(listed in section 6).
-
if you have high levels of calcium in your blood.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking One-Alpha
®
Take special care with One-Alpha
®
-
During treatment with One-Alpha
®
, the levels of calcium and phosphate in your blood should be
monitored regularly by your doctor.
-
If you have a renal bone disease a phosphate binding agent may be used
to maintain serum
phosphate at an acceptable level. Consult your doctor.
-
As high levels of calcium in the blood (hypercalcaemia) might appear
when you are treated with
One-Alpha
®
you should be aware of the clinica

Summary of Product characteristics

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_Version 4, 02/2016 _
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
One-Alpha Capsules 0.25 microgram.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alfacalcidol (1-

hydroxyvitamin D3) 0.25

g.
3.
PHARMACEUTICAL FORM
White soft gelatin capsules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
One-Alpha is indicated in all conditions where there is a disturbance
of calcium metabolism due to
impaired 1-α hydroxylation such as when there is reduced renal
function. The main indications are:
a)
Renal osteodystrophy
b)
Hyperparathyroidism (with bone disease)
c)
Hypoparathyroidism
d)
Neonatal hypocalcaemia
e)
Nutritional and malabsorptive rickets and osteomalacia
f)
Pseudo-deficiency (D-dependent) rickets and osteomalacia
g)
Hypophosphataemic vitamin D resistant rickets and osteomalacia
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Route of administration: oral
Initial dose for all indications:
Adults:
1 microgram/day
Dosage in the elderly:
0.5 microgram/day
Neonates and premature infants:
0.05-0.1 microgram/kg/day
Children under 20 kg bodyweight:
0.05 microgram/kg/day
Children over 20 kg bodyweight:
1 microgram/day
Method of administration
The dose of One-Alpha should be adjusted thereafter to avoid
hypercalcaemia according to the
biochemical response. Indices of response include plasma levels of
calcium (ideally corrected for
protein binding), alkaline phosphatase, parathyroid hormone, as well
as radiographic and histological
investigations.
Plasma levels should initially be measured at weekly intervals. The
daily dose of One-Alpha may be
increased by increments of 0.25-0.5 microgram. When the dose is
stabilised, measurements may be
taken every 2-4 weeks.
Most adult patients respond to doses between 1 and 3 micrograms per
day. When there is biochemical
or radiographic evidence of bone healing, (and in hypoparathyroid
patients when normal plasma
calcium levels have been attained), the dose generally decreases.
Maintenance doses are generally in
3
the range of 0.25 to 1 microgram