One-Alpha 2 micrograms/ml oral drops

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Alfacalcidol

Available from:

CHEPLAPHARM Arzneimittel GmbH

ATC code:

A11CC; A11CC03

INN (International Name):

Alfacalcidol

Dosage:

2 microgram(s)/millilitre

Pharmaceutical form:

Oral drops, solution

Therapeutic area:

Vitamin D and analogues; alfacalcidol

Authorization status:

Marketed

Authorization date:

1999-07-26

Patient Information leaflet

LEAFLET ONE-ALPHA 2MCG/ML 10ML TRO (IE)
DRAFT (DATE) 04.06.2021 [17:00 uhr] (3)
COLOURS Black linework
DIMENSIONS 170 x 320 mm
MATERIAL NUMBER CP 90004761/10
FONT SIZE 9 pt
MATERIAL NUMBER LEO 070086
PREVIOUS MATERIAL NUMBER LEO 069195
PACKAGE LEAFLET: INFORMATION FOR THE USER
ONE-ALPHA
® 2 MICROGRAMS/ML ORAL DROPS
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, pharmacist or
nurse.
• 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, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
• In this leaflet One-Alpha oral drops will be called One-Alpha.
WHAT IS IN THIS LEAFLET:
1. What One-Alpha
®
is and what it is used for
2. What you need to know before you take 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 contains the active substance alfacalcidol.
One-Alpha belongs to a group of medicines called vitamin D
analogues. It is a type of vitamin D.
Vitamin D controls the levels of two substances in your body.
These substances are called calcium and phosphate. Your
body needs both of these substances for healthy bones and
teeth.
One-Alpha works by increasing the amount of vitamin D in
your body. This means the levels of calcium and phosphate in
your body will increase too.
One-Alpha is used to treat diseases where the amount of
calcium in your body needs to be changed. It is used to treat:
• Changes in bone caused by kidney failure (osteodystrophy).
• Changes to your parathyroid glands. These are small glands
found in your neck. They make a substance called the
pa

Summary of Product characteristics

Health Products Regulatory Authority
28 May 2021
CRN00C6JT
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
One-Alpha 2 micrograms/ml oral drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Alfacalcidol 2 micrograms/ml. Each drop (0.05 millilitre) contains 0.1
micrograms (100 nanograms) alfacalcidol.
Excipients with known effect:
Ethanol equivalent to 14 vol%, methylparahydroxybenzoate (E218) 1.5
mg/ml, macrogolglycerol hydroxystearate 22.6 mg/ml,
sorbitol (E420) 452 mg/ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral drops, solution.
Slightly turbid to clear, colourless solution.
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 a-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
Initial dose for all indications:
Adults and children over 20 kg bodyweight: 1 microgram/day
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
To administer this medicine hold the dropper in a vertical position,
upside down. The drops should flow immediately but if they
do not, tap the bottle gently. Do not shake the bottle.
Half-drop doses should be rounded up to the next whole number of
drops.
Health Products Regulatory Authority
28 May 2021
CRN00C6JT
Page 2 of 7
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