One-Alpha 1microgram capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Alfacalcidol

Available from:

Neon Healthcare Ltd

ATC code:

A11CC03

INN (International Name):

Alfacalcidol

Dosage:

1microgram

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09060400; GTIN: 5702191004915

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ONE-ALPHA
®
0.25 MICROGRAM SOFT CAPSULES
ONE-ALPHA
®
0.5 MICROGRAM SOFT CAPSULES
ONE-ALPHA
®
1 MICROGRAM SOFT 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, 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 soft capsules 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 changing. 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
parathyroid hormone. This changes the amount of calcium
in your body.
°
The glands may make the amount of calcium in your blood
too high (hyperparathyroidism).

Summary of Product characteristics

OBJECT 1
ONE-ALPHA CAPSULES
Summary of Product Characteristics Updated 09-Nov-2017 | Leo
Laboratories Limited
1. Name of the medicinal product
One-Alpha 1 microgram soft capsules
One-Alpha 0.25 microgram soft capsules
One-Alpha 0.5 microgram soft capsules
2. Qualitative and quantitative composition
Each capsule contains 1 microgram of alfacalcidol
Each capsule contains 0.25 micrograms of alfacalcidol
Each capsule contains 0.5 micrograms of alfacalcidol
Excipient with known effect:
Sesame oil
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
One-Alpha 1 microgram soft capsules: brown, egg-shaped soft gelatin
capsules, holding 0.1 g oily
solution.
One-Alpha 0.25 microgram soft capsules: Cream-coloured, egg-shaped
soft gelatin capsules, holding 0.1
g oily solution.
One-Alpha 0.5 microgram soft capsules: Reddish, egg-shaped soft
gelatin capsules, holding 0.1 g oily
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-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
INITIAL DOSE FOR ALL INDICATIONS:
Adults and children over 20 kg
bodyweight:
Elderly:
Neonates and premature infants:
Children under 20 kg bodyweight:
1 microgram/day
0.5 microgram/day
0.05 - 0.1 microgram/kg/day
0.05 microgram/kg/day
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
investigatio