ZODORAY 0,5 ug CAPSULES

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Strides Pharma (SA) (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

CAPSULES

Composition:

EACH CAPSULE CONTAINS ALFACALCIDOL 0,5 ug

Authorization status:

Registered

Patient Information leaflet

Strides Pharma SA (Pty) Ltd
Date: 09 March 2021
Page 1 of 9
J.Viljoen
PROPOSED PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
ZODORAY 0,25 ΜG CAPSULES, ZODORAY 0,5 ΜG CAPSULES,
ZODORAY 1 ΜG CAPSULES
ALFACALCIDOL
CONTAINS SUGAR: Sorbitol 10 mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ZODORAY

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor, pharmacist,
nurse or other health
care provider.

ZODORAY has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the same as
yours. _ _
_ _
WHAT IS IN THIS LEAFLET
1.
What ZODORAY is and what it is used for
2.
What you need to know before you take ZODORAY
3.
How to take ZODORAY
4.
Possible side effects
5.
How to store ZODORAY
6.
Contents of the pack and other information
1.
WHAT ZODORAY IS AND WHAT IT IS USED FOR
Alfacalcidol belongs to a group of medicines called vitamin D
analogues. It is a type of
vitamin D.
Strides Pharma SA (Pty) Ltd
Date: 09 March 2021
Page 2 of 9
J.Viljoen
Vitamin D controls the levels of calcium and phosphate in your body.
Your body needs both
of these substances for healthy bones and teeth. Alfacalcidol 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.
ZODORAY 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 (renal bone disease).

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.
o
The glands may make the amount of calcium in your blood too low
(hypoparathyroidism).
o
The glands may make the amount of calcium in your blood too high
(hyperparathyroidism).

Softening and deformity of the bones due to lack of calcium,
phosphorus or vitamin D
(rickets or osteomalac

Summary of Product characteristics

Strides Pharma SA (Pty) Ltd
Date: 09 March 2021
Page 1 of 11
J.Viljoen
PROPOSED PROFESSIONAL INFORMATION
SCHEDULING STATUS
S4
1
NAME OF THE MEDICINE
ZODORAY 0,25 µg capsules
ZODORAY 0,5 µg capsules
ZODORAY 1 µg capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZODORAY 0,25 ΜG CAPSULES: Each capsule contains 0,25 µg
alfacalcidol.
ZODORAY 0,5 ΜG CAPSULES: Each capsule contains 0,50 µg alfacalcidol.
ZODORAY 1 ΜG CAPSULES: Each capsule contains 1 µg alfacalcidol.
Excipient: Contains 98,7 mg arachis oil (peanut oil).
Contains sugar: Sorbitol 10 mg.
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
ZODORAY 0,25 µg capsules: Reddish brown coloured, oval shaped soft
gelatine capsules
containing clear oily liquid.
ZODORAY
0,5
µg capsules:
Light
pink
coloured,
oval
shaped soft gelatine
capsules
containing clear oily liquid.
ZODORAY
1 µg
capsules:
Pale yellow
coloured,
oval
shaped soft
gelatine capsules
containing clear oily liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Strides Pharma SA (Pty) Ltd
Date: 09 March 2021
Page 2 of 11
J.Viljoen
a) Renal osteodystrophy
b) Hypoparathyroidism
c) Hyperparathyroidism (with bone disease)
d) Hypophosphataemic vitamin D resistant rickets and osteomalacia
e) Pseudo-deficiency (vitamin D-dependent) rickets
f) Nutritional and malabsorptive rickets and osteomalacia
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
INITIAL DOSE FOR ALL INDICATIONS
_Adults:_
1 µg daily
_Children 20 kg body weight and above:_
1 µg daily
_Children less than 20 kg body weight:_
0,05 µg/kg daily
Elderly:
0,5 μg daily
It is important to adjust dosage thereafter according to the
biochemical responses and to avoid
hypercalcaemia. Indices of response include levels of plasma calcium,
alkaline phosphatase,
parathyroid hormone, urinary calcium excretion as well as radiographic
and histological
investigations. Correct plasma levels should initially be measured at
weekly intervals. The
daily dose of Alfacalcidol may be increased by increments of 0,25 –
0,5 μg. When the