Sical

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Calcitriol

Available from:

Alphapharm Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

SICAL
®

_contains the active ingredient calcitriol_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sical capsules.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Sical capsules
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT SICAL IS USED FOR
Sical contains the active ingredient
calcitriol, one of the naturally
occurring and biologically active
forms of Vitamin D. Calcitriol acts in
the body in a similar manner to
Vitamin D.
Sical is used to treat people with
osteoporosis, a disease where the
bones of the body weaken, and in the
prevention of osteoporosis in people
taking oral corticosteroids.
Sical capsules are also prescribed for
patients who have low blood calcium
levels due to osteodystrophy (a type
of bone disease), hypoparathyroidism
(a condition where the parathyroid
glands have decreased function) and
rickets.
Sical increases calcium absorption in
the intestine and stimulates healthy
bone growth.
There are many different types of
medicines used to treat bone
conditions. Sical belongs to a group
of medicines known as vitamin D
compounds.
Your doctor may have prescribed
Sical for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY SICAL HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
Sical is not addictive.
BEFORE YOU TAKE SICAL
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE SICAL IF:
•
YOU HAVE HAD AN ALLERGIC
REACTION TO SICAL, CALCITRIOL OR
ANY INGREDIENTS LISTED IN THE
INGREDIENTS SECTION OF THIS
LEAFLET
•
YOU HAVE HIGH BLOOD CALCIUM
LEVELS (HYPERCALCAEMIA)
•
YOU HAVE VITAMIN D TOXICITY
•
YOU ARE BREASTFEEDING OR WISH
TO BREASTFEED.
Sical may pass into the bre

Summary of Product characteristics

SICAL

_Calcitriol _
_ _
PRODUCT INFORMATION 
NAME OF THE MEDICINE 
Active ingredient: 
Calcitriol 
Chemical name: 
1,25-dihydroxycholecalciferol 
Structural formula: 

Molecular formula: 
C
27
H
44
O
3
   Molecular 
weight: 
416.65. 

       CAS 
Registry 
no.: 
32222-06-3 
DESCRIPTION 
Calcitriol is a white, crystalline compound, which occurs naturally
in humans.  It is soluble in organic 
solvents but practically insoluble in water.  
Calcitriol is available as soft gelatin capsules containing 0.25
micrograms of calcitriol.  Each capsule 
also contains butylated
hydroxyanisole, butylated hydroxytoluene, coconut oil -
fractionated, gelatin, 
glycerol, sorbitol solution (70 percent, non-crystallising), iron
oxide red, iron oxide yellow and 
purified water. 
PHARMACOLOGY 
PHARMACODYNAMICS 
Calcitriol is the most important active metabolite of vitamin D3.
 It is normally formed in the kidney 
from its precursor 25-hydroxycholecalciferol (25-HCC).
 Physiological daily production is normally 
0.5 - 1.0 
g and is somewhat higher during periods of increased bone
synthesis (eg growth or 
pregnancy). 
Sical 
- 
Product 
Information 

3 

The natural supply of vitamin D in humans depends mainly on
exposure to ultraviolet rays of the sun 
for conversion of 7-dehydrocholesterol in the skin to vitamin D3
(cholecalciferol).   
Vitamin D
3 
must be metabolically activated in the liver and
the kidney before it is fully active as a 
regulator of calcium and phosphorus metabolism at target tissues.
 The initial transformation of 
vitamin D
3 
is catalysed by a vitamin D
3
-25-hydroxylase enzyme (25-OHase) present in the liver, and 
the product of this reaction is 25-hydroxyvitamin D
3 
[25-(OH) D
3
].  Hydroxylation of 25-(OH) D
3 
occurs in the mitochondria of kidney tissue, activated by the
renal 25-hydroxyvitamin D
3
-1 alpha-
hydroxylase (alpha-OHase), to produce 1,25-(OH)2 D
3
 (calcitriol), the