SICAL calcitriol 0.25 microgram capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

calcitriol, Quantity: 0.25 microgram

Available from:

Alphapharm Pty Ltd

INN (International Name):

Calcitriol

Pharmaceutical form:

Capsule, soft

Composition:

Excipient Ingredients: fractionated coconut oil; butylated hydroxyanisole; butylated hydroxytoluene; Gelatin; glycerol; sorbitol solution (70 per cent) (non-crystallising); purified water; iron oxide red; iron oxide yellow

Administration route:

Oral

Units in package:

100 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SICAL is indicated for the treatment of established osteoporosis diagnosed by objective measuring techniques, such as densitometry, or by radiographic evidence of atraumatic fracture. SICAL a is also indicated for the prevention of corticosteroid-induced osteoporosis in patients commencing oral steroid therapy in a dose and regimen expected to result in a significant bone loss. SICAL is indicated in the treatment of hypocalcemia in patients with uremic osteodystrophy, hypoparathyroidism and in hypophosphataemic rickets.

Product summary:

Visual Identification: Red coloured, oval, soft-gelatin capsules containing a clear, oily liquid.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-06-10

Patient Information leaflet

SICAL
®
_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,
OTHER VITAMIN D COMPOUNDS, 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 breastmilk
and have un

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
SICAL
_Calcitriol capsule _
1
NAME OF THE MEDICINE
Calcitriol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft gelatin capsule contains 0.25 micrograms of calcitriol as
the active ingredient.
Excipients with known effect: traces of sulfites.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
_ _
3
PHARMACEUTICAL FORM
Sical 0.25 microgram is supplied as a red coloured, oval shaped soft
gelatin capsule containing clear
oily fluid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sical is indicated for the treatment of established osteoporosis
diagnosed by objective measuring
techniques, such as densitometry, or by radiographic evidence of a
traumatic fracture.
Sical is also indicated for the prevention of corticosteroid-induced
osteoporosis in patients commencing
oral steroid therapy in a dose and regimen expected to result in a
significant bone loss.
Sical is indicated in the treatment of hypocalcaemia in patients with
uraemic osteodystrophy,
hypoparathyroidism and in hypophosphataemic rickets.
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL
The optimal daily dose of Sical must be carefully determined for each
patient and indication. Dosage
optimisation should be accompanied by regular monitoring of serum
calcium concentration.
When the optimal dosage of Sical has been determined, the serum
calcium levels should be checked
regularly. As soon as serum calcium nears hypercalcaemic levels (1 mg
per 100 mL [0.25mmol/L]
above normal 9-11 mg per 100 ml [2.25-2.75 mmol/L] on average), the
dosage of Sical should be
substantially reduced or treatment stopped altogether until
normocalcaemia ensues. If hypercalcaemia
occurs, the drug should be immediately discontinued until
normocalcaemia ensues. Withdrawal of
additional doses of calcium can also be of benefit in bringing about
rapid normalisation of serum
calcium levels. Careful consideration should also be given to lowering
the dietary calcium intake.
Should hypercalcaemia occur, Sical should be suspended immediately and