Ostelin Specialist Range Vitamin D 7000IU

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

colecalciferol, Quantity: 175 microgram

Available from:

Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare

INN (International Name):

colecalciferol

Pharmaceutical form:

Capsule, soft

Composition:

Excipient Ingredients: Soya Oil; purified water; patent blue V; Gelatin; glycerol; dl-alpha-tocopherol; allura red AC; titanium dioxide; propylene glycol; ethyl acetate; ethanol; isopropyl alcohol; strong ammonia solution; polyvinyl acetate phthalate; macrogol 400

Administration route:

Oral

Units in package:

24, 48, 4

Prescription type:

(S3) Pharmacist Only Medicine

Therapeutic indications:

For the treatment of vitamin D deficiency in adults and adolescents as directed by your medical practitioner or pharmacist.,For the prevention of vitamin D deficiency in high risk individuals under the supervision of a medical practitioner.

Product summary:

Visual Identification: Translucent blue oval shaped softgel capsule with 7000 printed in white ink lengthwise on shell and filled with a translucent pale yellow solution; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-09-07

Patient Information leaflet

OSTELIN SPECIALIST RANGE VITAMIN D 7000IU
(WEEKLY)
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING OSTELIN SPECIALIST RANGE VITAMIN D 7000IU?
Ostelin Specialist Range Vitamin D 7000IU contains the active
ingredient Colecalciferol. Ostelin Specialist Range Vitamin D
7000IU is a supplement that is used for the treatment of vitamin D
deficiency in adults and adolescents as directed by your medical
practitioner or pharmacist, and the prevention of vitamin D deficiency
in high risk individuals under the supervision of a medical
practitioner.
For more information, see Section 1. Why am I using Ostelin Specialist
Range Vitamin D 7000IU? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE OSTELIN SPECIALIST RANGE VITAMIN D
7000IU?
Do not use if you have ever had an allergic reaction to Ostelin
Specialist Range Vitamin D 7000IU or any of the ingredients listed at
the end of the CMI. TALK TO YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY
OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR
ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. DO NOT
GIVE TO CHILDREN UNDER 12 YEARS OLD.
For more information, see Section 2. What should I know before I use
Ostelin Specialist Range Vitamin D 7000IU? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Ostelin Specialist Range Vitamin D
7000IU and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE OSTELIN SPECIALIST RANGE VITAMIN D 7000IU?
•
Swallow the whole capsule with a glass of water.
•
The usual dose is one capsule once a week. Take the capsule on the
same day each week.
More instructions can be found in Section 4. How do I use Ostelin
Specialist Range Vitamin D 7000IU? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING OSTELIN SPEC

Summary of Product characteristics

Property of the Sanofi group - strictly confidential
Ostelin-specialist-range-7000iu-ccdsv1-piv3-1sept22
Page 1 of 8
AUSTRALIAN PRODUCT INFORMATION – OSTELIN SPECIALIST RANGE
VITAMIN D 7000IU (COLECALCIFEROL) SOFT CAPSULE
1
NAME OF THE MEDICINE
Colecalciferol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Ostelin Specialist Range Vitamin D 7000IU capsule contains 175mcg
of colecalciferol.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Colecalciferol is a naturally occurring form of Vitamin D. It is
produced from 7-dehydro
cholesterol, a sterol present in mammalian skin, by ultraviolet
irradiation. Colecalciferol
appears as white/almost white crystals.
Ostelin Specialist Range Vitamin D are formulated as soft capsules for
oral administration.
Ostelin Specialist Range Vitamin D 7000IU are blue coloured capsules
printed with ‘7000’.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For:
The treatment of vitamin D deficiency in adults and adolescents as
directed by your medical
practitioner or pharmacist.
The prevention of vitamin D deficiency in high risk individuals under
the supervision of a
medical practitioner or pharmacist.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Adults and adolescents from 12 years of age.
Swallow the capsule with a glass of water.
Recommended doses:
Ostelin Specialist Range Vitamin D 7000IU: one capsule to be taken
weekly.
Take the capsule on the same day each week.
Property of the Sanofi group - strictly confidential
Ostelin-specialist-range-7000iu-ccdsv1-piv3-1sept22
Page 2 of 8
4.3
C
ONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients.
Colecalciferol should not be given to patients with hypercalcaemia
(see Section 4.8 Adverse
Effects (undesirable Effects) and 4.9 Overdose).
Diseases and/or conditions, which lead to hypercalcaemia (e.g.
nephrocalcinosis, myeloma, bone
metastases, primary hyperparathyroidism, sarcoidosis, prolonged
immobilisation accompanied
by hypercalcaemia).
Hypervitaminosis D.
4.4
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PE