Osteofos D3 1200mg/800 I.U. powder for oral suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Calcium phosphate; Cholecalciferol

Available from:

Menarini International Operations Luxembourg S.A.

ATC code:

A12AX

INN (International Name):

Calcium phosphate; Cholecalciferol

Dosage:

1200mg/800 international unit(s)

Pharmaceutical form:

Powder for oral suspension

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Calcium, combinations with vitamin D and/or other drugs

Authorization status:

Not marketed

Authorization date:

2002-06-28

Patient Information leaflet

Package leaflet: Information for the user
OSTEOFOS D3 1200 MG/ 800 I.U. POWDER FOR ORAL SUSPENSION
Calcium and Colecalciferol
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 questions, ask your doctor or pharmacist.

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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What OSTEOFOS D3 is and what it is used for
2.
What you need to know before you take OSTEOFOS D3
3.
How to take OSTEOFOS D3
4.
Possible side effects
5.
How to store OSTEOFOS D3
6.
Contents of the pack and other information
1.
WHAT OSTEOFOS D3 IS AND WHAT IT IS USED FOR
OSTEOFOS D3 is a calcium and vitamin D3 supplement for the treatment
of certain bone conditions in adults
and elderly.
Both calcium and vitamin D are found in the diet and vitamin D is also
produced in the skin following
exposure to the sun.
A lack of vitamin D and calcium may lead to reduced bone density and
bone fractures. OSTEOFOS D3 may be
taken to make up for this deficiency of calcium and vitamin D.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OSTEOFOS D3
DO NOT TAKE OSTEOFOS D3:

if you are allergic to calcium, colecalciferol
_ _
or any of the other ingredients of this medicine (listed in section
6)

if you are inactive and have high levels of calcium in your blood
(hypercalcaemia) or urine (hypercalciuria)

if you have
_ _
calcium deposits in the tissues of your body

if you have
_ _
serious kidney problems

if you have
_ _
kidney stones or calcium stones in general

if you have
_ _
abnormally high levels of vitamin D.

if you are pregnant or breast feeding

if you are less than 18 years of age
WARNING AND PRECAUTIONS
Talk to your doctor

Summary of Product characteristics

Health Products Regulatory Authority
07 April 2021
CRN00C1JZ
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Osteofos D3 1200mg/800 I.U. powder for oral suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains:
Colecalciferol (Vitamin D3) 20 micrograms (equivalent to 800 I.U.)
Calcium phosphate 3100 mg
(equivalent to 1200 mg or 30 mmol of elemental calcium per sachet)
Excipients with known effect: also contains 2 mg Sunset yellow FCF
(E110), not more than 8.8 mg sucrose and 640 mg
propylene glycol (E 1520) per dose
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral suspension
White or slightly orange, granular powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Correction of calcium and Vitamin D deficiency.
OSTEOFOS D3 is indicated in adults and elderly.
OSTEOFOS D3 may be used as an adjunct to specific therapy for
osteoporosis, in patients with either established vitamin D and
calcium combined deficiencies or in those patients at high risk of
needing such therapeutic supplements.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly _
1 sachet/day for oral use.
_Patients with hepatic impairment_
No dosage adjustment is required.
_Patients with renal impairment _
OSTEOFOS D3 should not be used in patients with severe renal
dysfunction.
_Paediatric population_
The safety and efficacy of OSTEOFOS D3 in children has not been
established; therefore, OSTEOFOS D3 should not be used in
this population.
No data are available.
Method of administration
Pour the contents of the sachet into a glass of non-carbonated water.
Stir with a spoon to obtain a pleasant-tasting suspension.
Drink immediately.
It is advisable to take the preparation during the evening meal.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
Hypercalcaemia (>10.5 mg/dl), hypercalciuria (300 mg or 7.5 mmol/24
hours), severe renal insufficiency, kidney stones, calcium
lithiasis, calci