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

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Calcium phosphate; Cholecalciferol

Inapatikana kutoka:

Menarini International Operations Luxembourg S.A.

ATC kanuni:

A12AX

INN (Jina la Kimataifa):

Calcium phosphate; Cholecalciferol

Kipimo:

1200 mg/800 international unit(s)

Dawa fomu:

Powder for oral suspension

Dawa ya aina:

Product subject to prescription which may be renewed (B)

Eneo la matibabu:

Calcium, combinations with vitamin D and/or other drugs

Idhini hali ya:

Not marketed

Idhini ya tarehe:

2002-06-28

Taarifa za kipeperushi

Package leaflet: Information for the user
CALFOVIT 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 CALFOVIT D3 is and what it is used for
2.
What you need to know before you take CALFOVIT D3
3.
How to take CALFOVIT D3
4.
Possible side effects
5.
How to store CALFOVIT D3
6.
Contents of the pack and other information
1.
WHAT CALFOVIT D3 IS AND WHAT IT IS USED FOR
CALFOVIT 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. CALFOVIT D3
may be taken to make up for this deficiency of calcium and vitamin D.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALFOVIT D3
DO NOT TAKE CALFOVIT 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 or pharma

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calfovit 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) per dose and not
more than 8.8 mg
sucrose 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.
CALFOVIT D3 is indicated in adults and elderly.
CALFOVIT 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_
CALFOVIT D3 should not be used in patients with severe renal
dysfunction.
_Paediatric population_
The safety and efficacy of CALFOVIT D3 in children has not been
established; therefore, CALFOVIT D3 should not
be used in this population. No data are available.
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