Calcium D3 Nycomed tablets chewable with orange flavour

Χώρα: Αρμενία

Γλώσσα: Αγγλικά

Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Δραστική ουσία:

calcium (calcium carbonate), colecalciferol

Διαθέσιμο από:

Takeda AS

Φαρμακολογική κατηγορία (ATC):

առկա չէ (A12AX)

INN (Διεθνής Όνομα):

calcium (calcium carbonate), colecalciferol

Δοσολογία:

500mg+ 5mcg(200IU)

Φαρμακοτεχνική μορφή:

tablets chewable with orange flavour

Μονάδες σε πακέτο:

(20), (50), (100) in plastic container

Τρόπος διάθεσης:

OTC

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2018-03-12

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Calcium D3 Nycomed 500 mg/200 IU chewable tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
Calcium carbonate equivalent to 500 mg calcium
Cholecalciferol concentrate (powder form) equivalent to 200 IU (5
microgram) cholecalciferol
(vitamin D3)
Excipients:
Isomalt (E953)
Sucrose
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Chewable tablets with orange flavour.
Round, white and convex tablets. May have small specks.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention and treatment of vitamin D and calcium deficiency.
Vitamin D and calcium supplement as an adjunct to specific
osteoporosis treatment of patients who
are at risk of vitamin D and calcium deficiency.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_ _
_ADULTS AND ELDERLY _
_Adjunctive therapy in osteoporosis _
One tablet 2-3 times per day
_Calcium and vitamin D deficiency _
One tablet 1-3 times per day
_PAEDIATRIC POPULATION _
_Calcium and vitamin D deficiency (only) _
One tablet 1-2 times per day.
_IMPAIRED RENAL FUNCTION _
Calcium D3 Nycomed tablets should not be used in patients with severe
renal impairment (see section
4.3).
_ _
_IMPAIRED HEPATIC FUNCTION _
No dose adjustment is required.
METHOD OF ADMINISTRATION
Oral. The tablets should be chewed or sucked.
4.3
CONTRAINDICATIONS

Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1

Severe renal impairment (glomerular filtration rate < 30 ml/min/1.73m
2
)

Diseases and/or conditions resulting in hypercalcaemia and/or
hypercalciuria

Renal calculi (nephrolithiasis)

Hypervitaminosis D
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
During long-term treatment, serum calcium levels should be followed
and renal function should be
monitored through measurement of serum creatinine. Monitoring is
especially important in elderly
patients on concomitant treatment with cardiac glycosides or diuretics
(see section 4.5) and in patie