Calcium D3 Nycomed Forte tablets chewable with lemon flavour

Maa: Armenia

Kieli: englanti

Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiivinen ainesosa:

calcium (calcium carbonate), colecalciferol

Saatavilla:

Takeda AS

ATC-koodi:

առկա չէ (A12AX)

INN (Kansainvälinen yleisnimi):

calcium (calcium carbonate), colecalciferol

Annos:

500mg+ 10mcg(400IU)

Lääkemuoto:

tablets chewable with lemon flavour

Kpl paketissa:

(30), (60), (120) in plastic container

Prescription tyyppi:

OTC

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2017-08-30

Valmisteyhteenveto

SUMMARY OF THE PRODUCT CHARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
Calcium D3 Nycomed Forte 500 mg/400 IU chewable tablets
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
One tablet contains:
Calcium carbonate equivalent to 500 mg calcium_ _
Cholecalciferol concentrate (powder form) equivalent to 400 IU (10
microgram) cholecalciferol
(vitamin D
3
)
Excipients: with known effect:
One tablet contains 44.3 mg isomalt (E953) (contained in the flavour),
0.7 mg sucrose
For a full list of excipients, see section 6.1
3
P
HARMACEUTICAL
F
ORM
Chewable tablets with lemon flavour.
Round, white, uncoated and convex tablets of 14 mm. May have small
specks.
4
C
LINICAL
P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention and treatment of vitamin D and calcium deficiency in the
elderly.
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 _
One tablet twice daily.
_ _
SPECIAL PATIENT POPULATIONS
_ _
_PAEDIATRIC POPULATION: _
Calcium D3 Nycomed Forte 500 mg/400 IU are not intended for use in
children.
_IMPAIRED RENAL FUNCTION: _
Calcium D3 Nycomed Forte 500 mg/400 IU 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 measurements of serum creatinine. Monitoring is
especially important in elderly
patients on conco