Calcigran-D3 Spearmint 500 mg/400 IE Tuggtablett

Țară: Suedia

Limbă: suedeză

Sursă: Läkemedelsverket (Medical Products Agency)

Ingredient activ:

kalciumkarbonat; kolekalciferol

Disponibil de la:

Orifarm AB

Codul ATC:

A12AX

INN (nume internaţional):

calcium carbonate; cholecalciferol

Dozare:

500 mg/400 IE

Forma farmaceutică:

Tuggtablett

Compoziție:

aspartam Hjälpämne; sackaros Hjälpämne; kolekalciferol 10 mikrog Aktiv substans; sorbitol Hjälpämne; isomalt Hjälpämne; kalciumkarbonat 1250 mg Aktiv substans

Clasă:

Apotek

Tip de prescriptie medicala:

Receptbelagt

Zonă Terapeutică:

kombinationer med vitamin D och/eller övriga läkemedel

Statutul autorizaţiei:

Avregistrerad

Data de autorizare:

2013-07-02

Caracteristicilor produsului

SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
N
AME OF THE
M
EDICINAL
P
RODUCT
Calcichew-D
3
Spearmint 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 20.5 mg isomalt (E953), 0.8 mg sucrose
For a full list of excipients, see section 6.1
3.
P
HARMACEUTICAL
F
ORM
Chewable tablet
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 adults
with an identified risk.
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, INCLUDING ELDERLY_
One tablet twice daily.
SPECIAL PATIENT POPULATIONS
_PAEDIATRIC POPULATION:_
Calcichew-D
3
Spearmint is not intended for use in children.
_IMPAIRED RENAL FUNCTION:_
Calcichew-D
3
Spearmint 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 other
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 monitored.
Renal function should also be
monitored, through measurements of serum creatinine. Monitoring is
especially important in elderly
patients on concomitant treatment with cardiac glycosides or diuretics
(see secti