Calcigran-D3 Spearmint 500 mg/400 IE Tuggtablett

Država: Švedska

Jezik: švedščina

Source: Läkemedelsverket (Medical Products Agency)

Aktivna sestavina:

kalciumkarbonat; kolekalciferol

Dostopno od:

Orifarm AB

Koda artikla:

A12AX

INN (mednarodno ime):

calcium carbonate; cholecalciferol

Odmerek:

500 mg/400 IE

Farmacevtska oblika:

Tuggtablett

Sestava:

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

Razred:

Apotek

Tip zastaranja:

Receptbelagt

Terapevtsko območje:

kombinationer med vitamin D och/eller övriga läkemedel

Status dovoljenje:

Avregistrerad

Datum dovoljenje:

2013-07-02

Lastnosti izdelka

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