Recikalc-D forte 500 mg/800 IE Filmdragerad tablett

Land: Zweden

Taal: Zweeds

Bron: Läkemedelsverket (Medical Products Agency)

Werkstoffen:

kalciumkarbonat; kolekalciferol

Beschikbaar vanaf:

2care4 ApS

ATC-code:

A12AX

INN (Algemene Internationale Benaming):

calcium carbonate; cholecalciferol

Dosering:

500 mg/800 IE

farmaceutische vorm:

Filmdragerad tablett

Samenstelling:

kolekalciferol 20 mikrog Aktiv substans; sackaros Hjälpämne; kalciumkarbonat 1261 mg Aktiv substans

klasse:

Apotek

Prescription-type:

Receptbelagt

Therapeutisch gebied:

kombinationer med vitamin D och/eller övriga läkemedel

Autorisatie-status:

Avregistrerad

Autorisatie datum:

2015-02-03

Productkenmerken

SUMMARY OF THE PRODUCT CHARACTERISTICS
1
NAME
OF
THE
MEDICINAL
PRODUCT
Recikalc-D forte 500 mg/ 800 IU film-coated tablets
2
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
Each film-coated tablet contains calcium carbonate equivalent to 500
mg calcium,
cholecalciferol (Vitamin D
3
) 800 IU (20 microgram).
Excipients with known effect: sucrose 1.8 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL
FORM
Film-coated tablet
White, oval, engraved R150, 8.5 x 19 mm.
4
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention and treatment of calcium and vitamin D deficiency in the
elderly. Vitamin D and
calcium supplement in addition to specific osteoporosis treatment of
patients who are at risk
of vitamin D and calcium deficiency.
Recikalc-D forte film-coated tablets is indicated in adults aged 18
years and over.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and older people_
One film-coated tablet (500 mg/800 IU) daily.
The amount of calcium in Recikalc-D forte is less than the usually
recommended daily intake.
Recikalc-D forte is therefore primarily to be used by patients with
need of D-vitamin
substitution but with a dietary intake of calcium of 500 mg-1000 mg
per day. The patients
dietary intake of calcium should be estimated by the prescriber.
_Patients with hepatic impairment_
No dose adjustment is required
_Patients with renal impairment_
Recikalc-D forte should not be used in patients with severe renal
impairment (see section 4.3).
_Paediatric population_
There is no relevant use of Recikalc-D forte film-coated tablets in
children or adolescents.
Method of administration
Tablets shall be swallowed with water, whole, crushed or divided.
4.3
CONTRAINDICATIONS

Hypercalciuria and hypercalcaemia and diseases and/or conditions,
which lead to hypercalcaemia and/or hypercalciuria (e.g. myeloma, bone
metastases,
primary hyperparathyroidism).

Nephrolithiasis.

Nephrocalcinosis

Hypervitaminosis D.

Severe renal impairment and renal failure.

Hypersensitivity to the active