Calcichew-D3 Forte Double Strength 1000 mg / 800 IU Chewable Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Calcium carbonate; Cholecalciferol concentrate (powder form)

Available from:

Takeda Products Ireland Ltd

ATC code:

A12AX

INN (International Name):

Calcium carbonate; Cholecalciferol concentrate (powder form)

Dosage:

1000mg/800IU mg/IU

Pharmaceutical form:

Chewable tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Calcium, combinations with vitamin D and/or other drugs

Authorization status:

Marketed

Authorization date:

2009-12-11

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calcichew-D
3
Forte Double Strength 1000 mg / 800 IU Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
Calcium carbonate equivalent to 1000 mg calcium.
Cholecalciferol concentrate (powder form) equivalent to 800 IU (20
microgram) cholecalciferol (vitamin D
3
)
Excipients with known effect:
One tablet contains 88.6 mg isomalt (E953) (contained in the flavour)
and 1.4 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet
Round, white, uncoated and convex tablets of 18 mm. May have small
specks.
4 CLINICAL PARTICULARS
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, once daily.
SPECIAL PATIENT POPULATIONS
_PAEDIATRIC POPULATION:_
Calcichew-D3 Forte Double Strength 1000mg/800 IU Chewable Tablets are
not intended for use in children and
adolescents.
_IMPAIRED RENAL FUNCTION_
Calcichew-D3 Forte Double Strength 1000mg/800 IU Chewable 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 tablet should be chewed or sucked.
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