CALCICHEW-D3 FORTE DOUBLE STRENGTH 1000MG / 800 IU
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
CALCIUM CARBONATE CHOLECALCIFEROL CONCENTRATE (POWDER FORM)
Available from:
Shire Pharmaceuticals Limited
Dosage:
1000/20
Pharmaceutical form:
Tablets Chewable
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
)
Excipient(s):
Isomalt (E953), 99.9 mg
Soya-bean oil, hydrogenated, 0.66 mg
Sucrose, 3.3 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet
Round, white, uncoated and convex tablets. 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
_Adults and elderly_
One chewable tablet once daily. The tablet may be chewed or sucked.
_Dosage in hepatic impairment_
No dose adjustment is required
_Dosage in renal impairment_
Calcichew-D
3
Forte Double Strength 1000 mg / 800 IU Chewable Tablets should not be used in patients with severe
renal impairment.
Calcichew-D
3
Forte Double Strength 1000 mg / 800 IU Chewable Tablets are not intended for use in children.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 25/11/2011_
_CRN 2098233_
_page number: 1_
4.3 CONTRAINDICATIONS
Diseases and/or conditions resulting in hypercalcaemia and/or hypercalcuria
Severe renal impairment
Nephrolithiasis
Hypervitaminosis D
Hypersensitivity to soya or peanut
Hypersensitivity to the active substances or to any of the excipients
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Dur
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