CALCICHEW-D3 FORTE 500 MG/ 400 IU FILM-COATED TA
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
01-05-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
CALCIUM CARBONATE CHOLECALCIFEROL CONCENTRATE (POWDER FORM)
Available from:
Shire Pharmaceuticals Limited
Dosage:
500/10
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2009-12-11
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calcichew-D
3
Forte 500 mg / 400 IU Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
Calcium carbonate equivalent to 500 mg calcium
Cholecalciferol concentrate (powder form) equivalent to 400 IU (10 microgram ) cholecalciferol (vitamin D
3
)
Excipient(s):
Sorbitol (E420), 154 mg
Sucrose, 1.6 mg
Soya-bean oil, hydrogenated, 0.33 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Oval, white/off white, film-coated tablets. May have hardly visible grey spots.
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 film-coated tablet twice daily. The tablet may be swallowed or chewed.
_Dosage in hepatic impairment_
No dose adjustment is required
_Dosage in renal impairment_
Calcichew-D
3
Forte 500 mg / 400 IU Film-coated Tablets should not be used in patients with severe renal impairment.
Calcichew-D
3
Forte 500 mg / 400 IU Film-coated Tablets are not intended for use in children.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 29/09/2011_
_CRN 2098232_
_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
During long-term treatm
Read the complete document
