Calceos®

Prescribing Information

Adverse events should be reported.
Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/.
Adverse events should also be reported to Galen Limited on 028 3833 4974 and select the customer services option, or e-mail customer.services@galen-pharma.com.
Medical information enquiries should also be directed to Galen Limited.

Calceos® 500mg/400IU Chewable Tablets Prescribing Information
Please refer to the Summary of Product Characteristics (SPC) before prescribing Calceos®.
Presentation: Square, white-grey chewable tablets containing calcium carbonate 1250mg (equivalent to 500mg of elemental calcium) and colecalciferol (Vitamin D3) 400IU (equivalent to 10μg) for oral use. Indications: Vitamin D and calcium deficiency correction in the elderly. Vitamin and calcium supplement as an adjunct to specific therapy for osteoporosis and in patients at high risk of vitamin D and calcium combined deficiencies. Dosage: Adults: One tablet to be chewed and taken with a glass of water, twice per day. These chewable tablets are a fixed combination of calcium and vitamin D. The high calcium and vitamin D concentration in each dose unit facilitates absorption of a sufficient quantity of calcium with a limited number of doses. Children: Not recommended. Contraindications: Calceos® is contraindicated in patients with hypercalcaemia, hypercalciuria, calcium lithiasis, tissue calcification, vitamin D overdose, myeloma and bone metastases, renal insufficiency and hypersensitivity to any of the ingredients. This product contains partially hydrogenated soybean oil. Patients should not take this medicinal product if they are allergic to peanut or soya. Warnings and Precautions: Care should be taken with use of other medication containing vitamin D. During long term treatment, serum and urinary calcium levels and kidney function should be monitored. This monitoring is particularly important in the elderly, in cases of combined treatment with cardiac glycosides or diuretics and in patients who are frequently subject to the formation of kidney stones. The dose should be reduced or treatment interrupted if urinary calcium exceeds 7.5mmol/24h (300mg/24h), in the presence of hypercalcaemia or if there are signs of problems with renal function. Use with caution in patients with renal insufficiency and the effects on calcium and phosphate homeostasis should be monitored. In patients with severe renal insufficiency, other forms of vitamin D3 (other than colecalciferol) must be used. Also use with caution in patients with sarcoidosis, in whom serum and urinary calcium should be monitored. This product contains sorbitol (E420) and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. The sucrose in this product may be harmful to teeth if taken chronically e.g. for two weeks or more. Interactions: Caution should be exercised when combining Calceos® with cardiac glycosides, thiazide diuretics and orlistat. Calcium may impair the absorption of tetracyclines, etidronate, fluoride and iron and therefore allow at least 3 hours between taking Calceos® and these agents. Calcium may reduce the absorption of strontium and so patients should avoid taking Calceos® immediately before and after taking strontium-containing medications. Calcium may also reduce the absorption of estramustine and levothyroxine and therefore these medicines should be taken at least two hours before or after taking Calceos®. Possible interaction with some foods, refer to SPC for more details. Fertility, pregnancy and lactation: Calceos® may be used during pregnancy and lactation. However, the daily intake should not exceed 1500mg calcium and 600IU vitamin D3. In pregnancy, an overdose of colecalciferol must be avoided (refer to SPC for more details). Vitamin D and its metabolites pass into the breast milk. This should be considered when giving additional vitamin D to the child. Effects on ability to drive and use machines: None known. Undesirable effects: Cases of hypersensitivity reactions such as angioedema or laryngeal oedema have been reported. Uncommon (≥1/1,000 to <1/100): hypercalcaemia, hypercalciuria and injury to teeth. Rare (≥1/10,000 to <1/1,000): constipation, flatulence, nausea, abdominal pain, diarrhoea, pruritus, rash and urticaria. Overdose: Please refer to SPC. Basic NHS cost: Packs containing 4 tubes of 15 tablets £3.94. Legal classification: P. Marketing Authorisation Holder: Laboratoire Innotech International, 22 avenue Aristide Briand, 94110 Arcueil, France. Marketing Authorisation Number: PL 19152/0001. Full prescribing information available from: Galen Limited, Seagoe Industrial Estate, Craigavon, Northern Ireland, BT63 5UA. Date of Preparation: July 2019