Calceos

1. Name Of The Medicinal Product

CALCEOS Chewable Tablets.

2. Qualitative And Quantitative Composition

Calcium Carbonate 1250mg (i.e. 500mg or 12.5mmol of elemental calcium).

Colecalciferol (INN) (Vitamin D₃) 10μg (corresponding to 400IU of Vitamin D₃).

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Chewable tablets, for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

Vitamin D and calcium deficiency correction in the elderly. Vitamin and calcium supplement as an adjunct to specific therapy for osteoporosis.

4.2 Posology And Method Of Administration

Oral use. For adults only. One tablet, twice per day. Chew the tablets and drink a glass of water.

4.3 Contraindications

Hypersensitivity to one of the constituents. Hypercalcaemia as a result of hyperparathyroidism (primary or secondary), hypercalciuria, calcium lithiasis, tissue calcification (nephrocalcinosis). Vitamin D overdose. Myeloma and bone metastases. Renal insufficiency (creatinine clearance less than 20ml/min). Calceos tablets are also contra-indicated in patients where prolonged immobilisation is accompanied by hypercalcaemia and/or hypercalciuria. In these cases, treatments should only be resumed when the patient becomes mobile.

This product contains partially hydrogenated soybean oil. Patients should not take this medicinal product if they are allergic to peanut or soya.

4.4 Special Warnings And Precautions For Use

Calculate the total Vitamin D intake in case of treatment with another drug containing this vitamin.

The following may be important in patient monitoring: plasma calcium and urinary calcium determinations.

Precautions:

Plasma and urinary calcium levels should be monitored regularly.

In the elderly, renal function must be monitored regularly.

In patients with renal failure, dosage has to be adapted according to the creatinine clearance.

In case of long term treatment, the urinary calcium excretion must be monitored and treatment must be reduced or momentarily suspended if urinary calcium exceeds 7.5 to 9mmol/24h (300 to 360mg/24h).

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In case of treatment with digitalis glycosides: risk of cardiac arrhythmias. Clinical surveillance is required and possibly electrocardiographic and plasma calcium monitoring are recommended.

Associations to be taken into account in the case of treatment with thiazide diuretics: risk of hypercalcaemia by decreasing urinary calcium excretion.

Calcium may impair the absorption of tetracyclines, etidronate, fluoride and iron. At least 3 hours should intervene between taking Calceos and these agents.

Possible interaction with food, for example foods containing oxalic acid (e.g. spinach, rhubarb, sorrel, cocoa, tea), phosphate (e.g. ham, sausages, cheese spread) or phytic acid (e.g. pulses, whole cereals, chocolate). These types of foods may reduce the absorption of calcium. It is therefore recommended that meals containing these foods be taken some time (e.g. two hours) before or after ingestion of the product.

4.6 Pregnancy And Lactation

Normal requirements for calcium and vitamin D are raised during pregnancy and lactation. If supplementation is necessary, it should be given at a different time to iron supplements. Calcium is excreted in breast milk but not sufficiently to produce an adverse effect in the infant.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

- Hypercalciuria in cases of prolonged treatment at high doses, exceptionally hypercalcaemia.

- Hypophosphataemia

- Nausea

- Mild gastro-intestinal disturbances such as constipation can occur but are infrequent

- This product contains sucrose. May be harmful to teeth if taken chronically, e.g. for two weeks or more.

4.9 Overdose

Clinical signs: Anorexia, intense thirst, nausea, vomiting, polyuria, polydipsia, dehydration, hypertension, vasomotor disorders, constipation.

Laboratory signs: Hypercalcaemia, hypercalciuria, impaired renal function tests.

Emergency treatment:

- Stop all calcium and vitamin D supplements.

- Rehydration and, according to the severity of the intoxication, isolated or combined use of diuretics, corticosteroids, calcitonin, peritoneal dialysis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Calceos is 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. Vitamin D is involved in calcium-phosphorus metabolism. It allows active absorption of calcium and phosphorus from the intestine and their uptake by bone.

5.2 Pharmacokinetic Properties

Calcium Carbonate:

Absorption:

In the stomach, calcium carbonate releases calcium ion as a function of pH. Calcium is essentially absorbed in the proximal part of the small intestine. The rate of absorption of calcium in the gastrointestinal tract is of the order of 30% of the dose ingested.

Elimination:

Calcium is eliminated in sweat and gastrointestinal secretions. The urinary calcium excretion depends on the glomerular filtration and rate of tubular resorption of calcium.

Vitamin D₃:

Vitamin D₃ is absorbed from the intestine and transported by protein binding in the blood to the liver (first hydroxylation) and to the kidney (second hydroxylation).

Non-hydroxylated Vitamin D₃ is stored in reserve compartments such as muscle and adipose tissues. Its plasma half-life is of the order of several days; it is eliminated in faeces and urine.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Xylitol

Sorbitol (E420)

Povidone

Lemon flavouring*

Magnesium stearate

^* Composition of the lemon flavouring: essential oils of lemon, orange and litsea cubeba, maltodextrin, acacia gum and sodium citrate.

The colecalciferol is present as a concentrate powder that also contains:

DL-alpha-Tocopherol

Partially hydrogenated soybean oil

Gelatin

Sucrose

Corn starch

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Polypropylene tube and polyethylene stopper with silica gel desiccant containing 10, 15, 30, 60 and 100 tablets. Packs of 1, 2, 4 or 10 tubes in card outers.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Laboratoire Innotech International

22 avenue Aristide Briand

94110 Arcueil

France

8. Marketing Authorisation Number(S)

PL 19152/0001

9. Date Of First Authorisation/Renewal Of The Authorisation

31 October 2001

10. Date Of Revision Of The Text

11 August 2011