Calcium And Ergocalciferol Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
CALCIUM AND ERGOCALCIFEROL TABLETS
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Calcium Lactate 300mg, Calcium Phosphate 150mg
2+
equivalent to 2.415mmol of calcium (Ca ) and Ergocalciferol (Vitamin D2) 10pg (equivalent to 400iu).
3 PHARMACEUTICAL FORM
White uncoated tablets.
White circular, biconvex uncoated tablets impressed with the identifying letters “C” and “CV” on one face.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of nutritional deficiency in:
1) Vitamin D deficiency including nutritional rickets.
4.2 Posology and method of administration
Adults and children over 6 years: One tablet daily, crushed before administration. It is recommended that the tablets are taken after meals. Children under 6years: Not recommended.
Elderly: Continuous regular use in the elderly (more than 1-2 months) is not recommended.
For oral administration.
4.3 Contraindications
Patients with known hypersensitivity to calcium or ergocalciferol (vitamin D) or any ingredient in the tablet.
Severe hypercalcaemia and hypercalciuria (eg in hypervitaminosis D, hyperthyroidism, severe renal failure, osteoporosis due to immobility and decalcifying tumours such as plasmocytoma and skeletal metastases).
Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose - galactose malabsorption should not take this medicine.
Patients with rare hereditary problems of fructose intolerance, glucose -galactose malabsorption or sucrase - isomaltase insufficiency should not take this medicine. Calcium salts should be given cautiously to patients with impaired renal function or cardiac disease.
During long-term treatment, serum calcium levels should be followed and renal function should be monitored through measurements of serum creatinine. Monitoring is especially important in elderly patients on concomitant treatment with cardiac glycosides or diuretics (see section 4.5) and in patients with a high tendency to calculus formation. In case of hypercalcaemia or signs of impaired renal function the dose should be reduced or the treatment discontinued.
Caution should be used in patients suffering from sarcoidosis because of the risk of increased metabolism of vitamin D to its active metabolite. In these patients, serum calcium levels and urinary calcium excretion must be monitored.
Changes in dose may not be apparent for up to six weeks, as ergocalciferol has a cumulative action and dosing must be carefully controlled.
Allowances should be made for calcium and vitamin D supplements from other sources.
4.5 Interaction with other medicinal products and other forms of interaction
Diuretics - thiazide diuretics reduce the urinary excretion of calcium. Due to increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics.
Cardiac glycosides - the effects of digitalis and other cardiac glycosides may be accentuated with oral administration of calcium combined with vitamin D. Electrocardiogram (ECG) and serum calcium levels should be monitored.
Anticonvulsants - the effects of vitamin D may be reduced in patients taking anticonvulsants or barbiturates, due to increased metabolism of the vitamin D.
Tetracycline - calcium may interfere with the absorption of tetracycline preparations, therefore two - three hours should be left in between doses if used concomitantly.
Systemic corticosteroids - reduce calcium absorption
Calcium and ergocalciferol reduces the absorption of bisphosphonate or sodium fluoride therefore if used concomitantly they should be taken at least three hours apart.
Oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole cereals) may inhibit calcium absorption through formation of insoluble calcium salts. The patient should not take calcium products within two hours of eating foods high in oxalic acid and phytic acid.
During pregnancy and lactation treatment with calcium and ergocalciferol should always be under the direct of a physician and the daily intake should not exceed 1500mg calcium and 600 IU vitamin D. If the product is administered during pregnancy, allowances should be made for vitamins obtained from other sources.
Overdoses of vitamin D have shown teratogenic effects in pregnant animals. In human, long term hypercalcaemia can lead to physical and mental retardation, aortic stenosis and retinopathy in a new born child. Vitamin D and its metabolites pass into the breast milk.
4.7 Effects on ability to drive and use machines
None Known.
4.8 Undesirable effects
Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: Uncommon (>1/1,000,<1/100) or rare
(>1/10,000,<1/1,000).
Metabolism and nutrition disorders Uncommon: Hypercalcaemia and hypercalciuria.
Gastrointestinal disorders
Rare: Constipation, flatulence, nausea, abdominal pain, and diarrhoea.
Skin and subcutaneous disorders Rare: Pruritus, rash and urticaria
4.9 Overdose
Deliberate overdosage is unlikely due to the size of the tablets and the necessity to crush them before swallowing. The symptoms of overdosage as hypercalcaemia with calcium and vitamin D include abdominal pain, anorexia, bone pain, constipation, headache, lassitude, mental disturbances, nausea, nephrocalcinosis, polydipsia, polyuria, renal calculi, vertigo and raised blood urea, vomiting, and in severe cases, cardiac arrhythmias and coma; calcium may be deposited in many tissues including the kidney and arteries and the plasma cholesterol level may become elevated.
Calcium and vitamin D intake should be reduced to a minimum and dehydration and electrolyte imbalance corrected immediately. Careful monitoring of serum-electrolyte is essential throughout therapy. Intravenous rehydration may be given with, or followed by, furosemide or other loop diuretics to increase calcium excretion. Hypercalcaemia may be corrected by the administration of hydrocortisone (40mg every 8 hours). If this fails, calcitonin, sodium edetate or plicamycin may be administered by injection. The absorption of calcium may be reduced by the oral administration of sodium phosphates with a pH of 7.4 ("neutral phosphates") and magnesium sulphate by injection. Phosphate infusion must not be given because of the
danger of metastatic calcification. Significant amounts of calcium and vitamin D may be removed by peritoneal dialysis. Haemodialysis may be considered as a last resort.
Patients with symptoms of overdosage should avoid exposure to direct sunlight. Special care must be exercised when treating overdosage in patients with impaired renal or cardiac function.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Calcium lactate and calcium phosphate are used in calcium deficiency. Ergocalciferol is a vitamin (D2).
5.2 Pharmacokinetic properties
Calcium is absorbed from the small intestine. About one third of ingested
calcium is absorbed although this can vary depending upon dietary factors and the state of the small intestine; also the absorption is increased during periods of high physiological requirement such as during pregnancy and lactation.
After absorption calcium is eventually incorporated into bones and teeth with 99% of the body’s calcium content being present in such skeletal tissue. The remaining calcium is present in both the intra- and extracellular fluids. About 50% of the total blood-calcium content is in the physiologically active ionised form with 5% being complexed to citrate, phosphate, or other anions and 45% being bound to proteins. Excretion of calcium occurs in the urine although a large proportion is reabsorbed in the renal tubules. Excretion also occurs in the faeces, this consisting of unabsorbed calcium as well as that secreted in the bile and pancreatic juice. Minor amounts are lost in the sweat. Calcium crosses the placenta and is also excreted in breast milk.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
The tablet contains: lactose, maize starch, sucrose, stearic acid, magnesium stearate.
6.2 Incompatibilities
None known.
6.3 Shelf life
Three years from the date of manufacture.
6.4 Special precautions for storage
Store below 25°C in a dry place.
Protect from light.
6.5 Nature and contents of container
Pack sizes: 28s, 30s, 56s, 58s, 60s, 84s, 96s, 100s, 112s, 120s, 250s, 500s, 1000s.
Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.
Maximum size of bulk packs: 25,000.
The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene tablet containers with polyfoam wad or polyethylene ullage filler and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass bottles with screw caps and polyfoam wad or cotton wool.
The product may also be supplied in blister packs in cartons:
a) Carton: Printed carton manufactured from white folding box board.
b) Blister pack: (i) 250pm white rigid PVC. (ii) Surface printed 20pm hard temper aluminium foil with 5-7g/M2 PVC and PVdC compatible heat seal lacquer on the reverse side.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Actavis UK Limited (Trading style: Actavis)
Whiddon Valley Barnstaple N Devon EX32 8NS
MARKETING AUTHORISATION NUMBER
PL 0142/5425R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17/10/2006
10 DATE OF REVISION OF THE TEXT
06/06/2007