Calcium Lactate Tablets 300mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calcium Lactate Tablets BP 300 mg.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Calcium Lactate BP 300 mg.
For excipients see section 6.1
3 PHARMACEUTICAL FORM
Uncoated tablets for oral administration.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Indicated for the treatment of calcium deficiency states as a therapeutic supplement in pregnancy, lactation, osteoporosis, post-gastrectomy malabsorption, osteomalacia and rickets.
4.2 Posology and method of administration
Calcium Lactate Tablets BP should not be taken for long periods without medical advice.
Adults including elderly: 1-2 tablets (300-600mg) daily.
Pregnant women: (During the third trimester and also during lactation) 3-4 tablets (0.9-1.2g) daily.
Children over 3 years: One tablet (300mg) daily.
For oral administration.
4.3 Contraindications
Severe hypercalcaemia and hypercalciuria (eg hypervitaminosis D, hyperparathyroidism, severe renal failure, osteoporosis due to immobility and decalcifying tumours such as plasmocytoma and skeletal metastases). Patients receiving therapy with cardiac glycosides such as digoxin must not be given calcium supplements.
4.4 Special warnings and precautions for use
Tablets are unlikely to cause problems unless taken with vitamin D, but care should be exercised in patients with impaired renal function, cardiac disease and sarcoidosis. If a potassium deficiency is also present this must be treated first. Calcium salts should be administered with care to infants with hypokalaemia, as elevation of serum calcium levels may further reduce serum potassium levels.
Careful monitoring of blood levels and urinary calcium excretion is necessary, particularly when high dose calcium therapy has been used, especially in children.
Treatment should be suspended if calcium blood levels exceed 2.625-2.75mmol/litre (105-110mg/litre) or if urinary calcium excretion exceeds 5mg/kg.
4.5 Interaction with other medicinal products and other forms of interaction
Calcium Lactate inhibits absorption of tetracyclines. Calcium Lactate Tablets BP must be used with care in patients receiving alternative compound vitamin or mineral preparations, which often contain additional sources of calcium. Calcium enhances the effects of digitalis on the heart and may precipitate digitalis intoxication.
4.6 Fertility, Pregnancy and lactation
There are no problems in normal doses.
4.7 Effects on ability to drive and use machines
No adverse effects known.
4.8 Undesirable effects
May cause constipation and prolonged high dose could induce hypercalcaemia. (Most unlikely with these tablets).
The symptoms of overdosage with calcium include anorexia, lassitude, nausea, vomiting, headache, extreme thirst, vertigo, and raised blood urea; calcium may be deposited in many tissues including the kidney and arteries and the plasma cholesterol level may become elevated. Cardiac arrhythmias and bradycardia may also occur.
Calcium intake should be reduced to a minimum and any dehydration and electrolyte imbalance corrected immediately. Severe hypercalcaemia should be treated with an iv infusion of sodium chloride 0.9%; a loop diuretic may be given to increase urinary calcium excretion. If this fails, calcitonin may be administered by injection, or alternative, biphosphonates, plicamycin or corticosteroids may be used. Phosphate infusion must not be given due to the danger of metastatic calcification. In severe cases, significant amounts of calcium may be removed by peritoneal dialysis.
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 hepatic function.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Calcium Lactate is a source of body calcium; an essential electrolyte involved in the maintenance of normal muscle and nerve function and is essential in blood clotting.
5.2 Pharmacokinetic properties
The normal adult requirement of calcium is about 500 mg per day, it is absorbed from the small intestine and absorption is increased in vitamin D. Excretion is via urine, sweat, faeces and saliva.
5.3 Preclinical safety data
Not applicable.
Potato Starch Talc
Stearic Acid Magnesium Stearate
6.2 Incompatibilities
None known.
6.3 Shelf life
The product has a five year shelf life for all packs and this applies whether opened or unopened.
6.4 Special precautions for storage
Store in airtight containers below 20°C.
6.5
Nature and contents of container
These are Johnsen & Jorgensen securitainers in packs of 100, 250, 500 and 1000.
6.6 Special precautions for disposal
No special instructions.
7 MARKETING AUTHORISATION HOLDER
Strides Pharma Limited Themistokli Dervi 3 Julia House CY-1066 Nicosia Cyprus
8 MARKETING AUTHORISATION NUMBER(S)
PL 41061/0005
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
22 September 2005
10 DATE OF REVISION OF THE TEXT
03/10/2012