CALCIUM LACTATE Tablet Ref.[27583] Active ingredients: Calcium lactate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

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.

4.9. Overdose

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.

6.3. Shelf life

Shelf-life: Three years from the date of manufacture.

Shelf-life after dilution/reconstitution: Not applicable.

Shelf-life after first opening: Not applicable.

6.4. Special precautions for storage

Store in a cool dry place.

6.5. Nature and contents of container

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene 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 containers with screw caps and polyfoam wad or cotton wool. An alternative closure for polyethylene containers is a polypropylene, twist on, push down and twist off child-resistant, tamper-evident lid.

Pack sizes: 14s, 28s, 30s, 56s, 60s, 84s, 100s, 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.

6.6. Special precautions for disposal and other handling

Not applicable.

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