CALCIUM LACTATE Tablet (2019)

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Περιεχόμενα

1. Name of the medicinal product

CALCIUM LACTATE TABLETS BP 300mg.

2. Qualitative and quantitative composition

Each tablet contains 300mg Calcium Lactate BP equivalent to 0.96mmol calcium (Ca2+).

3. Pharmaceutical form

White uncoated tablets.

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 ...

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). ...

4.4. Special warnings and precautions for use

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 ...

4.5. Interaction with other medicinal products and other forms of interaction

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 ...

4.6. Pregnancy and lactation

There is epidemiological evidence of the safety of calcium in pregnancy. No problems are anticipated with the administration of Calcium Lactate Tablets during lactation.

4.7. Effects on ability to drive and use machines

None known.

4.8. Undesirable effects

Calcium salts may cause constipation. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring ...

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 ...

5.1. Pharmacodynamic properties

Calcium lactate is used in calcium deficiency.

5.2. Pharmacokinetic properties

Calcium is absorbed from the small intestine; about one third of ingested calcium is absorbed. Absorption decreases with age and may be more efficient when the body is deficient in calcium or from diets ...

5.3. Preclinical safety data

Not applicable.

6.1. List of excipients

Also contains lactose, magnesium stearate, maize starch and stearic acid.

6.2. Incompatibilities

None known.

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 ...

6.6. Special precautions for disposal and other handling

Not applicable.

7. Marketing authorization holder

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

8. Marketing authorization number(s)

PL 0142/6140 R

9. Date of first authorization / renewal of the authorization

11.7.86 / 14.11.96

10. Date of revision of the text

22/11/2019

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