Calcium carbonate..................................... 1500 mg
(equivalent to 600 mg of calcium)
Vitamin D3 ........................................... 400 IU
Excipients q.s ………………………………. 1 tablet
Effervescent tablet.
Product description: A pink or light orange round tablet, plain on both sides and intact edges with aromatic odour, sweetish sour taste.
Box of 1 tube x 10 effervescent tablets.
Pharmacotherapeutic group: A12AX01. Calcium carbonate and colecalciferol
Strong evidence that supplemental calcium and vitamin D3 can reduce the incidence of hip and other non-vertebral fractures derives.
The pharmacokinetic profiles of calcium and its salts are well known. Calcium carbonate is converted to calcium chloride by gastric acid. Calcium is absorbed to the extent of about 15 - 25% from the gastro-intestinal tract while the remainder reverts to insoluble calcium carbonate and calcium stearate, and is excreted in the faeces.
The pharmacokinetics of vitamin D is also well known. Vitamin D is well absorbed from the gastro-intestinal tract in the presence of bile. It is hydroxylated in the liver to form 25-hydroxycolecalciferol and then undergoes further hydroxylation in the kidney to form the active metabolite 1, 25 dihydroxycolecalciferol (calcitriol). The metabolites circulate in the blood bound to a specific α-globin. Vitamin D and its metabolites are excreted mainly in the bile and faeces.
No studies on the effects on the ability to drive and use machines have been performed.
During pregnancy and lactation, treatment should always be under the direction of a physician. During pregnancy and lactation, requirements for calcium and vitamin D are increased but in deciding on the required supplementation allowances should be made for availability of these agents from other sources. If Davita Bone Sugar Free and iron supplements are both required to be administered to the patient, they should be taken at different times.
Overdoses of vitamin D have shown teratogenic effects in pregnant animals. However, there have been no studies on the use of this medicinal product in human pregnancy and lactation. In humans, long term hypercalcaemia can lead to physical and mental retardation, aortic stenosis and retinopathy in a newborn child. Vitamin D and its metabolites pass into the breast milk.
The risk of hypercalcaemia should be considered in patients taking thiazide diuretics since these drugs can reduce urinary calcium excretion. Hypercalcaemia must be avoided in digitalised patients.
Certain foods (e.g. those containing oxalic acid, phosphate or phytinic acid) may reduce the absorption of calcium.
Concomitant treatment with phenytoin or barbiturates can decrease the effect of vitamin D because of metabolic activation. Concomitant use of glucocorticoids can decrease the effect of vitamin D.
The effects of digitalis and other cardiac glycosides may be accentuated with the oral administration of calcium combined with vitamin D. Strict medical supervision is needed and, if necessary monitoring of ECG and calcium.
Calcium salts may reduce the absorption of thyroxine, bisphosphonates, sodium fluoride, quinolone or tetracycline antibiotics or iron. It is advisable to allow a minimum period of four hours before taking the calcium.
Hypersensitivity reactions including pruritus, wheezing, urticaria and oropharyngeal swelling have been reported in the postmarketing environment.
The use of calcium supplements has, rarely, given rise to mild gastro-intestinal disturbances, such as constipation, flatulence, nausea, gastric pain, diarrhoea. Following administration of vitamin D supplements occasional skin rash has been reported. Hypercalciuria, and in rare cases, hypercalcaemia have been seen with long term treatment at high dosages.
Please inform your doctor of all undesirable effects upon drug administration.
The most serious consequence of acute or chronic overdose is hypercalcaemia due to vitamin D toxicity. Symptoms may include nausea, vomiting, polyuria, anorexia, weakness, apathy, thirst and constipation. Chronic overdoses can lead to vascular and organ calcification as a result of hypercalcaemia. Treatment should consist of stopping all intake of calcium and vitamin D and rehydration.
Store in dry places, not exceeding 30oC, protect from light.
Patients with mild to moderate renal failure or mild hypercalciuria should be supervised carefully including periodic checks of plasma calcium levels and urinary calcium excretion.
In patients with a history of renal stones urinary calcium excretion should be measured to exclude hypercalciuria.
With long-term treatment it is advisable to monitor serum and urinary calcium levels and kidney function, and reduce or stop treatment temporarily if urinary calcium exceeds 7.5mmol/24 hours (300mg/24 hours).
Caution is required in patients receiving treatment for cardiovascular disease.
This medicinal product should also be used with caution in other patients with increased risk of hypercalcaemia e.g. patients with sarcoidosis or those suffering from malignancies.
Allowances should be made for calcium and vitamin D supplements from other sources.
Excipients
This medicinal product contains approximately 45.1 mg sodium per tablet, equivalent to 2.3% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Aspartame: This medicinal product contains 20 mg of aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
This medicinal product contains 80 mg of sodium benzoate. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
Sunset yellow may cause allergic reactions.
Prevention and treatment of osteoporosis in those associated with getting a high risk: women aged > 30 years, the elderly, diabetics, dieters, smokers, and alcoholics, etc.
Prevention and treatment of osteomalacia.
Supplement of calcium and vitamin D for pregnant and breast-feeding women, children and adolescents during the growth phase.
Absolute contra-indications are hypercalcaemia resulting for example from myeloma, bone metastases or other malignant bone disease, sarcoidosis; primary hyperparathyroidism and vitamin D overdosage. Severe renal failure. Hypersensitivity to any of the tablet excipients.
Relative contra-indications are osteoporosis due to prolonged immobilisation, renal stones, severe hypercalciuria.
Oral.
Adults and elderly and children over 12 years of age: Take 2 effervescent tablets daily, preferably one tablet each morning and evening.
One Davita Bone Sugar Free effervescent tablet should be dissolved in a glass of water (approx. 200ml) and drunk immediately.
Children: not recommended for children under 12 years.
Or as directed by the physician.
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