Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: GlaxoSmithKline Consumer Healthcare (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Correction of combined vitamin D and calcium deficiencies in older people.
Supply of vitamin D and calcium as an adjunct to specific treatments for osteoporosis, in patients where combined vitamin D and calcium deficiencies have been diagnosed or those at high risk of such deficiency.
One tablet twice a day (e.g. one tablet in the morning and one tablet in the evening). Dose reduction should be considered as necessary following the monitoring of calcium levels as indicated in section 4.4 and 4.5.
No data are available
One tablet a day (see section 4.6).
The dose does not require adjustment.
The tablet should be swallowed with a large glass of water.
An overdose can lead to hypervitaminosis and hypercalcaemia. The symptoms of hypercalcaemia can include: anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, polyuria, skeletal pain, renal calcinosis, kidney stones, alkalosis, hypophosphataemia, and in severe cases, cardiac arrhythmia, “Burnett's syndrome”. Extreme hypercalcaemia may lead to coma and death. Continuous high calcium levels may lead to irreversible damage to the kidneys and soft tissue calcification.
All calcium and vitamin D3 treatments must be stopped. Treatment with thiazide diuretics, lithium, vitamin A and cardiac glycosides must also be stopped. Gastric lavage should be performed on patients with problems affecting consciousness. Rehydrate and, depending on severity, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids should be considered. Serum electrolytes, kidney function and diuresis must be monitored. In severe cases, ECG and calcaemia should be monitored.
2 years.
Store below 25°C. Keep the bottle tightly closed in order to protect from moisture.
Opaque white high density polyethylene bottles with a polypropylene cap and induction sealed foil liner.
Bottles contain 20, 30, 60, 90 or 180 tablets.
Not all pack sizes may be marketed.
No special requirements.
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