Do not take Cholecalciferol Sandoz 500 IE, tabletten:
- if you are allergic to cholecalciferol or any of the other ingredients of this medicine (listed in section 6).
- if you suffer from hypercalcaemia (high calcium levels in the blood).
- if you have hypercalciuria (high calcium levels in the urine).
- if you have been diagnosed with hypervitaminosis D (high vitamin D levels in the blood).
- if you have kidney stones.
Warnings and precautions
Talk to your doctor or pharmacist before taking Cholecalciferol Sandoz 500 IE, tabletten.
Take special care with Cholecalciferol Sandoz 500 IE, tabletten
- if you have a tendency to get calcium-containing kidney stones.
- if you have problems in calcium and phosphate excretion through your kidneys.
- if you are being treated with medicines to increase urine output (benzothiadiazine derivatives).
- if your mobility is greatly restricted, as there is a risk in this case of hypercalcaemia (high calcium levels in the blood) and hypercalciuria (high calcium levels in the urine).
- if you have sarcoidosis (a specific disease that affects the connective tissue of the lungs, skin and joints), as there is a risk of increased conversion of vitamin D into its active form. In such cases, blood and urine calcium levels should be monitored by the doctor.
- if you have parathyroid hormone imbalance (pseudohypoparathyroidism), as vitamin D requirements may be reduced by the sometimes normal sensitivity to vitamin D. In this case, there is a risk of long-term overdose. For such patients, more manageable active substances with vitamin D activity are available.
If your kidneys are not working properly and you are being treated with Cholecalciferol Sandoz 500 IE, tabletten, the effect of treatment on the calcium and phosphate balance should be monitored by your doctor.
If other medicines containing vitamin D are prescribed, the vitamin D dose consumed when using Cholecalciferol Sandoz 500 IE, tabletten must be taken into account. Additional vitamin D or calcium should only be administered under medical supervision. In such cases, calcium levels in the blood and urine must be monitored.
During long-term treatment with Cholecalciferol Sandoz 500 IE, tabletten at daily doses above 500 IU of vitamin D, your doctor should monitor the calcium levels in your blood and urine and check your kidney function via measurements of serum creatinine. Such monitoring is particularly important in elderly patients and when treating at the same time with cardiac glycosides (medicines to stimulate heart muscle function) or diuretics (medicines to stimulate urine output). In the event of increased calcium levels in the blood (hypercalcaemia) or signs of impaired kidney function, the dose must be reduced or treatment discontinued. It is recommended to reduce the dose or discontinue treatment when calcium levels in the urine exceed 7.5 mmol/24 hours (300 mg/24 hours).
Infants and toddlers
Cholecalciferol Sandoz 500 IE, tabletten should be used with particular caution in infants and toddlers, as they may not be able to swallow the tablets. It is advisable to dissolve the tablets as stated or to use drops.
Other medicines and Cholecalciferol Sandoz 500 IE, tabletten
Tell your doctor or pharmacist if you are taking/ using, have recently taken/ used or might take/ use any other medicines.
The effect of Cholecalciferol Sandoz 500 IE, tabletten can be affected by the simultaneous use of
- phenytoin (medicine used to treat epilepsy) or barbiturates (medicines used to treat epilepsy and sleep disorders and for anaesthesia)
- glucocorticoids (medicines used to treat certain allergic conditions)
- rifampicin and isoniazid (medicines used to treat tuberculosis)
- cholestyramine (medicine used to lower high cholesterol levels), laxatives containing liquid paraffin.
The effect/side effects of Cholecalciferol Sandoz 500 IE, tabletten can be increased by the simultaneous use of
- vitamin D metabolites or analogues (e.g. calcitriol). Combination with Cholecalciferol Sandoz 500 IE, tabletten is recommended only in exceptional cases under strict medical supervision.
- medicines for increasing urine output (thiazide diuretics). A reduction in the elimination of calcium via the kidneys can cause calcium concentrations in the blood to rise (hypercalcaemia). Calcium levels in the blood and urine should therefore be monitored during long-term treatment.
When taken at the same time, Cholecalciferol Sandoz 500 IE, tabletten can increase the risk of side effects of
- cardiac glycosides (medicines used to increase the functioning of the heart muscles). The risk of heart rhythm disturbances can increase as a result of a rise in calcium levels in the blood during treatment with vitamin D. In such cases, the doctor in charge should carry out ECG monitoring as well as monitoring of calcium levels in the blood and urine and of levels of the medicine in the blood.
Please note that this information may also apply to medicines that you have recently used.
Cholecalciferol Sandoz 500 IE, tabletten with food and drink
Cholecalciferol Sandoz 500 IE, tabletten can be taken either on its own or together with food and drink.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Daily intake up to 500 I.U./d
In this dose range, there are no known risks to date.
Long-term overdoses of vitamin D must be avoided during pregnancy, as a resulting hypercalcaemia (increased blood level of calcium) may lead to physical and mental disability as well as to congenital heart and eye diseases in the child.
Daily intake more than 500 I.U./d
During pregnancy,Cholecalciferol Sandoz 500 IE, tabletten should be taken only when strictly indicated and dosed only as it is absolutely necessary to correct the vitamin D deficiency. Overdoses of vitamin D must be avoided during pregnancy, as prolonged hypercalcaemia (increased blood level of calcium) may lead to physical and mental disability as well as to congenital heart and eye diseases in the child.
Women may breast-feed during treatment with Cholecalciferol Sandoz 500 IE, tabletten. As vitamin D and its metabolites are excreted in breast milk, this should be borne in mind however when administering additional vitamin D to the child.
Driving and using machines
Cholecalciferol Sandoz 500 IE, tabletten is not known to have any effect on driving or using machines.
Cholecalciferol Sandoz 500 IE, tabletten contains lactose and sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.