NATECAL D3

g. one tablet in the morning and one tablet in the evening). 5. The tablets may be chewed or sucked, they should not be swallowed whole. The tablets should be taken preferably after meals. 6). Dosage in hepatic impairment No dose adjustment is required.

Undesirable effects are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1,000, <1/100), rare (≥ 1/10,000, <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Metabolism and nutrition disorders Uncommon:

Hypercalcaemia and hypercalciuria Gastrointestinal disorders Rare: Constipation, flatulence, nausea, stomach pain and diarrhoea Skin and subcutaneous disorders Rare: Pruritus, rash and urticaria Immune system disorders: Not known (cannot be estimated from the available data): Serious allergic (hypersensitivity) reactions such as angioedema or laryngeal oedema.

Other special population Patients with renal impairment: potential risk of hyperphosphatemia, nephrolithiasis and nephrocalcinosis. 4. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Natecal D3 tablets are not intended for children and adolescents. - During long-term treatment it is advisable to monitor the serum and urinary calcium levels and to monitor the kidney function through measurement of serum creatinine.

Monitoring is especially important in elderly patients on concomitant treatment with cardiac glycosides or diuretics. In case of hypercalcaemia or signs of impaired renal function the dose must be reduced or the treatment interrupted.

5 mmol/24 h (300 mg/24 h). ) when prescribing other drugs containing vitamin D or food supplemented with vitamin D. - Additional administration of vitamin D or calcium should be given under medical supervision. In such cases the plasma and urinary levels of calcium must be regularly monitored.

- This medicine should be prescribed with caution to patients suffering from sarcoidosis, because the risk of increased metabolism of vitamin D to its active metabolite. These patients should have their urinary and plasma calcium levels monitored.

- Patients with renal insufficiency have disturbed metabolism of vitamin D and if treated with cholecalciferol, the effect on calcium and phosphate homeostasis should be monitored. 8) - This medicine should be used with caution in immobilised patients with osteoporosis due to the increased risk of hypercalcaemia.

- The calcium and alkali intake from other sources (food, dietary supplements and other drugs) should be taken into consideration when prescribing calcium supplements. e. hypercalcaemia, metabolic alkalosis, renal failure and soft tissue calcification.

In these cases, frequent monitoring of the calcium level in the serum and urine is necessary Excipients - This medicinal product contains aspartame, source of phenylalanine. Aspartame is hydrolysed in the gastrointestinal tract when orally ingested.

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. Neither non-clinical or clinical data are available to assess aspartame use in infants below 12 weeks of age.

- This medicinal product contains hydrogenated soya oil. 3). - This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

- This medicinal product contains 565,25mg sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. - This medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

May be harmful to the teeth. - This medicinal product contains croscarmellose sodium and saccharin sodium, sources of sodium. This medicinal product contains less then 1 mmol sodium (23 mg) in each chewable tablet, that is to say essentially “sodium free”.

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