THEICAL-D3

Posology Adults and elderly 1 chewable tablet daily (corresponding to 1,000 mg of calcium and 880 IU of vitamin D3). 3). U. of vitamin D3. 6). Method of administration Oral use. Calcium Vitamin D3 1000 mg / 880 IU chewable tablets should be taken at any time, with or without food.

The chewable tablets should be chewed and swallowed. 3).

The evaluation of adverse reactions is based on the following definition of frequency: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Immune system disorders Not known (cannot be estimated from the available data): Hypersensitivity reactions such as angioedema or laryngeal oedema.

Metabolism and nutrition disorders Uncommon:

Hypercalcaemia, hypercalciuria.

Gastrointestinal disorders Rare:

Nausea, diarrhoea, abdominal pain, constipation, flatulence, abdominal distension.

Skin and subcutaneous tissue disorders Rare:

Rash, pruritus, urticaria.

During long-term treatment, serum calcium levels should be followed and renal function should be monitored through measurements of serum creatinine. 5) and in patients with a high tendency to calculus formation. 5 mmoles/24 hours) the dose shouldbe reduced or the treatment discontinued.

Vitamin D should be used with caution in patients with impairment of renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account. 3). Calcium Vitamin D3 1000 mg / 880 IU chewable tablets should be prescribed with caution to patients suffering from sarcoidosis, due to the risk of increased metabolism of vitamin D into its active form.

These patients should be monitored with regard to the calcium content in serum and urine. Calcium Vitamin D3 1000 mg / 880 IU chewable tablets should be used cautiously in immobilised patients with osteoporosis due to increased risk of hypercalcaemia.

5). The content of vitamin D (880 IU) in Calcium Vitamin D3 1000 mg / 880 IU chewable tablets should be considered when prescribing other medicinal products containing vitamin D. Additional doses of calcium or vitamin D should be taken under close medical supervision.

In such cases it is necessary to monitor serum calcium levels and urinary calcium excretion frequently. , Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

02 mg benzyl alcohol in each chewable tablet. Benzyl alcohol may cause allergic reactions. Large amounts of benzyl alcohol can build-up in the body and may cause side effects (metabolic acidosis) in those who are pregnant, breast-feeding or have a liver or kidney disease.

This medicine contains less than 1 mmol sodium (23 mg) per chewable tablet, that is to say essentially ‘sodium-free’. 694 mg sucrose in each chewable tablet. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

32 mg sorbitol (E420) and 370 mg isomalt (E953) per chewable tablet.

1. g. myeloma, bone metastases,primary hyperparathyroidism, prolonged immobilisation accompanied by hypercalciuria and/or hypercalcaemia). - Nephrolithiasis - Nephrocalcinosis - Hypervitaminosis D - Severe renal impairment Due to its high content of vitamin D the use in children or adolescents is not indicated.