EVACAL D3

Posology Adults, elderly and children over 12 years of age 2 chewable tablets daily (corresponding to 1,200 mg of calcium and 800 IU of vitamin D3), preferably one tablet each morning and evening. Dosage in hepatic impairment No dose adjustment is required.

3). Method of administration Oral use. Evacal D3 1500 mg/400 iu Chewable Tablets should be taken at any time, with or without food. The chewable tablets should be chewed and swallowed. Evacal D3 1500 mg/400 iu Chewable Tablets are not intended for use in children under 12 years.

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.

Not known:

Milk-alkali syndrome Gastrointestinal disorders Rare: Nausea, diarrhoea, abdominal pain, constipation, flatulence, abdominal distension.

Skin and subcutaneous tissue disorders Rare:

Rash, pruritus, urticaria. 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.

Calcium and alkali intake from other sources (food, enriched foods, or other medicinal products) should be monitored when calcium carbonate is prescribed. When high calcium doses are given together with alkaline substances such as carbonate, there is a risk of milk-alkali syndrome.

Calcium levels in serum should be monitored when administering high doses of calcium carbonate. 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 should be 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). Evacal D3 1500 mg/400 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. Evacal D3 1500 mg/400 iu Chewable Tablets should be used cautiously in immobilised patients with osteoporosis due to increased risk of hypercalcaemia.

The content of vitamin D (400 IU) in Evacal D3 1500 mg/400 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. Excipient(s) Aspartame Aspartame is hydrolysed in the gastrointestinal tract when orally ingested. One of the major hydrolysis products is phenylalanine.

It may be harmful for patients with phenylketonuria (PKU). Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per chewable tablet, that is to say essentially ‘sodium-free’. Sorbitol The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.

The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. Isomalt Patients with rare hereditary problems of fructose intolerance should not take this medicine Sucrose Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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 under 12 years is not indicated.