ACCRETE D3 ONE A DAY

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). 3). Method of administration Oral use. Accrete D3 One a Day Chewable tablets can be taken at any time, with or without food.

The chewable tablets should be chewed and swallowed.

Summary of the safety profile:

The medicinal product may cause hypersensitivity reactions including rash, pruritis, urticaria and other systemic allergic reactions including anaphylactic reaction, face oedema, angioneurotic oedema. Uncommon cases of hypercalcaemia, hypercalciuria have been observed and rare cases of gastrointestinal disorders such as nausea, diarrhoea, abdominal pain, constipation, flatulence, abdominal distension and vomiting have been reported.

All adverse reactions are listed by system organ class and frequency which is defined as follows: 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) Tabulated list of adverse reactions: System Organ Class Frequency Adverse Drug Reactions Immune system disorders Not known Hypersensitivity reactions such as angioedema or laryngeal oedema Metabolism and nutrition disorders Uncommon Not known hypercalcaemia, hypercalciuria Milk-alkali syndrome (frequent urge to urinate, continuing headache, continuing loss of appetite, nausea or vomiting, unusual tiredness or weakness, hypercalcaemia, alkalosis and renal impairment).

9). 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.

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.

Calcium/cholecalciferol should be used with caution in patients with increased risk of hypercalcaemia or signs of 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). Accrete D3 One a Day 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.

Accrete D3 One a Day Chewable tablets should be used cautiously in immobilised patients with osteoporosis due to increased risk of hypercalcaemia. The content of vitamin D (880 IU) in Accrete D3 One a Day Chewable tablets should be considered when prescribing other medicinal products containing vitamin D.

Additional doses of calcium or vitamin D should be taken only under close medical supervision. In such cases it is necessary to monitor serum calcium levels and urinary calcium excretion frequently. A potential additional ingestion of calcium and alkaline products (due to the intake of nutrients, fortified foods or other medicinal products) should be considered.

e. hypercalcaemia, metabolic alkalosis, renal failure and soft tissue calcification can occur if high doses of calcium are taken concomitantly with absorbable alkali medicinal products (like carbonate). 5). There have been literature reports alluding to possible increased absorption of aluminium with citrate salts.

Accrete D3 One a Day Chewable tablets contains citric acid. 3). Accrete D3 One a Day Chewable tablets contains sodium, aspartame, sorbitol, isomalt, sucrose and benzyl alcohol This medicinal product contains less than 1 mmol sodium (23 mg) per chewable tablet, that is to say essentially ‘sodium-free’.

1. g. myeloma, bone metastases, primary hyperparathyroidism, prolonged immobilisation accompanied by hypercalciuria and/or hypercalcaemia). 73 m2) - Use in children or adolescents below 18 years of age due to the high content of vitamin D in this medicinal product