VICOMBIL Coated tablet Ref.[50696] Active ingredients: Calcium Folic acid Nicotinic acid Pyridoxine Riboflavin Vitamin A Vitamin B1 Vitamin B12 Vitamin C Vitamin D2 Vitamin E

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: BIAL – Portela & Cª, S.A., À Av. da Siderurgia Nacional, 4745 457 S. Mamede do Coronado, Portugal

4.1. Therapeutic indications

Prophylaxis and treatment of multivitamin deficiencies.

4.2. Posology and method of administration

Posology

Adults and adolescents

Prophylaxis: 1 tablet daily.

Treatment: 1 tablet, 2 to 4 times daily.

4.9. Overdose

Some vitamins included in VICOMBIL (e.g. vitamins A and D) may develop symptoms of hypervitaminosis, if large doses are administered, for long term periods. Therefore the recommended dose should not be exceeded.

Toxicity due to high doses of vitamin A is more common in young children than in adults. Some hours after the intake of vitamin A at a dose approximately of 25.000 units/kg may develop irritability, nausea, diarrhoea, vomiting, vertigo, delirium and coma.

Usually ascorbic acid is nontoxic. However diarrhoea may occur after an oral dose of 1 g or over.

Acute or chronic administration of excessive doses of vitamin D analogues may lead to hypervitaminosis D manifested by hypercalcemia. The necessary dose of vitamin D analogue to develop hypervitaminosis varies from individual to individual.

Early symptoms of hypercalcemia may include asthenia, fatigue, somnolence, headache, anorexia, dry mouth, metallic taste, nausea, vomiting, constipation, diarrhoea, vertigo, ataxia, exanthema, hypotonia (in children), muscle pain, bone pain, and irritability. Later, and sometimes more serious, complications of hypercalcemia may include nephrocalcinosis, renal function impairment (resulting in polyuria, nocturia, polydipsia and proteinuria), osteoporosis in adults, growth retardation in children, weight loss, anaemia, calcific conjunctivitis, photophobia, metastatic calcification, pancreatitis, generalised vascular calcification, and seizures.

Treatment of intoxication due to vitamin D analogues consists of the withdrawal of the medicine and of calcium supplementation, use of a low calcium diet, oral or endovenous administration of fluids and, if needed, corticosteroids or other drugs, particularly calcium diuretics (e.g. furosemide and etacrinic acid) to reduce serum calcium concentrations. Haemodialysis or peritoneal dialysis may also be used. In acute intoxication due to a vitamin D analogue, if intake was recent, gastric lavage or emesis should be induced to prevent absorption.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 25ºC.

6.5. Nature and contents of container

Carton box containing 60 tablets in blister Alu/Alu and a leaflet information.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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