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

Allergic hypersensitivity to one or more vitamins included in VICOMBIL.

Some of the vitamins included in VICOMBIL may have interactions with other drugs. However, if therapeutically adequate, usually the doses of vitamins included in VICOMBIL are not too high to develop such interactions. The administration of cholestyramine may result in decreased absorption of vitamin A and D. Oral administration of neomycin may also result in decreased absorption of vitamin A. Since tendency for additive adverse effects is relevant, patients receiving a retinoid (e.g., etretinate, isotretinoin) should be warned to avoid concomitant use of preparations containing vitamin A. Concurrent administration of thiazide diuretics and pharmacological doses of vitamin D analogues in patients with hypoparathyroidism may result in hypercalcemia. Corticosteroids counteract the effects of vitamin D analogues. Concurrent use of vitamin D analogues and cardiac glycosides may result in cardiac arrhythmias. Vitamin E or one of its metabolites may have anti-vitamin K effects. Pyridoxine HCl reverses the therapeutic effects of levodopa by accelerating peripheral metabolism of levodopa. Absorption of vitamin B₁₂ from the GI tract may be decreased by aminoglycoside antibiotics, colchicine, extended-release potassium preparations, aminosalicylic acid and its salts and anticonvulsants (e.g. phenytoin and phenobarbital). Increased urinary excretion of ascorbic acid and decreased excretion of aspirin occur when the drugs are administered concurrently. Folic acid may increase phenytoin metabolism, resulting in decreased phenytoin serum concentrations and so an increase in seizure frequency may occur in some patients. In epileptic patients, undergoing anticonvulsivant therapy, high doses of folic acid may lead, especially in children, to convulsions, thus requiring an increase of the anticonvulsivant dose.

Vicombil may be used during pregnancy and lactation. However, the use of large doses of vitamin A should be avoided generally during normal pregnancy. The use of large doses of pyridoxine during pregnancy has been associated to pyridoxine-dependence seizures in neonates.

Vicombil has no or negligible influence on the ability to drive and use machines.

If the recommended doses are not exceeded side effects will not be observed. Overdosage may develop signs of hypervitaminosis A and D.

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. Healthcare professionals are asked to report any suspected directly to the Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +35722608649.

Not applicable.