Ketovite

Ketovite Liquid.

Oral emulsion.

As a sugar-free therapeutic supplement for the prevention of vitamin deficiency in conditions such as galactosaemia, disaccharide intolerance, phenylketonuria and other disorders of carbohydrate or amino acid metabolism, as well as in patients who are on restricted, specialised or synthetic diets. In order to achieve complete vitamin supplementation Ketovite Liquid should be used in conjunction with Ketovite Tablets.

For adults, children and the elderly: 5 ml daily, by oral administration.

Hypersensitivity to the product. Hypercalcaemia.

The recommended dose should not be exceeded without medical advice. No other vitamin supplement containing Vitamins A and D should be taken with Ketovite Liquid except under medical supervision. The methyl parahydroxybenzoate (E218) in Ketovite Liquid may cause allergic reactions which can be delayed. Warning: do not exceed the stated dose.

Absorption of some vitamins in this preparation may be reduced in conditions of fat malabsorption or with the concurrent use of neomycin, colestyramine, liquid paraffin, aminoglycosides, aminosalicylic acid, anticonvulsants, biguanides, chloramphenicol, cimetidine, colchicine, potassium salts and methyl-dopa. Serum B₁₂ concentrations may be decreased by concurrent administration of oral contraceptives.

Caution should be used in pregnancy as excessive doses of Vitamin A may be teratogenic, especially when taken in the first trimester. Large doses of Vitamin D in lactating mothers may cause hypercalcaemia in infants.

None known.

None, in the absence of overdosage.

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 adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Symptoms of overdosage may include anorexia, nausea, vomiting, rough dry skin, polyuria, thirst, loss of hair, painful bones and joints as well as raised plasma and urine calcium and phosphate concentration. No emergency procedure or antidote is applicable and symptoms are rapidly reduced upon withdrawal of the preparation.

The product is a multivitamin supplemental product.

The pharmacokinetics of the active substances would not differ from that of the same substance when derived naturally from oral foodstuffs.

No relevant pre-clinical data has been generated.

None known.

24 months.

Store at 2-8°C.

Amber glass bottle with plastic screw cap. Pack sizes 100, 150 and 140.

Not applicable.

Essential Pharmaceuticals Limited Unit 7, Egham Business VillageCrabtree Road EghamSurrey TW20 8RB,UK.

PL 41094/0002

14/06/2012

08/09/2015