SUMMARY OF PRODUCT CHARACTERISTICS 1    NAME OF THE MEDICINAL PRODUCT

Ketovite Liquid.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Vitamin A as palmitate (1.7 x 106 units/g)	HSE	2500	units
Vitamin D2 (ergocalciferol)	BP	400	units
Cyanocobalamin	BP	12.5	microgram
Choline chloride	HSE	150.0	mg

3    PHARMACEUTICAL FORM

Oral emulsion.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

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.

4.2 Posology and method of administration

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

4.3 Contraindications

Hypersensitivity to the product. Hypercalcaemia.

4.4 Special warnings and precautions for use

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.

4.5 Interaction with other medicinal products and other forms of interaction

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.

4.6 Fertility, Pregnancy and lactation

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.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

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.

4.9 Overdose

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.

5 PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

The product is a multivitamin supplemental product.

5.2    Pharmacokinetic properties

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

5.3 Preclinical safety data

No relevant pre-clinical data has been generated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Methyl cellulose (methocel E4M) Saccharin

6.2 Incompatibilities

None known.

6.3 Shelf life

24 months.

6.4 Special precautions for storage

Store at 2-8°C.

6.6 Special precautions for disposal

Not applicable.

MARKETING AUTHORISATION HOLDER

Essential Pharmaceuticals Limited

Unit 7, Egham Business Village

Crabtree Road

Egham

Surrey TW20 8RB,

UK.

8. MARKETING AUTHORISATION NUMBER(S)

PL 41094/0002

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

14/06/2012

10    DATE OF REVISION OF THE TEXT

08/09/2015