Paines & Byrne Limited

Ketovite Liquid

Each 5 ml contains:

Excipients: also includes methyl parahydroxybenzoate (E218) 7.5mg/5ml

For a full list of excipients, see section 6.1.

Oral solution (oral liquid)

Pale pinkish clear to opalescent liquid.

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.

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.

Prolonged excessive ingestion of Vitamin A and Vitamin D can lead to hypervitaminosis states which may occur if foods high in this vitamin, (for example liver), are ingested in association with the recommended doses of this product.

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.

This product should not be used in pregnancy unless considered essential by the physician. Large doses of Vitamin A have been found to be teratogenic especially if administered during the first trimester of pregnancy.

Vitamin D given during the last trimester of pregnancy may cause hypercalcaemia in infants.

It is advised that if possible women receiving Vitamin D do not breastfeed their infants as this may lead to the development of hypercalcaemia in the infant.

None known.

None, in the absence of overdosage.

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.

Methylcellulose

Saccharin

Methyl Parahydroxybenzoate (E218)

Polysorbate 80

Ascorbic acid

Alpha tocopherol

Terpeneless Orange Oil

Strong Ammonia Solution

Purified Water

Not applicable.

2 years.

Store in a refrigerator (2°C - 8°C).

Amber glass bottle with plastic screw cap containing 100 ml, 140 ml or 150 ml.

Not all pack sizes may be marketed.

No special requirements.

Paines and Byrne Limited

3^rd Floor

Future House

The Glanty

Egham

Surrey

TW20 9AH

United Kingdom

PA 90/12/1

Date of first authorisation: 10 November 1987

Date of last renewal: 09 November 2007

13^th December 2010

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