Ketovite Liquid

Excipient(s) with known effect

5 ml solution contains 7.5 mg methyl parahydroxybenzoate (E218).

For a full list of excipients, see section 6.1.

Oral solution (oral liquid).

A pale pink to yellow 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.

In order to achieve complete vitamin supplementation Ketovite Liquid should be used in conjunction with Ketovite Tablets.

Posology

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

Method of administration

For oral use.

• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

• 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 except under medical supervision.

Warning: do not exceed the stated dose.

Methyl parahydroxybenzoate

This medicinal product contains methyl parahydroxybenzoate (E218). May cause allergic reactions (possibly delayed).

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.

Pregnancy

Caution should be used in pregnancy as excessive doses of Vitamin A may be teratogenic, especially when taken in the first trimester.

Breast-feeding

Large doses of Vitamin D in lactating mothers may cause hypercalcaemia in infants.

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

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

Pharmacotherapeutic group: Combinations of vitamins, ATC code: A11JA.

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.

Hypromellose

Saccharin

Methyl parahydroxybenzoate (E218)

Polysorbate 80

Ascorbic acid

α-tocopherol

Terpeneless orange oil

Ammonia solution, concentrated

Water, purified

Not applicable.

2 years.

Store in a refrigerator (2°C-8°C).

Amber glass bottle with tamper-evident child-resistant closure. Pack-sizes: 100 ml, 140 ml or 150 ml.

Not all pack sizes may be marketed.

No special requirements.

Rosemont Pharmaceuticals Ltd

Rosemont House

Yorkdale Industrial Park

Braithwaite Street

Leeds

LS11 9XE

UK

PL00427/0283

First authorisation granted: 30 January 1990

Renewal granted: 9 September 2005

08 February 2022