SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Ketovite Tablets.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Thiamine hydrochloride BP	1.0	mg
Riboflavin BP	1.0	mg
Pyridoxine hydrochloride	0.33	mg
Nicotinamide BP	3.3	mg
Calcium pantothenate PhEur	1.16	mg
Ascorbic acid BP	16.6	mg
Acetomenaphthone BP 1973	0.5	mg
Alpha-tocopheryl acetate BP	5.0	mg
Inositol NF XII	50.0	mg
Biotin USP	0.17	mg
Folic acid BP	0.25	mg

3 PHARMACEUTICAL FORM

Tablet

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

As a 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 Tablets should be used in conjunction with Ketovite Liquid.

4.2 Posology and method of administration

For Adults, Children and the Elderly: One tablet three times a day, by oral administration.

4.3 Contraindications

Hypersensitivity to the product.

4.4 Special warnings and precautions for use

None stated.

4.5 Interaction with other medicinal products and other forms of interaction

Pyridoxine may increase the peripheral metabolism of levodopa reducing therapeutic efficacy in patients with Parkinson’s disease.

4.6 Fertility, Pregnancy and lactation

The recommended dose should not be exceeded without medical advice.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

None stated.

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.

Large overdoses of water-soluble vitamins are readily excreted in the urine. No emergency procedure or antidote is applicable and any symptoms are rapidly reduced upon withdrawal of the preparation.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Multivitamin preparation.

5.2 Pharmacokinetic properties

In normal circumstances the active constituents are obtained by the same route of administration (oral) from food.

5.3 Preclinical safety data

No relevant pre-clinical data has been generated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Heavy magnesium carbonate Magnesium stearate Magnesium trisilicate Stearic acid Methylcellulose Colloidal silicon dioxide

6.2 Incompatibilities

None.

Shelf life

Two years.