POM: Prescription only medicine
This information is intended for use by health professionals
Thiamine hydrochloride BP
Calcium pantothenate PhEur
Ascorbic acid BP
Acetomenaphthone BP 1973
Alpha-tocopheryl acetate BP
Inositol NF XII
Folic acid BP
For the full list of excipients, see section 6.1.
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.
For Adults, Children and the Elderly: One tablet three times a day, by oral administration.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Interference with clinical laboratory tests
Biotin may interfere with laboratory tests that are based on a biotin/streptavidin interaction, leading to either falsely decreased or falsely increased test results, depending on the assay. The risk of interference is higher in children and patients with renal impairment and increases with higher doses. When interpreting results of laboratory tests, possible biotin interference has to be taken into consideration, especially if a lack of coherence with the clinical presentation is observed (e.g. thyroid test results mimicking Graves' disease in asymptomatic patients taking biotin or false negative troponin test results in patients with myocardial infarction taking biotin). Alternative tests not susceptible to biotin interference should be used, if available, in cases where interference is suspected. The laboratory personnel should be consulted when ordering laboratory tests in patients taking biotin.
Pyridoxine may increase the peripheral metabolism of levodopa reducing therapeutic efficacy in patients with Parkinson's disease.
The recommended dose should not be exceeded without medical advice.
Ketovite Tablets have no or negligible influence on the ability to drive and use machines.
Tabulated list of adverse reactions
System Organ Class
Immune system disorders
Not known (cannot be estimated from the available data)
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.
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.
Pharmacotherapeutic group: Vitamin B-complex, other combinations
ATC code: A11EX
In normal circumstances the active constituents are obtained by the same route of administration (oral) from food.
No relevant pre-clinical data has been generated.
Heavy magnesium carbonate
Colloidal silicon dioxide
Store in a refrigerator (2°C -8°C).
Securitainers containing 84, 90, 100 or 500 tablets.
Not all pack sizes may be marketed.
No special requirements.
Essential Pharmaceuticals Limited
Unit 7, Egham Business Village
Surrey TW20 8RB,
Date of first authorisation: 27 March 1987
Date of latest renewal: 29 June 1999
7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, UK
+44 (0) 1784 471 776
+44 (0) 1784 477 167
+44 (0)1784 477 167