Summary of medicine characteristics - KETOVITE TABLETS
1 NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
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
Posology
For Adults, Children and the Elderly: One tablet three times a day, by oral administration.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
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.
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
Ketovite Tablets have no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
Tabulated list of adverse reactions
| System Organ Class | Frequency | Adverse reactions |
| Immune system disorders | Not known (cannot be estimated from the available data) | Anaphylactic reaction |
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.
4.9 Overdose
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.
Pharmacotherapeutic group: Vitamin B-complex, other combinations ATC code: A11EX
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
5.3 Preclinical safety dataNo 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.
6.3 Shelf life
2 years.
6.4 Special precautions for storage
Store in a refrigerator (2°C –8°C).
6.5 Nature and contents of container
Securitainers containing 84, 90, 100 or 500 tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special requirements.
7 MARKETING AUTHORISATION HOLDER
Essential Pharmaceuticals Limited
Unit 7, Egham Business Village
Crabtree Road
Egham
Surrey TW20 8RB, UK.
8 MARKETING AUTHORISATION NUMBER(S)
PL 41094/0001
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Date of first authorisation: 27 March 1987
Date of latest renewal: 29 June 1999