This information is intended for use by health professionals

1. Name of the medicinal product

Ketovite Tablets.

2. Qualitative and quantitative composition

Thiamine hydrochloride BP

Riboflavin BP

Pyridoxine hydrochloride

Nicotinamide BP

Calcium pantothenate PhEur

Ascorbic acid BP

Acetomenaphthone BP 1973

Alpha-tocopheryl acetate BP

Inositol NF XII

Biotin USP

Folic acid BP

1.0

1.0

0.33

3.3

1.16

16.6

0.5

5.0

50.0

0.17

0.25

mg

mg

mg

mg

mg

mg

mg

mg

mg

mg

mg

For the full list of excipients, see section 6.1.

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 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.

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

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.

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 and other handling

No 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 the authorisation

Date of first authorisation: 27 March 1987

Date of latest renewal: 29 June 1999

10. Date of revision of the text

25/03/2019