Active substance(s): ACETOMENAPHTHONE / ALPHA TOCOPHERYL ACETATE / ASCORBIC ACID / BIOTIN / CALCIUM PANTOTHENATE / FOLIC ACID / INOSITOL / NICOTINAMIDE / PYRIDOXINE HYDROCHLORIDE / RIBOFLAVIN / THIAMINE HYDROCHLORIDE
NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
Thiamine hydrochloride BP
Calcium pantothenate PhEur
Ascorbic acid BP
Acetomenaphthone BP 1973
Alpha-tocopheryl acetate BP
Inositol NF XII
Folic acid BP
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.
Posology and method of administration
For Adults, Children and the Elderly: One tablet three times a day, by oral
Hypersensitivity to the product.
Special warnings and precautions for use
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.
Fertility, Pregnancy and lactation
The recommended dose should not be exceeded without medical advice.
Effects on ability to drive and use machines
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:
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.
In normal circumstances the active constituents are obtained by the same route
of administration (oral) from food.
Preclinical safety data
No relevant pre-clinical data has been generated.
List of excipients
Heavy magnesium carbonate
Colloidal silicon dioxide
Special precautions for storage
Store at 2-8°C.
Nature and contents of container
Securitainers containing 84, 90, 100 or 500 tablets.
Special precautions for disposal
MARKETING AUTHORISATION HOLDER
Essential Pharmaceuticals Limited
Unit 7, Egham Business Village
Surrey TW20 8RB,
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
27 March 1987; renewed 29 June 1999
DATE OF REVISION OF THE TEXT