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KETOVITE TABLETS

Active substance(s): ACETOMENAPHTHONE / ALPHA TOCOPHERYL ACETATE / ASCORBIC ACID / BIOTIN / CALCIUM PANTOTHENATE / FOLIC ACID / INOSITOL / NICOTINAMIDE / PYRIDOXINE HYDROCHLORIDE / RIBOFLAVIN / THIAMINE HYDROCHLORIDE / ACETOMENAPHTHONE / ALPHA TOCOPHERYL ACETATE / ASCORBIC ACID / BIOTIN / C

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SUMMARY OF PRODUCT CHARACTERISTICS

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

3

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

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.

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.

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
Two years.

6.4

Special precautions for storage
Store at 2-8°C.

6.5

Nature and contents of container
Securitainers containing 84, 90, 100 or 500 tablets.

6.6

Special precautions for disposal
None.

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
27 March 1987; renewed 29 June 1999

10

DATE OF REVISION OF THE TEXT
18/11/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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