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Paines & Byrne Limited
3rd Floor, Future House, The Glanty, Egham, Surrey, TW20 9AH, UK Telephone: +44 (0)1784 419 620 Fax: +44 (0)1784 419 583 Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 14/04/2011

SPC	Ketovite Tablets

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
Administrative Data
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
11. LEGAL CATEGORY

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1. NAME OF THE MEDICINAL PRODUCT

Ketovite Tablets.

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Thiamine hydrochloride BP	1.0	mg
Riboflavin BP	1.0	mg
Pyridoxine hydrochloride	0.33	mg
Nicotinamide BP	3.3	mg
Calcium pantothenate PhEur	1.16	mg
Ascorbic acid BP	16.6	mg
Acetomenaphthone BP 1973	0.5	mg
Alpha-tocopheryl acetate BP	5.0	mg
Inositol NF XII	50.0	mg
Biotin USP	0.17	mg
Folic acid BP	0.25	mg

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3. PHARMACEUTICAL FORM

Tablet

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4. CLINICAL PARTICULARS

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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.

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4.2 Posology and method of administration

For Adults, Children and the Elderly: One tablet three times a day, by oral administration.

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4.3 Contraindications

Hypersensitivity to the product.

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4.4 Special warnings and precautions for use

None stated.

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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.

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4.6 Pregnancy and lactation

The recommended dose should not be exceeded without medical advice.

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4.7 Effects on ability to drive and use machines

None.

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4.8 Undesirable effects

None stated.

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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.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Multivitamin preparation.

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5.2 Pharmacokinetic properties

In normal circumstances the active constituents are obtained by the same route of administration (oral) from food.

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5.3 Preclinical safety data

No relevant pre-clinical data has been generated.

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