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Essential Pharmaceuticals Ltd

7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, UK
Telephone: +44 (0) 1784 477 167
Fax: +44 (0) 1784 471 776
Medical Information Direct Line: +44 (0)1784 477 167
Medical Information e-mail: info@essentialpharmaceuticals.com

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Summary of Product Characteristics last updated on the eMC: 03/10/2012
SPC Ketovite Tablets


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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 Fertility, 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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6. Pharmaceutical particulars

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6.1 List of excipients

Heavy magnesium carbonate

Magnesium stearate

Magnesium trisilicate

Stearic acid

Methylcellulose

Colloidal silicon dioxide


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6.2 Incompatibilities

None.


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6.3 Shelf life

Two years.


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6.4 Special precautions for storage

Store at 2-8°C.


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6.5 Nature and contents of container

Securitainers containing 84, 90, 100 or 500 tablets.


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6.6 Special precautions for disposal and other handling

None.


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7. Marketing authorisation holder

Essential Pharmaceuticals Limited

Unit 7, Egham Business Village

Crabtree Road

Egham

Surrey TW20 8RB,

UK.


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8. Marketing authorisation number(s)

PL 41094/0001


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9. Date of first authorisation/renewal of the authorisation

27 March 1987; renewed 29 June 1999


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10. Date of revision of the text

14/06/2012



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/1408/SPC/


Active Ingredients/Generics