- 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 Fertility, 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
- 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
1. Name of the medicinal product
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|
3. Pharmaceutical form
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.
Hypersensitivity to the product.
4.4 Special warnings and precautions for use
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
4.8 Undesirable effects
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
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 carbonateMagnesium stearateMagnesium trisilicateStearic acidMethylcelluloseColloidal silicon dioxide
6.3 Shelf life
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 and other handling
7. Marketing authorisation holder
Essential Pharmaceuticals Limited Unit 7, Egham Business VillageCrabtree Road Egham Surrey TW20 8RB,UK.
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
27 March 1987; renewed 29 June 1999
10. Date of revision of the text
Essential Pharmaceuticals Ltd
7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, UK
+44 (0) 1784 471 776
Medical Information e-mail
+44 (0) 1784 477 167
Medical Information Direct Line
+44 (0)1784 477 167