Ketovite Tablets - Summary of Product Characteristics (SPC)

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Paines & Byrne Limited
3rd Floor, Future House, The Glanty, Egham, Surrey, TW20 9AH, UK Telephone: +44 (0)1784 419 615 Fax: +44 (0)1784 419 583

Summary of Product Characteristics last updated on medicines.ie: 19/04/2011

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
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

Each tablet contains;

Thiamine hydrochloride	1.0	mg
Riboflavin	1.0	mg
Pyridoxine hydrochloride	0.33	mg
Nicotinamide	3.3	mg
Calcium pantothenate	1.16	mg
Ascorbic acid	16.6	mg
all-rac-Alpha-Tocopheryl acetate	5.0	mg
Inositol	50.0	mg
Biotin	0.17	mg
Folic acid	0.25	mg
Acetomenaphthone	0.50	mg

For a full list of excipients, see section 6.1

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3. PHARMACEUTICAL FORM

Tablets.

Yellow tablets.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Vitamin 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.

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4.2 Posology and method of administration

For adults, children over 4 years, and the elderly: One tablet three times daily, 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

The recommended dose should not be exceeded without medical advice

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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 efficiency in patients with Parkinson's disease.

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4.6 Pregnancy and lactation

The product should not be used in pregnancy unless considered essential by the physician.

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4.7 Effects on ability to drive and use machines

None known.

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4.8 Undesirable effects

None known.

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4.9 Overdose

Overdosage of water-soluble vitamins would be rapidly excreted on cessation of dosage.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

The product is a multivitamin supplemental product.

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5.2 Pharmacokinetic properties

The pharmacokinetics of the active substances would not differ from that of the same substance when derived naturally from oral foodstuffs.

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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 anhydrous silica

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6.2 Incompatibilities

Not applicable

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6.3 Shelf life

2 years

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6.4 Special precautions for storage

Store in a refrigerator (2^oC-8^oC).

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6.5 Nature and contents of container

LDPE plastic tablet container with cap containing 84, 90, 100 or 500 tablets.

Not all pack sizes may be marketed.

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6.6 Special precautions for disposal and other handling

No special requirements.

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7. MARKETING AUTHORISATION HOLDER

Paines and Byrne Limited

3^rd Floor

Future House

The Glanty

Egham

Surrey

TW20 9AH

United Kingdom

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8. MARKETING AUTHORISATION NUMBER(S)

PA 90/11/1

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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 7^th March 1988

Date of last renewal: 9^th November 2007

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10. DATE OF REVISION OF THE TEXT

13^th December 2010

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11. Legal Category

Link to this document from your website:
http://www.medicines.ie/medicine/7039/SPC/Ketovite+Tablets/

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Active Ingredients

Folic Acid

Ascorbic Acid (Vitamin C)

Riboflavine (Vitamin B2)

Nicotinamide

Thiamine Hydrochloride (Vitamin B1)

Pyridoxine Hydrochloride (Vitamin B6)

Vitamin E (tocopherol)

Biotin

Calcium pantothenate

Inositol

Acetomenaphthone

Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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Paines & Byrne Limited

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Active Ingredients