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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Seven Seas Pure Cod Liver Oil Seven Seas Original Pure Cod Liver Oil.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Constituents    Quantity per Dose

Cod Liver Oil, HSE with vitamins

A, D & E    5.0 ml

Containing:

Eicosapentaenoic Acid (EPA):    415.8 mg

Docosahexaenoic Acid (DHA):    369.6 mg

Vitamin A (Retinol):    2000.0    iu

Vitamin D (Colecalciferol):    200.0    iu

Vitamin E (Alpha Tocopheryl Acetate):    5.0 iu

3    PHARMACEUTICAL FORM

Liquid Oil.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A)    Treatment of combined vitamins A, D and E deficiencies.

B)    Combined vitamins A, D and E and polyunsaturates supplement to the diet in adults with very poor dietary status.

C)    Traditional remedy in the symptomatic relief of muscular and joint stiffness and aches.

4.2 Posology and method of administration

For mild to moderate	5-10ml per day depending on the severity of the deficiency. Treatment of the deficiency state should be continued usually between 2 weeks - 2 months or until the deficiency state is corrected.
deficiency states:
As a dietary supplement:	Adults - 10ml (two teaspoons) daily Not recommended for children under 15.

Do not exceed the stated dose.

To be taken by oral administration.

4.3 Contraindications

Hypersensitivity to any of the ingredients. Hypercalcaemia. Hypervitaminoses A, D and E.

4.4 Special warnings and precautions for use

Do not take other supplements of Vitamin A and D whilst taking this product. Benefits from Cod Liver Oil supplementation in malabsorption syndromes are unlikely.

4.5 Interaction with other medicinal products and other forms of interaction

Co-administration of thiazide diuretics with Vitamin D may raise calcium levels.

Oestrogen contraceptive pills raise plasma levels of vitamin A.

Do not take other vitamin or mineral supplements whilst taking this product.

4.6 Fertility, Pregnancy and lactation

Women who are pregnant, lactating or likely to become pregnant should not take this product.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

Vitamin excess can be harmful but a very large overdose of this product would be needed to produce ill effects.

4.9 Overdose

Symptoms of overdosage are unlikely following a single acute intake of Vitamin A less than 1,500,000 units, Vitamin D less than 50,000 units or Vitamin E less than 500 units.

Vitamin A toxicity generally presents as irritability, vomiting, loss of appetite and skin changes.

Vitamin D toxicity leads to disturbing of calcium metabolism and calcification of soft tissues including the lungs and kidneys.

Vitamin E toxicity may lead to biochemical disturbances such as a fall in thyroid hormone.

In a case of recent ingestion gastric lavage is recommended ensuring that tracheal aspiration does not occur. In delayed presentations, administration of mineral oil purgative is recommended to diminish absorption of vitamins as well as to increase gastro intestinal motility. Other symptomatic and supportive measures should be provided when indicated. Hepatic, renal, cardiac and fluid electrolyte status should be carefully monitored.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

The vitamin A and D content of Cod liver oil ensures that normal dietary requirements are met and that Vitamin A and D deficiency states are corrected.

5.2 Pharmacokinetic properties

The essential fatty acids, Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA), found in Cod Liver Oil, undergo beta oxidation, EPA is a precursor of the ‘3’ series of prostaglandins and in a cascade reaction can lead to the production of thrombozane A3 and prostacyclin PG13.

Precise data on the rate of turnover of EPA and DHA in lipids of nervous tissue have not been determined.

5.3 Preclinical safety data

There are no preclinical data of relevance which are additional to those already included in other sections of the SPC.

6    PHARMACEUTICAL PARTICULARS

6.1 List of excipients

None.

6.2 Incompatibilities

None known.

6.3 Shelf life

36 months.

6.4 Special precautions for storage

Store at or below 25°C. Protect from sunlight and direct heat.

6.5 Nature and contents of container

Clear glass bottles containing 170ml, 250 ml, 300ml and 450ml of Seven Seas Cod Liver Oil, closed with metal caps, plastic caps or seven sided plastic caps with E.P.E wads. Each bottle is individually cartonned.

6.6 Special precautions for disposal

No specific instructions required.

7 MARKETING AUTHORISATION HOLDER

SEVEN SEAS LIMITED HEDON ROAD MARFLEET