Seven Seas One A Day Pure Cod Liver Oil Caps
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Seven Seas One-A-Day Pure Cod Liver Oil Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
|
Active Constituents |
Quantity per dose |
|
Cod Liver Oil with vitamins A, D & E* |
1.0ml |
|
Containing: | |
|
Vitamin A (Retinol) | |
|
Vitamin D3 (Colecalciferol) |
4000iu |
|
Vitamin E (Alpha Tocopherol Acetate) |
400iu |
|
1.0iu |
Cod Liver Oil complies with the current BP/Ph.Eur monograph for Cod Liver Oil Type B with the exception of the vitamin content.
3 PHARMACEUTICAL FORM
Capsule
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 during childhood and 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 deficiency states:1 capsule per day depending on the age of the patient and the severity of the deficiency. Treatment of the deficiency state should be continued usually between 2 weeks - 2 months, until the deficiency is corrected.
As a dietary supplement:Adults and children over 6 years old - 1 capsule per day.
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 or E.
4.4 Special warnings and precautions for use
Do not take other supplements of Vitamin A and D whilst taking this product.
Benefits of Cod Liver Oil supplementation in malabsorption syndromes is unlikely.
4.5 Interaction with other medicinal products and other forms of interaction
Thiazide diuretics with Vitamin D raise calcium levels. Oestrogen containing contraceptive pills raise plasma levels of Vitamin A
4.6 Fertility, Pregnancy and lactation
Do not use during pregnancy and lactation unless advised by your doctor
Doses of vitamins A, D and E in excess of those recommended should be avoided during pregnancy and lactation.
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 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 prostagladins 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 preclinincal data of relevance which are additional to those already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Gelatin, glycerin, water
6.2 Incompatibilities
None known
6.3 Shelf life
36 months
6.4 Special precautions for storage
Store under cool conditions away from sunlight and direct heat.
6.5 Nature and contents of container
PVC blister packs with PVDC heat sealed into foil cartons containing 10, 20, 30, 60, 90, 100, 120 or 150 capsules.
6.6 Special precautions for disposal
No specific instructions required.
7 MARKETING AUTHORISATION HOLDER
Seven Seas Limited Hedon Road Marfleet HULL HU9 5NJ
8 MARKETING AUTHORISATION NUMBER(S)
PL 01932/0262
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
04/06/2007
10 DATE OF REVISION OF THE TEXT
02/07/2013