Seven Seas Original Cod Liver Oil
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Seven Seas Cod Liver Oil Seven Seas Original 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
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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. |
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deficiency states: | |
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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 the active substances or to any of the excipients listed in section 6.1
- 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.
There is some evidence to suggest that fish oil supplements may adversely affect patients with aspirin-sensitive asthma.
Omega-3 fatty acids may have antithrombotic activity at high doses and in patients susceptible to bleeding. Therefore, they should be given with caution to patients with haemorrhagic disorders or to those receiving anticoagulants or other drugs affecting coagulation. Caution is required in hepatic impairment, particularly if receiving high doses. It is advisable that patients with hepatic impairment do not receive high doses.
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 containing contraceptive pills can raise plasma levels of vitamin A.
In view of a potential effect on bleeding time and platelet aggregation (see Section 4.4), great care should be exercised in patients on concomitant anticoagulation therapy or receiving other drugs which may affect coagulation factors, e.g aspirin, warfarin, cephalosporin.
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.
As most undesirable effects are based on post-marketing spontaneous reporting, precise frequency estimation is not possible.
- Gastrointestinal disorders, particularly at high doses, e.g. eructation, fishy after-taste, nausea, vomiting, abdominal pain, constipation, diarrhoea
- Moderate increases in hepatic transaminases have been reported in patients with hypertriglyceridaemia
- Skin reactions, e.g. acne, eczema and rash Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
4.9 Overdose
Vitamin A toxicity generally presents as irritability, vomiting, loss of appetite and skin changes.
Vitamin D toxicity leads to disturbance of calcium metabolism and calcification of soft tissues including the lungs and kidneys.
The benefit of gastric decontamination is uncertain. Consider activated charcoal (charcoal dose: 50 g for adults; 1 g/kg for children) only if the patient presents within 1 hour of ingestion of 1.5 mg/kg (5000 iu/kg) or more vitamin A. 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 Bedfont Cross Stanwell Road Feltham
Middlesex TW14 8NX United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 01932/0257.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of grant: 16th June1988
Date of Renewal: 26th November 1998.
10 DATE OF REVISION OF THE TEXT
29/09/2016