SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Seven Seas Cod Liver Oil Capsules

Seven Seas Original Pure Cod Liver Oil Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Constituents	Quantity per Capsule
Cod Liver Oil with vitamins A, D & E *	320 mg
containing:
Vitamin A (Retinol)	670iu
Vitamin D3 (Colecalciferol)	67iu
Vitamin E (Alpha Tocopherol Acetate)	0.3iu
Eicosapentaenoic Acid (EPA)	22.4mg minimum
Docosahexaenoic Acid (DHA)	19.2mg minimum

• 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:    1-3 capsules three times a day

depending on the age of the patient and the severity of the deficiency. Treatment of the deficiency should be continued usually between 2 weeks - 2 months until the deficiency state is corrected.

As a dietary supplement:    Adults and children over 6 years old - 1-2

capsules three times a day before meals.

Women who are pregnant, lactating or likely to become pregnant - 1 capsule three times a day.

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.

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.

There is some evidence to suggest that fish oil supplements may adversely affect patients with aspirin-sensitive asthma.

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

Thiazide diuretics with vitamin D may raise calcium levels.

Oestrogen 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 anti-coagulation therapy or receiving other drugs which may affect coagulation factors, e.g aspirin, warfarin, cephalosporin.

4.6    Fertility, pregnancy and lactation

Seven Seas Cod Liver Oil capsules should only be used after the consultation with a physician when planning a pregnancy, during pregnancy and lactation. The recommended dosage must not be exceeded.

Large doses of vitamin A (exceeding 10,000 IU) have been found to be teratogenic if administered during the first trimester of pregnancy.

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

Tel: Freephone 0808 100 3352 (available between 10 am - 2 pm Monday -Friday)

Website: www.mhra.gov.uk/yellowcard

Overdose

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.

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 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

Vegetable Lecithin

Vegetable Oil Water

6.2 Incompatibilities

None known.

6.3 Shelf life

36 months

6.4 Special precautions for storage

Store under cool dry condition, away from sunlight and direct heat.

6.5 Nature and contents of container

White polypropylene tub with polypropylene screw cap fitted with bore seal containing 30, 60, 120 250 and 500 capsules or triangular shaped, clear plastic bottles, with a ROPP metal cap, EPE wad containing 250 & 500 capsules. Packed in individual cartons.

6.6 Special precautions for disposal

No specific instructions required.

7 MARKETING AUTHORISATION HOLDER

SEVEN SEAS LIMITED

HEDON ROAD

MARFLEET

HULL

HU9 5NJ

UNITED KINGDOM

MARKETING AUTHORISATION NUMBER(S)

PL 01932/0259

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

04/06/2007

DATE OF REVISION OF THE TEXT

20/10/2013