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SEVEN SEAS ORANGE SYRUP AND COD LIVER OIL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Seven Seas Orange Syrup & Cod Liver Oil

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Constituents

Quantity per 5ml
Cod Liver Oil with vitamins A, D & E containing: Vitamin A (Retinol) Vitamin D3 (Colecalciferol) Vitamin E (Alpha Tocopherol Acetate) Eicosapentaenoic Acid (EPA) Docosahexaenoic Acid (DHA) 1.4g 2000IU 200IU 1.5IU 126mg 112mg

*Cod Liver Oil complies with the current BP/Ph.Eur monograph for Cod Liver Oil Type B with the exception of the vitamin content

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PHARMACEUTICAL FORM
Pale yellowish syrup (emulsion)

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4.1

CLINICAL PARTICULARS
Therapeutic indications A) Treatment of combined vitamins A, D and E deficiencies. B) Combined vitamins A, D, 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: 5-10ml 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 or until the deficiency state is corrected. As a dietary supplement: Adults: 10ml per day. Children 5-15 years: 5ml per day. Women who are pregnant, lactating or likely to become pregnant: 5.0ml 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 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 Thiazide diuretics with vitamin D may raise calcium levels. Oestrogencontaining contraceptive pills can raise plasma levels of vitamin A.

4.6

Fertility, Pregnancy and lactation Do not exceed the recommended dose.

Doses of vitamins A, D and E in excess of those recommended should be avoided during lactation and pregnancy.

4.7

Effects on ability to drive and use machines None stated.

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.

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5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Bibliography quoted.

5.2

Pharmacokinetic properties Bibliography quoted.

5.3

Preclinical safety data None stated.

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6.1

PHARMACEUTICAL PARTICULARS
List of excipients Vitamin C (Ascorbic Acid) Vitamin B6 (Pyridoxine Hydrochloride) Sugar Citric Acid Sodium Methylhydroxybenzoate Orange Juice Concentrate Orange flavour Oil Gum Acacia Imitation Blood Orange Flavour Water.

6.2

Incompatibilities None known.

6.3

Shelf life 18 months.

6.4

Special precautions for storage

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

6.5

Nature and contents of container Brown glass bottles containing 150ml or 300ml with metal screw caps with EPE wad.

6.6

Special precautions for disposal None stated.

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MARKETING AUTHORISATION HOLDER
Seven Seas Limited Hedon Road Marfleet Hull HU9 5NJ United Kingdom

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MARKETING AUTHORISATION NUMBER(S)
PL 01932/0261

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24/06/2008

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DATE OF REVISION OF THE TEXT
26/09/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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