SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

MaxEPA® Liquid

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Each gram of liquid contains:

Eicosapentaenoic Acid (EPA)    170 mg

Docosahexaenoic Acid (DHA)    115 mg

For full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Oral Liquid Clear, golden oil.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

MaxEPA Liquid is recommended for the reduction of levels in patients with severe hypertriglyceridaemia who special risk of ischaemic heart disease and/or pancreatitis. conjunction with appropriate dietary measures and after diet alone has failed to produce an adequate response.

Other risk factors such as hypertension and smoking should be dealt with.

4.2    Posology and method of administration

Adults: One 5ml spoonful to be taken twice daily with food Neonates: The use of MaxEPA Liquid has not been established in neonates Children: The use of MaxEPA Liquid has not been established in children Elderly: The normal adult dosage is appropriate for elderly patients

4.3    Contraindications

Use in caution in insulin-dependent diabetics with aspirin sensitive asthma.

Maxepa is contraindicated in patients with hypersensitivity to any of the active ingredients or excipients.

4.4 Special warnings and precautions for use

(i)    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.

(ii) There is some evidence to suggest that fish oil supplements may adversely affect patients with aspirin sensitive asthma and that doses of MaxEPA above 5g/day may cause mild deterioration of glycaemic control in noninsulin dependent diabetic patients causing a slight rise in glucose levels.

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

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

There has been no reported experience of the use of MaxEPA in pregnancies or breast feeding.

It should therefore only be given during pregnancy when benefits outweigh risks.

4.7 Effects on ability to drive and use machines

No effects on ability to drive and use machines have been observed.

4.8 Undesirable 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, diarrhoea, constipation.

Skin reactions, e.g. acne, eczema.

Moderate increases in hepatic transaminases have been reported in patients with hypertriglyceridaemia.

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

4.9 Overdose

MaxEPA Liquid is composed entirely of constituents which are found as a normal part of the diet, and, as such, may be regarded as harmless at the proposed dosage levels.

Deleterious effects due to overdosage have been shown to be unlikely and studies in rats have shown no upper toxic levels of administration.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

ATC Code: C10AX06

Pharmacotherapeutic Group: Omega-3-triglycerides

A fish lipid concentrate with a high content of the essential polyunsaturated fatty acids (PUFA) of the 3 series, namely eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

A regular intake of the concentrate in diet leads to a sustained reduction in plasma triglyceride levels following which the values remain on a plateau with continued use or return within two or three months to previous levels if the concentrate is discontinued. The PUFA are incorporated into the normal lipid metabolism but are not identifiable to any extent in depot fat. The mechanism of effect appears to be via inhibition of triglyceride synthesis.

5.2 Pharmacokinetic properties

The absorption of MaxEPA is similar to that of other dietary lipids, i.e., mainly from the upper part of the small intestine and it is distributed into plasma fatty acids and blood cell lipids. The total plasma glyceride levels of EPA and DHA increase from a pre-treatment level of 0.5% to a peak of 30% and 15% at 12 days respectively, falling then to plateau levels of 23% and 18% after 16 days.

There is a corresponding decrease in the level of m6 fatty acids in free and bound form as plasma triglycerides. EPA and DHA are widely distributed following absorption from the gut and the effect has been quantified in weanling and adult rats. The proportion of 20:5 m3 in heart, retina and brain, suggest that these tissues have a low affinity for this fatty acid. DHA accumulated in all tissues except adipose tissue and to a lesser extent in platelets. DHA has a high affinity for retina, brain and heart lipids.

5.3 Preclinical safety data

Not applicable

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

All-rac-alpha-tocopheryl acetate

6.2    Incompatibilities

None known

6.3    Shelf life

The shelf life expiry date for this product shall not exceed 3 years from the date of manufacture.

Once opened, use within one month.

6.4    Special precautions for storage

(i)    Store below 25°C

(ii)    Do not refrigerate

(iii)    Protect from light

6.5    Nature and contents of container

150ml amber glass bottle with a screw cap closure and oil resistant wad.

2 x 150ml amber glass bottles with a screw cap closure and oil resistant wad packed in a cardboard carton.

6.6    Special precautions for disposal

Not applicable

7    MARKETING AUTHORISATION HOLDER

Seven Seas Limited Bedfont Cross Stanwell Road Feltham TW14 8NX United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 01932/0003

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

02/02/1987 / 12/06/2007

10    DATE OF REVISION OF THE TEXT

11/08/2015