Maxepa Capsules
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
MaxEPA R Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
Eicosapentaenoic Acid (EPA) 170 mg
Docosahexaenoic Acid (DHA) 115 mg
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsules, soft
Clear, colourless, oblong soft gelatin capsules containing 1 gram of clear, golden oil.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the reduction of plasma triglyceride levels in patients with severe hypertriglyceridaemia who are judged to be at special risk of ischaemic heart disease and/or pancreatitis.
MaxEPA Capsules should be used in 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: The usual dose is 5 capsules twice daily with food
Neonates: The use of MaxEPA Capsules has not been established in neonates
Children: The use of MaxEPA Capsules has not been established in children
Elderly: As for adult dosage
The capsules may be difficult to swallow in patients with poor motor co-ordination reflexes.
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, eg. aspirin, warfarin, cephalosporin.
4.6 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 Capsules are 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 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 tt>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, ie:- 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 ro6 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 tt>3 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
Capsule contents:
All-rac alpha-tocopheryl acetate Citric acid anhydrous
Capsule shell:
Gelatin
Glycerol
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
6.4 Special precautions for storage
(i) Store in a cool, dark, dry place
(ii) Do not refrigerate
6.5 Nature and contents of container
Polypropylene tubs fitted with snap-on polyethylene caps. Each tub contains 200 capsules
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
Seven Seas Limited Hedon Road Kingston-upon-Hull HU9 5NJ United Kingdom
8 MARKETING AUTHORISATION NUMBER
PL01932/0002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
12/06/2007
10 DATE OF REVISION OF THE TEXT
20/10/2013