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• spc-doc_PL 14894-0723
• spc-doc_PL 35730-0011

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Vitomeg 1000 mg Soft Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains 1000 mg omega-3-acid ethyl esters 90, comprising principally 840 mg ethylesters of eicosapentaenoic acid (EPA) 460 mg and docosahexaenoic acid (DHA) 380 mg.

Excipient with known effect: This medicinal product contains soya oil.

For the full list of excipients see section 6.1.

3 PHARMACEUTICAL FORM

Capsule, soft.

Slightly yellow oblong soft capsules approximately 24 mm in length and 10 mm in width.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Post Myocardial Infarction

Adjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy (e.g. statins, anti-platelet medicinal products, beta-blockers, ACE inhibitors).

Hypertriglyceridaemia

Endogenous hypertriglyceridaemia as a supplement to diet when dietary measures alone are insufficient to produce an adequate response:

-    type IV hypertriglyceridaemia in monotherapy

-    type IIb/III hypertriglyceridaemia in combination with statins, when control of triglycerides through statins alone is not sufficient.

4.2 Posology and method of administration

Posology

Post Myocardial Infarction

The recommended dose is one capsule daily.

Hypertriglyceridaemia

Initial treatment two capsules daily. If adequate response is not obtained, the dose may be increased to four capsules daily.

The soft capsules should be taken with food to avoid gastrointestinal disturbances.

Elderly people

There is no information regarding the use of Vitomeg in elderly patients over 70 years of age.

Patients with renal impairment There is only limited information regarding the use in impairment.

Patient with hepatic impairment There is no information regarding the use of Vitomeg in patients with hepatic impairment (see section 4.4).

Paediatric population

There is no information regarding the use of Vitomeg in children and adolescents.

Method of administration

The soft capsules should be taken with food to avoid gastrointestinal disturbances.

4.3 Contraindications

Hypersensitivity to the active substance, to soya, peanut or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Because of the moderate increase in bleeding time (with the high dosage, i.e. 4 capsules per day), patients receiving anticoagulant therapy must be monitored and the dosage of anticoagulant adjusted if necessary (see section 4.5 Interaction with other Medicinal Products and other forms of Interaction). Use of Vitomeg 1000 mg Soft Capsules does not eliminate the need for the surveillance usually required for patients of this type.

Make allowance for the increased bleeding time in patients at high risk of haemorrhage (because of severe trauma, surgery, etc).

During treatment with Vitomeg 1000 mg Soft Capsules, there is a fall in thromboxane A2 production. No significant effect has been observed on the other coagulation factors. Some studies with omega-3-acids demonstrated a prolongation of bleeding time, but the bleeding time reported in these studies has not exceeded normal limits and did not produce clinically significant bleeding episodes.

In some patients a small but significant increase (within normal values) in ASAT and ALAT was reported, but there are no data indicating an increased risk for patients with hepatic impairment. ALAT and ASAT levels should be monitored in patients with any signs of liver damage (in particular with the high dosage, i.e. 4 capsules).

Vitomeg 1000 mg Soft Capsules is not indicated in exogenous hypertriglyceridaemia (type 1 hyperchylomicronaemia). There is only limited experience in secondary endogenous hypertriglyceridaemia (especially uncontrolled diabetes).

There is no experience regarding the treatment of hypertriglyceridaemia in combination with fibrates.

Paediatric population

In the absence of efficacy and safety data, use of this medication in children is not recommended.

Soya oil

This medicinal product contains soya oil. If the patient is allergic to peanut or soya, do not take this medicinal product (see section 4.3).

4.5 Interaction with other medicinal products and other forms of interaction

Oral anticoagulants: See also section 4.4.

Vitomeg 1000 mg Soft Capsules has been given in conjunction with warfarin without haemorrhagic complications. However, the prothrombin time must be checked when Vitomeg 1000 mg Soft Capsules is combined with warfarin or when treatment with Vitomeg 1000 mg Soft Capsules is stopped.

4.6 Fertility, Pregnancy and lactation

Pregnancy

There are no adequate data from the use of Vitomeg 1000 mg Soft Capsules in pregnant women.

Studies in animals have not shown reproductive toxicity. The potential risk for humans is unknown and therefore Vitomeg 1000 mg Soft Capsules should not be used during pregnancy unless clearly necessary.

Lactation

There are no data on the excretion of Vitomeg 1000 mg Soft Capsules in animal and human milk. Therefore, Vitomeg 1000 mg Soft Capsules should not be used during lactation.

Fertility

There are no data on the impact on fertility of Vitomeg 1000 mg Soft Capsules.

4.7 Effects on ability to drive and use machines

Effects on ability to drive and use machines have not been studied. Nevertheless, Vitomeg 1000 mg Soft Capsules is expected to have no or negligible influence on the ability to drive and use machines.

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

There are no special recommendations for overdose. Treatment should be symptmatic.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: omega-3-triglycerides, incl. other esters and acids ATC code: C10AX06.

The omega-3 series polyunsaturated fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are essential fatty acids.

Vitomeg 1000 mg Soft Capsules is active on the plasma lipids by lowering triglyceride levels as a result of a fall in VLDL (very low density lipoprotein). Vitomeg 1000 mg Soft Capsules is also active on haemostasis and blood pressure.

Vitomeg 1000 mg Soft Capsules reduces the synthesis of triglycerides in the liver because EPA and DHA are poor substrates for the enzymes responsible for triglyceride synthesis and they inhibit esterification of other fatty acids.

The increase in peroxisomes of P-oxidation of fatty acids in the liver also contributes to the fall in triglycerides, by reducing the quantity of free fatty acids available for their synthesis. The inhibition of this synthesis lowers VLDL.

Vitomeg 1000 mg Soft Capsules increases LDL-cholesterol in some patients with hypertriglyceridaemia. A rise in HDL-cholesterol is only small, significantly smaller than seen after administration of fibrates, and not consistent.

The long-term lipid-lowering effect (after more than one year) is not known. Otherwise there is no strong evidence that lowering triglycerides reduces the risk of ischaemic heart disease.

During treatment with Vitomeg 1000 mg Soft Capsules, there is a fall in thromboxane A2 production and a slight increase in bleeding time. No significant effect has been observed on the other coagulation factors.

11324 patients, with recent myocardial infarction MI (<3 months) and receiving a recommended preventative treatment associated with a Mediterranean diet, were randomised in the GISSI-Prevenzione study in order to receive Omega-3-acid ethyl esters 90 (n=2836), vitamin E (n=2830), Omega-3-acid ethyl esters 90 + vitamin E (n=2830) or no treatment (n=2828). GISSI-P was a multicentre, randomised, open-label study performed in Italy.

The results observed over 3.5 years, with Omega-3-acid ethyl esters 90 1g/day, have shown a significant reduction of a combined endpoint including all-cause death, non fatal MI and non fatal stroke (decrease in relative risk of 15% [226] p=0.0226 in patients taking Omega-3-acid ethyl esters 90 alone compared to control, and of 10% [1-18] p=0.0482 in patients taking Omega-3-acid ethyl esters 90 with or without vitamin E). A reduction of the second pre-specified endpoint criteria including cardiovascular deaths, non fatal MI and non-fatal stroke has been shown (decrease in relative risk of 20% [5-32] p=0.0082 in patients taking Omega-3-acid ethyl esters 90 alone compared to control, decrease in relative risk of 11% [1-20] p= 0.0526 in patients taking Omega-3-acid ethyl esters 90 with or without vitamin E). The secondary analysis for each component of the primary endpoints has shown a significant reduction of all cause deaths and cardiovascular deaths, but no reduction of non fatal cardiovascular events or fatal and non fatal strokes.

5.2 Pharmacokinetic properties

During and after absorption, there are three main pathways for the metabolism of the omega-3 fatty acids:

-    The fatty acids are first transported to the liver where they are incorporated into various categories of lipoproteins and then channelled to the peripheral lipid stores;

-    The cell membrane phospholipids are replaced by lipoprotein phospholipids and the fatty acids can then act as precursors for various eicosanoids;

-    The majority is oxidised to meet energy requirements.

The concentration of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in the plasma phospholipids corresponds to the EPA and DHA incorporated into the cell membranes.

Animal pharmacokinetic studies have shown that there is a complete hydrolysis of the ethyl ester accompanied by satisfactory absorption and incorporation of EPA and DHA into the plasma phospholipids and cholesterol esters.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction. In addition non-clinical literature data on safety pharmacology are indicating that there is no hazard for humans.

6.1 List of excipients

Capsule core: alpha-tocopherol (Ph. Eur.)

Capsule shell: gelatine, glycerol, purified water, medium-chain triglycerides, sunflower lecithin

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C.

Do not freeze.

After first opening:

20caps-75ml: 20 days 28caps-75ml: 28 days 100caps-250ml: 100 days 20 caps x 10 bottles each bottle 20 days

6.5 Nature and contents of container

White (HDPE) bottles of 75 ml with a LDPE push-fit tamper-evident cap.

White (HDPE) bottles of 250 ml with a white PE flip-top cap or white PE screw cap.

HDPE bottles 75 ml 20 capsules 28 capsules

200 capsules (10 bottles x 20 capsules)

HDPE bottles 250 ml

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7    MARKETING AUTHORISATION HOLDER

NTC Srl

Via Luigi Razza 3 20124 Milan Italy

8    MARKETING AUTHORISATION NUMBER(S)

PL 35730/0011

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

11/06/2015

10    DATE OF REVISION OF THE TEXT

27/11/2015