Supplement of omega-3 (EPA/DHA) fatty acids,
omega-9 (oleic acid) and vitamin E.
1. PRODUCT NAME
OMEGOR VITALITY, health supplement of omega-3 EPA (eicosapentaenoic) and DHA (docosahexaenoic) fatty acids, omega-9 (oleic acid) from extra-virgin olive oil and vitamin E.
• OMEGOR VITALITY 1000– 1,4g soft gel capsules containing 700mg of omega-3 fatty acids comprising 400mg of eicosapentaenoic acid (EPA) and 200mg of docosahexaenoic acid (DHA), 160mg of omega-9 fatty acids comprising 150mg oleic acid (OA), 5mg of vitamin E (d-alpha tocopherol). Shell composition: gelatin, glycerol.
• OMEGOR VITALITY 500 – 700mg soft gel capsules containing 350mg of omega-3 fatty acids comprising 200mg of eicosapentaenoic acid (EPA) and 100mg of docosahexaenoic acid (DHA), 80mg omega-9 fatty acids comprising 75mg of oleic acid (OA), 2,5mg of vitamin E (d-alpha tocopherol). Shell composition: gelatin, glycerol.
3. DOSAGE FORM
Soft gel capsules of respectively 1,4g (OMEGOR® VITALITY 1000) and 700mg (OMEGOR VITALITY 500).
4. CLINICAL INFORMATION
4.1 Products characteristics
OMEGOR® VITALITY is a health supplement of premium strength fish oil (85% omega-3 fatty acids), extra virgin olive oil (an extremely rich source in omega-9 fatty acids and polyphenols) and vitamin E. Research has shown that fish oil and extra-virgin olive oil, may have a favourable impact on a number of risk factors associated to pathologies affecting the cardiovascular system.
4.2 Active ingredients’ properties as reported in the international scientific literature
• EPA and DHA omega-3 fatty acids. Medical literature provides extensive evidence of the protective role of omega-3 fatty acids of the cardiovascular system. EPA and DHA fatty acids may have an important impact acting on several levels: they reduce the risk of sudden death before or after a first heart attack; increase the “good” cholesterol (HDL) and decrease the triglycerides (TG) levels; exert an anti-platelet aggregation activity (contrasting the formation of thrombi); favourably modulate the endogenous synthesis of prostaglandins and leukotrienes.
• Polyphenols and omega-9 fatty acids (oleic acid). Extra virgin olive oil is one of the basic components of the Mediterranean Diet. Research has shown that olive polyphenols exert a potent antioxidant activity. They are particularly effective in protecting LDL cholesterol from oxidation, a process that is conducive to the formation of the atherosclerotic plaque. Research has also shown that omega-9 oleic acid decreases the LDL/HDL ratio, thus contributing to the reduction of the cardiovascular risk.
• Vitamin E. Thanks to its antioxidant activity, vitamin E may be helpful in contrasting the damage caused to the blood vessels by the free radicals, thus contributing to the prevention of the atherosclerotic plaque formation.
Known hypersensitivity to one or more of the product ingredients or to associated substances.
4.4 Side effects
Symptoms such as belching, flatulence and diarrhoea are very rare. Such symptoms generally occur when the recommended dosage is significantly exceeded and readily disappear by reducing the dosage or temporarily suspending the administration of the product.
Supplements are not intended as a substitute for a balanced diet. Do not exceed the recommended dosage. Keep out of the reach of children under the age of three.
4.6 Usage during pregnancy and lactation
There are no contraindications for use during pregnancy and lactation.
Patients in therapy with antithrombotic or anti-platelet aggregation drugs must inform their physician before starting the administration of OMEGOR® VITALITY.
4.8 Recommended dosage and mode of administration
-The recommended dosage for OMEGOR® VITALITY 500 is 2-4 soft gels daily to be preferably taken with a meal.
-The recommended dosage for OMEGOR® VITALITY 1000 is 1-2 soft gels daily to be preferably taken with a meal.
Administration with meals improves absorption of the active nutrients.
4.9 Excessive dosage
Please refer to point 4.4.
4.10 Other warnings
Due to the natural origin of the components, different production batches may vary in colour.
4.11 Effects on the ability to drive or operate machinery
5. PHARMACEUTICAL INFORMATION
Carton box containing 2 thermo-sealed PVDC blisters, containing 15 soft gels each.
Store the product away from direct light, in a dry place and at a temperature not higher than 30°C.
36 months from the day of the production, when properly stored. For the expiry date see side of the box.
6. TRADEMARK AND MARKETING HOLDER INFORMATION
6.1 Property and trademark holder
U.G.A. Nutraceuticals S.r.l. unipersonate – via dell’Arboreto, 62 – 06024 Gubbio (PG).
6.2 Marketing holder
Bruno Farmaceutici S.p.A. via Delle Ande, 15 – 00144 Roma.
7. SELECTED REFERENCES
1. Marchioli R. etal., Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Gruppo ltaliano per Io Studio della Sopravvivenza nell’infarto miocardico. Lancet 1999.
2. Covas MI. et al., The effect of polyphenols in olive oil on heart disease risk factors: a randomized trial. Ann Intern Mad. 2006.
U.G.A. Nutraceuticals S.r.l.
via dell’Arboreto 62, 06024 Gubbio (PG)