Vivacia Omega 3 Fish Oil (Capsules) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

Maryvery, Limited (UK)

Dosage Form

Vivacia Omega 3 Fish oil

Capsules: 60 pcs.

Dosage Form, Packaging, and Product Composition

Capsules soft gelatin, mass 1402 mg.

* Engraulis ringens – Peruvian anchovy.

Excipients: capsule shell (gelatin, glycerol, purified water), vitamin E (DL-alpha-tocopherol).

^# recommended daily intake.

Energy value (100 g): 3762 kJ/900 kcal.

60 pcs. – bottles (1) – cardboard packs.

Therapeutic Category

Dietary supplement – source of polyunsaturated omega-3 fatty acids

Indications

• Vivacia Omega 3 Fish Oil is indicated as a dietary supplement to provide additional intake of omega-3 polyunsaturated fatty acids (PUFAs), specifically eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
• It is used to support cardiovascular health by helping to maintain healthy triglyceride levels and promoting normal blood flow.
• The supplement contributes to the normal function of the brain and nervous system, supporting cognitive processes such as memory and concentration.
• It aids in the maintenance of normal vision and supports the health of the retina.
• It is utilized to support a healthy inflammatory response in the body and promote overall cellular health.

Contraindications

• Hypersensitivity or known allergy to fish or any of the product’s components, including gelatin from the capsule shell, is an absolute contraindication.
• The use of this supplement is contraindicated in individuals with severe blood coagulation disorders (e.g., hemophilia) or those taking anticoagulant medications without direct medical supervision, due to the potential increased risk of bleeding.
• It is not recommended for use in children under 14 years of age unless specifically advised by a healthcare professional, as safety and efficacy in this age group may not be established.
• Contraindicated in patients with severely impaired liver function or active liver disease, as this may affect the metabolism of fats.
• Use is contraindicated during pregnancy and breastfeeding without prior consultation with a physician, as the specific effects of high-dose omega-3 supplementation during these periods require professional assessment.

Dosage Regimen

The standard recommended dosage for adults and children over 14 years of age is one to two capsules per day, taken with meals.

For optimal absorption and to minimize potential gastrointestinal discomfort, the capsules should be swallowed whole with a sufficient amount of water or other liquid and should not be chewed.

The duration of use is not limited; however, it is advisable to consult a healthcare provider for prolonged continuous use exceeding 3-4 months to assess individual needs and appropriateness.

Do not exceed the recommended daily dose. The need for a specific dosage regimen (e.g., a higher dose for pronounced triglyceride management) should be determined exclusively by a physician based on the patient’s health status and laboratory parameters.

Adverse Reactions

Vivacia Omega 3 Fish Oil is generally well-tolerated when taken at the recommended dosage. The most commonly reported adverse reactions are mild and related to the gastrointestinal system.

These may include fishy aftertaste or burping, nausea, dyspepsia (indigestion), abdominal discomfort or pain, diarrhea, or loose stools. Taking the capsules with meals or refrigerating the product can often reduce these effects.

In rare cases, allergic reactions such as skin rash, urticaria, or itching may occur, particularly in individuals with known fish or shellfish allergies.

High doses of omega-3 fatty acids may affect blood coagulation parameters, potentially leading to prolonged bleeding time or an increased tendency for nosebleeds or easy bruising. It is important to monitor for these signs, especially in patients taking anticoagulant therapy.

If any adverse reactions persist or worsen, or if you experience any other unusual symptoms, discontinue use and consult your doctor or pharmacist.

Drug Interactions

Omega-3 fatty acids can interact with several classes of medications, necessitating caution and medical supervision.

The most significant interaction is with anticoagulant and antiplatelet drugs (e.g., warfarin, acenocoumarol, clopidogrel, aspirin in antiplatelet doses). Concurrent use may potentiate the anticoagulant effect, increasing the risk of bleeding and bruising. Close monitoring of coagulation parameters (INR) is essential if combined use is necessary.

Potential interactions may occur with blood pressure-lowering medications. Omega-3 fatty acids can have a mild hypotensive effect, which may add to the effects of these drugs, potentially leading to hypotension. Blood pressure should be monitored regularly.

While not a direct interaction, high doses of omega-3s may slightly increase fasting blood glucose levels in some individuals with diabetes. Patients taking antidiabetic medications should monitor their blood sugar levels carefully when starting supplementation.

Inform your doctor or pharmacist about all the products you are using, including prescription, over-the-counter medicines, and other herbal or dietary supplements, before starting Vivacia Omega 3 Fish Oil.

Overdose

Acute overdose with omega-3 fish oil capsules is unlikely to be life-threatening. However, significantly exceeding the recommended daily dose may lead to pronounced adverse effects.

Symptoms of overdose are primarily gastrointestinal and may include severe nausea, diarrhea, abdominal cramping, and persistent fishy aftertaste.

Chronic excessive intake of very high doses (typically several grams of EPA/DHA daily) may lead to more serious consequences, such as clinically significant prolongation of bleeding time, increased risk of hemorrhagic events, and potential immunosuppression at extreme doses.

In case of suspected overdose, discontinue use immediately. Treatment is symptomatic and supportive. If a large quantity has been ingested accidentally, seek medical attention or contact a Poison Control Center. There is no specific antidote.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.