Epadol neo

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT EPADOLNEO (EPADOLNEO)

Composition:

Active ingredient: 1 capsule contains 1000 mg of omega-3 acid ethyl esters, consisting of:

eicosapentaenoic acid 300 mg;

docosahexaenoic acid 200 mg;

other fatty acids 498 mg;

d-α-tocopherol (vitamin E) 2 mg;

Excipients: gelatin, glycerin (in the capsule shell).

Pharmaceutical form. Soft capsules.

Main physicochemical properties: soft gelatin capsules of light yellow to dark yellow color, oval-shaped, with a seam. The capsule contents are an oily liquid ranging from light yellow to dark yellow with a characteristic odor.

Pharmacotherapeutic group. Omega-3-triglycerides, including other esters and acids.

ATC code C10AX06.

Pharmacological properties.

Pharmacodynamics.

Omega-3 polyunsaturated fatty acids – eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) – are essential fatty acids.

The medicinal product actively affects plasma lipids by reducing levels of triglycerides and low-density and very low-density lipoproteins (VLDL). The drug affects hemostasis and reduces the risk of thrombosis by influencing platelet aggregation; it also moderately lowers blood pressure.

Normalization of the blood lipid profile also occurs due to reduced triglyceride synthesis in the liver, since EPA and DHA inhibit esterification of other fatty acids, as well as due to reduced levels of free fatty acids (increased numbers of peroxisomal β-oxidation of fatty acids), which participate in triglyceride synthesis. Reduced triglyceride synthesis leads to decreased VLDL levels.

Alpha-tocopherol acts as an antioxidant and prevents oxidation of polyunsaturated fatty acids.

Pharmacokinetics.

Data on pharmacokinetics are not available.

Clinical characteristics.

Indications.

For primary prevention of atherosclerosis and cardiovascular diseases.

As part of combination therapy for atherosclerosis, ischemic heart disease, arterial hypertension; for secondary prevention of myocardial infarction as an adjunct to standard treatment methods (e.g. statins, antiplatelet agents, beta-blockers, ACE inhibitors); in hypertriglyceridemia as an adjunct to dietary therapy when the latter is insufficiently effective.

Contraindications.

Hypersensitivity to any component of the medicinal product. Exacerbation of chronic cholecystitis, exacerbation of chronic pancreatitis, exacerbation of hepatobiliary system disorders, cholelithiasis, pathological conditions involving hemorrhagic syndrome.

Interaction with other medicinal products and other forms of interaction.

Concomitant use with fibrates is not recommended due to lack of clinical experience.

Co-administration of Epadol Neo with warfarin did not lead to hemorrhagic complications; however, when these drugs are used in combination or when treatment with Epadol Neo is discontinued, prothrombin time should be monitored.

Special precautions for use

In cases of moderate prolongation of bleeding time (when using the medicinal product at high doses, i.e. 4 capsules per day), it is necessary to monitor patients receiving anticoagulant therapy and, if needed, adjust the anticoagulant dose accordingly. The possibility of prolonged bleeding time should be considered in patients with an increased risk of hemorrhage (due to severe trauma, surgical intervention, or other causes).

The medicinal product should not be prescribed for the treatment of exogenous hypertriglyceridemia (chylomicronemia type I).

In patients with hepatic impairment (especially when taking the medicinal product at high doses), regular monitoring of liver function (ALT and AST) is required.

The likelihood of adverse reactions is reduced when the medicinal product is taken during meals.

Systematic reviews and meta-analyses of randomized controlled clinical trials have revealed a dose-dependent increased risk of developing atrial fibrillation (highest at a dose of 4 g/day) in patients with established cardiovascular diseases or cardiovascular risk factors when using omega-3 acid ethyl esters, compared to placebo. If symptoms of atrial fibrillation occur, such as dizziness, asthenia, rapid heartbeat, or dyspnea, medical advice should be sought immediately. In the event of atrial fibrillation, the use of the medicinal product Epadol Neo must be permanently discontinued.

Use during pregnancy or breastfeeding

Use of Epadol Neo during pregnancy is possible only under medical supervision and based on an assessment of the benefit-risk ratio.

During breastfeeding, the medicinal product may be used only after consultation with a physician.

Ability to affect reaction rate while driving or operating machinery. No effect.

Dosage and Administration.

Take orally during meals.

For prophylactic use, adults and children aged 12 years and older should take 1 capsule per day. Depending on individual indications, the dose may be increased to 2 capsules per day.

In complex therapy of cardiovascular diseases – 2 capsules per day.

For hypertriglyceridemia, the initial dose is 2 capsules per day (in 1 or 2 doses). If the effect is insufficient, the dose may be increased up to 4 capsules per day.

Treatment should be continued until the desired therapeutic effect is achieved.

Children.

The medicinal product is not intended for use in children under 12 years of age.

Overdose.

In case of overdose, allergic reactions similar to those observed with adverse effects may occur.

Treatment. Symptomatic therapy.

Adverse reactions.

Immune system: hypersensitivity reactions.

Metabolism and nutrition: hyperglycemia.

Nervous system: dizziness, dysgeusia, headache.

Vascular system: arterial hypotension.

Blood and lymphatic system: hemorrhagic diathesis.

Respiratory, thoracic and mediastinal system: dryness of nasal mucosa.

Hepatobiliary system: liver function disorders.

Skin and subcutaneous tissue: skin rashes, pruritus, skin redness, urticaria, acne.

Gastrointestinal system: dyspeptic disorders, nausea, abdominal pain, gastrointestinal disorders (gastroesophageal reflux, belching, vomiting, flatulence, diarrhea, constipation), gastritis, gastroenteritis, gastrointestinal bleeding from lower parts.

Laboratory test changes: increased leukocyte count, increased blood lactate dehydrogenase levels. Elevated transaminase activity.

Cardiovascular system: frequent – atrial fibrillation.

Shelf life. 2 years.

Storage conditions.

Store in original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

5 capsules in a blister; 6 blisters in a carton.

5 capsules in a blister; 12 blisters in a carton.

10 capsules in a blister; 3 blisters in a carton.

10 capsules in a blister; 6 blisters in a carton.

Supply category. Over-the-counter.

Manufacturer. JSC "KYIV VITAMIN PLANT".

Manufacturer's address and location of business activity.

38 Kopilivska St., Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua.