Instructions for Epadol Neo soft capsules 1 g blister No. 60
Composition
active ingredient: 1 capsule contains 1000 mg of omega-3 acid ethyl esters, which include:
eicosapentaenoic acid 300 mg;
docosahexaenoic acid 200 mg;
other fatty acids 498 mg;
d-α-tocopherol (vitamin E) 2 mg;
excipients: excipients: gelatin, glycerin (as part of the gelatin capsule shell).
Dosage form
Soft capsules.
Main physicochemical properties: soft gelatin capsules from light yellow to dark yellow, oval in shape, with a seam. The contents of the capsule are an oily liquid from light yellow to dark yellow with a specific odor.
Pharmacotherapeutic group
Omega-3 triglycerides, including other esters and acids.
ATX code C10A X06.
Pharmacological properties
Pharmacodynamics
Omega-3 polyunsaturated fatty acids – eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) – are essential fatty acids.
The drug actively affects blood plasma lipids, reducing the level of triglycerides, low-density lipoproteins and very low-density lipoproteins (LDL). The drug affects hemostasis and reduces the risk of thrombosis by affecting the aggregation ability of platelets; moderately reduces blood pressure.
Normalization of the blood lipid spectrum also occurs due to a decrease in triglyceride synthesis in the liver, since EPA and DHA inhibit the esterification of other fatty acids, as well as due to a decrease in the number of free fatty acids (the number of peroxisomes of β-oxidation of fatty acids increases), which are involved in the synthesis of triglycerides. A decrease in triglyceride synthesis leads to a decrease in the level of VLDL.
Alpha tocopherol is an antioxidant that prevents the oxidation of polyunsaturated fatty acids.
Pharmacokinetics
Pharmacokinetic data are not available.
Indication
As a primary prevention of atherosclerosis and cardiovascular diseases.
As part of complex therapy for atherosclerosis, coronary 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); for hypertriglyceridemia as an adjunct to diet therapy, if the latter is not effective enough.
Contraindication
Hypersensitivity to any of the components of the drug. Exacerbation of chronic cholecystitis, exacerbation of chronic pancreatitis, exacerbation of diseases of the hepatobiliary system, cholelithiasis, pathological conditions including hemorrhagic syndrome.
Interaction with other medicinal products and other types of interactions
It is not recommended to prescribe concomitantly with fibrates due to the lack of clinical experience.
The administration of the drug Epadol Neo simultaneously with warfarin did not lead to hemorrhagic complications, however, in the case of combined use of these drugs or discontinuation of treatment with Epadol Neo, prothrombin time should be monitored.
Application features
In case of moderate increase in bleeding time (when using the drug in high doses, i.e. 4 capsules per day), it is necessary to monitor the condition of patients receiving anticoagulant therapy and, if necessary, adjust the dose of the anticoagulant accordingly. It is necessary to take into account the possibility of an increase in bleeding time in patients with an increased risk of hemorrhage (due to severe trauma, surgery or other reasons).
The drug should not be prescribed for the treatment of exogenous hypertriglyceridemia (chylomicronemia type I).
In patients with hepatic insufficiency (especially when taking the drug in high doses), regular monitoring of liver function (ALT and AST) is necessary.
The likelihood of developing adverse reactions is reduced when the drug is taken with meals.
Use during pregnancy or breastfeeding
The use of Epadol Neo during pregnancy is possible only as prescribed by a doctor, taking into account the risk/benefit ratio.
During breastfeeding, the medicine can be used after consulting a doctor.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
Take orally with meals.
For preventive purposes, adults and children over 12 years of age should be prescribed 1 capsule per day. According to individual indications, the dose of the drug can be increased to 2 capsules per day.
In the complex therapy of cardiovascular diseases - 2 capsules per day.
In case of hypertriglyceridemia, the initial dose is 2 capsules per day (in 1 or 2 doses). In case of insufficient effect, the dose of the drug should be increased to 4 capsules per day.
Treatment should be continued until the desired therapeutic effect is achieved.
Children
The medicine should not be used in children under 12 years of age.
Overdose
Treatment: Symptomatic therapy.
Side effects
Immune system disorders: hypersensitivity reactions.
Metabolism and nutrition disorders: hyperglycemia.
From the nervous system: dizziness, dysgeusia, headache.
Vascular disorders: arterial hypotension.
From the circulatory and lymphatic systems: hemorrhagic diathesis.
Respiratory, thoracic and mediastinal disorders: dryness of the nasal mucosa
From the hepatobiliary system: liver dysfunction.
Skin and subcutaneous tissue disorders: skin rashes, itching, redness of the skin, urticaria, acne.
Gastrointestinal: dyspeptic disorders, nausea, abdominal pain, gastrointestinal disorders (gastroesophageal reflux, belching, vomiting, flatulence, diarrhea, constipation), gastritis, gastroenteritis, bleeding from the lower gastrointestinal tract.
Changes in laboratory parameters: increased leukocyte count, blood lactate dehydrogenase levels. Increased transaminase activity.
Expiration date
2 years.
Storage conditions
Store in the 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 pack.
5 capsules in a blister; 12 blisters in a pack.
10 capsules in a blister; 3 blisters in a pack.
10 capsules in a blister; 6 blisters in a pack.
Vacation category
Without a prescription.
Producer
JSC "KYIV VITAMIN FACTORY".
Address
04073, Ukraine, Kyiv, Kopylivska St., 38.
Website: www.vitamin.com.ua.
