Instructions Fish oil-Teva capsules 500 mg blister No. 90
Composition
active ingredient: fish oil;
1 capsule contains 500 mg of fish oil;
Excipients: gelatin; glycerin; sorbitol solution, non-crystallizing (E 420); purified water.
Dosage form
Capsules.
Main physicochemical properties: pale yellow transparent soft gelatin capsules of oval shape containing a transparent, particle-free, slightly viscous yellow oil with a characteristic pleasant odor.
Pharmacotherapeutic group
Hypolipidemic drugs. ATX code C10A X.
Pharmacological properties
Pharmacodynamics.
Fish oil contains two polyunsaturated fatty acids (PUFAs) - eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which have a hypolipidemic effect and exert minor anticoagulant, antiplatelet, anti-inflammatory, and immunomodulatory effects.
The hypolipidemic effect is due to the normalization of the content of low-density lipoproteins and very low-density lipoproteins, changes in the fluid properties of cell membranes and increased functional activity of membrane receptors, which contributes to improving the interaction of lipoproteins with receptors and normalizing lipoprotein metabolism.
The antiplatelet effect is associated with a change in the lipid composition of cell membranes, including platelet membranes, characterized by a decrease in the content of arachidonic acid (AA) and an increase in the level of eicosapentaenoic acid. As a result, the synthesis of thromboxane A and other diunsaturated eicosanoids (AA derivatives) that enhance platelet aggregation and stimulate the synthesis of thromboxane from EPA, thromboxane A and other triunsaturated eicosanoids that do not have an aggregating effect is reduced. In this regard, the risk of bleeding may increase. No significant effect on blood clotting factors is observed.
The vasodilator effect is associated with the effect on the synthesis of vasodilator prostaglandins, as well as other vasoactive substances involved in the regulation of vascular tone (release of depressor adenosine, reduction of noradrenaline levels in blood plasma, inhibition of calcium transport into the cell).
Pharmacokinetics.
EPA and DHA enter the body in the form of triacylglycerols, where they are hydrolyzed by pancreatic and small intestinal lipases and enter the intestinal epithelial cells as free fatty acids. After reacylation in enterocytes, they form chylomicrons with phospholipids, cholesterol, and apoproteins. Chylomicrons enter the systemic circulation via the lymphatic circulation. Chylomicrons are broken down by lipoprotein lipases, which ultimately causes the release of essential fatty acids. The fatty acids are then either incorporated into the membranes of various cell types, or are broken down, or accumulated.
Indication
The drug is used for the prevention of diseases or in the complex therapy of the following diseases:
prevention of early atherosclerosis and slowing down the atherosclerosis process;
in the complex therapy of diseases accompanied by pathologically elevated lipid levels.
Contraindication
Hypersensitivity to the components of the drug, blood clotting disorders, hemophilia, all disorders associated with bleeding, idiopathic hypercalcemia, hypercalciuria, active forms of pulmonary tuberculosis, acute and chronic liver or kidney diseases, nephrourolithiasis, acute and chronic cholecystitis and pancreatitis, period of exacerbation of chronic cholecystitis and pancreatitis, hypervitaminosis D, sarcoidosis, prolonged immobilization, thyrotoxicosis.
Interaction with other medicinal products and other types of interactions
With special care, it is necessary to use Fish Oil-Teva simultaneously with anticoagulant drugs. Interaction with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) may also be observed. Signs of such interactions may be nosebleeds, hematuria, melena, very rarely - vomiting with blood, hemoptysis. In such cases, it is recommended to immediately stop using the drug and consult a doctor.
The activity of vitamin D may be reduced when used simultaneously with anticonvulsants or barbiturates.
When used simultaneously with estrogens, the risk of hypervitaminosis A increases. Vitamin A reduces the anti-inflammatory effect of glucocorticoids.
Application features
Special care should be taken when taking the drug Fish Oil-Teva to patients who use anticoagulants (for example, warfarin); with heart damage, acute and chronic diseases of the digestive tract, gastric and duodenal ulcers, hypothyroidism; elderly patients.
It is not recommended to use the drug together with other vitamin preparations containing vitamins A and D to avoid overdose of these vitamins.
If the drug is prescribed in courses, it is necessary to regularly conduct laboratory monitoring of blood coagulation parameters (usually every 2-3 months).
The drug contains sorbitol, so if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Use during pregnancy or breastfeeding
Due to the antithrombotic effect of the drug, its use during pregnancy is possible only with the permission of a doctor and after a careful assessment of the risk/benefit ratio.
There is insufficient data on the use of the drug during breastfeeding. Use is possible only as prescribed by a doctor.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect was observed.
Method of administration and doses
Fish oil-Teva should be administered orally to adults and children over 6 years of age, 1-2 capsules 3 times a day.
It is recommended to use the drug in courses (2-3 months). After 2-3 months of use, it is necessary to monitor the parameters of the blood coagulation system and, depending on this result, continue the course of treatment.
It is advisable to take the capsules after meals and with sufficient liquid.
The duration of the course of treatment is determined by the doctor individually.
Children
The drug should not be used in children under 6 years of age.
Overdose
Overdose cases have not been registered. With prolonged use of high doses, the risk of side effects may increase: in adults - drowsiness, lethargy, headache; in children - increased body temperature, drowsiness, increased sweating, vomiting, skin rashes.
Treatment: symptomatic, drug withdrawal, restriction of calcium intake into the body with food.
Side effects
The frequency of adverse reactions is defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/1000 to < 1/1000) and very rare (< 1/10000, including isolated reports), frequency unknown (cannot be estimated due to insufficient data).
On the part of the immune system
Not known: allergic reactions.
From the vascular system
Not known: nosebleeds, bleeding (in case of wounds or abrasions).
From the digestive tract
Rare: stomach upset.
Not known: breath odor, diarrhea, exacerbation of chronic cholecystitis, pancreatitis.
Expiration date
2 years.
Storage conditions
Store at a temperature not exceeding 25 ºС in the original packaging.
Packaging
10 capsules in a blister; 7 or 9 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Teva Pharmaceutical Plant JSC.
Location of the manufacturer and address of its place of business.
Precinct 1; H-4042 Debrecen, Pallagi Str. 13, Hungary.
