Fish oil (Capsules) Instructions for Use

Marketing Authorization Holder

Minskintercaps Up (Republic Of Belarus)

ATC Code

A11CB (Vitamins A and D in combination)

Active Substance

Fish oil, rich in omega-3-acids (Ph.Eur. European Pharmacopoeia)

Dosage Form

Fish oil

Capsules 500 mg: 50 pcs.

Dosage Form, Packaging, and Composition

Capsules soft gelatin, oval in shape, with a seam, elastic, transparent, light yellow in color; the capsule contents are a transparent oily liquid from light yellow to yellow in color with a weak specific, non-rancid odor.

*contains vitamin A – 500 IU, vitamin D – 50 IU, eicosapentaenoic acid – not less than 8%, docosahexaenoic acid – not less than 9%, polyunsaturated fatty acids – not less than 20%

Capsule shell composition gelatin – 136.13 mg, glycerol – 62.92 mg, purified water – 17.6 mg, methylparaben – 0.28 mg, propylparaben – 0.07 mg.

10 pcs. – blister packs (aluminum/PVC) (5) – cardboard packs.

Clinical-Pharmacological Group

Complex of vitamins of animal origin regulating lipid metabolism

Pharmacotherapeutic Group

Vitamin – calcium-phosphorus metabolism regulator

Pharmacological Action

“Fish oil” capsules are a medicinal product of animal origin, the action of which is determined by the properties of its constituent vitamins A and D.

Vitamin A is a fat-soluble vitamin that plays an important role in redox processes, participates in the synthesis of mucopolysaccharides, proteins, and lipids. It is involved in the formation of visual pigments necessary for normal twilight and color vision, ensures the integrity of epithelial tissues, and regulates bone growth.

Vitamin D stimulates the absorption of calcium and phosphorus in the intestines, the reabsorption of calcium and phosphorus in the kidneys, the transport of calcium across the cell membrane, and regulates the preservation of bone structure. It also has a positive effect on the development of the immune system, cell proliferation and differentiation, the synthesis of lipids and a number of hormones, the functional activity of the cardiovascular system and the gastrointestinal tract, and reduces the level of parathyroid hormone in the blood. It is necessary for the normal functioning of the parathyroid glands and is involved in the synthesis of adenosine triphosphate.

Pharmacokinetics

Absorption

Retinol is absorbed from the gastrointestinal tract (mainly from the duodenum and jejunum) after emulsification by bile acids. Retinol that enters the intestinal microvilli undergoes esterification. The resulting retinyl palmitate binds to specific lipoproteins, penetrates into the lymphatic pathways and, as part of chylomicrons, enters the liver, where it is captured by stellate reticuloendothelial cells and then by hepatocytes, where chylomicrons are broken down, releasing retinyl palmitate, retinol, and retinal and the retinoic acid formed from it. Retinol binds to a specific protein, enters the blood, combines with albumins and is transported to various organs.

Absorption of vitamin D occurs in the proximal part of the small intestine, necessarily in the presence of bile. Part of vitamin D is absorbed in the middle sections of the small intestine and a small part in the ileum. After absorption, cholecalciferol is found in the composition of chylomicrons in free form and only partially in the form of an ester. In the blood, most of it is in a bound state with gamma globulins and albumins.

Distribution

Retinol is distributed unevenly in the body: the largest amount is in the liver and retina of the eye, less is in the kidneys, heart, lungs, lactating mammary gland, and adrenal glands. Retinol is deposited in the form of retinyl palmitate, its reserves are slowly but constantly renewed. In tissues, retinol is localized mainly in the microsomal fraction, mitochondria, lysosomes, in the membranes of cells and organelles. Vitamin D accumulates in large quantities in the bones, in smaller quantities in the liver, muscles, blood, small intestine, and persists especially long in adipose tissue. It penetrates into breast milk in small amounts.

Metabolism and Excretion

Retinol binds to glucuronic acid: D3-glucuronate undergoes enterohepatic circulation and oxidation to retinal and retinoic acid. Retinoic acid undergoes decarboxylation and binds to glucuronic acid, subsequently being excreted in bile and feces. The half-life of retinol is very long and ranges from several weeks to several months. Retinoic acid and other water-soluble metabolites are also excreted in urine and feces.

The main processes of biotransformation of vitamin D occur in the skin, liver and kidneys. In the skin, under the influence of ultraviolet radiation, vitamin D3 is formed from precursors. In the liver, vitamin D, by hydroxylation, is converted into 25-hydroxycholecalciferol (25-OH-D3). The latter in the kidneys, with the participation of parathyroid hormone, is converted into the most active metabolite of vitamin D – calcitriol, or 1,25-dihydroxycholecalciferol (1,25(OH)2-D3). The half-life of vitamin D from the body is about 19 days. It is excreted by excretion with bile, initially into the intestine (15-30% of the administered dose within 24 hours), where it undergoes enterohepatic circulation (reabsorption). The remaining part is excreted in the feces.

Indications

• Prevention of hypovitaminosis A and D.

ICD codes

Dosage Regimen

Take orally, 1-2 capsules 3 times a day, after meals, with cold or slightly warm water.

It is recommended to swallow the capsules immediately, washing them down with plenty of water; they should not be kept in the mouth for a long time, because the gelatin that is part of the shell can make the capsule sticky, which will make subsequent swallowing difficult. The course of application is at least 1 month. The duration of taking the drug is determined by the doctor.

Adverse Reactions

When using the drug in recommended doses, side effects are usually not observed. Allergic reactions and decreased blood clotting are possible.

Contraindications

• Hypersensitivity to the components of the drug;
• Idiopathic hypercalcemia;
• Hypercalciuria;
• Acute and chronic diseases of the liver and kidneys;
• Chronic pancreatitis;
• Urolithiasis;
• Hypervitaminosis A and D;
• Pulmonary tuberculosis (active form);
• Cholelithiasis;
• Prolonged immobilization (large doses);
• Thyrotoxicosis;
• Acute inflammatory skin diseases;
• Sarcoidosis and other granulomatoses;
• Pregnancy, breastfeeding period;
• Children under 7 years of age.

With caution organic heart lesions, heart failure stages II-III, gastric and duodenal ulcers, atherosclerosis, alcoholism, hypothyroidism, old age.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

Contraindicated in acute and chronic liver diseases.

Use in Renal Impairment

Contraindicated in acute and chronic kidney diseases.

Pediatric Use

Contraindicated in children under 7 years of age.

Special Precautions

The drug “Fish oil” is not recommended to be used simultaneously with other vitamin preparations containing vitamins A and D, in order to avoid an overdose of these vitamins.

Long-term use in high doses leads to chronic hypervitaminosis. When using vitamin D prophylactically, it is necessary to keep in mind the possibility of overdose, especially in children.

In old age, the need for vitamin D may increase. One capsule of the drug contains 500 IU of vitamin A and 50 IU of vitamin D.

Effect on the ability to drive vehicles, mechanisms

The use of the drug does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Symptoms of acute vitamin A overdose double vision, dizziness, diarrhea, irritability, osteoporosis, bleeding gums, dryness and ulceration of the oral mucosa, peeling of the lips, skin, confusion, increased intracranial pressure.

Symptoms of chronic intoxication loss of appetite, bone pain, cracks and dry skin, dryness of the oral mucosa, gastralgia, vomiting, hyperthermia, asthenia, fatigue, discomfort, headache, photosensitivity, pollakiuria, nocturia, polyuria, irritability, hair loss, yellow-orange spots on the soles, palms, in the nasolabial triangle area, hepatotoxic phenomena, intraocular hypertension, oligomenorrhea, portal hypertension, hemolytic anemia, changes on bone X-rays, convulsions.

Symptoms of acute vitamin D intoxication (early) dry mouth, thirst, constipation or diarrhea, polyuria, anorexia, metallic taste in the mouth, nausea, vomiting, fatigue, weakness, adynamia, hypercalcemia, hypercalciuria, dehydration; (late) bone pain, cloudy urine, increased blood pressure, skin itching, eye photosensitivity, conjunctival hyperemia, arrhythmia, drowsiness, myalgia, nausea, vomiting, pancreatitis, gastralgia, weight loss, rarely – psychosis and mood changes.

Symptoms of chronic intoxication calcification of soft tissues, kidneys, lungs, blood vessels, arterial hypertension, renal and chronic heart failure; in children – growth impairment.

Treatment drug withdrawal, diet low in calcium, consumption of large amounts of fluid. Symptomatic treatment. A specific antidote is unknown.

Drug Interactions

The activity of vitamin D may decrease 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.

It weakens the effect of calcium preparations, benzodiazepines and increases the risk of hypercalcemia.

Cholestyramine, colestipol, mineral oils, neomycin reduce the absorption of vitamin A.

Isotretinoin increases the risk of toxic effects.

Simultaneous use of tetracycline and vitamin A in high doses (50 thousand IU and above) increases the risk of intracranial hypertension.

High doses of vitamin E may reduce the body’s reserves of vitamin A.

In case of hypovitaminosis D, the effect of cardiac glycosides may be enhanced and the risk of arrhythmia may increase.

Under the influence of barbiturates (including phenobarbital), phenytoin, primidone, the need for vitamin D may increase significantly.

Long-term therapy with the drug against the background of simultaneous use of aluminum- and magnesium-containing antacids increases the concentration of vitamins A and D in the blood. Calcitonin, bisphosphonates, isoniazid, rifampicin, plicamycin, glucocorticosteroids reduce the effect of the drug.

It increases the absorption of phosphorus-containing drugs and the risk of hyperphosphatemia. When used simultaneously with sodium fluoride, the interval between doses should be at least 2 hours; with oral forms of tetracyclines – at least 3 hours.

Storage Conditions

In a dry place protected from light at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

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.