Fish oil refined for internal use (Oil) Instructions for Use

ATC Code

A11CB (Vitamins A and D in combination)

Active Substance

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

Clinical-Pharmacological Group

Complex of vitamins of animal origin regulating lipid metabolism

Pharmacotherapeutic Group

Vitamin – calcium-phosphorus metabolism regulator

Pharmacological Action

The action of the drug is due to the content of vitamins A and D and unsaturated fatty acids.

Vitamin A (retinol) is involved in metabolic processes in the mucous membranes and skin, in the formation of visual pigments necessary for normal twilight and color vision; it ensures the integrity of epithelial tissues and regulates bone growth.

Vitamin D (cholecalciferol) regulates the metabolism of calcium (Ca²⁺) and phosphates, the process of building bone structure; it increases the absorption of Ca²⁺ in the intestine; unsaturated fatty acids are involved in the synthesis of arachidonic acid, leukotrienes and prostaglandins; they help reduce cholesterol in the blood serum, lower platelet aggregation, and improve the rheological properties of blood.

Indications

• Hypo- and avitaminosis A and D (frequent respiratory diseases, convalescence, impaired bone growth, decreased vision, impaired structure of skin, hair, nails, teeth, rickets);
• Prevention of osteopathies of various origins.

ICD codes

Dosage Regimen

Oil

Orally. The drug is recommended to be taken with meals.

Dosage regimenfor children from 3 months – 1/2 teaspoon (2.5 ml) per day; for children aged 1 year – 1 teaspoon (5 ml) per day; for children from 2 years – 1-2 teaspoons per day; for children from 3 to 6 years – 1 dessert spoon (10 ml) per day; for children from 7 years and adults – 1 tablespoon (15 ml) per day. The course of treatment is prescribed by the attending physician depending on the indications for use.

1 g of the drug contains: from 350 to 1000 IU of vitamin A, from 50 to 100 IU of vitamin D.

1 ml of the drug contains: from 320 to 927 IU of vitamin A, from 45.85 to 92.7 IU of vitamin D.

5 ml of the drug contains: from 1600 to 4635 IU of vitamin A, from 229.25 to 463.5 IU of vitamin D.

10 ml of the drug contains: from 3200 to 9270 IU of vitamin A, from 458.5 to 927 IU of vitamin D.

15 ml of the drug contains: from 4800 to 13905 IU of vitamin A, from 687.75 to 1390.5 IU of vitamin D.

Adverse Reactions

Allergic reactions, diarrhea, decreased blood clotting, fishy odor from the mouth.

Contraindications

• Hypersensitivity;
• Hypocoagulation;
• Hemophilia;
• Chronic cholecystitis and pancreatitis (and periods of their exacerbation);
• Active form of pulmonary tuberculosis;
• Thyrotoxicosis;
• Chronic renal failure;
• Hypervitaminosis of vitamins A and D;
• Hypercalcemia;
• Hypercalciuria;
• Sarcoidosis;
• Calcium nephrourolithiasis;
• Long-term immobilization;
• Children under 3 months of age.

With caution acute and chronic nephritis, gastric and duodenal ulcer, hypothyroidism, breastfeeding period, organic heart disease, acute and chronic diseases of the liver and kidneys, old age.

Use in Pregnancy and Lactation

Use during pregnancy is not recommended. Use during breastfeeding is possible if the expected benefit to the mother outweighs the potential risk to the child. It is necessary to consult a doctor!

Use in Hepatic Impairment

With caution in acute and chronic liver diseases.

Use in Renal Impairment

With caution in acute and chronic kidney diseases.

Pediatric Use

Contraindicated in children under 3 months.

Geriatric Use

With caution in old age.

Special Precautions

Consult your doctor before using the drug! It is recommended to stop taking the drug at least 4 days before surgical treatment or other surgical intervention.

Effect on the ability to drive vehicles and mechanisms

The drug does not affect the ability to perform potentially hazardous activities that require increased concentration and speed of psychomotor reactions (including driving vehicles, working with moving mechanisms).

Overdose

With prolonged use of the drug, drowsiness, lethargy, headache, loss of appetite, nausea, vomiting, diarrhea, pain in the bones of the lower extremities may occur.

Treatment symptomatic, drug withdrawal.

Drug Interactions

When the drug is used simultaneously with other medicines containing vitamins A and D, there is a possibility of vitamin intoxication. Particular caution should be exercised when taking the drug simultaneously with medicines that affect blood clotting.

Storage Conditions

In a dry, light-protected place at a temperature not exceeding 10°C (50°F). Freezing is allowed. 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.