Fish oil-Teva (Capsules) Instructions for Use

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Teva Pharmaceutical Works, Private Limited Company (Hungary)

ATC Code

A11JA (Vitamins in combination)

Active Substance

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

Dosage Form

Fish oil-Teva

Capsules 500 mg: 100 pcs.

Dosage Form, Packaging, and Composition

Capsules soft gelatin; the capsule contents are a slightly viscous, transparent, yellow oil with no visible particles and a characteristic odor.

Excipients: gelatin – 128.95 mg, glycerol – 42.04 mg, 70% non-crystallizing sorbitol – 17.19 mg, water – 10.87 mg.

10 pcs. – blisters (10) – cardboard packs.

Clinical-Pharmacological Group

Hypolipidemic agent

Pharmacotherapeutic Group

Vitamin – calcium-phosphorus metabolism regulator

Pharmacological Action

The pharmacological action of the product is determined primarily by the content of omega-3 polyunsaturated fatty acids (eicosapentaenoic, docosahexaenoic).

These acids are structural components of cell membranes, help reduce blood cholesterol levels, lower triglyceride content by reducing the concentration of very low-density lipoproteins, reduce platelet aggregation, and improve the rheological properties of blood.

Indications

• Prevention of conditions caused by dyslipidemia (lipid metabolism disorder);
• Complex therapy of lipid metabolism disorders, including diet, statins, antiplatelet agents.

ICD codes

Dosage Regimen

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

It is recommended to swallow the capsules immediately with plenty of water; they should not be held in the mouth for a long time, as the gelatin in the shell can make the capsule sticky, which will make subsequent swallowing difficult.

The course of treatment is 2-3 months. After that, it is recommended to do a complete blood count and continue taking the drug depending on the results.

Adverse Reactions

Possibleallergic reactions, decreased blood clotting, exacerbation of chronic cholecystitis and pancreatitis/diarrhea, fishy breath.

Contraindications

• Chronic cholecystitis and pancreatitis (and periods of their exacerbation);
• Concomitant use of fibrates, oral anticoagulants;
• In case of severe injuries, surgical operations (due to the risk of increased bleeding time);
• Pregnancy;
• Lactation period;
• Childhood;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation.

Pediatric Use

Contraindicated: childhood.

Special Precautions

Patients on anticoagulant therapy should be under constant medical supervision during the intake of Fish Oil, and if necessary, an appropriate adjustment of the anticoagulant dose should be made.

Overdose

Symptoms: possible exacerbation of cholelithiasis and chronic pancreatitis.

Treatment: symptomatic, drug withdrawal.

Drug Interactions

Patients undergoing a course of treatment for cardiovascular diseases or taking drugs that affect the rate of blood clotting are not recommended to take Fish Oil.

Storage Conditions

Store in a dry, light-protected place, out of reach of children, at a temperature of 15-25°C (59-77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.