Phase 1 (Capsules) Instructions for Use

Marketing Authorization Holder

DIOD Plant of Environmental Technology and Ecopitanie, PJSC (Russia)

Dosage Form

Phase 1

Capsules

Dosage Form, Packaging, and Product Composition

Composition Korean pine nut oil.

Content of biologically active components not less than polyunsaturated fatty acids – 60%, octadecatrienoic acid – 14%.

Dosage form and packaging
Capsules 1.3 g.

Therapeutic Category

Dietary supplement – a source of choline, vitamins, polyunsaturated fatty acids

Scope of Application

Of the Phase 1 product

Recommended as a dietary supplement to food – an additional source of polyunsaturated fatty acids, including octadecatrienoic (pinolenic) acid.

Indications

• Utilize as a dietary supplement to provide an additional source of polyunsaturated fatty acids.
• Employ to supplement dietary intake of octadecatrienoic acid, also known as pinolenic acid.
• Intended for use in adults to support overall nutritional status where dietary intake may be insufficient.

ICD codes

Dosage Regimen

Ingest three capsules orally twice daily, ensuring administration coincides with main meals to enhance absorption.

Continue this regimen for a duration of one to two months. For sustained nutritional support, this course of supplementation may be repeated three to four times per annum.

Not a medicine.

Adverse Reactions

Adverse reactions are uncommon and typically mild in nature. Monitor for gastrointestinal discomfort or signs of an allergic response.

Discontinue use immediately and consult a healthcare professional if any adverse effects persist or worsen. Report any unexpected reactions.

Drug Interactions with Medications and Other Supplements

No specific drug interactions are currently documented. Exercise caution when concurrently using other supplements rich in fat-soluble vitamins or with anticoagulant medications.

Maintain a comprehensive list of all concomitant medications and supplements and review it with a physician or pharmacist to preclude potential interactions.

Contraindications for Patient Safety and Health Status

• Do not use in cases of known hypersensitivity or individual intolerance to any component of the capsules, primarily Korean pine nut oil.
• Strictly contraindicated for use during all trimesters of pregnancy.
• Strictly contraindicated for use throughout the entire period of breastfeeding and lactation.

Seek medical consultation prior to initiating use, particularly in the presence of any underlying chronic health conditions.

Overdose Management and Symptoms of Excessive Intake

While significant toxicity is not anticipated, excessive intake may lead to gastrointestinal disturbances such as nausea, diarrhea, or abdominal discomfort.

In the event of suspected overdose, discontinue use immediately and institute supportive measures. Treat symptoms symptomatically and seek medical attention if severe symptoms occur.

Dispensing Status

Distributed to the public through pharmacy networks and specialized stores, departments of the retail chain.

Storage Conditions

Store in a dry, light-protected place at a temperature not exceeding 20°C (68°F).

Shelf Life

Shelf life – 18 months.

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.