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Semina Lini usitatissimi (Herbal raw material) Instructions for Use

ATC Code

A03AX (Other drugs for functional gastrointestinal disorders)

Active Substance

Linseed oil (Ph.Eur. European Pharmacopoeia)

Clinical-Pharmacological Group

Herbal laxative preparation

Pharmacotherapeutic Group

Herbal demulcent agent

Pharmacological Action

An agent of plant origin. It exerts an demulcent effect, which is provided by the content of a large amount of mucilage (5-12%) and the glycoside linamarin.

It also contains fatty acids (30-45%), including linoleic, linolenic, oleic acids; proteins, lignans, phenylpropane derivatives. It has an anti-inflammatory effect and promotes the acceleration of regeneration processes.

It has a laxative effect.

Indications

For oral administration: constipation; functional intestinal disorders due to abuse of laxatives; irritable bowel syndrome; as an agent that reduces irritation of the mucous membrane in gastritis and enteritis.

For external use: inflammatory diseases of the skin.

ICD codes

ICD-10 code Indication
K29 Gastritis and duodenitis
K52.9 Noninfective gastroenteritis and colitis, unspecified
K58 Irritable bowel syndrome
K59.0 Constipation
K59.9 Unspecified functional intestinal disorder
L30.9 Dermatitis, unspecified
ICD-11 code Indication
DA42.Z Gastritis, unspecified
DA51.Z Duodenitis, unspecified
DA7Z Diseases of stomach or duodenum, unspecified
DA90.0 Syndromic diarrhea
DB32.1 Slow-transit constipation
DD91.0Z Irritable bowel syndrome, unspecified
DD91.1 Functional constipation
DD91.Z Irritable bowel syndrome or functional intestinal disorders, unspecified
DD93.Z Functional gastrointestinal disorders in infants, toddlers, and school-age children, unspecified
DE2Z Diseases of the digestive system, unspecified
EA85.2Z Hand dermatitis, unspecified
EA85.3 Foot dermatitis
EA89 Generalized eczematous dermatitis of unspecified type
EA8Z Dermatitis or eczema, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

For oral administration, prepare an infusion by pouring 150-200 mL (approx. 1 cup) of boiling water over 1-2 teaspoons (3-5 grams) of whole or crushed seeds.

Infuse the mixture for 15-20 minutes, then strain. Take the prepared infusion 2-4 times daily.

Alternatively, ingest 1-2 tablespoons (10-20 grams) of whole seeds with at least 150-200 mL of water or another liquid. Ensure adequate fluid intake of at least 1.5-2 liters daily during treatment.

For external use as a poultice, apply crushed seeds mixed with hot water to affected skin areas.

The daily dose for adults and adolescents over 12 years should not exceed 30-50 grams of seeds. The duration of therapy is determined individually, typically not exceeding 2-4 weeks for constipation without medical supervision.

Administer the preparation at least 1 hour before or 2 hours after taking other oral medications to prevent impaired absorption.

Adverse Reactions

Possibleallergic reactions, flatulence; rarely – nausea, in the first days of administration – pasty stools.

Contraindications

Hypersensitivity to the agent, dyspeptic symptoms (diarrhea), acute cholecystitis, chronic cholecystitis (exacerbation), gastrointestinal bleeding, intestinal obstruction, children under 12 years of age (for oral administration).

Use in Pregnancy and Lactation

Use during pregnancy and lactation (breastfeeding) is not recommended.

Use in Hepatic Impairment

Contraindicated for use in acute cholecystitis, exacerbation of chronic cholecystitis.

Pediatric Use

Contraindicated for oral use in children under 12 years of age.

Special Precautions

Use of linseed as a laxative without sufficient fluid intake may lead to ileus.

Administration with food improves the absorption of linseed oil.

Drug Interactions

When used concomitantly with other drugs, it impairs their absorption.

Use with caution concomitantly with drugs that slow down intestinal peristalsis (loperamide, opiates).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Lek S+, LLC (Russia)

Dosage Form

Bottle OTC Icon Semina Lini usitatissimi Herbal raw material 50 g: packs 1 pc.

Dosage Form, Packaging, and Composition

Herbal raw material 1 pack
Linseed 50 g

Paper bags (1) – cardboard packs.

Marketing Authorization Holder

Health Firm, LLC (Russia)

Dosage Form

Bottle OTC Icon Semina Lini usitatissimi Whole seeds: packs 40 g, 50 g, 75 g, 80 g, 90 g, 100 g, 150 g or 200 g

Dosage Form, Packaging, and Composition

Whole seeds flattened, ovoid in shape, pointed at one end and rounded at the other, inequilateral, up to 6 mm long, up to 3 mm wide; the seed surface is smooth, shiny or matte, with a light yellow, clearly visible seed hilum; seed color from light yellow to dark brown; odorless; the taste of the aqueous extract is mucilaginous-oily.

1 pack
Common flax seeds 100 %

40 g – cardboard packs.
50 g – cardboard packs.
75 g – cardboard packs.
80 g – cardboard packs.
90 g – cardboard packs.
100 g – cardboard packs.
150 g – cardboard packs.
200 g – cardboard packs.

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