Foeniculi vulgaris fructus (Herbal raw material) Instructions for Use

Marketing Authorization Holder

Fito-Em Agrarian And Industrial Firm, CJS (Russia)

ATC Code

A03AX (Other drugs for functional gastrointestinal disorders)

Active Substance

Foeniculi fructus (DAB German Pharmacopoeia)

Dosage Form

Foeniculi vulgaris fructus

Herbal raw material: packs 50, 75, or 100 g

Dosage Form, Packaging, and Composition

Cardboard packs with inserted polypropylene bags.

Bags (1) – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with carminative and antispasmodic effects

Pharmacotherapeutic Group

Spasmolytic agent of plant origin

Pharmacological Action

Fennel fruit infusion. It has a carminative, antispasmodic, and also expectorant effect. It possesses weak diuretic properties and promotes lactation enhancement. The pharmacological properties of the drug are largely due to reflex reactions associated with the irritation of sensitive nerve endings of the gastrointestinal tract and respiratory tract.

Indications

• flatulence (as a carminative agent);
• intestinal colic;
• As an expectorant in the complex therapy of inflammatory diseases of the respiratory tract (tracheitis, bronchitis, pneumonia, whooping cough).

ICD codes

Dosage Regimen

Approximately 10 g (1.5 tablespoons) of the fruits are placed in an enamel bowl, poured with 200 ml (1 glass) of hot boiled water, covered with a lid, and infused in a boiling water bath for 15 minutes, cooled at room temperature for 45 minutes, strained, and the remaining raw material is squeezed out. The volume of the obtained infusion is adjusted to 200 ml with boiled water. The infusion is taken orally warm 3-4 times/day:

adults and children over 12 years – 1/3 glass;

children from 7 to 12 years – 1-2 tablespoons;

children from 3 to 6 years – 1 tablespoon;

children under 3 years – 1/2-1 teaspoon.

It is recommended to shake the infusion before use.

Adverse Reactions

Possible allergic reactions.

Contraindications

• Hypersensitivity.

Use in Pregnancy and Lactation

The use of the drug during pregnancy and lactation is possible if the expected benefit to the mother outweighs the potential risk to the fetus and child. A doctor’s consultation is necessary.

Pediatric Use

children from 7 to 12 years – 1-2 tablespoons;

children from 3 to 6 years – 1 tablespoon;

children under 3 years – 1/2-1 teaspoon.

Special Precautions

Effect on the ability to drive vehicles and machinery

No effect.

Overdose

Cases of overdose have not been reported to date.

Drug Interactions

Not described

Storage Conditions

The drug should be stored in a dry, light-protected place, out of reach of children.

Shelf Life

Shelf life – 3 years. The prepared infusion should be stored in a cool place for no more than 2 days.

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.