Omanu rhizoma cum radicibus

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT INULAE RHIZOMATA ET RADICES (INULAE RHIZOMES AND ROOTS)

Composition:

Active substance: Inulae rhizomes and roots (Rhizomata et radices Inulae);

1 pack contains Inulae rhizomes and roots (Rhizomata et radices Inulae) – 50 g; 1 filter bag contains Inulae rhizomes and roots (Rhizomata et radices Inulae) – 4 g.

Pharmaceutical form. Rhizomes and roots.

Main physico-chemical properties:

Ground raw material: fragments of roots and rhizomes of various shapes, passing through a sieve with 7 mm diameter openings. Color is grayish-brown, yellowish-white, yellowish-gray. Odor is pleasant. Taste is pungent, slightly bitter;

Coarse powder: fragments of roots and rhizomes of various shapes, sized 3–4 mm. Color is grayish-brown, yellowish-white, yellowish-gray. Odor is pleasant. Taste is pungent, slightly bitter.

Pharmacotherapeutic group.

Agents used for cough and colds. Expectorants. ATC code R05C A.

Pharmacological Properties.

Pharmacodynamics.

Biologically active substances of the drug exert expectorant, anti-inflammatory, antimicrobial, choleretic, diuretic, and tonic effects; normalize motor and secretory functions of various parts of the gastrointestinal tract, and improve metabolism.

Pharmacokinetics.

Pharmacokinetics has not been determined.

Clinical characteristics.

Indications.

Respiratory tract diseases (bronchitis, tracheitis, acute respiratory infections, pneumonia); gastrointestinal tract diseases (gastritis, enterocolitis, loss of appetite, digestive disorders).

Contraindications.

Hypersensitivity to biologically active substances of the drug. Severe cardiovascular and renal diseases.

Special precautions.

None.

Interaction with other medicinal products and other forms of interactions.

Concomitant use with antitussive medicinal products is not recommended (including medicinal products containing codeine, dextromethorphan).

Instructions for use.

Use during pregnancy or breastfeeding.

The use of the drug is contraindicated during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

Does not affect.

Method of Administration and Dosage

Place 1 tablespoon of rhizomes and roots into an enameled container, pour 200 mL of hot boiled water, cover with a lid, and steep in a boiling water bath for 30 minutes. Cool at room temperature for 10 minutes, then strain and squeeze the residue into the strained decoction. Adjust the decoction volume to 200 mL with boiled water. Take warm, 2–3 times daily, 1 hour before meals: for adults and children aged 14 years and older – ½ cup; for children aged 12–14 years – ⅓ cup; for children aged 7–12 years – 2 tablespoons; for children aged 3–7 years – 1 tablespoon. Shake the decoction before administration.

Place 2 filter bags into a glass or enameled container, pour 100 mL of boiling water, cover, and steep for 15–20 minutes. Take warm, 2–3 times daily, 1 hour before meals: for adults and children aged 14 years and older – 100 mL; for children aged 12–14 years – ⅓ cup; for children aged 7–12 years – 2 tablespoons; for children aged 3–7 years – 1 tablespoon.

The duration of treatment is determined individually by a physician.

Children

The drug may be administered to children aged 3 years and older.

Overdose

Overdose or prolonged use may cause inflammation of the mucous membranes of the gastrointestinal tract and urinary tract, as well as headache.

Adverse reactions.

Possible allergic reactions (including hyperemia, rash, swelling), heartburn, abdominal pain. If adverse reactions occur, discontinue use of the product and consult a physician.

Shelf life. 2 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C, in a place inaccessible to children. Prepared decoction (infusion) should be stored in a cool place (8–15 °C) for no more than 2 days.

Packaging.

50 g in packs with inner pouch; 4 g in filter bags №12 or 4 g in filter bags №20.

Availability. Over-the-counter (without prescription).

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's address and place of business.

4 Skladska Street, Zaporizhzhia, 69050, Ukraine.

Marketing Authorization Holder. JSC Pharmaceutical Factory "Viola".

Address of the Marketing Authorization Holder.

75 Amosov Academician Street, Zaporizhzhia, 69063, Ukraine.