Plantago major leaf

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PLANTAGO MAJOR LEAVES (FOLIUM PLANTAGINIS MAJORIS)

Composition:

Active substance: Plantago major leaves (Folia Plantaginis majoris);

1 pack contains Plantago major leaves (Folia Plantaginis majoris) – 50 g; 1 filter bag contains Plantago major leaves (Folia Plantaginis majoris) – 1.5 g.

Dosage form. Leaves.

Main physicochemical properties:

Ground raw material: fragments of leaves of various shapes passing through a sieve with 7 mm diameter openings. Color is green or brownish-green. Odor is weak. Taste is slightly bitter.

Coarse powder: fragments of leaves of various shapes passing through a sieve with 2 mm diameter openings. Color is green or brownish-green. Odor is weak. Taste is slightly bitter.

Pharmacotherapeutic group. Expectorants. ATC code R05C A.

Pharmacological properties.

Pharmacodynamics.

The biologically active components of the drug exert expectorant, anti-inflammatory, analgesic, hemostatic, wound-healing, and bacteriostatic effects; enhance the functional activity of the respiratory tract epithelium, promote secretion and evacuation of mucus, reduce coughing; stimulate gastric juice secretion and increase its acidity; promote cleansing of wounds and ulcerated surfaces from pus-forming bacteria, and enhance granulation processes in affected tissues.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Respiratory tract diseases (bronchitis, pertussis, pneumosclerosis, pulmonary tuberculosis), gastrointestinal disorders (gastritis with reduced acidity, peptic ulcer of the stomach and duodenum, enteritis and enterocolitis) – as part of complex therapy. For external use as a wound-healing agent.

Contraindications.

Hypersensitivity to the biologically active components of the drug. Hyperacid gastritis, peptic ulcer with increased acidity; increased blood coagulation and predisposition to thrombosis, reflux esophagitis.

Interaction with other medicinal products and other forms of interactions.

Do not use simultaneously with antitussive drugs and medicinal agents that reduce sputum secretion.

Special precautions.

Use during pregnancy or breastfeeding.

May be used during pregnancy or breastfeeding only if prescribed by a physician who has determined that the potential benefit to the mother outweighs the potential risk to the fetus/child.

Ability to affect reaction speed when driving or operating machinery. Has no effect.

Method of administration and dosage.

Place 2 tablespoons of leaves into an enameled container, pour 200 ml of hot boiled water, cover with a lid and infuse in a water bath for 15 minutes. Cool at room temperature for 45 minutes, strain, squeeze the residue into the strained infusion. Adjust the volume of the infusion to 200 ml with boiled water. For adults, take warm, ⅓ cup three times daily, 10–15 minutes before meals; for children aged 1–3 years – 1 teaspoon, 3–5 years – 1 dessert spoon, 5–10 years – 1 tablespoon, 10–14 years – ¼ cup, three times daily, 10–15 minutes before meals.

Place 3 filter packets into a glass or enameled container, pour 200 ml of boiling water, cover and let stand for 15 minutes. For adults, take warm, ½ cup four times daily, 10–15 minutes before meals; for children aged 1–3 years – 1 dessert spoon, 3–5 years – 2 dessert spoons, 5–10 years – 2 tablespoons, 10–14 years – ⅓–½ cup three times daily, 10–15 minutes before meals.

Externally: soak a gauze pad with the infusion and apply to affected areas of skin.

The duration of treatment is determined individually by a physician.

Children.

The drug may be used in children aged 1 year and older under medical supervision.

Overdose.

No reports available.

Adverse Reactions.

Allergic reactions (including hyperemia, rash, itching, skin swelling), heartburn.

Shelf life. 3 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 infusion – in a cool place for no more than 2 days.

Packaging.

50 g in packets, with insertion into a carton; 1.5 g in filter packets, 20 filter packets in a carton.

Category of supply. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's address and place of business.

69050, Ukraine, Zaporizhzhia, Skladska Street, 4.

Marketing Authorization Holder. JSC Pharmaceutical Factory "Viola".

Address of the Marketing Authorization Holder. 69063, Ukraine, Zaporizhzhia, Amosova Akademika Street, 75.