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Plantacid (Granules) Instructions for Use

Marketing Authorization Holder

Pharmaceutical Company Zdorovye, LLC (Ukraine)

ATC Code

A03 (Drugs for the treatment of functional gastrointestinal disorders)

Active Substance

Plantago major (BP British Pharmacopoeia)

Dosage Form

Bottle OTC Icon Plantacid Granules for the preparation of an oral suspension 2 g: sachets 4, 10, 20, 25, or 30 pcs.

Dosage Form, Packaging, and Composition

Granules for the preparation of an oral suspension 1 sachet
Extract of Plantago major leaves 2 g

1 g – sachets made of combined heat-sealable material (4) – cardboard packs.
2 g – sachets made of combined heat-sealable material (4) – cardboard packs.
2 g – sachets made of combined heat-sealable material (10) – cardboard packs.
2 g – sachets made of combined heat-sealable material (20) – cardboard packs.
2 g – sachets made of combined heat-sealable material (25) – cardboard packs.
2 g – sachets made of combined heat-sealable material (30) – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation that stimulates the secretory and motor functions of the gastrointestinal tract and bronchi

Pharmacotherapeutic Group

Spasmolytic agent of plant origin

Pharmacological Action

Herbal remedy. It has antiseptic, anti-inflammatory, spasmolytic, enveloping, and expectorant effects, promotes tissue regeneration and activates gastric secretion.

The antiseptic effect (against staphylococci, Pseudomonas aeruginosa, hemolytic streptococcus) is due to the presence of phytoncides.

The anti-inflammatory, wound- and ulcer-healing effects are associated with the presence of polysaccharides, pectin and tannins, benzoic and salicylic acids. Polysaccharides activate the formation of interferon; zinc and flavonoids contribute to the normalization of phagocytosis. The combination of polysaccharides with enzymes and vitamins promotes the acceleration of regeneration. These effects are also closely related to the ability of plantain to increase the resistance of cells and tissues to oxygen deficiency. A pronounced antihypoxic effect is provided by organic (especially citric) and phenolcarboxylic (ferulic, caffeic, coumaric) acids, flavonoids (derivatives of luteolin, quercetin, apigenin), vitamin C, copper, and zinc. The hemostatic effect is associated with the presence of vitamin K.

Plantain regulates digestion, increases appetite, reduces the tone of the smooth muscles of the stomach and intestines, and has an anti-inflammatory and regenerating effect in gastritis, gastroduodenitis, and other inflammatory diseases of the gastrointestinal tract. Iridoid glycosides, aucubin, catalpol, and bitters included in its composition enhance the secretion of gastric juice and increase the acidity of the gastric contents.

Due to mucus, enzymes, and phytoncides, plantain also has an expectorant effect, restoring the protective function of the ciliated epithelium of the respiratory tract.

Saponins, oxycinnamic acids, flavonoids, and pectin substances contribute to the reduction of blood cholesterol levels.

Indications

Used as part of combination therapy: for the treatment of gastrointestinal diseases – acute and chronic gastritis, gastric and duodenal ulcers with preserved and reduced secretion, enterocolitis, enzymopathies, dysbiosis; for the treatment of infectious and inflammatory diseases of the respiratory organs, including rhinitis, tonsillopharyngitis, bronchitis, pneumonia, whooping cough.

For external use: dermatitis of various etiologies, wounds, cuts, bruises, trophic ulcers, boils, abscesses, burns.

For local use: gynecological diseases, cervical erosion.

ICD codes

ICD-10 code Indication
A37 Whooping cough
J00 Acute nasopharyngitis (common cold)
J02 Acute pharyngitis
J03 Acute tonsillitis
J04 Acute laryngitis and tracheitis
J15 Bacterial pneumonia, not elsewhere classified
J20 Acute bronchitis
J31 Chronic rhinitis, nasopharyngitis and pharyngitis
J31.0 Chronic rhinitis (including ozaena, atrophic and hypertrophic rhinitis)
J31.2 Chronic pharyngitis
J35.0 Chronic tonsillitis
J37 Chronic laryngitis and laryngotracheitis
J42 Unspecified chronic bronchitis
K25 Gastric ulcer
K26 Duodenal ulcer
K29 Gastritis and duodenitis
K52.9 Noninfective gastroenteritis and colitis, unspecified
K63.8 Other specified diseases of intestine
L02 Cutaneous abscess, furuncle and carbuncle
L30.9 Dermatitis, unspecified
L98.4 Chronic skin ulcer, not elsewhere classified
N76 Other inflammatory diseases of vagina and vulva
N86 Erosion and ectropion of cervix
T14.0 Superficial injury of unspecified body region (including abrasion, bruise, contusion, hematoma, bite of nonvenomous insect)
T14.1 Open wound of unspecified body region
T30 Burns and corrosions of unspecified body region
ICD-11 code Indication
1B75.0 Furuncle
1B75.1 Carbuncle
1B75.2 Furunculosis
1B75.3 Pyogenic skin abscess
1C12.Z Whooping cough, unspecified
CA00 Acute nasopharyngitis
CA02.Z Acute pharyngitis, unspecified
CA03.Z Acute tonsillitis, unspecified
CA05 Acute laryngitis or tracheitis
CA09 Chronic rhinitis, nasopharyngitis or pharyngitis
CA09.0 Chronic rhinitis
CA09.2 Chronic pharyngitis
CA0F.Y Other specified chronic diseases of the palatine tonsils and adenoids
CA0G Chronic laryngitis or laryngotracheitis
CA20.1Z Chronic bronchitis, unspecified
CA40.0Z Bacterial pneumonia, unspecified
CA42.Z Acute bronchitis, unspecified
DA42.Z Gastritis, unspecified
DA51.Z Duodenitis, unspecified
DA60.Z Gastric ulcer, unspecified
DA63.Z Duodenal ulcer, unspecified
DA7Z Diseases of stomach or duodenum, unspecified
DA90.0 Syndromic diarrhea
DA92.1 Pneumatosis intestinalis of the small intestine
DA98.Z Polyps of small intestine, unspecified
DB31.1 Pneumatosis of the colon
DB36.Z Certain infections of the colon, unspecified
DE2Z Diseases of the digestive system, unspecified
EA40 Tropical phagedenic ulcer
EA85.2Z Hand dermatitis, unspecified
EA85.3 Foot dermatitis
EA89 Generalized eczematous dermatitis of unspecified type
EA8Z Dermatitis or eczema, unspecified
EF60 Ischemic ulceration of the skin
EH92 Dermatoses provoked by friction or mechanical impact
EH92.1 Blister due to friction
EM0Z Unspecified skin disorder
GA00 Vulvitis
GA02.Z Unspecified vaginitis
GA0Z Inflammatory diseases of female genital tract, unspecified
GA15.1 Erosion or ectropion of cervix
ME60.2 Ulcerative skin lesion of unspecified nature
ND56.0 Superficial injury of unspecified body region
ND56.1 Open wound of unspecified body region
NE11 Burn of unspecified body region

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 the treatment of gastrointestinal diseases, plantain is taken orally in the form of a prepared infusion, 15-50 ml 15-30 minutes before meals. The course of treatment is 1-8 weeks. The juice is used, 1 tablespoon (dissolved in 50 ml of warm water) 15-20 minutes before meals 3-4 times/day for 1 month.

For the treatment of respiratory diseases, plantain is used in the form of an infusion or juice in the same doses but 30 minutes after meals. For colds, juice diluted 5-10 times with warm water can be instilled, 2-3 drops into each nostril 3-6 times/day.

For the treatment of dermatological diseases, juice and infusion can be used externally in the form of dressings, lotions, or washings, 3-4 times/day, and for burns – regularly, at intervals of 1-1.5 hours.

In gynecological practice, the juice is used in the form of douches, baths, instillations, and vaginal tampons.

Adverse Reactions

Rarely: allergic reactions; when taken orally – heartburn.

Contraindications

Hypersensitivity to Plantago major; increased secretion of the digestive glands; gastric and duodenal ulcer in the acute phase.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, it is possible to use according to indications in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Pediatric Use

It is possible to use in children according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the leaflets of Plantago major preparations regarding the indications and contraindications for the use of specific dosage forms of Plantago major in children of different ages.

Special Precautions

The therapeutic effects of Plantago major are most fully manifested when using the juice.

The prepared infusion is stored in a cool place for no more than 2 days.

Drug Interactions

When treating respiratory diseases, it should not be used simultaneously with antitussive medications, as this makes it difficult to expectorate the liquefied sputum.

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

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