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Eucalyptus-M (Tablets, Pastilles) Instructions for Use

ATC Code

R07AX (Other drugs for the treatment of respiratory diseases)

Active Substances

Eucalyptus oil (BP British Pharmacopoeia)

Levomenthol (Rec.INN WHO registered)

Clinical-Pharmacological Group

A drug with antimicrobial and anti-inflammatory action for topical use in ENT practice

Pharmacotherapeutic Group

Antiseptic of plant origin

Pharmacological Action

It exerts a local anti-inflammatory and antiseptic action.

Indications

Use for symptomatic relief of inflammatory conditions affecting the upper respiratory tract and oropharyngeal mucosa.

  • Pharyngitis;
  • Laryngitis;
  • Tracheitis.

ICD codes

ICD-10 code Indication
J02 Acute pharyngitis
J04 Acute laryngitis and tracheitis
J31.2 Chronic pharyngitis
J37 Chronic laryngitis and laryngotracheitis

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.

Adhere strictly to the recommended dosage and method of administration for the specific pharmaceutical form.

For tablets, dissolve completely in the mouth without chewing. For adults, administer 1 tablet 3-4 times daily. For children from 8 years old, administer 1-2 tablets per day.

For pastilles, apply topically 1 to 4 times per day, with frequency determined by age. Do not exceed a treatment duration of 5 days.

Adverse Reactions

Monitor for signs of hypersensitivity and gastrointestinal discomfort during therapy.

Possible adverse effects include allergic reactions and, rarely, dyspeptic symptoms.

Discontinue use immediately and consult a physician if any unlisted side effects occur.

Contraindications

Do not administer under any circumstances to patients with specific conditions or sensitivities.

  • Confirmed hypersensitivity to eucalyptus oil, levomenthol, or any excipient.
  • Patients under 8 years of age due to lack of safety data and risk of adverse effects.
  • Hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.

Use in Pregnancy and Lactation

Use of the drug during pregnancy and breastfeeding is not recommended due to the lack of safety data for use in this category of patients.

Pediatric Use

Use of the drug is contraindicated in children under 8 years of age.

Special Precautions

If symptoms of the disease persist or the condition worsens during the use of the drug for 5 days, the patient should inform the attending physician.

Effect on the ability to drive vehicles and mechanisms

The use of the drug does not affect the ability to perform potentially hazardous activities requiring increased concentration and speed of psychomotor reactions (driving vehicles, working with moving mechanisms).

Overdose

No specific antidote exists; management is supportive and directed at symptom relief.

No cases of overdose have been reported. In the event of suspected excessive ingestion, provide symptomatic and supportive care. Monitor for gastrointestinal distress or neurological symptoms.

Drug Interactions

Exercise caution with concomitant use of antidiabetic agents and herbal preparations.

Eucalyptus may potentiate the effect of antidiabetic drugs, leading to hypoglycemia. Monitor blood glucose levels closely.

Avoid concurrent use with herbs containing pyrrolizidine alkaloids due to increased risk of hepatotoxicity.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

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

Bausch Health, LLC (Russia)

Manufactured By

Herkel B.V. (Netherlands)

Quality Control Release

HERKEL B.V. (Netherlands)

Or

NATUR PRODUKT EUROPE, B.V. (Netherlands)

Contact Information

BAUSH HEALTH LLC (Russia)

Dosage Form

Bottle OTC Icon Eucalyptus-M Lozenges 6 mg+5.5 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Lozenges flat, round, with a beveled edge, light green in color with lighter and darker inclusions, with a smell of menthol and eucalyptus; on both sides of the tablet an engraving “NP” against a tree background.

1 tab.
Levomenthol 6 mg
Eucalyptus oil 5.5 mg

Excipients : saccharin, sorbitol, magnesium stearate, colloidal silicon dioxide, “honey” flavor, quinoline yellow dye (E104), indigo carmine dye (E132).

10 pcs. – blisters (2) – carton packs.

Marketing Authorization Holder

VALEA NT, LLC (Russia)

Manufactured By

Natur Produkt Europe, B.V. (Netherlands)

Or

Dr. med. Aufdermaur AG (Switzerland)

Dosage Form

Bottle OTC Icon Eucalyptus-M Lozenges 6 mg+5.5 mg: 12 or 24 pcs.

Dosage Form, Packaging, and Composition

Pastilles flat, round, with a beveled edge, with a rough surface from greenish-yellow to greenish-yellow with a brownish tint, with a specific smell; uneven coloring, the presence of air bubbles in the caramel mass and slight unevenness of the edges are allowed.

1 pastille
Levomenthol 6 mg
Eucalyptus oil 5.5 mg

Excipients : dextrose syrup, sucrose, flower honey, extract of 20 plants, vegetable dye from nettle and spinach leaf extract, purified water.

12 pcs. – blisters (1) – carton packs.
12 pcs. – blisters (2) – carton packs.

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