Evamenol^® (Ointment) Instructions for Use

Marketing Authorization Holder

Moscow Pharmaceutical Factory CJS (Russia)

Contact Information

Moscow Pharmaceutical Factory CJS (Russia)

ATC Code

R01AX30 (Other nasal preparations for topical use in combination)

Active Substances

Levomenthol (Rec.INN registered by WHO)

Eucalyptus oil (BP British Pharmacopoeia)

Dosage Form

Evamenol®

Nasal ointment 1 g+1 g/100 g: tube 15 g, jar 20 g

Dosage Form, Packaging, and Composition

Nasal ointment from light yellow to yellow in color with a characteristic odor of menthol and eucalyptus oil.

Excipients: petrolatum – up to 100 g.

15 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Drug with vasoconstrictive, anti-inflammatory, antiseptic, and counterirritant action for topical use in ENT practice

Pharmacotherapeutic Group

Drugs for the treatment of nasal diseases; decongestants and other preparations for topical use; other drugs for the treatment of nasal diseases

Pharmacological Action

Combined drug. It has a locally irritating (“distracting”), anti-inflammatory, some antiseptic action, and promotes constriction of blood vessels of the nasal passages mucosa.

The pharmacological effect of the drug is due to the properties of its constituent components.

Menthol is a locally irritating agent, the effect of which is due to reflex reactions associated with irritation of sensitive receptors of the mucous membranes. It has a mild local anesthetic (“distracting”) effect and has weak antiseptic properties.

Eucalyptus oil has a stimulating effect on the receptors of the mucous membranes, as well as anti-inflammatory and antiseptic action.

Pharmacokinetics

Data not provided.

Indications

• As a symptomatic agent in the treatment of acute and chronic rhinitis.

ICD codes

Dosage Regimen

For adults and children over 2 years of age, apply approximately 0.5 cm of the drug into each nasal passage onto the surface of the mucosa of the anterior parts of the nasal cavity. A cotton swab or cotton bud can be used for application. Then, with confident pressure on the wings of the nose, spread the ointment over the nasal mucosa. Repeat the procedure 2-3 times/day.

The duration of treatment is 5-10 days. Increasing the duration of the treatment course is possible on the recommendation of a doctor.

Adverse Reactions

Allergic reactions: itching, burning, redness or swelling of the nasal mucosa, lacrimation are possible.

If any of the specified side effects worsen or other side effects not listed in the instructions are noted, the patient should discontinue the drug and inform the attending physician.

Contraindications

• Tendency to laryngo- and bronchospasm;
• Bronchial asthma;
• Whooping cough;
• False croup (acute stenosing laryngotracheitis);
• Cough caused by accumulation of sputum (mucus);
• Prolonged or chronic cough caused by smoking or emphysema;
• Allergic rhinitis;
• Children under 2 years of age;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Due to the lack of experience of use during pregnancy and breastfeeding, the prescription of the drug to this group of patients is not recommended.

Pediatric Use

The drug is contraindicated in children under 2 years of age.

Special Precautions

The drug should not be swallowed.

Avoid getting the drug on the mucous membrane of the eyes.

If the ointment accidentally gets into the eyes, it is recommended to rinse thoroughly with water.

If the condition worsens or symptoms persist for more than 5-10 days, the patient should consult a doctor.

Effect on the ability to drive vehicles and mechanisms

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

Overdose

To date, no cases of overdose have been reported.

Drug Interactions

Not studied.

Storage Conditions

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

Shelf Life

The shelf life is 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.