Evalement (Ointment) Instructions for Use

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

ATC Code

R01AX (Other nasal preparations for topical use)

Active Substances

Levomenthol (Rec.INN registered by WHO)

Eucalyptus oil (BP British Pharmacopoeia)

Dosage Form

Evalement

Nasal ointment: tubes 15 g, jars 15 g or 20 g

Dosage Form, Packaging, and Composition

Nasal ointment is homogeneous, ranging 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.
15 g – dark glass jars (1) – cardboard packs.
20 g – dark glass jars (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with counterirritant action for topical use in ENT practice

Pharmacotherapeutic Group

Local irritant

Pharmacological Action

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

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

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

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

Indications

• Employ as a symptomatic agent for the management of nasal congestion and inflammation associated with acute rhinitis.
• Use for the symptomatic relief of nasal symptoms in patients diagnosed with chronic rhinitis.

ICD codes

Dosage Regimen

Apply a small amount of ointment to the surface of the mucosa in the anterior parts of each nasal passage.

Administer the ointment two to three times daily for a duration of five to ten days.

Consult a physician for evaluation and potential extension of the treatment course if symptoms persist beyond the initial treatment period.

Adverse Reactions

Local allergic reactions may occur, including sensations of itching, burning, redness, or swelling of the nasal mucosa.

Systemic hypersensitivity reactions, such as lacrimation, are also possible. Discontinue use immediately if any adverse reactions develop.

Contraindications

• Do not use in patients with a known hypersensitivity to levomenthol, eucalyptus oil, or any excipient of the ointment.
• Avoid use in individuals with a predisposition to laryngospasm or bronchospasm, including those with bronchial asthma, whooping cough, or false croup (acute stenosing laryngotracheitis).
• Contraindicated for the treatment of cough with copious sputum, chronic cough due to smoking or emphysema, and allergic rhinitis.
• Do not administer to children under two years of age due to the risk of severe respiratory adverse effects.

Use in Pregnancy and Lactation

Due to the lack of experience of use during pregnancy and breastfeeding, use in this category of patients is not recommended.

Pediatric Use

Contraindicated in children under 2 years of age.

Special Precautions

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

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.