Evamenol^® Active (Ointment) Instructions for Use

Marketing Authorization Holder

Moscow Pharmaceutical Factory CJS (Russia)

ATC Code

M02AX (Other drugs for topical application for joint and muscle pain)

Active Substances

Camphor (Ph.Eur. European Pharmacopoeia)

Levomenthol (Rec.INN WHO registered)

Eucalyptus oil (BP British Pharmacopoeia)

Dosage Form

Evamenol® Active

Ointment for external use: 30 g tube

Dosage Form, Packaging, and Composition

Ointment for external use white or white with a yellowish tint, homogeneous, with a characteristic odor.

* or Mentha piperita leaf oil (Peppermint oil) (with L-menthol content 70%) – 25.75 g.
Excipients : Clove flower oil – 1 g, Hard paraffin – 30.5 g, Petroleum jelly – up to 100 g.

Excipients : Clove flower oil – 1 g, Hard paraffin – 26 g, Petroleum jelly – up to 100 g.

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

Clinical-Pharmacological Group

Drug with local irritant and analgesic action

Pharmacotherapeutic Group

Local irritant of natural origin

Pharmacological Action

A combined herbal preparation. Its action is due to reflex reactions associated with the irritation of sensitive nerve endings of the skin and subcutaneous structures.

It exerts a locally irritating (“counterirritant”), weak local anesthetic effect.

Indications

As a “counterirritant”, local analgesic agent for neuralgia, myalgia, arthralgia, myositis.

ICD codes

Dosage Regimen

Apply the ointment externally only to intact skin.

Use a small amount of ointment, approximately the size of a pea, for each application site.

Rub the ointment into the painful area using light, massaging movements until fully absorbed.

Apply the ointment two to three times daily, depending on the intensity of pain.

Allow a minimum interval of several hours between applications.

Do not apply the ointment under occlusive dressings or bandages.

Limit the total duration of continuous use to seven days for acute pain.

Discontinue use and consult a physician if symptoms persist or worsen after one week of treatment.

Seek immediate medical advice if excessive skin irritation, redness, or swelling occurs.

Avoid contact with eyes, mucous membranes, and open wounds.

Wash hands thoroughly with soap and water immediately after each application.

Adverse Reactions

Possible allergic reactions, burning, tingling, sensation of cold at the site of ointment application.

Contraindications

Dermatological diseases; impaired skin integrity at the site of intended application of the drug; children under 12 years of age; hypersensitivity to the drug components.

Use in Pregnancy and Lactation

Use of the drug during pregnancy and breastfeeding is possible considering the intended benefit for the mother and the potential risk for the fetus/child.

Pediatric Use

Use of the drug is contraindicated in children under 12 years of age.

Special Precautions

After applying the ointment, wash hands thoroughly with soap and water.

Avoid getting the ointment into the eyes and on mucous membranes.

In case of contact with eyes and mucous membranes, rinse them abundantly with water and consult a doctor.

Effect on ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and engage in other activities requiring increased concentration and speed of psychomotor reactions.

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.