Doktor MOM^® Fito (Ointment) Instructions for Use

Marketing Authorization Holder

J&JTL, LLC (Russia)

Manufactured By

Unique Pharmaceutical Laboratories (A Division of J. B. Chemicals & Pharmaceuticals Ltd.) (India)

Contact Information

J&JTL LLC (Russia)

ATC Code

R05X (Other remedies for the treatment of colds)

Dosage Form

Doktor MOM® Fito

Ointment for external use: jar 20 g

Dosage Form, Packaging, and Composition

Ointment for external use is semi-transparent, white or almost white in color, with an odor of levomenthol and camphor.

Excipients: nutmeg oil – 0.11 ml, thymol – 0.02 g, white soft paraffin – q.s. to 20.0 g.

20 g – polypropylene jars, sealed with aluminum foil laminated with polyethylene, with a screw cap (1) – cardboard packs.

Clinical-Pharmacological Group

Topical irritant of natural origin

Pharmacotherapeutic Group

Local irritant of natural origin

Pharmacological Action

It has a local irritant, distracting, anti-inflammatory, and antiseptic effect.

Indications

• Symptomatic therapy of acute respiratory diseases accompanied by a runny nose, feeling of nasal congestion;
• Muscle pain;
• Back pain;
• Headache.

ICD codes

Dosage Regimen

Use for external application only. Avoid contact with eyes, nasal and oral mucosa, and damaged skin.

For rhinitis and nasal congestion, apply a small amount of ointment to the skin of the wings of the nose. Do not apply inside the nostrils.

For muscle pain or back pain, apply the ointment to the painful area and rub in gently. For enhanced effect, cover the area with a warm, dry bandage after application.

For headache, apply the ointment to the skin of the temporal areas.

Apply the ointment two to three times daily. The duration of use depends on symptom persistence.

Discontinue use and consult a physician if symptoms persist for more than 3-5 days, worsen, or if new symptoms appear.

Contraindicated in children under 3 years of age. Use in children aged 3 years and older should be under adult supervision to prevent accidental ingestion or contact with sensitive areas.

If accidental ingestion occurs, particularly in a child, seek immediate medical attention.

Adverse Reactions

Allergic reactions.

Adverse reactions identified during the post-registration use of the drug were classified as follows: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), isolated reports of unspecified frequency (frequency cannot be estimated from the available data).

Systemic reactions very rare – hypersensitivity (allergic reactions), anaphylactic shock.

Respiratory system disorders very rare – bronchospasm.

Local reactions very rare – allergic dermatitis.

Contraindications

• Hypersensitivity to the components of the drug;
• Damage to the skin or irritation, presence of skin diseases in the areas of the intended application of the drug, including burns, eczema, dermatitis, and purulent skin diseases;
• Bronchial asthma;
• Children under 3 years of age.

Use in Pregnancy and Lactation

Due to the lack of experience of use in pregnant and breastfeeding women, the use of the drug in this group of patients is not recommended.

Pediatric Use

The drug is contraindicated in children under 3 years of age.

Special Precautions

If the symptoms of the disease persist or the condition worsens, or new symptoms appear, the patient must stop using the drug and consult a doctor.

The drug should be stored out of the reach of children. If the drug is swallowed by a child, seek medical help immediately.

Avoid getting the ointment into the eyes, on the mucous membranes of the nose and oral cavity, as well as on damaged areas of the skin.

If the medicinal product has deteriorated or the expiration date has passed, it should not be disposed of in wastewater or on the street. It is necessary to place the medicinal product in a bag and put it in a trash container. These measures will help protect the environment.

Effect on the ability to drive vehicles and mechanisms

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

No cases of overdose have been observed when using the drug in recommended doses.

Drug Interactions

There is no information on interaction with other medicinal products.

Storage Conditions

The drug should be stored out of the reach of children at a temperature from 15°C (59°F) to 25°C (77°F).

Shelf Life

The shelf life is 3 years. Do not use after the expiration date printed on the package.

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.