Theraflu^® BRO (Ointment) Instructions for Use

Marketing Authorization Holder

GlaxoSmithKline Healthcare, JSC (Russia)

Manufactured By

Novartis Consumer Health S.A. (Switzerland)

ATC Code

R05X (Other remedies for the treatment of colds)

Dosage Form

Theraflu® BRO

Ointment for external use: tube 40 g

Dosage Form, Packaging, and Composition

Ointment for external use is homogeneous, white in color, with a characteristic odor of camphor and essential oils.

Excipients: carbomer 974R – about 1%, sodium hydroxide solution 30% – about 0.71%, polysorbate 20 – 5%, purified water – about 64.79%.

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

Clinical-Pharmacological Group

Preparation with antimicrobial, anti-inflammatory and expectorant action for external use in respiratory tract diseases

Pharmacotherapeutic Group

Herbal remedy

Pharmacological Action

A combined preparation of herbal origin, the action of which is due to the properties of its constituent components. It has anti-inflammatory, antiseptic, and expectorant effects.

Pharmacokinetics

Pharmacokinetic data for Theraflu^® BRO are not provided.

Indications

As part of the complex therapy of inflammatory and infectious-inflammatory diseases of the respiratory tract, accompanied by cough:

• Acute bronchitis;
• Chronic bronchitis;
• Tracheobronchitis;
• Tracheitis;
• Acute respiratory diseases.

ICD codes

Dosage Regimen

Apply a small amount of ointment to the upper and middle chest and back two to three times daily.

Gently rub the ointment into the skin until it is completely absorbed.

After application, cover the treated areas with a dry, warm cloth to enhance the therapeutic effect.

Use this regimen for a maximum of five to seven days; discontinue use and consult a physician if symptoms persist or worsen.

This dosage is indicated for adults and for children over 3 years of age.

Ensure the ointment is used for external application only and is never ingested.

Avoid contact with mucous membranes, including the nose, eyes, and mouth; if contact occurs, rinse thoroughly with cold water.

Do not apply to damaged skin, open wounds, or burn surfaces.

Adverse Reactions

Possibleallergic reactions.

Patients should be informed that if any adverse reactions occur, they should inform their doctor.

Contraindications

• Epileptic syndrome (in history);
• Children under 3 years of age;
• Skin lesions, presence of skin diseases at the sites of intended application of the ointment;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Theraflu^® BRO is not recommended for use during pregnancy (camphor crosses the placental barrier) and during breastfeeding (due to lack of clinical data).

Pediatric Use

Contraindicated: children under 3 years of age.

Special Precautions

Do not apply the ointment to mucous membranes (especially the nose and mouth), to burn surfaces, or to damaged skin.

If it gets into the eyes or on the mucous membrane, rinse with cold water.

The drug is intended for external use only. The drug must not be taken orally.

Does not leave greasy marks or stains on clothing.

Does not irritate healthy skin.

Effect on the ability to drive vehicles and mechanisms

Theraflu^® BRO ointment does not affect the ability to drive vehicles or mechanisms.

Overdose

Symptoms of overdose (in case of accidental ingestion of the drug), due to the presence of camphor and eucalyptus oil in the composition: nausea, vomiting, spasmodic abdominal pain, headache, severe dizziness, facial redness, difficulty breathing, delirium, convulsions, CNS depression, coma.

Treatment: gastric lavage, administration of activated charcoal, saline laxative. Emergency care is carried out in a hospital setting: for convulsions – intravenous administration of diazepam or the use of short-acting barbiturates.

Drug Interactions

No clinically significant interaction with other drugs was observed when using Theraflu^® BRO.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life – 5 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.