Pulmex^® baby (Ointment) Instructions for Use

Marketing Authorization Holder

Novartis Consumer Health S.A. (Switzerland)

ATC Code

R05CA10 (Expectorants in combination)

Active Substances

Rosemary oil (BP British Pharmacopoeia)

Eucalyptus oil (BP British Pharmacopoeia)

Peru balsam (BP British Pharmacopoeia)

Dosage Form

Pulmex® baby

Ointment for external use 50 mg+50 mg+60 mg/1 g: tube 20 g

Dosage Form, Packaging, and Composition

Ointment for external use white color, homogeneous, with smell of essential oils.

Auxiliary substances : carbomer 974R – 1.2%, sodium hydroxide solution 30% – 0.92%, polysorbate 20 – 5%, purified water – about 76.88%.

20 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

Indications

• Pulmex^® baby ointment is indicated as an adjunctive therapy for the symptomatic relief of upper respiratory tract congestion associated with the common cold and other uncomplicated respiratory infections.
• It is used to help alleviate symptoms such as cough and nasal congestion in infants and young children.
• The preparation’s action is based on the local effects of its essential oils, which provide a soothing sensation and help to ease breathing when applied topically to the chest and back.

Contraindications

• Hypersensitivity to any of the active substances (rosemary oil, eucalyptus oil, Peru balsam) or to any of the excipients.
• Patients with a known history of allergic contact dermatitis, especially to balsams or essential oils.
• Do not apply to damaged skin, such as open wounds, burns, or eczematous skin, as this increases systemic absorption and the risk of irritation.
• Avoid use in children with a history of bronchospasm, such as in asthma or bronchial hyperreactivity, as inhalation of vaporized essential oils may trigger bronchoconstriction.
• Contraindicated in cases of whooping cough (pertussis) or pseudo-croup.

Dosage Regimen

For external use only. Pulmex^® baby ointment is intended for topical application on the skin of the chest and back. It must not be applied to the face, nostrils, or mucous membranes.

The recommended dosage for infants and children is application two to three times daily. A thin layer of the ointment should be rubbed gently onto the skin of the chest and upper back. For enhanced effect, especially at night, the area can be covered with a warm, dry cloth. The duration of use should be in accordance with the physician’s recommendations, typically for the duration of acute symptoms.

Critical Administration Instructions: Always wash hands before and after application. Avoid contact with eyes. Do not use with tight-fitting occlusive dressings that may promote excessive absorption. If symptoms persist after one week of use, or if the condition worsens, a physician should be consulted.

Adverse Reactions

Like all medicines, Pulmex^® baby ointment can cause adverse reactions, although not everybody gets them. Due to the topical route of administration, adverse reactions are primarily localized to the site of application.

Common (May affect up to 1 in 10 people): Mild, transient skin reactions at the application site, such as redness (erythema), a warming sensation, or mild pruritus (itching). These reactions typically subside with continued use.

Uncommon (May affect up to 1 in 100 people): More pronounced local skin reactions including contact dermatitis, skin rash, urticaria (hives), or a burning sensation. In very rare cases, systemic allergic reactions are possible, particularly if the product is applied to large areas of damaged skin, leading to increased absorption.

Special Populations: In children with very sensitive skin or pre-existing skin conditions, the risk of local adverse reactions may be increased. Discontinue use immediately if signs of a severe skin reaction or systemic allergic response (such as dyspnea or wheezing) occur and seek medical attention.

Drug Interactions

Formal studies of drug interactions with Pulmex^® baby ointment have not been conducted. However, due to the pharmacological properties of the active ingredients, potential interactions should be considered.

The percutaneous absorption of essential oils is generally low, but may be increased if applied to large body surface areas or damaged skin. There is a theoretical potential for interaction with other centrally acting drugs, as some components like camphor (though not present in this formulation) and eucalyptol are known to have neurological effects.

Concurrent use with other topical products applied to the same area (e.g., other ointments, creams, or medicated patches) should be avoided, as this may alter the absorption of either product or increase the potential for skin irritation. Patients using medications for seizure disorders or other neurological conditions should use this product with caution and under medical supervision.

Overdose

Overdose due to topical application is unlikely. However, accidental ingestion of the ointment is a medical emergency, especially in children, and requires immediate medical attention.

Symptoms of Ingestion: Ingestion of even small amounts can lead to gastrointestinal irritation, nausea, vomiting, and abdominal pain. Larger ingestions may result in more severe symptoms, including central nervous system effects such as dizziness, confusion, and seizures. Essential oils can be highly toxic when ingested and may cause aspiration pneumonia.

Management: There is no specific antidote. In case of accidental ingestion, do not induce vomiting. Seek immediate medical help or contact a Poison Control Center. Provide supportive and symptomatic treatment. If topical overdose occurs (e.g., excessive application), it may lead to intense skin irritation; the ointment should be thoroughly washed off with soap and water.

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

Rx Only

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.