Paxeladin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PAXELADINE® (PAXELADINE®)

Composition:

Active substance: Oxeladin Citrate;

10 mg of oxeladin citrate is contained in 5 ml of syrup;

Excipients: sucrose solution, cocoa flavour (a mixture of natural and synthetic flavouring agents, purified water, ethanol), potassium sorbate, purified water.

Pharmaceutical form. Syrup.

Main physicochemical characteristics: clear yellowish liquid with a chocolate and cherry aroma.

Pharmacotherapeutic group.

Antitussive agents, excluding combination medicinal products containing expectorants.

ATC code R05DB09.

Pharmacological properties.

Pharmacodynamics.

Central-acting antitussive agent, non-opioid, non-antihistaminic.

Pharmacokinetics.

Data on oxeladine pharmacokinetics are very limited.

Clinical characteristics.

Indications.

Symptomatic treatment of difficult non-productive cough.

Contraindications.

Paxeladin® is contraindicated in cases of allergy to any component of this medicinal product.

Interaction with other medicinal products and other forms of interaction.

Available data do not indicate clinically significant interactions.

Special precautions for use.

Warning

• This medicinal product should not be used to treat productive cough, as it may impair the expectoration of mucus.
• Treatment with this antitussive agent should not be combined with the use of mucolytic and expectorant agents.
• Before using the antitussive agent, the etiology of the cough should be determined, as it may require specific treatment.
• If cough persists despite using the recommended doses of the antitussive agent, the dose should not be increased; instead, the clinical picture should be re-evaluated.

Special precautions for use

• The presence of sugar should be taken into account: 4.25 mg in a 5 ml dose and 2.125 mg in a 2.5 ml dose of syrup, particularly when on a low-sugar diet or in case of diabetes.
• Due to lack of data on efficacy and safety in children under 30 months of age, this medicinal product is not recommended for use in this age group.
• The medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency should not take this medicinal product.
• The medicinal product contains a small amount of ethanol (alcohol): 24 mg in a 5 ml dose and 12 mg in a 2.5 ml dose of syrup.

Use during pregnancy or breastfeeding.

Pregnancy

Reliable data on teratogenicity in animals are lacking.

To date, a teratogenic or fetotoxic effect has not been clinically observed.

However, studies on the effects of oxeladin citrate during pregnancy are insufficient to exclude any risk.

Therefore, the use of this medicinal product is not recommended during pregnancy.

Lactation

Due to the lack of data on the passage of the medicinal product into breast milk, its use is not recommended during breastfeeding.

Ability to influence reaction speed when driving or operating machinery.

No effect.

Dosage and Administration.

The medicinal product should be administered to adults and children aged 30 months and older with body weight exceeding 15 kg.

Treatment should be short-term (several days), initiated immediately after the onset of cough.

The package contains a measuring spoon or a measuring cup of 2.5 ml and 5 ml.

1 dose of 2.5 ml contains 5 mg of oxeladine citrate.

1 dose of 5 ml contains 10 mg of oxeladine citrate.

Children with body weight from 15 to 20 kg (aged from 30 months to 6 years) should be given 1 dose of 2.5 ml of syrup every 4 hours as needed. Maximum dose – 3–4 times daily, depending on the child's body weight.

Children with body weight from 20 to 30 kg (aged from 6 to 10 years) should be given 1 dose of 5 ml of syrup every 4 hours as needed. Maximum dose – 2–3 times daily, depending on the child's body weight.

Children with body weight from 30 to 50 kg (aged from 10 to 15 years) should be given 1 dose of 5 ml of syrup every 4 hours as needed. Maximum dose – 3–5 times daily, depending on the child's body weight.

Adults should be given 1 dose of 5 ml of syrup every 4 hours as needed. Maximum dose – 5 times daily.

Children.

Do not administer to children under 30 months of age (2.5 years) or with body weight less than 15 kg.

Overdose.

Information on the frequency of overdose is limited; reported cases of overdose did not describe symptoms.

Side effects.

Rarely, hypersensitivity reactions have been reported (urticaria, rash, angioedema).

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after marketing authorization of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national pharmacovigilance system.

Shelf life. 3 years.

After first opening of the bottle – 6 months.

Storage conditions. No special storage conditions required. Keep out of the reach of children.

Packaging. 100 ml or 125 ml of syrup in a bottle, with 1 measuring spoon or measuring cup, in a cardboard box.

Classification. Over-the-counter (without prescription).

Manufacturer.

BOFUR IPSSEN INDUSTRIE / BEAUFOUR IPSEN INDUSTRIE.

Manufacturer's address.

Rue Ethe Virton 28100 DREUX, France.

Marketing Authorization Holder.

IPSEN CONSUMER HEALTHCARE Simplified Joint Stock Company.

Address of the Marketing Authorization Holder and/or its representative.

65 Quai Georges Gorse 92100 Boulogne-Billancourt, France.