BALSAMORHINOL S nas Fl/20ml

Chlorobutanol hemihydrate..............................................................................................................................350 mg

Levomenthol.......................................................................................................................................................105 mg

For 100 ml of solution.

Excipients with known effect: citral, farnesol, geraniol, limonene, linalool.

Treatment of post-traumatic atrophic (crusty) rhinitis and post-operative care after endonasal surgery.

BALSAMORHINOL is indicated in adults and children over 30 months of age.

Dosage

Adults and adolescents over 15 years: 3 drops in each nostril 2 to 5 times a day.

Paediatric population

Method of administration

Nasal use.

Nasal instillation after blowing the nose.

• Hypersensitivity to the active substances or to any of the excipients listed in section Composition.

• Due to the presence of terpene derivatives (levomenthol and essential oils):

• Child under 30 months of age.
• Children with a history of convulsions (febrile or not).
• Pregnancy (see section Fertility, pregnancy and breastfeeding).

Special warnings

This medicinal product contains terpene derivatives (levomenthol and essential oils) which may lower the epileptogenic threshold.

The patient should be advised to follow the instructions for use and the recommended dosages and never to exceed the recommended doses.

Oily pneumonia due to pulmonary deposition following repeated nasal instillations and chronic use (most often more than 1 month of treatment) has been reported. It should therefore be ensured that the patient does not misuse this medicinal product and the prescription should always be restricted to the minimum duration of use.

This medicinal product contains perfumes containing citral, farnesol, geraniol, limonene and linalool which may cause allergic reactions.

Precautions for use

• In case of a history of epilepsy, take into account the presence of terpene derivatives.

• The indication does not justify prolonged treatment.

Associations to be taken into account

+ Other medicinal products lowering the epileptogenic threshold

Increased risk of convulsions.

Pregnancy

A study in rats showed embryotoxicity after oral administration of high doses of chlorobutanol (see section Preclinical safety).

Due to the presence of terpene derivatives, this medicinal product may have respiratory and neurological toxicity for the foetus. BALSAMORHINOL is therefore contraindicated during pregnancy (see section Contraindications).

Breast-feeding

The use of this medicinal product is not recommended during breast-feeding due to:

• the absence of kinetic data on the passage of chlorobutanol and terpene derivatives into milk,

• the potential respiratory and neurological toxicity of terpene derivatives in infants.

Fertility

There is no data on the effect of levomenthol or chlorobutanol on human fertility. A reproductive toxicity study in rats showed deleterious effects on female fertility after oral administration of high doses of chlorobutanol (see section Preclinical safety).

Within each system organ class, adverse reactions are ranked by frequency, with the most frequent first, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10 000 to < 1/1000); very rare (< 1/10 000); not known (cannot be estimated from the available data).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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 reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

• In case of prolonged use (more than 1 month of treatment) (see section 4.4), oily aspiration pneumonia has been reported.

• In case of exceeding the recommended doses and due to the presence of terpene derivatives:

• risk of neurological adverse events such as convulsions in children,
• possibility of agitation and confusion in elderly subjects.

• Acute toxicity from chlorobutanol (at excessive doses) may lead to depression of the central nervous system, respiratory depression and loss of consciousness. Symptomatic treatment should be initiated.

Pharmacotherapeutic class: DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR LOCAL USE, ATC code: R01AX10.

Levomenthol is a terpene derivative. Terpene derivatives may lower the epileptogenic threshold.

Paraffin is a mineral oil consisting of saturated long-chain aliphatic hydrocarbons that are neither absorbable nor metabolisable.

Levomenthol

Preclinical studies show no specific toxicity with levomenthol applicable to the clinical situation.

Chlorobutanol

A combined screening study of repeated-dose toxicity and of toxicity for reproduction and development showed that chlorobutanol affects fertility and is embryotoxic after oral administration in rats. However, the effects were only observed at maternally toxic doses considered sufficiently higher than the maximum recommended human dose, indicating low relevance for clinical use. After repeated-dose oral treatment in rats, effects on the kidneys and liver were observed. In addition, the reduction in locomotor activity was considered a sign of sedative effects of chlorobutanol. Chlorobutanol is not genotoxic and no experimental study was available to assess its carcinogenic potential.

Before opening: 2 years.

After opening: 30 days.

This product does not require any special storage precautions before or after opening.

Upon opening the packaging, and even more so upon first use of a nasal preparation, microbial contamination is possible.

For storage conditions of the medicine after first opening, see section Shelf life.

No special requirements.