BALSOLENE S p inh/fumiga 1Fl/100ml

Laos benzoin (Styrax Tonkinensis (Pierre) Craib ex Hartwich.) (tincture of)......................................8,000 g

Extraction solvent: ethanol 80% (V/V)

Plant drug/total solvent ratio: 1/5

Eucalyptus essential oil...................................................................................................................1,165 g

Niaouli essential oil........................................................................................................................0,720 g

Levomenthol.................................................................................................................................................0,720 g

For 100 mL of solution for inhalation

Alcoholic strength: 60% v/v

Excipients: ethanol at 96%.

Adjunctive treatment in congestive states of the upper airways.

RESERVED FOR ADULTS AND CHILDREN OVER 12 YEARS

Inhalation by fumigation - DO NOT SWALLOW.

Pour one teaspoon of solution into a bowl of very hot but not boiling water and inhale the vapours. Repeat the inhalations 3 times a day.

• Hypersensitivity to the active substances or to any of the excipients listed in section Composition,
• Linked to the presence of terpene derivatives: children with a history of convulsions (febrile or not).

Special warnings

This specialty contains terpene derivatives (eucalyptus, niaouli, levomenthol) which may cause, at excessive doses:

• convulsive-type reactions, in infants and children,
• respiratory pauses and collapse in infants.

Observe the directions for use and dosages, in particular: never exceed the recommended doses.

Precautions for use

• If symptoms persist and/or are accompanied by signs of superinfection, the therapeutic approach should be re-evaluated.
• Do not swallow.
• In case of allergic reaction, stop the treatment.
• In case of a history of epilepsy, take into account the presence of terpene derivatives.

The data available to date do not suggest the existence of clinically significant interactions.

During breastfeeding, it is preferable not to use this medicine due to:

• the absence of kinetic data on the passage of terpene derivatives into milk,
• and their potential neurological toxicity in infants.

No effect on the ability to drive vehicles or use machines has been observed.

• Hypersensitivity reactions.
• Due to the presence of terpene derivatives and in case of non-compliance with the recommended doses :
  • risk of convulsions in children,
  • possibility of agitation and confusion in elderly subjects.

Reporting of adverse effects 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: www.signalement-sante.gouv.fr.

Pharmacotherapeutic class: DECONGESTANT

(R. respiratory system)

Terpene derivatives (eucalyptus, niaouli, levomenthol) may lower the seizure threshold.

5 years.

Store below 25°C.

No special requirements.