PERUBORE Caps inh par vapeur inhalation Plq/15

Lavender essential oil.....................................................................................................................18,0 mg

Red thyme essential oil...............................................................................................................34,0 mg

Rosemary essential oil.....................................................................................................................48,0 mg

Thymol............................................................................................................................................................2,0 mg

For one capsule.

Adjunctive treatment in congestive states of the upper airways.

RESERVED FOR ADULTS AND CHILDREN OVER 12 YEARS.

Inhalation by fumigation - DO NOT SWALLOW.

Adults and children over 12 years:

By inhalation: 1 capsule morning, noon and evening in an inhaler or a bowl of boiling water.

The duration of treatment must not exceed 5 days without medical advice.

Hypersensitivity to the active substances or to any of the excipients.

Linked to the presence of terpene derivatives: children with a history of convulsions (febrile or not).

Special warnings

This product contains terpene derivatives (essential oils and thymol) which may lead, at excessive doses, to:

• Convulsion-type accidents in infants and children.

• Breathing pauses and collapse in infants.

Respect the instructions for use and dosages, in particular: never exceed the recommended doses.

In children under 12 years, this medicine must not be used without medical advice.

Precautions for use

• In case of allergic reaction, stop treatment.

• Do not swallow.

• If symptoms persist and/or signs of superinfection appear, the therapeutic management should be reassessed.

• 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.

Concomitant use with other medicinal products containing terpene derivatives is not recommended.

Pregnancy

In clinical practice, no particular malformative or fetotoxic effect has been reported to date. However, epidemiological studies are necessary to exclude the absence of risk. Consequently, as a precautionary measure, it is preferable not to use this medicinal product during pregnancy.

Breast-feeding

In case of 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.

Possibility of local irritation, allergy.

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 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/

Pharmacotherapeutic class: DECONGESTANT, (R: respiratory system).

ATC code: R07AX.

Terpene derivatives (essential oils and thymol) may lower the epileptogenic threshold.

3 years.

No special precautions for storage.

No special requirements.