CALYPTOL INHALANT Emulsion for inhalation/fumigation 10Ampoule/5ml

VIDAL
Medicines
Update of 09/01/2025

CALYPTOL INHALANT^®

Forms and presentations

Emulsion for inhalation by fumigation:  Self-breaking ampoules of 5 ml, box of 10.

Composition

	per ampoule
Eucalyptol (cineole)	250 mg
Alpha-terpineol	25 mg
Scots pine, essential oil	50 mg
Thyme, essential oil	50 mg
Rosemary, essential oil	50 mg

Excipients: macrogol glycerol hydroxystearate, polyoxyethylene (4) sorbitan monolaurate, purified water.

Indications

Adjunctive treatment in congestive states of the upper airways.

Dosage and administration

Dosage

For adults and children over 12 years.

1 to 3 inhalations per day: pour the contents of one ampoule into a bowl of very hot but not boiling water, and inhale the vapours.

Never heat or reheat after mixing.

The indication does not justify prolonged treatment beyond 5 days without medical advice.

Method of administration:

Strictly inhaled route by fumigation.

Do not swallow.

Contraindications

• Hypersensitivity to the active substances or to any of the excipients listed in section Composition.
  
• Child under 12 years.
  
• Child with a history of convulsions (febrile or not).
  

Warnings and precautions

Follow the instructions for use and the dosage, in particular: never exceed the recommended doses.

Do not swallow.

If symptoms persist beyond 5 days and/or associated fever occurs, the course of action should be re-evaluated.

In case of a history of epilepsy, take into account the presence of terpenes.

Interactions

Associations to be taken into account:

+ Medicines lowering the epileptogenic threshold: increased risk of convulsions.

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

Fertility, pregnancy and breastfeeding

Pregnancy:

Calyptol Inhalant contains terpene derivatives: there are no data or there are limited data on the use of these substances in pregnant women. As a precaution, it is preferable to avoid using Calyptol Inhalant during pregnancy.

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.

Driving and using machines

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

Adverse effects

Related to the presence of terpene derivatives and in case of non-compliance with the recommended doses:

• risk of convulsions in children;
  
• possibility of agitation, confusion and drowsiness in the elderly.
  

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should 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 Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.

Pharmacodynamics

Pharmacotherapeutic class: For antiseptic and decongestant use (ATC code: R05X; R: respiratory system).

Eucalyptol, terpineol, essential oils of pine and thyme: traditionally used as antiseptics of the respiratory tract. Terpene derivatives may lower the epileptogenic threshold.

Storage conditions

No special precautions for storage.

HANDLING/DISPOSAL INSTRUCTIONS

No special requirements.

Prescription, supply and reimbursement

Marketing authorisation (AMM)

3400930174555 (1947/98, RCP rev 19.11.2024).

Not reimbursed by Social Security.

TECHNI-PHARMA Laboratories
7, rue de l'Industrie. BP 717. 98014 Monaco cdx
Tel: 00 377 92 05 75 10