NOTICE
ANSM - Last updated: 13/10/2016
Name of the medicinal product
CALYPTOL INHALANT, emulsion for inhalation by fumigation
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
· This medication can be used in self-medication, ie used without consultation or prescription from a doctor.
· If symptoms persist, worsen or new symptoms appear, seek advice from your pharmacist or doctor.
· This leaflet is designed to help you use this medicine. Keep there, you might need to reread it.
DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
Review summary
In this notice :
1. WHAT CALYPTOL INHALANT, fumigating inhalation emulsion AND IN WHAT CASES IS IT USED?
2. BEFORE YOU USE CALYPTOL INHALANT, fumigating inhalation emulsion?
3. HOW TO USE CALYPTOL INHALANT, emulsion for inhalation by fumigation?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE CALYPTOL INHALANT, emulsion for inhalation by fumigation?
6. ADDITIONAL INFORMATION
1. WHAT CALYPTOL INHALANT, fumigating inhalation emulsion AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
ANTISEPTICALLY SCREENING AND DECONGESTING.
Therapeutic indications
This medicinal product is used in fumigation as a decongestant during common respiratory infections (colds, rhinitis, nasopharyngitis), in adults and children over 12 years of age.
2. BEFORE YOU USE CALYPTOL INHALANT, fumigating inhalation emulsion?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use CALYPTOL INHALANT, fumigating inhalation emulsion:
· hypersensitivity to eucalyptol (cineole) or to any of the components.
· in children with a history of convulsions (febrile or not);
· in children under 12 years of age.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with CALYPTOL INHALANT, emulsion for inhalation by fumigation:
Special warnings
Observe the instructions for use and the dosages, in particular: never exceed the recommended doses.
In case of fever, purulent expectorations (sputum), as in case of aggravation or lack of improvement after 5 days: CONSULT YOUR DOCTOR.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use
In case of epilepsy or recent epilepsy, ASK YOUR DOCTOR ADVICE. Do not swallow.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
IN ORDER TO AVOID INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, YOU MUST SIGNAL SYSTEMATICALLY ANY OTHER TREATMENT IN PROGRESS TO YOUR DOCTOR OR YOUR PHARMACIST.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
It is best not to use this medication while breastfeeding.
Generally, during pregnancy and breast-feeding, always seek the advice of your doctor or pharmacist before using any medication.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO USE CALYPTOL INHALANT, emulsion for inhalation by fumigation?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Reserved for adults and children over 12 years of age.
1 to 3 inhalations per day: pour the contents of a bulb into a bowl of very hot but not boiling water and inhale the vapors.
NEVER HEAT OR REHEAT AFTER MIXING.
Method and route of administration
Strict inhalation route by fumigation.
Do not swallow.
Duration of treatment
Treatment will not exceed 5 days without medical advice.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
If you forget to use CALYPTOL INHALANT, emulsion for inhalation by fumigation:
Do not take a double dose to make up for a missed dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, CALYPTOL INHALANT, emulsion for inhalation by fumigation is likely to have undesirable effects, although not everyone is subject to it.
In the event of non-compliance with recommended doses:
· risk of convulsions in children,
· possibility of agitation, confusion in the elderly.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE CALYPTOL INHALANT, emulsion for inhalation by fumigation?
Keep out of the reach and sight of children.
Expiration date
Do not use CALYPTOL INHALANT, fumigating inhalation emulsion after the expiry date which is stated on the outer packaging. The expiry date refers to the last day of the month.
Storage conditions
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does CALYPTOL INHALANT, Fumigating Inhalation Emulsion contain?
The active substances are:
Eucalyptol (cineole) .............................................. .................................................. 250 mg
Alphaterpineol ............................................... .................................................. .................................. 25 mg
Scots pine essential oil ............................................. .................................................. .......... 50 mg
Essential oil of thyme .............................................. .................................................. 50 mg
Rosemary essential oil .............................................. .................................................. ................ 50 mg
For a 5 ml ampoule
The other components are:
Macrogolglycerol hydroxystearate, Polyoxyethylene (4) sorbitan monolaurate, purified water.
Pharmaceutical form and content
What is CALYPTOL INHALANT, fumigating inhalation emulsion and contents of the pack?
This medication is in the form of an emulsion for inhalation by fumigation in ampoules, boxes of 10 or 100.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
TECHNI-PHARMA LABORATORIES
7, RUE DE L'INDUSTRIE
BP 717
98014 MONACO CEDEX
exploiting
TECHNI-PHARMA LABORATORIES
7 STREET OF INDUSTRY
98000 MONACO
Maker
TECHNI-PHARMA LABORATORIES
7 STREET OF INDUSTRY
98000 MONACO
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.