NOTICE
ANSM - Updated on : 11/06/2025
Product name
BRONCHODERMINE CHILDREN, suppository
Cineole, damylein hydrochloride, guaiacol, reconstituted pine essential oil
Enclosed
Please read this leaflet carefully before using this medicine, as it contains important information for you.
You must always use this medicine in strict accordance with the information provided in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 3 days.
What does this leaflet contain?
1. What is BRONCHODERMINE CHILDREN, suppository and what is it used for?
2. What do I need to know before using BRONCHODERMINE CHILDREN, suppository?
3. How do I use BRONCHODERMINE CHILDREN, suppository?
4. What are the possible side effects?
5. How to store BRONCHODERMINE CHILDREN, suppository?
6. Package contents and other information.
1. WHAT IS BRONCHODERMINE ENFANTS, suppository AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code: ANTISEPTIC AND EXPECTORANT ASSOCIATION (R. Respiratory system)
Adjunctive treatment of benign acute bronchial disorders in children aged 30 months and over.
Treatment duration is limited to 3 days.
Consult your doctor if there is no improvement or if you feel less well after 3 days.
2. WHAT DO I HAVE TO KNOW BEFORE USING BRONCHODERMINE CHILDREN, suppository?
Never use BRONCHODERMINE ENFANTS, suppository:
- if you are allergic to local anaesthetics (amylein)
- if you are allergic to the active substances or to any of the other ingredients listed in section 6.
- in children under 30 months of age,
- in children with a history of seizures or febrile convulsions,
- in children with a recent history of anorectal lesions.
Warnings and precautions
- This product contains cineole and pine essential oil, which in excessive doses may cause neurological accidents such as convulsions in infants and children.
- Do not prolong treatment beyond 3 days due to :
o of the risk of accumulation of terpene derivatives (cineole and pine essential oil) in the body, including the brain, and in particular the risk of neurological disorders,
o risk of rectal burns.
- Do not exceed recommended doses, as there is an increased risk of adverse reactions and disorders associated with overdosage.
- As terpene derivatives are flammable, keep this speciality away from flames.
Medical advice is required:
- in case of oily or purulent expectoration,
- if the child suffers from chronic (long-term) bronchial or lung disease.
In case of old or recent seizures, ASK YOUR DOCTOR FOR ADVICE.
If you have had convulsions before or recently, ASK YOUR DOCTOR FOR ADVICE.
Ask your doctor or pharmacist before using BRONCHODERMINE CHILDREN, suppository.
Children
Do not use in children under 30 months.
Other medicines and BRONCHODERMINE ENFANTS, suppository
Do not use at the same time as other products (medicines or cosmetics) containing terpene derivatives (e.g. camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needles, eucalyptus and turpentine), whatever the route of administration (oral, rectal, cutaneous or pulmonary).
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
BRONCHODERMINE CHILDREN, suppository with food and drink
Not applicable.
Pregnancy and breast-feeding
Do not use this product during pregnancy or while breast-feeding.
If you discover that you are pregnant during treatment, consult your doctor, who is the only person who can judge whether it is necessary to continue treatment.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
BRONCHODERMINE CHILDREN, suppository contains
Not applicable.
3. HOW TO USE BRONCHODERMINE CHILDREN, suppository?
Always use this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
FOR CHILDREN AGED 30 MONTHS AND OVER
The recommended dose is :
- from 30 months to 6 years: 1 suppository per day.
- from 6 to 10 years: 2 suppositories per day.
- from 10 to 15 years: 3 suppositories per day.
Method of administration
Rectal route.
The choice of rectal route is determined solely by the convenience of administering the drug.
Duration of treatment
Do not exceed 3 days' treatment. If symptoms persist, consult your doctor.
If you have used more BRONCHODERMINE CHILDREN suppository than you should have
Due to the presence of cineole and pine essential oil, and if the recommended doses are not followed: risk of convulsions in children and infants.
Please consult your doctor.
If you forget to use BRONCHODERMINE CHILDREN, suppository
Not applicable.
If you stop using BRONCHODERMINE CHILDREN, suppository
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
As with all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
- Possible digestive disorders (nausea, vomiting).
- Due to the presence of terpene derivatives (cineole, pine essential oil), and if the recommended doses are not followed, there is a risk of convulsions in children.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO USE BRONCHODERMINE CHILDREN, suppository?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What BRONCHODERMINE CHILDREN, suppository contains
- The active ingredients are :
Cineole............................................................................................................................... 0.0200 g
Damylein hydrochloride...................................................................................................... 0.0025 g
Guaiacol.............................................................................................................................. 0.0700 g
Reconstituted pine essential oil..................................................................................... 0.0250 g
For a 2 g suppository
- The other excipient components are : Rocou (E 160b), semi-synthetic triglycerides.
What is BRONCHODERMINE CHILDREN, suppository and what does it contain?
This medicine is available as a suppository in boxes of 10 suppositories.
Marketing authorization holder
SOCIETE DETUDES ET DE RECHERCHES PHARMACEUTIQUES (S.E.R.P.)
5, RUE DU GABIAN
IMMEUBLE LE TRITON
98000 MONACO
MONACO
Marketing authorization holder
SOCIETE DETUDES ET DE RECHERCHES PHARMACEUTIQUES (S.E.R.P.)
5, RUE DU GABIAN
IMMEUBLE LE TRITON
98000 MONACO
MONACO
Manufacturer
SOCIETE DETUDES ET DE RECHERCHES PHARMACEUTIQUES (S.E.R.P.)
5, RUE DU GABIAN
IMMEUBLE LE TRITON
98000 MONACO
MONACO
Drug names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.