NOTICE
ANSM - Updated on : 06/02/2025
Name of medicinal product
BRONCHODERMINE ADULT, suppository
{Active substance(s)}
Box
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.
What does this leaflet contain?
1. What is BRONCHODERMINE ADULT, suppository and what is it used for?
2. What do I need to know before using BRONCHODERMINE ADULT, suppository?
3. How do I use BRONCHODERMINE ADULT, suppository?
4. What are the possible side effects?
5. How should BRONCHODERMINE ADULT suppositories be stored?
6. Package contents and other information.
1. WHAT IS BRONCHODERMINE ADULT, 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 adults.
2. WHAT DO I HAVE TO KNOW BEFORE USING BRONCHODERMINE ADULT, suppository?
Never use BRONCHODERMINE ADULT, suppository:
- if you are allergic to the active substances or to any of the other ingredients of this medicine, as listed in section 6,
- if you are allergic to local anaesthetics (amylein),
- in case of recent lesions of the anus and rectum (contraindication linked to the route of administration).
Warnings and precautions
Follow recommended dosage and duration of treatment.
Medical advice is required:
- in case of oily or purulent expectoration,
- in case of chronic (long-term) bronchial or lung disease.
If you have had seizures for a long time or have had them recently, ASK YOUR DOCTOR FOR ADVICE.
Ask your doctor or pharmacist before using BRONCHODERMINE ADULT, suppository.
Children and teenagers
A dosage more suitable for children is available.
Other medicinal products and BRONCHODERMINE ADULT, suppository
This medicine contains terpene derivatives (cineole, pine essential oil). Other products (medicines or cosmetics) contain them or another terpene derivative.
Do not combine them, whatever the route of administration (oral, rectal, cutaneous or pulmonary), so as not to exceed the maximum recommended dosage (see Dosage and Administration).
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
BRONCHODERMINE ADULTS, suppository with food and drink
Not applicable.
Pregnancy and breast-feeding
This medicine should not be used during pregnancy.
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.
Because of the potential neurological toxicity of terpene derivatives (cineole, pine oil) in infants, avoid taking this medicine when breast-feeding.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacistfor advicebefore taking this medicine.
Driving and using machines
Not applicable.
BRONCHODERMINE ADULT, suppository contains
Not applicable.
3. HOW TO USE BRONCHODERMINE ADULT, 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 ADULTS ONLY.
The recommended dose is 1 to 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 a few days' treatment. If symptoms persist, consult your doctor.
This medicine has been supplied to you personally in a specific situation: it cannot be adapted to any other case. Do not recommend it for other people.
If you have used more BRONCHODERMINE ADULTS suppository than you should have
Repeated and prolonged use may cause rectal burns.
Due to the presence of cineole and pine essential oil, there is a risk of agitation and confusion in elderly patients if the recommended doses are not followed.
In the event of accidental ingestion or misadministration in children and infants, there is a risk of neurological disorders.
If you forget to use BRONCHODERMINE ADULT, suppository
Do not take a double dose to make up for the one you forgot to take.
If you stop using BRONCHODERMINE ADULT, 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).
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 ADULT, 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 temperatures 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 ADULTS, suppository contains
- The active ingredients are :
Cineole*............................................................................................................................... 0.040 g
Damylein hydrochloride........................................................................................................ 0.005 g
Guaiacol................................................................................................................................ 0.140 g
Reconstituted pine essential oil...................................................................................... 0.050 g
For a 3 g suppository
- Other ingredients include: annatto (E 160b), semi-synthetic triglycerides.
What BRONCHODERMINE ADULT suppository is and what it contains
This medicine is available as a suppository in boxes of 10.
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.