In this manual :
1. WHAT IS BRONCHOKOD SUGAR-FREE CHILDREN 2 PER CENT, drinkable solution sweetened with sodium saccharin AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE YOU TAKE BRONCHOKOD SWEETEN CHILDREN 2 PER CENT, Oral Solution sweetened with sodium saccharin
3. HOW DO I TAKE BRONCHOKOD SUGAR-FREE CHILDREN 2 PER CENT, Oral Solution Sweetened with Sodium Saccharin?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE BRONCHOKOD SUGAR-FREE CHILDREN 2 PER CENT, Oral Solution sweetened with sodium saccharin?
6. ADDITIONAL INFORMATION
1. WHAT IS BRONCHOKOD SUGAR-FREE CHILDREN 2 PER CENT, Oral Solution sweetened with sodium saccharin AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Mucolytic
(R: Respiratory System)
This medicine is a fluidifier of bronchial secretions and thus facilitates their evacuation by coughing.
This medicine is recommended in conditions of bronchial congestion, particularly in acute bronchitis.
2. WHAT YOU SHOULD KNOW BEFORE TAKING BRONCHOKOD SUGAR-FREE CHILDREN 2 PER CENT, Oral Solution sweetened with sodium saccharin
List of information needed before taking the medicine
Not applicable.
Do not use BRONCHOKOD SWEETEN CHILDREN 2 PER CENT, oral solution sweetened with sodium saccharin:
- in case of known allergy to one of the constituents (especially to methyl parahydroxybenzoate and other parabens);
- in infants (under 2 years of age) because of the risk of aggravating bronchial congestion.
In case of doubt, it is essential to ask your doctor or pharmacist for advice.
Precautions for use; special warnings
Take special care with BRONCHOKOD SWEET CHILDREN 2 PER CENT, oral solution sweetened with saccharin sodium:
Special Warnings
Medical advice is necessary:
- If you have oily or purulent sputum.
- If you have chronic (long-term) bronchial and lung disease.
As this medicine is intended to treat a condition requiring medical advice, it should not be used in children without medical advice (for paediatric forms).
Do not take any cough suppressant or bronchial secretion drying medication during treatment with carbocistein.
Treatment should not be continued if symptoms worsen. In this case, consult your doctor for a re-evaluation of your treatment.
Precautions for use
In case of stomach or duodenum ulcer, DO NOT take this medicine without consulting your doctor.
This medicine contains sodium. This medicine contains 13.68 mg of sodium per 5 ml of oral solution. This should be taken into account in patients who are controlling their dietary sodium intake.
This medicine contains methyl parahydroxybenzoate (E218) and may cause allergic reactions.
If in doubt, do not hesitate to ask your doctor or pharmacist for advice.
Interactions 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.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
Pregnancy and lactation
In case of pregnancy or breastfeeding, WARN YOUR DOCTOR.
Ask your doctor or pharmacist for advice before taking any medication.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notable effect: sodium, methyl parahydroxybenzoate (E218).
3. HOW TO TAKE BRONCHOKOD SWEET FOR CHILDREN 2 PER CENT, Oral Solution sweetened with sodium saccharin
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
This product is suitable for patients on a hypoglucidic or hypocaloric diet.
1 measuring spoon of 5 ml contains 100 mg of carbocistein.
- Children over 5 years of age: 300 mg per day, divided into 3 doses, i.e. one measuring spoon (5 ml) 3 times a day.
- Children aged 2 to 5 years: 200 mg per day, divided into 2 doses, i.e. one measuring spoon (5 ml) twice a day.
THIS MEDICINE HAS BEEN PERSONALLY GIVEN TO YOU IN A SPECIFIC SITUATION:
- IT MAY NOT BE SUITABLE FOR ANOTHER CASE.
- DO NOT ADVISE IT TO ANOTHER PERSON.
How to take it
Oral administration.
Duration of treatment
The duration of treatment should be short.
Do not exceed 8 to 10 days of treatment without medical advice.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, BRONCHOKOD SWEETEN CHILDREN 2 PER CENT, Oral Solution sweetened with saccharin sodium may have side effects, although not everyone is likely to experience them:
- Risk of worsening bronchial congestion in infants.
- Allergic skin reactions such as itching, rash, hives and facial swelling.
- A few cases of erythema pigmentosum (brown skin spot) have been reported.
- Nausea, diarrhoea, vomiting and stomach upset may occur. In this case, it is advisable to reduce the dosage.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please inform your doctor or pharmacist.
5. HOW TO USE BRONCHOKOD SUGAR-FREE CHILDREN 2 PER CENT, Oral Solution sweetened with sodium saccharin
Keep out of the reach and sight of children.
Do not use BRONCHOKOD SWEETEN CHILDREN 2 PER CENT, Oral Solution sweetened with sodium saccharin after the expiry date stated on the box.
Store at a temperature not exceeding 25°C.
If necessary, warnings against certain visible signs of deterioration
Do not throw medicines down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does BRONCHOKOD SWEETEN CHILDREN 2 PER CENT, oral solution sweetened with sodium saccharin, contain?
The active substance is:
Carbocistein ......................................................................................................................................... 2 g
Per 100 ml.
One 5 ml measuring spoon contains 100 mg of carbocistein.
The other components are:
Saccharin sodium, methyl parahydroxybenzoate (E218), sodium hydroxyethylcellulose, aromatic composition, sodium hydroxide, purified water.
Pharmaceutical form and content
What is BRONCHOKOD SWEETEN CHILDREN 2 PER CENT, drinkable solution sweetened with sodium saccharin and what does it contain?
This medicine is available as a drinkable solution. Bottle of 125 ml and 300 ml with measuring spoon.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
SANOFI-AVENTIS FRANCE
1-13, BOULEVARD ROMAIN ROLLAND
75014 PARIS
Operator
SANOFI-AVENTIS FRANCE
1-13, BOULEVARD ROMAIN ROLLAND
75014 PARIS
Manufacturer
A NATTERMANN & CIE. GMBH
NATTERMANNALLEE 1
D - 50829 KOLN-BOCKLEMUND
GERMANY
or
PIERRE FABRE MEDICAMENT PRODUCTION
RUE DU LYCEE - ZONE INDUSTRIELLE DE CURY
45500 GIEN
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information for health professionals only
Not applicable.
Not applicable.
Français
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