1. WHAT IS SURBRONC EXPECTORANT AMBROXOL SUGAR-FREE, drinkable solution sweetened with acesulfame potassium and sorbitol AND WHEN IS IT USED?
Pharmacotherapeutic class
MUCOLYTICS
Therapeutic indications
Treatment of bronchial secretion disorders in adults, particularly during acute bronchial illnesses and acute episodes of chronic bronchopneumopathy.
This medicine is an expectorant. It facilitates the coughing up of bronchial secretions.
2. WHAT YOU SHOULD KNOW BEFORE TAKING SURBRONC EXPECTORANT AMBROXOL SUGAR-FREE, drinkable solution sweetened with acesulfame potassium and sorbitol
List of information needed before taking the medicine
Not applicable.
Contraindications
Never take SURBRONC EXPECTORANT AMBROXOL SUGAR-FREE, drinkable solution sweetened with acesulfame potassium and sorbitol if you have a history of allergy to this medicine or to any of its components.
IN CASE OF DOUBT, IT IS ESSENTIAL TO SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Precautions for use; special warnings
Take care with SURBRONC EXPECTORANT AMBROXOL SUGAR-FREE, drinkable solution sweetened with acesulfame potassium and sorbitol:
Special Warnings
Due to the presence of sorbitol (2.9 g per sachet), this medicine should not be used in cases of fructose intolerance (hereditary metabolic disease).
Precautions for use
It is advisable not to take any cough medicine or medicine that dries out bronchial secretions during the period of treatment with this medicine.
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 breastfeeding
It is preferable not to use this medicine during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor, as only he or she can decide whether you should continue treatment.
Ask your doctor or pharmacist for advice before taking any medication.
Sportsmen
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notable effect:sorbitol.
3. HOW TO TAKE SURBRONC EXPECTORANT AMBROXOL SUGAR-FREE, drinkable solution sweetened with acesulfame potassium and sorbitol?
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS.
The dosage of this medicine is 1 to 2 cups filled to the 5 ml mark morning and evening.
Mode and route of administration
Oral administration.
Frequency of administration
The doses should be taken at regular intervals.
Duration of treatment
The duration of treatment should not exceed 8 to 10 days 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, SURBRONC EXPECTORANT AMBROXOL SUGAR-FREE, drinkable solution sweetened with acesulfame potassium and sorbitol is likely to have undesirable effects, although not everyone is subject to them:
Minor gastrointestinal effects such as nausea, vomiting, stomach ache or heartburn, disturbance of digestion have been reported infrequently.
The following have been described:
-casesof allergic skin reactions such as redness, rash, itching, urticaria;
Veryrarely, generalised allergic reactions with angioedema (swelling of the face and respiratory problems).
In these cases, treatment must be stopped.
Headaches and dizziness have also been reported very rarely.
Due to the presence of sorbitol, digestive disorders and diarrhoea may occur.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO USE SURBRONC EXPECTORANT AMBROXOL SUGAR-FREE, drinkable solution sweetened with acesulfame potassium and sorbitol
Keep out of the reach and sight of children.
Expiry date
Do not use SURBRONC EXPECTORANT AMBROXOL SUGAR-FREE, drinkable solution sweetened with acesulfame potassium and sorbitol after the expiry date stated on the bottle.
Storage conditions
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of 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 SURBRONC EXPECTORANT AMBROXOL SUGAR-FREE contain, drinkable solution sweetened with acesulfame potassium and sorbitol?
The active substance is:
Ambroxol hydrochloride ....................................................................................................................... 0.6 g
Per 100 ml.
Other components are:
Benzoic acid, hydroxyethylcellulose, acesulfame potassium, 70% sorbitol solution (non-crystallisable), 85% glycerol, strawberry cream flavour, vanilla flavour, purified water.
Pharmaceutical form and content
What is SURBRONC EXPECTORANT AMBROXOL SUGAR-FREE, drinkable solution sweetened with acesulfame potassium and sorbitol and what does it contain?
This medicine comes in the form of a drinkable solution. Bottle of 100 or 150 ml.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
BOEHRINGER INGELHEIM FRANCE
14, rue Jean Antoine de Baif
75013 PARIS
Français
English
