NOTICE
ANSM - Last updated: 03/11/2016
Name of the medicinal product
AMBROXOL EXPECTOR WITHOUT SUGAR, SOFTENED SOLUTION WITH ACESULPHAMOUS POTASSIUM AND SORBITOL
Ambroxol hydrochloride
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor, or your pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you feel unwell or if you experience no improvement after 8 to 10 days.
Do not use this medication for children.
What is in this leaflet?
1. What is SURFACE EXPECTOR AMBROXOL WITHOUT SUGAR, oral solution sweetened with acesulfame potassium and sorbitol and in which cases it is used?
2. What should be known before taking SURBRONC EXPECTORANT AMBROXOL WITHOUT SUGAR, oral solution sweetened with acesulfame potassium and sorbitol?
3. How to take SURBRONC EXPECTOR AMBROXOL WITHOUT SUGAR, oral solution sweetened with acesulfame potassium and sorbitol?
4. What are the possible side effects?
5. How to store SURBRONC EXPECTOR AMBROXOL WITHOUT SUGAR, oral solution sweetened with acesulfame potassium and sorbitol?
6. Package contents and other information.
1. WHAT AMBROXOL EXPECTOR WITHOUT SUGAR EXPRESSOR, SWEETENED SOLUTION WITH ACESULPHAMA POTASSIUM AND SORBITOL AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group : ATC code
Mucolytics (R05CB06)
Treatment of disorders of adult bronchial secretion, particularly in acute bronchial disorders and acute episodes of chronic bronchopneumonia.
This drug is an expectorant. It facilitates the evacuation by coughing of the bronchial secretions.
2. BEFORE YOU TAKE SURBRONC EXPECTOR AMBROXOL WITHOUT SUGAR, drinkable solution sweetened with acesulfame potassium and sorbitol?
Never take SURFACE EXPECTOR AMBROXOL WITHOUT SUGAR, oral solution sweetened with acesulfame potassium and sorbitol:
· if you are allergic (hypersensitive) to ambroxol hydrochloride or to any of the other ingredients of this medication mentioned in section 6.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Warnings and Precautions
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Take special care with SURFACE EXPECTOR AMBROXOL WITHOUT SUGAR, oral solution sweetened with acesulfame potassium and sorbitol:
Warnings
Severe skin reactions have been reported with ambroxol hydrochloride. If a rash appears on your skin (including mucosal lesions, eg in the mouth, throat, nose, eyes, genitals), stop using SURBRONC EXPECTORANT AMBROXOL WITHOUT SUGAR, oral solution sweetened with acesulfame potassium and sorbitol, and contact your doctor immediately.
The use of this medication is not recommended in patients with fructose intolerance (rare hereditary disease).
Precautions for use
It is advisable not to take a cough medication or bronchial drying medication during the treatment period with this medication.
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Children and Youth
Not applicable.
Other medicines and SUBREGIUM AMBROXOL EXPECTOR EXCLUSIVE, oral solution sweetened with acesulfame potassium and sorbitol
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
SURFROST EXPECTOR AMBROXOL WITHOUT SUGAR, oral solution sweetened with acesulfame potassium and sorbitol with food and beverages
Not applicable.
Pregnancy, breast-feeding and fertility
It is best not to use this medication during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need for further treatment.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Driving and using machines
Not applicable.
SURFRONT EXPECTOR AMBROXOL WITHOUT SUGAR, oral solution sweetened with acesulfame potassium and sorbitol contains sorbitol
3. HOW TO TAKE SURFACE EXPECTOR AMBROXOL WITHOUT SUGAR, oral solution sweetened with acesulfame potassium and sorbitol?
Dosage
RESERVED FOR ADULTS
The dosage of this medication is 1 to 2 buckets filled up to the graduation 5 ml morning and evening.
Administration mode
Oral use
Frequency of Administration
The catch will be spaced at regular intervals
Duration of treatment
The duration of treatment will not exceed 8 to 10 days without medical advice.
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Use in children and adolescents
Not applicable.
If you take more AMBROXOL EXPECTOR WITHOUT SUGAR, sugar solution sweetened with acesulfame potassium and sorbitol you should have:
Not applicable.
If you forget to take SURBRONC EXPECTORANT AMBROXOL WITHOUT SUGAR, drinkable solution sweetened with acesulfame potassium and sorbitol:
Not applicable.
If you stop taking SURBRONC EXPECTORANT AMBROXOL WITHOUT SUGAR, drinkable solution sweetened with acesulfame potassium and sorbitol:
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Rare: may occur in 1 in 1,000 people:
Hypersensitivity reactions
Rash, hives
Not known: can not be estimated from the available data
Anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissue, mucosa or submucosal tissue) and pruritus
Severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome / Lyell syndrome, and generalized acute exanthematous pustulosis).
In these cases the treatment must be interrupted.
Minor gastrointestinal effects such as nausea, vomiting, sore or heartburn, digestive upset have been reported infrequently.
Were also very rarely described cases of headaches and dizziness.
Due to the presence of sorbitol, possibility of digestive disorders and diarrhea.
Declaration of side effects
If you experience any side effects, talk to 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: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE AMBROXOL EXCLUSIVE SURFACE WITHOUT SUGAR, oral solution sweetened with acesulfame potassium and sorbitol?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the vial.
No special storage conditions.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What SURBRONC EXPECTORANT AMBROXOL WITHOUT SUGAR contains, oral solution sweetened with acesulfame potassium and sorbitol
· The active substance is:
Ambroxol hydrochloride .............................................. .................................................. 0.6 g
For 100 ml.
· The other components are:
Benzoic acid, hydroxyethylcellulose, acesulfame potassium, 70% sorbitol solution (non-crystallizable), 85% glycerol, strawberry cream flavor, vanilla flavor, purified water.
What is SURFACE EXPECTOR AMBROXOL WITHOUT SUGAR, oral solution sweetened with acesulfame potassium and sorbitol and contents of the pack
This medication is in the form of a drinkable solution. Bottle of 100 ml or 150 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder
BOEHRINGER INGELHEIM FRANCE
14 rue Jean Antoine de Baïf
75013 PARIS
Marketing Authorization Operator
BOEHRINGER INGELHEIM FRANCE
14 rue Jean Antoine de Baïf
75013 PARIS
Maker
DELPHARM REIMS
10 rue Colonel Charbonneaux
51100 REIMS
LA FRANCE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this notice has been revised is
{MM / YYYY}.
Other
Detailed information on this medicine is available on the ANSM website (France).