NOTICE
ANSM - Updated on: 16/06/2016
Name of the medicinal product
AMBROXOL BIOGARAN CONSULTING 0.6% WITHOUT SUGAR, oral solution sweetened with 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, pharmacist or nurse.
· 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, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you experience no improvement or feel less well after 8 to 10 days.
Do not use this medication for children.
What is in this leaflet?
1. What is AMBROXOL BIOGARAN COUNCIL 0.6% NO SUGAR, oral solution sweetened with sorbitol and in which cases it is used?
2. What should I know before taking AMBROXOL BIOGARAN CONSULTING 0.6% WITHOUT SUGAR, oral solution sweetened with sorbitol?
3. How to take AMBROXOL BIOGARAN COUNCIL 0.6% WITHOUT SUGAR, oral solution sweetened with sorbitol?
4. What are the possible side effects?
5. How to store AMBROXOL BIOGARAN TIP 0.6% WITHOUT SUGAR, oral solution sweetened with sorbitol?
6. Package contents and other information.
1. WHAT AMBROXOL BIOGARAN COUNCIL 0.6% sugar-free, oral solution sweetened with sorbitol AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group - ATC code:
R05CB06 - MUCOLYTICS
This drug is an expectorant. It facilitates the evacuation by coughing of the bronchial secretions.
It is indicated for the treatment of disorders of adult bronchial secretion, particularly in acute bronchial disorders and acute episodes of chronic bronchopneumonia.
2. BEFORE YOU TAKE AMBROXOL BIOGARAN COUNCIL 0.6% sugar free, oral solution sweetened with sorbitol?
Do not take AMBROXOL BIOGARAN TIP 0.6% WITHOUT SUGAR, oral solution sweetened with sorbitol:
· if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medication mentioned in section 6.
· if your doctor has informed you of an intolerance to some sugars, contact him or her before taking this medication.
Warnings and Precautions
Talk to your doctor or pharmacist before taking AMBROXOL BIOGARAN COUNCIL 0.6% WITHOUT SUGAR, oral solution sweetened with sorbitol .
Severe skin reactions have been reported with ambroxol hydrochloride.
If a rash appears on your skin (including mucosal lesions, eg on the mouth, throat, nose, eyes, genitals), stop using AMBROXOL BIOGARAN TIP 0.6% SANS SUGAR, oral solution sweetened with sorbitol and contact your doctor immediately.
It is advisable not to take a cough medication or bronchial drying medication during the treatment period with this medication.
Observe the recommended dosage and treatment time.
The use of this medication is not recommended in patients with fructose intolerance (rare hereditary disease). Due to the presence of sorbitol, this drug may cause mild digestive disorders (diarrhea).
Caloric value 2.6 kcal / g sorbitol.
This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) and may cause allergic reactions (possibly delayed).
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 AMBROXOL BIOGARAN CONSULTING 0.6% WITHOUT SUGAR, oral solution sweetened with sorbitol
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
AMBROXOL BIOGARAN COUNCIL 0.6% SUGAR-FREE, oral solution sweetened with sorbitol with food, drink and alcohol
Not applicable.
Pregnancy and breast feeding
It is best not to use this medication during pregnancy and during breastfeeding.
If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Driving and using machines
Not applicable.
AMBROXOL BIOGARAN COUNCIL 0.6% SUGAR-FREE, oral solution sweetened with sorbitol contains sorbitol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216).
3. HOW TO TAKE AMBROXOL BIOGARAN COUNCIL 0.6% WITHOUT SUGAR, oral solution sweetened with sorbitol?
Always take this medication exactly as prescribed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor or pharmacist or nurse if in doubt.
Dosage
Reserved for adults only.
The dosage of this medication is 5 to 10 ml of oral solution morning and evening:
either 1 dose of 5 ml to 1 dose of 10 ml of the measuring cup or 1 to 2 measuring spoon, morning and evening.
If you feel that the effect of AMBROXOL BIOGARAN TIPS 0.6% WITHOUT SUGAR, oral solution sweetened with sorbitol is too strong or too weak, talk to your doctor or pharmacist.
Administration mode
Oral use.
Use the supplied measuring cup or measuring spoon to measure the amount of product to be taken per outlet.
To measure the quantity of product with the measuring cup:
Position the dosing cup horizontally,
Place in front of the measuring cup and at eye level when filling.
Rinse with water after each use.
Do not re-use the measuring cup or measuring spoon to administer any other medication.
Frequency of Administration
The catch will be spaced at regular intervals.
Duration of the treatment
The duration of treatment will not exceed 8 to 10 days without medical advice.
If you take more AMBROXOL BIOGARAN TIP 0.6% WITHOUT SUGAR, oral solution sweetened with sorbitol you should:
Immediately consult your doctor or pharmacist.
If you forget to take AMBROXOL BIOGARAN TIP 0.6% WITHOUT SUGAR, oral solution sweetened with sorbitol:
Do not take a double dose to make up for a missed dose.
If you stop taking AMBROXOL BIOGARAN TIP 0.6% WITHOUT SUGAR, oral solution sweetened with sorbitol:
Not applicable.
If you have any further questions on the use of this medication, ask your doctor, pharmacist or nurse for more information.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
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.
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.
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, pharmacist or nurse. 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 BIOGARAN COUNCIL 0.6% WITHOUT SUGAR, oral solution sweetened with 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 after EXP {MM / YYYY}. The expiry date refers to the last day of that month.
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 AMBROXOL BIOGARAN CONSEIL contains 0.6% WITHOUT SUGAR, oral solution sweetened with sorbitol
· The active substance is:
Ambroxol hydrochloride .............................................. .................................................. ...... 0.6 g
For 100 ml of oral solution.
· Other components are: glycerol, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), banana flavor, liquid (non crystallizable) sorbitol, purified water.
What is AMBROXOL BIOGARAN CONSULTING 0.6% WITHOUT SUGAR, oral solution sweetened with sorbitol and contents of the pack
This medication is in the form of a drinkable solution. Bottle of 100 or 150 ml with measuring spoon or measuring cup.
Marketing Authorization Holder
BIOGARAN
15 BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Marketing Authorization Operator
BIOGARAN
15 BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Maker
H2 PHARMA
21 RUE JACQUES TATI - ZAC THE CROIX BONNET
78390 BOIS D'ARCY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Other
Not applicable.