NOTICE
ANSM - Updated: 23/10/2017
Name of the drug
AMBROXOL EG LABO ADVICE 0.6%, oral solution
Ambroxol hydrochloride
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you feel worse or if you do not feel any improvement after 8 to 10 days.
Do not let this medicine within the reach of children.
What does this booklet contain ?
1. What is AMBROXOL EG LABO CONSEIL 0.6% oral solution and in which cases is it used?
2. What you need to know before taking AMBROXOL EG LABO CONSEIL 0.6% oral solution?
3. How to take AMBROXOL EG LABO CONSEIL 0.6%, oral solution?
4. What are the possible side effects?
5. How to store AMBROXOL EG LABO CONSEIL 0.6%, oral solution?
6. Contents of the package and other information.
1. WHAT AMBROXOL EG LABO TIP 0.6% oral solution AND WHAT IT IS USED FOR
Pharmacotherapeutic group: Mucolytics, ATC code: R05CB06.
It is indicated for the treatment of bronchial secretion disorders in adults, particularly during acute bronchial affections and acute episodes of chronic bronchopneumopathies.
This medicine is an expectorant. It facilitates the evacuation by cough of bronchial secretions.
2. BEFORE YOU TAKE AMBROXOL EG LABO ADVICE 0.6% oral solution?
Do not take AMBROXOL EG LABO CONSEIL 0.6%, oral solution:
· in case of known allergy to any of the components of this medicine.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking AMBROXOL EG LABO CONSEIL 0.6% oral solution .
Serious skin reactions have been reported with ambroxol administration. If a rash appears on your skin (including mucosal lesions, for example in the mouth, throat, nose, eyes, genitals), stop using AMBROXOL EG LABO CONSEIL 0.6% , oral solution and contact your doctor immediately.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
It is advisable not to take antitussive medication or bronchial secretion medicine during the treatment period with this medicine.
Respect the recommended dosages and duration of treatment.
Children and adolescents
Not applicable.
Other medicines and AMBROXOL EG LABO ADVICE 0.6%, oral solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
AMBROXOL EG LABO TIP 0.6%, oral solution with food and drink
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
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 because only he can judge the need to continue.
Driving and using machines
Not applicable.
AMBROXOL EG LABO CONSEIL 0.6% oral solution contains sorbitol and glycerol.
The use of this drug is not recommended in patients with fructose intolerance (rare hereditary disease).
This medicine contains glycerol and can cause digestive disorders (diarrhea).
3. HOW TO USE AMBROXOL EG LABO TIP 0.6% oral solution?
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
Dosage
The dosage of this medication is 5 to 10 ml of oral solution, morning and evening:
· either 1 dose of 5 ml at 1 dose of 10 ml of the measuring cup or
· 1 to 2 measuring spoons, morning and evening.
If you have the impression that the effect of AMBROXOL EG LABO TIP 0.6%, oral solution is too strong or too weak, consult your doctor or pharmacist.
Administration mode
Oral way.
Use the measuring cup or measuring spoon provided to measure the amount of product to be taken per shot.
To properly measure the amount of product with the measuring cup:
· Position the measuring cup horizontally,
· Stand 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 another medication.
Frequency of administration
The plugs will be spaced at regular intervals.
Duration of the treatment
The duration of treatment will not exceed 8 to 10 days without medical advice.
Use in children and adolescents
Not applicable.
If you take more AMBROXOL EG LABO CONSEIL 0.6%, oral solution than you should:
Not applicable.
If you forget to take AMBROXOL EG LABO CONSEIL 0.6%, oral solution:
Not applicable.
If you stop taking AMBROXOL EG LABO CONSEIL 0.6%, oral solution:
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare: May occur at most 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, mucous membrane or submucosal tissue) and pruritus
Severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome / Lyell's syndrome and generalized acute exanthematous pustulosis).
In these cases the treatment must be interrupted.
Minor gastrointestinal effects such as nausea, vomiting, headache or heartburn, digestive upset have been reported infrequently.
Cases of headache and vertigo have also been very rarely reported.
Due to the presence of sorbitol, possibility of digestive disorders and diarrhea.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE AMBROXOL EG LABO ADVICE 0.6%, oral solution?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle after EXP. The expiry date refers to the last day of this month.
No special storage conditions.
Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What AMBROXOL EG LABO BOARD contains 0.6% oral solution
· The active substance is:
Ambroxol hydrochloride .............................................. .................................................. 0.6 g
For 100 mL of oral solution.
· The other components are:
Glycerol, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), banana flavor, liquid sorbitol (non-crystallizable), purified water.
What AMBROXOL EG LABO CONSEIL 0.6% oral solution and contents of the pack
This medicine is in the form of an oral solution. Bottle of 150 ml with a measuring spoon or measuring cup.
Marketing Authorization Holder
EG LAB - LABORATORIES EUROGENERICS
THE QUINTET - BUILDING A
12 DANJOU STREET
92517 BOULOGNE BILLANCOURT CEDEX
Operator of the marketing authorization
EG LAB - LABORATORIES EUROGENERICS
THE QUINTET - BUILDING A
12 DANJOU STREET
92517 BOULOGNE BILLANCOURT CEDEX
Maker
H2 PHARMA
21, JACQUES TATI STREET
ZAC LA CROIX BONNET
78390 WOOD OF ARCY
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
March 2016.
Other
Detailed information on this medicine is available on the ANSM website (France).
Not applicable.