NOTICE
ANSM - Updated on: 16/06/2016
Name of the medicinal product
AMBROXOL BIOGARAN CONSEIL 30 mg, scored tablet
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 take this medicine with any of the following:
What is in this leaflet?
1. What is AMBROXOL BIOGARAN COUNCIL 30 mg, scored tablet and in which cases is it used?
2. What should I know before I take AMBROXOL BIOGARAN COUNCIL 30 mg, scored tablet?
3. How to take AMBROXOL BIOGARAN COUNCIL 30 mg, scored tablet?
4. What are the possible side effects?
5. How to store AMBROXOL BIOGARAN CONSEIL 30 mg, scored tablet?
6. Package contents and other information.
1. WHAT AMBROXOL BIOGARAN COUNCIL 30 mg, scored tablet AND WHAT CASES IS IT USED FOR?
MUCOLYTICS (R: Respiratory system)
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 AMBROXOL BIOGARAN COUNCIL 30 mg, scored tablet?
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Do not take AMBROXOL BIOGARAN CONSEIL 30 mg, scored tablet:
· if you are allergic (hypersensitive) to the active substance 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
Talk to your doctor, pharmacist or nurse before taking AMBROXOL BIOGARAN CONSEIL 30 mg, scored tablet .
Severe skin reactions have been reported with ambroxol hydrochloride. If a rash appears on your skin (including mucosal lesions, such as in the mouth, throat, nose, eyes, genitals), stop using AMBROXOL BIOGARAN CONSEIL 30 mg, scored tablet and contact your doctor immediately.
This medicine contains lactose. Its use is not recommended in patients with lactose intolerance (rare hereditary disease).
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 REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Children and Youth
Not applicable.
Other medicines and AMBROXOL BIOGARAN CONSEIL 30 mg, scored tablet
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
AMBROXOL BIOGARAN TIP 30 mg, scored tablet with food, drink and alcohol
Not applicable.
Pregnancy and breast feeding
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 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 30 mg, scored tablet contains lactose.
3. HOW TO TAKE AMBROXOL BIOGARAN TIP 30 mg, scored tablet?
Always take this medication exactly as prescribed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt.
Dosage
RESERVED FOR ADULTS.
The dosage of this medication is 1 to 2 tablets morning and evening.
Method and route of administration
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.
If you take more AMBROXOL BIOGARAN TIP 30 mg, scored tablet than you should:
Immediately consult your doctor or pharmacist.
If you forget to take AMBROXOL BIOGARAN CONSEIL 30 mg, scored tablet:
Not applicable.
If you stop taking AMBROXOL BIOGARAN COUNCIL 30 Mg, scored tablet:
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 acute generalized acute exanthematous pustulosis)
In these cases the treatment must be interrupted.
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 TIP 30 mg, scored tablet?
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 carton 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 30 mg contains: scored tablet
· The active substance is:
Ambroxol hydrochloride .............................................. .................................................. ..... 30 mg
For a scored tablet.
· The other components are: Lactose monohydrate, microcrystalline cellulose, povidone, sodium carboxymethyl starch (type A), magnesium stearate.
What is AMBROXOL BIOGARAN CONSEIL 30 mg, scored tablet and contents of the pack
This medication is in the form of a scored tablet. Box of 20, 30 or 50.
Marketing Authorization Holder
BIOGARAN
15 BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Marketing Authorization Operator
BIOGARAN
15 BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Maker
LABORATOIRES SERVIER INDUSTRIE
45520 GIDY
LA FRANCE
Or
EGIS PHARMACEUTICAL PLC
1106 BUDAPEST
KERESZTURI UT 30-38
HUNGARY
Or
EGIS PHARMACEUTICALS PLC
BOKENYFODI UT 118-120
1106 BUDAPEST
HUNGARY
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
Detailed information on this medicine is available on the ANSM website (France).