Surbronc is an over-the-counter tablet containing ambroxol, which has mucokinetic and expectorant properties.
For warnings, precautions for use and contraindications, please consult the instructions for use.
Coughing is a natural body mechanism used to purify the airways of inhaled impurities. It is usually due to irritation which can be found throughout the respiratory tree: the trachea, the bronchi. During bronchitis, the cough is usually first "dry" then becomes oily within a few days. But during a winter respiratory condition, the cough can be "mixed": sometimes dry, sometimes oily, depending on the moment. After such a viral episode, the cough continues for 3 to 8 weeks while the disease is cured, because the lining of the respiratory tree has been weakened: it is called "post-infectious" and "sub-acute".
SURBRONC EXPECTORANT AMBROXOL: how it works
Pharmacotherapeutic group: MUCOLYTICS, ATC code: R05CB06.
Ambroxol has mucokinetic and expectorant properties .
By stimulating secretory cells, it stimulates bronchial secretion and promotes the production of more mobilizable mucus. It increases ciliary activity.
RESERVED FOR ADULTS.
The average dosage of ambroxol hydrochloride is 60 mg to 120 mg per day in 2 divided doses, ie 1 to 2 tablets 2 times a day.
History of hypersensitivity reactions to any of the constituents.
The association of a bronchial mucomodifier with a cough suppressant and / or substances drying out secretions (atropinics) is irrational.
This medicine contains lactose. Its use is not recommended in patients with lactose intolerance.
Pregnancy
Animal studies have not shown any teratogenic effects. In the absence of a teratogenic effect in animals, a malformation effect in the human species is not expected. Indeed, to date, the substances responsible for malformations in the human species have proven to be teratogenic in animals during well-conducted studies on two species.
In clinical practice, there are currently no data sufficiently relevant to evaluate a possible malformation or foetotoxic effect of ambroxol hydrochloride when administered during pregnancy.
Therefore, as a precaution, it is best not to use ambroxol hydrochloride during pregnancy.
Feeding with milk
When breastfeeding, the use of this product is not recommended.
Minor gastrointestinal effects such as nausea, vomiting, gastralgia, heartburn, dyspepsia have been reported infrequently.
Have been described:
In these cases the treatment must imperatively be interrupted.
Also very rarely have been cases of headache and dizziness.
White scored tablet engraved 67C on one side.
Attention, the drug is not a product like the others. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 13/06/2017
SURBRONC EXPECTORANT AMBROXOL 30 mg, scored tablet
Ambroxol hydrochloride
You should always take this medicine by following the instructions 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.
1. What is SURBRONC EXPECTORANT AMBROXOL 30 mg, scored tablet and in which cases it is used?
2. What should be known before taking SURBRONC EXPECTORANT AMBROXOL 30 mg, scored tablet?
3. How to take SURBRONC EXPECTORANT AMBROXOL 30 mg, scored tablet?
4. What are the possible side effects?
5. How to store SURBRONC EXPECTORANT AMBROXOL 30 mg, scored tablet?
6. Package contents and other information.
1. WHAT IS SURFACE EXPECTOR AMBROXOL 30 mg, scored tablet AND WHAT IS IT USED FOR?
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 evacuation by coughing of bronchial secretions
You should contact your doctor if you feel unwell or if you experience no improvement after 8 to 10 days.
2. BEFORE YOU TAKE SURBRONC EXPECTORANT AMBROXOL 30 Mg, scored tablet?
Do not take SURBRONC EXPECTORANT AMBROXOL 30 mg, scored tablet:
· 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 SURBRONC EXPECTORANT AMBROXOL 30 mg, scored tablet:
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 30 mg, scored tablet , and contact your doctor immediately.
The use of this medication is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
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 SURBRONC EXPECTORANT AMBROXOL 30 mg, scored tablet
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
SURBRONC EXPECTORANT AMBROXOL 30 mg, scored tablet 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.
Not applicable.
SURBRONC EXPECTORANT AMBROXOL 30 mg, scored tablet contains lactose
3. HOW TO TAKE SURBRONC EXPECTORANT AMBROXOL 30 MG, scored tablet?
RESERVED FOR ADULTS
The dosage of this medication is 1 to 2 tablets 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 EXPRESSIVE SURBRONC AMBROXOL 30 Mg, scored tablet than you should:
Immediately consult your doctor or pharmacist.
If you forget to take SURBRONC EXPECTORANT AMBROXOL 30 Mg, tablet
breakable:
If you stop taking SURBRONC EXPECTORANT AMBROXOL 30 Mg, tablet
breakable:
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.
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 SURBRONC EXPECTORANT AMBROXOL 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 package.
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 30 mg contains, breakable tablet
· The active substance is:
Ambroxol hydrochloride .............................................. .................................................. ... 30 mg
For a scored tablet
· The other components are:
Lactose, corn starch, colloidal silicic acid, magnesium stearate.
What is SURBRONC EXPECTORANT AMBROXOL 30 mg, scored tablet and contents of the pack
This medication is in the form of scored tablets. Box of 20, 30, 40 or 50.
Not all pack sizes may be marketed.
Marketing Authorization Holder
82 AVENUE RASPAIL
94250 GENTILLY
Marketing Authorization Operator
82 AVENUE RASPAIL
94250 GENTILLY
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 leaflet was revised is:
[to be completed later by the holder]
Detailed information on this medicine is available on the ANSM website (France).
Bronchial Fluidifier
ambroxol
. Presentations . Composition . Indications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
SURBRONC EXPECTORANT 30 mg: scored tablet (white); box of 30.
-
EXPECTOR SURBRONC without sugar: oral solution (flavors: strawberry cream, vanilla); 100 ml bottle with graduated bucket.
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Laboratory Boehringer Ingelheim France
| p cp | p 5 ml | |
| Ambroxol hydrochloride | 30 mg | 30 mg |
| sorbitol | + |
Usual dosage:
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