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30MG TABLETS SURBRONC EXPECT SEC

Name: SURBRONC EXPECT 30MG COMPRIMES SEC
Brand: Sanofi Aventis
SKU: 2952
Price: 5.85 EUR
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Brand : Sanofi Aventis

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SURBRONC EXPECT 30MG TABLETS DRY

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".

Description

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.

Dosage

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.

A daily dose of 60 mg may be administered using a 30 mg dose twice a day.
A daily dose of 120 mg may be administered using a 60 mg dose twice a day.

Contraindications

History of hypersensitivity reactions to any of the constituents.

Precautions for use

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 - Breastfeeding

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.

Side effects

Minor gastrointestinal effects such as nausea, vomiting, gastralgia, heartburn, dyspepsia have been reported infrequently.

Have been described:

cases of mucocutaneous reactions such as erythema, rash, pruritus, hives;
very rarely anaphylactoid manifestations with the onset of shock and angioedema which have been favorable in the cases reported.

In these cases the treatment must imperatively be interrupted.

Also very rarely have been cases of headache and dizziness.

Presentation

White scored tablet engraved 67C on one side.

Warnings on drugs purchased online

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.

Please inform your online pharmacist of the treatments in progress in order to identify any incompatibilities. The order validation form contains a personalized message field provided for this purpose.
Click here to find the leaflet for this medication on the website of the National Agency for the Safety of Medicines and Health Products.

Notice

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Last updated: 13/06/2017

Name of the medicinal product

SURBRONC EXPECTORANT AMBROXOL 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 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.

What is in this leaflet?

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:

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 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.

Driving and using machines

Not applicable.

SURBRONC EXPECTORANT AMBROXOL 30 mg, scored tablet contains lactose

3. HOW TO TAKE SURBRONC EXPECTORANT AMBROXOL 30 MG, scored tablet?

Dosage

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:

Not applicable.

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

SANOFI-AVENTIS FRANCE

82 AVENUE RASPAIL

94250 GENTILLY

Marketing Authorization Operator

SANOFI-AVENTIS FRANCE

82 AVENUE RASPAIL

94250 GENTILLY

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 leaflet was revised is:

[to be completed later by the holder]

Other

Detailed information on this medicine is available on the ANSM website (France).

Vidal file

VIDAL OF THE FAMILY

EXPECTOR SURBRONC

Bronchial Fluidifier

ambroxol

. Presentations . Composition . Indications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS ^(summary)

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.
-

Laboratory Boehringer Ingelheim France

COMPOSITION ^(summary)

	p cp	p 5 ml
Ambroxol hydrochloride	30 mg	30 mg
sorbitol		+

INDICATIONS ^(summary)

This drug liquefies the secretions (mucus) present in the bronchi. It facilitates their evacuation by coughing.
It is used in cases of fatty cough with difficulty spitting, especially in acute bronchial conditions.

WARNING ^(Contents)

This medication can only be used in case of chronic bronchitis on medical advice.
Do not use a cough suppressant in addition to this medication without the advice of your doctor or pharmacist.
Allergic or skin reactions, rare but potentially serious, have been reported in patients treated with ambroxol. In case of skin reaction (rash, redness, blisters, itching), stop treatment and take an emergency medical opinion.
In case of fever, secretions that persist beyond a few days or become colored, consult your doctor.

PREGNANCY AND BREAST-FEEDING ^(summary)

The effect of this medication during pregnancy or lactation is not well known: only your doctor can evaluate the possible risk of its use in your case.

DIRECTIONS FOR USE AND DOSAGE ^(summary)

This medication can be taken indifferently during or outside meals.

Usual dosage:

Adult: 1 or 2 tablets or 5 to 10 ml of oral solution, 2 times a day.

Treatment may be interrupted as symptoms improve. The duration should not exceed 8 to 10 days without medical advice.

TIPS ^(summary)

Smoking, or being exposed to the smoke of others, is an important impediment to the evacuation of mucus.
It is necessary to fight against the dryness of the ambient air (humidifier ...) to avoid the dryness of the secretions. It is also recommended to drink a lot.
In the elderly, the inability to evacuate sputum can justify the help of a physiotherapist, on medical prescription.

POSSIBLE ADVERSE EFFECTS ^(summary)

Common: nausea.
Uncommon: vomiting, diarrhea, stomach pain.
Rare: urticaria.
Very rare: headache, dizziness , allergic reaction ( angioedema , shock), severe skin reaction (Stevens-Johnson syndrome, Lyell's syndrome ...).
Oral solution: possibility of diarrhea in case of large intake (presence of sorbitol).

GLOSSARY ^(summary)

antitussive
Medication that fights cough. The most potent antitussives contain codeine or codethylamine.

chronic bronchitis
Disease of the bronchi resulting in a cough, difficulty breathing and mucus more and more difficult to evacuate. These disorders, most often due to tobacco, become definitive after a certain period of evolution.

diarrhea
The strict medical sense of diarrhea is "emission of stools too frequent and too abundant". In fact, common sense equates diarrhea with the notion of fluid and frequent stools. Normally the stools are pasty, but the emission of stool fluid or barely formed, without pain or particular associated disorder, is not pathological. Diarrhea may occur when liquid stool emissions are repeated throughout the day and the needs are overwhelming or painful.
Many medicines can accelerate intestinal transit and make the stools more liquid, without this undesirable effect being of real concern.
Antibiotics can alter the digestive flora, essential for digestion, and cause more or less troublesome but benign diarrhea. The effect appears immediately or after a few days of treatment. A severe and exceptional form of diarrhea, pseudomembranous colitis, can be observed after antibiotic treatment; this condition results in the emission of mucus and false membranes (resembling skin flaps) associated with abdominal pain; constipation may replace the initial diarrhea. Pseudomembranous colitis can occur several days after discontinuation of antibiotic treatment and requires urgent medical advice.

angioedema
Allergy edema usually affects the face. Quincke edema results in a sometimes spectacular swelling. Eyelids are often the first to be affected. In rare cases where edema affects the throat, respiratory problems may occur and urgent treatment is required.

allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.

dizziness
Symptom that can mean an impression of loss of balance (common sense) or, more strictly, a sense of rotation on oneself or the environment (medical sense).