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Mylan Viatris Advice Carbocysteine 5% Adult Without Sugars 200ml

Name: Mylan Viatris Conseil Carbocystéine 5 % Adulte Sans Sucres 200 ml
Brand: Mylan Viatris
SKU: 2628
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Brand : Mylan Viatris

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Helps to expectorate. Mylan ADULTS EXPECTORANT syrup, thanks to the expectorant effect of carbocisteine, frees the airways, promoting the expulsion of mucus.

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For warnings, precautions for use and contraindications, please consult the instructions for use.

Helps to expectorate Mylan ADULTS EXPECTORANT syrup, thanks to the expectorant effect of carbocisteine, frees the airways , promoting the expulsion of mucus . Adults over 15 years old. Also available in a sugar-free version

Description

This drug is a thinner of bronchial secretions , it thus facilitates their evacuation by coughing .
This drug is indicated in adults in case of recent respiratory disease with difficulty in expectoration (difficulty in rejecting by spitting bronchial secretions).

using advice

The recommended daily dosage is :
750 mg of carbocisteine 3 times a day, either a 15 ml graduation of the scoop or a tablespoon (15 ml) 3 times a day. To be taken preferably without meals, 5 days maximum

Composition

The active substance is :
Carbocisteine (5.00 g)
For 100ml.
A 15 ml graduation of the cup corresponds to 750 mg of carbocisteine and 130 mg of sodium.

The other components are :
Liquid maltitol, sorbitol, methyl parahydroxybenzoate (E218), cochineal red A (E124), sodium hydroxide, purified water, cherry flavor.

List of excipients with known effect
Liquid maltitol, sorbitol, sodium, cochineal red A, methyl parahydroxybenzoate.

Precaution of use

Never take Carbocisteine Mylan 5% adults without sugar, oral solution sweetened with liquid maltitol and sorbitol in the following case :

History of hypersensitivity (allergy) to the active substance or to one of the excipients (see section "list of excipients with known effect").

Precautions for use :

The use of this medication is not recommended in patients with fructose intolerance (rare hereditary disease).
This medicine can cause mild digestive disorders (diarrhoea).
Caloric value 2.3 kcal / g of maltitol.
This medicine contains sodium. This medicinal product contains 130 mg of sodium per scoop (15 ml).
To be taken into account in patients controlling their dietary sodium intake.
This medicinal product contains an azo coloring agent (E124 Cochineal red) and may cause allergic reactions.
This medicine contains methyl parahydroxybenzoate and may cause allergic reactions.

Please note that the Syrup Prospan drug is not a product like any other. Read the medication leaflet carefully before ordering it. Do not leave medicines within the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

Advice

Wet cough, what is it ?
A wet cough is a symptom that is manifested by expectoration of mucus or more or less thick sputum. Often associated with a bronchial infection, chronic bronchitis or smoking, wet cough is treated in different ways. Bronchial secretions are made up of 95% water and 5% solid matter, including mucus. Bronchial thinners, also called mucolytics, act on the constituents of mucus, restore its elasticity and viscosity and increase the movements of the bronchial cilia necessary for purification.

Notice

Pharmacovigilance Report an adverse drug reaction(s)

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NOTICE

ANSM - Last updated: 11/05/2017

Name of the medicinal product

HUMEX EXPECTOR CARBOCISTEIN 750 mg / 10 ml ADULTS WITHOUT SUGAR, oral solution in sachet sweetened with saccharin sodium, sorbitol and liquid maltitol

carbocisteine

framed

Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.

· This medication can be used in self-medication, ie used without consultation or prescription from a doctor.

· If symptoms persist, worsen or new symptoms appear, seek advice from your pharmacist or doctor.

· This leaflet is designed to help you use this medicine. Keep it, you may need to reread it.

DO NOT LEAVE THIS MEDICINE FOR CHILDREN.

Review summary

In this notice :

1. WHAT HUMEX EXPECTORANT CARBOCISTEIN 750 mg / 10 ml ADULTS WITHOUT SUGAR, oral solution sweetened with saccharin sodium, sorbitol and liquid maltitol AND WHAT IT IS USED FOR?

2. BEFORE YOU TAKE CARE HUMEX EXPECTOR CARBOCISTEIN 750 mg / 10 ml ADULT WITHOUT SUGAR, oral solution in sachet sweetened with saccharin sodium, sorbitol and liquid maltitol?

3. HOW TO TAKE HUMEX EXPECTOR CARBOCISTEIN 750 mg / 10 ml ADULTS WITHOUT SUGAR, oral solution in sachet sweetened with saccharin sodium, sorbitol and liquid maltitol?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE HUMEX EXPECTORANT CARBOCISTEIN 750 mg / 10 ml ADULTS WITHOUT SUGAR, oral solution sweetened with saccharin sodium, sorbitol and liquid maltitol?

6. ADDITIONAL INFORMATION

1. WHAT HUMEX EXPECTORANT CARBOCISTEIN 750 mg / 10 ml ADULTS WITHOUT SUGAR, oral solution sweetened with saccharin sodium, sorbitol and liquid maltitol AND WHAT IT IS USED FOR?

Pharmacotherapeutic group

This medication is a fluidizer of bronchial secretions (MUCOLYTIC), it facilitates their evacuation by the cough.

Therapeutic indications

This drug is indicated in adults and children over 15 years of age in recent respiratory conditions with difficulty in expectoration (difficulty in rejecting by spitting bronchial secretions).

2. BEFORE YOU TAKE CARE HUMEX EXPECTOR CARBOCISTEIN 750 mg / 10 ml ADULT WITHOUT SUGAR, oral solution in sachet sweetened with saccharin sodium, sorbitol and liquid maltitol?

List of information needed before taking the medication

If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.

Cons-indications

Do not take HUMEX EXPECTORANT CARBOCISTEIN 750 mg / 10 ml ADULTS WITHOUT SUGAR, oral solution in sachet sweetened with saccharin sodium, sorbitol and liquid maltitol:

· if you are allergic (hypersensitive) to carbocistein or to any of the other ingredients of HUMEX EXPECTORANT CARBOCISTEINE 750 mg / 10 ml ADULTS WITHOUT SUGAR, oral solution sweetened with saccharin sodium, sorbitol and liquid maltitol.

If in doubt, it is essential to seek the advice of your doctor or pharmacist.

Precautions for use; special warnings

Take special care with HUMEX EXPECTORANT CARBOCISTEIN 750 mg / 10 ml ADULTS WITHOUT SUGAR, oral solution in sachet sweetened with saccharin sodium, sorbitol and liquid maltitol:

· Medical advice is required:

· in case of fatty and purulent expectoration, of fever,

· if you have chronic (long-term) bronchial and lung disease.

· in case of stomach or duodenal ulcer.

DO NOT LEAVE THIS MEDICINE FOR CHILDREN

This drug should always be accompanied by voluntary efforts of coughing, allowing the sputum.

Do not take cough suppressant medication or bronchial secretion-drying medication during the carbocistein treatment period.

IT IS IMPORTANT TO CONSULT A DOCTOR IN THE ABSENCE OF IMPROVEMENT

This medicine contains small amounts of ethanol (alcohol), less than 100 mg per sachet.

This medicine contains methyl parahydroxybenzoate and may cause allergic reactions.

This medicine contains maltitol and sorbitol. Its use is discouraged in patients with fructose intolerance (rare hereditary disease).

Precautions for use

This medicine contains sodium. This medicine contains 97.5 mg (4.24 mmol) sodium per sachet. To be taken into account in patients controlling their sodium dietary intake.

If in doubt, do not hesitate to seek the advice of your doctor or pharmacist.

Interaction with other medicines

Taking or using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription.

This medicine contains carbocistein. Other medicines contain do not combine them, so as not to exceed the maximum recommended doses ( see 3. HOW TO TAKE HUMEX EXPECTOR CARBOCISTEIN 750 mg / 10 ml ADULTS WITHOUT SUGAR, oral solution sweetened with saccharin sodium, sorbitol and liquid maltitol? ).

Interactions with food and beverages

Not applicable.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and breast feeding

Pregnancy

This medication will only be used during pregnancy on the advice of your doctor.

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.

feeding

It is possible to breast-feed your child if you are taking this medication.

Ask your doctor or pharmacist for advice before taking any medicine.

Sport

Not applicable.

Effects on ability to drive or use machines

Not applicable.

List of excipients with known effect

Important information about some of the ingredients of HUMEX EXPECTORANT CARBOCISTEINE 750 mg / 10 ml ADULTS WITHOUT SUGAR, oral solution in sachet sweetened with saccharin sodium, sorbitol and liquid maltitol:

List of excipients with known effect:

· Sodium

· Sodium methyl parahydroxybenzoate (E 219)

· maltitol

· sorbitol

· Ethanol (alcohol, present in caramel / vanilla flavor)

3. HOW TO TAKE HUMEX EXPECTOR CARBOCISTEIN 750 mg / 10 ml ADULTS WITHOUT SUGAR, oral solution in sachet sweetened with saccharin sodium, sorbitol and liquid maltitol?

Instructions for proper use

Not applicable.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Administration mode

Oral use.

RESERVED FOR ADULTS AND CHILDREN OVER 15 YEARS.

Do not use this medication in children less than 15 years of age.

Dosage

The usual dose is 750 mg of carbocistein 3 times a day, ie 1 sachet of 10 ml 3 times a day.

This medication is suitable for patients on hypoglucidic or hypocaloric diets.

If you feel that the effect of HUMEX EXPECTORANT CARBOCISTEINE 750 mg / 10 ml ADULTS WITHOUT SUGAR, oral solution sweetened with saccharin sodium, sorbitol and liquid maltitol is too strong or too weak, consult your doctor or your pharmacist.

Duration of treatment

Do not exceed 5 days of treatment without medical advice.

Symptoms and Instructions for Overdose

If you take more HUMEX EXPECTOR CARBOCISTEIN 750 mg / 10 ml ADULTS WITHOUT SUGAR, oral solution in sachet sweetened with saccharin sodium, sorbitol and liquid maltitol you should:

Tell your doctor or pharmacist.

Instructions for omission of one or more doses

If you forget to take HUMEX EXPECTORANT CARBOCISTEINE 750 mg / 10 ml ADULTS WITHOUT SUGAR, oral solution in sachet sweetened with saccharin sodium, sorbitol and liquid maltitol:

Do not take a double dose to make up for a missed dose.

Risk of withdrawal syndrome

Not applicable.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, HUMEX EXPECTORANT CARBOCISTEIN 750 mg / 10 ml ADULTS WITHOUT SUGAR, oral solution in sachet sweetened with saccharin sodium, sorbitol and liquid maltitol is liable to have undesirable effects, although not everyone is not subject.

· Possible phenomena of digestive intolerance (stomach pain, nausea, diarrhea). It is advisable to reduce the dose.

· Possibility of allergic skin reactions such as itching, rash, swelling of the face.

If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.

5. HOW TO STORE HUMEX EXPECTORANT CARBOCISTEIN 750 mg / 10 ml ADULTS WITHOUT SUGAR, oral solution sweetened with saccharin sodium, sorbitol and liquid maltitol?

Keep out of the reach and sight of children.

Expiration date

Do not use HUMEX EXPECTORANT CARBOCISTEIN 750 mg / 10 ml ADULTS WITHOUT SUGAR, oral solution in sachet sweetened with saccharin sodium, sorbitol and liquid maltitol after the expiry date stated on the box.

Storage conditions

Store at a temperature not exceeding 25 ° C.

If necessary, warnings against visible signs of deterioration

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

Full list of active substances and excipients

What HUMEX EXPECTORANT CARBOCISTEINE contains 750 mg / 10 ml ADULTS WITHOUT SUGAR, oral solution in sachet sweetened with saccharin sodium, sorbitol and liquid maltitol?

The active substance is:

Carbocistein ................................................. .................................................. 750 mg

For a bag of 10 ml.

The other components are:

Saccharin sodium, sodium methyl parahydroxybenzoate (E 219), hydroxyethylcellulose, caramel / vanilla flavoring (containing alcohol in particular), liquid (non-crystallizable) sorbitol, liquid maltitol, sodium hydroxide, purified water.

Pharmaceutical form and content

What is HUMEX EXPECTORANT CARBOCISTEINE 750 mg / 10 ml ADULTS WITHOUT SUGAR, oral solution sweetened with saccharin sodium, sorbitol and liquid maltitol and contents of the pack?

This medication is in the form of a drinkable solution in 10 ml sachets, boxes of 10, 12 or 15 sachets.

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Holder

URGO HEALTHCARE LABORATORIES

42 RUE DE LONGVIC

21300 CHENOVE

exploiting

URGO HEALTHCARE LABORATORIES

42 RUE DE LONGVIC

21300 CHENOVE

Maker

URGO LABORATORIES

2 AVENUE DE STRASBOURG

ZONE EXCELLENCE 2000

21800 CHEVIGNY-SAINT-SAUVEUR

LA FRANCE

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

Date of approval of the notice

The last date on which this leaflet was approved is {date}.

AMM under exceptional circumstances

Not applicable.

Internet Information

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

Information for health professionals only

Not applicable.

Other

Not applicable.

Vidal file

VIDAL OF THE FAMILY

HUMEX TOUX GRASSE oral solution

Bronchial Fluidifier

carbocistein

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

PRESENTATIONS ^(summary)

HUMEX SUGAR-FREE GRASS WITHOUT SUGAR: oral solution (caramel flavoring); bottle of 250 ml with measuring spoon of 5 ml.
-

HUMEX SUGAR-FREE FATS: oral solution (caramel-vanilla flavor); box of 15 sachets of 10 ml.
-

Laboratory

COMPOSITION ^(summary)

	pc my	p sachet
carbocisteine	250 mg	750 mg
Sodium	33 mg	97.5 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 during acute bronchitis.

WARNING ^(Contents)

This medication can only be used in case of chronic bronchitis on medical advice.
Precautions are necessary in case of ulcers of the stomach or duodenum .
Do not use a cough suppressant in addition to this medication without the advice of your doctor or pharmacist.
If the secretions persist beyond a few days, if they become colored or if you have a fever, consult your doctor.

PREGNANCY AND BREAST-FEEDING ^(summary)

This medicine contains only presumed safe substances during pregnancy or lactation. However, do not use it prolonged without the advice of your pharmacist or doctor.

DIRECTIONS FOR USE AND DOSAGE ^(summary)

This medication is taken preferably outside meals.

Usual dosage:

Adult and child over 15 years: 3 measuring spoons of 5 ml or 1 sachet, 3 times a day.
Treatment may be interrupted as symptoms improve. Its duration may not exceed 5 days without medical advice.

TIPS ^(summary)

This medicinal product may be freely available in certain pharmacies; nevertheless, do not hesitate to ask your pharmacist for advice.
Smoking, or being exposed to the smoke of others, is an important impediment to the evacuation of mucus.
It is important to fight against the dryness of the ambient air (humidifier ...) to avoid the drying of the secretions. It is also recommended to drink a lot.
In the elderly, the inability to evacuate sputum can warrant the help of a physiotherapist on prescription from your doctor.

POSSIBLE ADVERSE EFFECTS ^(summary)

Stomach pain, nausea, diarrhea.

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.

duodenum
A part of the intestine into which food from the stomach penetrates.

ulcer
Injury of skin, mucous membranes or cornea.

Leg ulcer: chronic wound due to poor circulation of blood.
Gastroduodenal ulcer: a localized wound in the mucosa of the stomach or duodenum due to excess acidity and very often to the presence of a bacterium (Helicobacter pylori). The ulcer is favored by stress, alcohol, smoking and certain medications (aspirin, NSAIDs, etc.).