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.
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.