NOTICE
ANSM - Last updated: 22/12/2011
Name of the medicinal product
CLARIX EXPECTORANT CARBOCISTEIN 2% CHILDREN, syrup
framed
Read this leaflet carefully before you start using 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 CLARIX EXPECTORANT CARBOCISTEINE 2% CHILDREN, SYRUP AND IN WHAT CASES IS IT USED?
2. BEFORE YOU TAKE CLARIX EXPECTORANT CARBOCISTEINE 2% CHILDREN, syrup?
3. HOW TO TAKE CLARIX EXPECTORANT CARBOCISTEINE 2% CHILDREN, SYRUP?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE CLARIX EXPECTORANT CARBOCISTEINE 2% CHILDREN, SYRUP?
6. ADDITIONAL INFORMATION
1. WHAT CLARIX EXPECTORANT CARBOCISTEINE 2% CHILDREN, SYRUP AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
This medication is a fluidiser of the bronchial secretions, it facilitates their evacuation by the cough.
Therapeutic indications
This medication is indicated in children with recent respiratory disease with difficulty in expectoration (difficulty in rejecting by spitting bronchial secretions).
2. BEFORE YOU TAKE CLARIX EXPECTORANT CARBOCISTEINE 2% CHILDREN, syrup?
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 use CLARIX EXPECTORANT CARBOCISTEINE 2% CHILDREN, syrup:
· In case of known allergy to any of the constituents (including methyl parahydroxybenzoate and other parabens);
· In infants (under 2 years of age) because of the risk of worsening bronchial congestion.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with CLARIX EXPECTORANT CARBOCISTEINE 2% CHILDREN, syrup:
Special warnings
A MEDICAL ADVICE IS NECESSARY:
· In case of fatty and purulent expectoration,
· If you have chronic (long-term) bronchial or lung disease.
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.
Treatment should not be continued if symptoms worsen. In this case, consult your doctor for a re-evaluation of your treatment.
The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
Precautions for use
In case of stomach or duodenal ulcer, PREVENT YOUR DOCTOR.
This medicine contains sodium. This medicine contains 13 mg of sodium per 5 ml of syrup. To be taken into account in patients controlling their sodium dietary intake.
In case of diabetes or low-sugar diet, take into account the daily intake of 3.5 g of sucrose (sugar) per teaspoon or 5 ml of syrup.
This medicinal product contains methyl parahydroxybenzoate (E218) and an azo dyestuff (orange yellow S (E110)); they can cause allergic reactions.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Interaction with other medicines
Taking or using other medicines
This medicine contains carbocistein. Other medicines contain it. Do not combine them, in order not to exceed the maximum recommended doses. |
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 if necessary.
feeding
As a precaution, it should be avoided during lactation.
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 CLARIX EXPECTORANT CARBOCISTEINE 2% ENFANTS, syrup:
This medicine contains sodium, sucrose, orange yellow S (E110) and methyl parahydroxybenzoate (E218).
3. HOW TO TAKE CLARIX EXPECTORANT CARBOCISTEINE 2% CHILDREN, SYRUP?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR THE CHILD.
1 teaspoon of 5 ml contains 100 mg of carbocistein.
Children over 5 years: 300 mg daily, divided into 3 doses, one teaspoon 3 times a day.
Children 2 to 5 years: 200 mg per day divided into 2 doses, one teaspoon twice a day.
If you feel that the effect of CLARIX EXPECTORANT CARBOCISTEINE 2% CHILDREN, syrup is too strong or too weak, talk to your doctor or pharmacist.
Method and route of administration
Oral use.
Duration of treatment
Do not exceed 8 to 10 days of treatment without medical advice.
Symptoms and Instructions for Overdose
If you used more CLARIX EXPECTORANT CARBOCISTEINE 2% CHILDREN, syrup you should:
Tell your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to use CLARIX EXPECTORANT CARBOCISTEINE 2% CHILDREN, syrup:
No double dose to compensate for the dose you have forgotten to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all drugs, CLARIX EXPECTORANT CARBOCISTEINE 2% CHILDREN, syrup is likely to have undesirable effects, although not everyone is subject to it:
· Risk of aggravation of bronchial congestion in infants.
· Allergic skin reactions such as itching, rash, urticaria and swelling of the face.
· Possible digestive disorders: nausea, diarrhea, vomiting, upset stomach. It is advisable in this case to reduce the dosage.
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 CLARIX EXPECTORANT CARBOCISTEINE 2% CHILDREN, SYRUP?
Keep out of the reach and sight of children.
Expiration date
Do not use CLARIX EXPECTORANT CARBOCISTEINE 2% CHILDREN, syrup after the expiry date stated on the bottle.
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 does CLARIX EXPECTORANT CARBOCISTEINE 2% CHILD contain, syrup?
The active substance is:
Carbocistein ................................................. .................................................. ...................................... 2 g
For 100 ml of syrup.
The other components are:
Sucrose, banana flavor, methyl parahydroxybenzoate (E218), orange yellow S (E110), sodium hydroxide, purified water.
Pharmaceutical form and content
What is CLARIX EXPECTORANT CARBOCISTEINE 2% CHILDREN, syrup and contents of the outer packaging?
This medication is in the form of a syrup in a 150 ml bottle.
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
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
exploiting
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Maker
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
or
DELPHARM TOURS
THE BARAUDIERE
37170 CHAMBRAY LES TOURS
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.