NOTICE
ANSM - Last updated: 23/11/2009
Name of the medicinal product
CLARIX EXPECTORANT CARBOCISTEIN 5% ADULTS WITHOUT SUGAR, oral solution sweetened with saccharin sodium
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 if new symptoms appear after 5 days, seek the advice of your pharmacist or doctor.
· This leaflet is designed to help you use this medicine. Keep there, you might need to reread it.
DO NOT LEAVE THIS MEDICINE FOR CHILDREN
Review summary
In this notice :
1. WHAT CLARIX EXPECTORANT CARBOCISTEIN 5% ADULTS WITHOUT SUGAR, oral solution sweetened with saccharin sodium AND WHAT IS IT USED FOR?
2. BEFORE YOU TAKE CLARIX EXPECTOR CARBOCISTEIN 5% ADULTS WITHOUT SUGAR, drinkable solution sweetened with saccharin sodium?
3. HOW TO TAKE CLARIX EXPECTORANT CARBOCISTEIN 5% ADULTS WITHOUT SUGAR, oral solution sweetened with saccharin sodium?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE CLARIX EXPECTORANT CARBOCISTEIN 5% ADULTS WITHOUT SUGAR, oral solution sweetened with saccharin sodium?
6. ADDITIONAL INFORMATION
1. WHAT CLARIX EXPECTORANT CARBOCISTEIN 5% ADULTS WITHOUT SUGAR, oral solution sweetened with saccharin sodium AND WHAT IS IT USED FOR?
Pharmacotherapeutic group
Not applicable.
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 CLARIX EXPECTOR CARBOCISTEIN 5% ADULTS WITHOUT SUGAR, drinkable solution sweetened with saccharin sodium?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never take CLARIX EXPECTORANT CARBOCISTEIN 5% ADULTS WITHOUT SUGAR, oral solution sweetened with saccharin sodium if you have a known allergy to any of the components of this medication.
Precautions for use; special warnings
Take special care with CLARIX EXPECTORANT CARBOCISTEIN 5% ADULTS WITHOUT SUGAR, oral solution sweetened with saccharin sodium:
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
A MEDICAL ADVICE IS NECESSARY:
· In case of fat and purulent expectoration, of fever,
· If you have chronic (long-term) bronchial or lung disease,
· In case of ulcer of the stomach or duodenum.
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.
This medicine contains 33.3 mg sodium per measuring spoon (100 mg sodium in 3 spoons-measuring 5 ml): take this into account in people on a strict diet low in salt.
IT IS IMPORTANT TO CONSULT A DOCTOR IN THE ABSENCE OF IMPROVEMENT.
Interaction with other medicines
Taking or using other medicines
This medicine contains carbocistein. Other medicines contain ... 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 - Breastfeeding
Do not take this medicine without consulting your doctor or pharmacist. |
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
List of excipients with a known effect : sodium.
3. HOW TO TAKE CLARIX EXPECTORANT CARBOCISTEIN 5% ADULTS WITHOUT SUGAR, oral solution sweetened with saccharin sodium?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
RESERVED TO THE DULTE AND THE CHILD OVER 15 YEARS.
Dosage
3 measuring spoons, 3 times a day, preferably outside meals.
If you feel that the effect of CLARIX EXPECTORANT CARBOCISTEINE 5% ADULTS WITHOUT SUGAR, oral solution sweetened with saccharin sodium is too strong or too weak, talk to your doctor or pharmacist.
Administration mode
Oral use.
Duration of the treatment
The duration of use is limited to 5 days. |
Symptoms and Instructions for Overdose
If you take more CLARIX EXPECTOR CARBOCISTEIN 5% ADULTS WITHOUT SUGAR, drinkable solution sweetened with saccharin sodium you should: Stop treatment and see your doctor promptly.
Instructions for omission of one or more doses
If you forget to take CLARIX EXPECTORANT CARBOCISTEINE 5% ADULTS WITHOUT SUGAR, oral solution sweetened with saccharin sodium: Do not take a double dose to compensate for the dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, CLARIX EXPECTORANT CARBOCISTEIN 5% ADULTS WITHOUT SUGAR, oral solution sweetened with saccharin sodium is likely to have undesirable effects, although not everyone is subject to it.
· Possible digestive disorders: stomach pain, nausea, diarrhea. In these cases, it is advisable 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 CARBOCISTEIN 5% ADULTS WITHOUT SUGAR, oral solution sweetened with saccharin sodium?
Keep out of the reach and sight of children.
Expiration date
Do not use CLARIX EXPECTORANT CARBOCISTEIN 5% ADULTS WITHOUT SUGAR, drinkable solution sweetened with saccharin sodium after the expiry date stated on the bottle.
Storage conditions
No special storage conditions.
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 5% ADULTS WITHOUT SUGAR contain, oral solution sweetened with saccharin sodium?
The active substance is:
Carbocistein ................................................. .................................................. ................................. 5.00 g
For 100 ml of oral solution.
The other components are:
Saccharin sodium, hydroxyethylcellulose, sodium hydroxide, methyl parahydroxybenzoate (E218), caramel flavor *, purified water.
* Composition of caramel flavor : vanilla extract, vanillin, ethylvanillin, piperonal, levulinic acid, triacetin, propylene glycol.
A measuring spoon (5 ml of oral solution) contains:
· 250 mg of carbocistein and
· 33.3 mg of sodium.
Pharmaceutical form and content
What is CLARIX EXPECTORANT CARBOCISTEINE 5% ADULTS WITHOUT SUGAR, oral solution sweetened with saccharin sodium and contents of the pack?
This medication is in the form of a drinkable solution.
Bottle 125, 150, 200, 250 or 300 ml.
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
H2 PHARMA
21 RUE JACQUES TATI
ZAC LA CROIX BONNET
78390 BOIS D'ARCY
or
SANOFI WINTHROP INDUSTRIE
1-3 ALLEE OF THE NESTE
ZI D'EN SIGAL
31770 COLOMIERS
Names of the medicinal product in the Member States of the European Economic Area
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
In accordance with the regulations.
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.