NOTICE
ANSM - Updated on: 12/09/2016
Name of the medicinal product
BRONCHOKOD WITHOUT SUGAR ADULTS 5 PER CENT, oral solution sweetened with saccharin sodium
carbocisteine
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed 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 pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
Do not use this medication for children.
What is in this leaflet?
1. What is BRONCHOKOD WITHOUT SUGAR ADULTS 5 PER CENT, oral solution sweetened with saccharin sodium and in which cases is it used?
2. What should I know before taking BRONCHOKOD WITHOUT SUGAR ADULTS 5 PERCENT, oral solution sweetened with saccharin sodium?
3. How to take BRONCHOKOD WITHOUT SUGAR ADULTS 5 PER CENT, oral solution sweetened with saccharin sodium?
4. What are the possible side effects?
5. How to store BRONCHOKOD WITHOUT SUGAR ADULTS 5 PERCENT, oral solution sweetened with saccharin sodium?
6. Package contents and other information.
1. WHAT IS BRONCHOKOD WITHOUT ADULT SUGAR 5 PERCENT, oral solution sweetened with saccharin sodium AND WHAT IT IS USED FOR?
This medicine liquefies the secretions (mucus) present in the bronchi and facilitates their evacuation by the cough.
This medication is reserved for adults and adolescents over 15 years of age.
It is used in cases of recent fatty cough with difficulty in expectorating.
2. BEFORE YOU TAKE BRONCHOKOD WITHOUT SUGAR ADULTS 5 PER CENT, oral solution sweetened with saccharin sodium?
Do not take BRONCHOKOD WITHOUT SUGAR ADULTS 5 PERCENT, oral solution sweetened with saccharin sodium:
· if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medication mentioned in section 6 (including methyl parahydroxybenzoate).
Warnings and Precautions
Talk to your doctor or pharmacist before taking BRONCHOKOD WITHOUT SUGAR ADULTS 5 PERCENT, oral solution sweetened with saccharin sodium :
· If you have a fever or if your expectoration is "greenish".
· If you have a chronic bronchial or lung disease.
· If you have a digestive ulcer (stomach or intestine).
· in the elderly.
· if administered concomitantly with medicinal products which may cause bleeding from the stomach or intestine.
If stomach or intestinal bleeding occurs, treatment should be discontinued.
children
Not applicable.
Other drugs and BRONCHOKOD WITHOUT SUGAR ADULTS 5 PER CENT, oral solution sweetened with saccharin sodium
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
BRONCHOKOD WITHOUT SUGAR ADULTS 5 PER CENT, oral solution sweetened with sodium saccharin with food and beverages
Not applicable.
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.
Driving and using machines
Not applicable.
BRONCHOKOD WITHOUT ADULT SUGAR 5 PERCENT, drinkable solution sweetened with saccharin sodium contains methyl parahydroxybenzoate (E218), sodium, ethanol.
3. HOW TO TAKE BRONCHOKOD WITHOUT SUGAR ADULTS 5 PER CENT, oral solution sweetened with saccharin sodium?
Dosage
The usual dose is 1 tablespoon 3 times a day (1 tablespoon = 15 ml).
If you are on a diet without sugar or low in sugar, this medication is suitable for your diet.
Do not exceed 5 days of treatment.
Check with your doctor if symptoms worsen or persist after 5 days of treatment
If you take more BRONCHOKOD WITHOUT ADULT 5% CONCENTRATE, oral solution saccharine sodium saccharine you should:
Immediately consult your doctor or pharmacist.
If you forget to take BRONCHOKOD WITHOUT SUGAR ADULTS 5 PERCENT, oral solution sweetened with saccharin sodium:
Do not take a double dose to make up for a missed dose.
If you stop taking BRONCHOKOD WITHOUT SUGAR ADULTS 5 PERCENT, oral solution sweetened with saccharin sodium:
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· Digestive disorders such as stomach pain, nausea, vomiting, diarrhea. It is advisable to reduce the dosage.
· Bleeding from the stomach or intestine. Treatment should be discontinued.
· Skin allergic reactions such as itching, itching, plaque or pimple eruption on the skin, swelling of the face and / or neck, which may cause difficulty breathing and endanger the patient (angioedema). should stop treatment and consult your doctor immediately.
· Eruption of brown or purplish patches that may leave a discolouration on the skin. In this case, you should consult your doctor immediately
· Eruption of pimples with sometimes bubbles on the skin that can also affect the mouth (erythema multiforme), bubble eruption with detachment of the skin that can extend to the whole body and endanger the patient (Stevens-Johnson Syndrome).
Due to the presence of methyl parahydroxybenzoate (E218), there is a risk of allergic reactions which may be delayed.
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 BRONCHOKOD WITHOUT SUGAR ADULTS 5 PER CENT, oral solution saccharine sodium saccharine?
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 carton.
Store at a temperature not exceeding 25 ° C.
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 BRONCHOKOD contains NO ADULT SUGAR 5 PERCENT, oral solution saccharine sodium saccharin
· The active substance is:
Carbocisteine ................................................. .................................................. ................. 5.00 g
For 100 ml.
· The other components are: sodium saccharin, methyl parahydroxybenzoate (E218), sodium hydroxyethylcellulose, aromatic composition, sodium hydroxide, purified water.
What is BRONCHOKOD WITHOUT SUGAR ADULTS 5 PER CENT, oral solution saccharine sodium saccharine and contents of the pack
This medication is in the form of a syrup. Bottle of 125 ml, 200 ml, 250 ml or 300 ml.
Marketing Authorization Holder
SANOFI-AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Marketing Authorization Operator
SANOFI-AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Maker
A NATTERMANN & CIE. GMBH
NATTERMANNALLE 1
50829 KOLN
GERMANY
OR
PIERRE FABRE MEDICAMENT PRODUCTION (REGISTERED OFFICE)
45, PLACE ABEL GANCE
92650 BOULOGNE
OR
UNITHER LIQUID MANUFACTURING
1-3 ALLEE OF THE NESTE
31770 COLOMIERS
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).