NOTICE
ANSM - Updated: 26/10/2017
Name of the drug
CARBOCISTEIN UPSA 5% ADULTS SUGAR-FREE, oral solution sweetened with sodium saccharin and liquid maltitol
carbocisteine
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects that are not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you feel no improvement or feel worse after 5 days.
What does this booklet contain ?
1. What is CARBOCISTEIN UPSA 5% SUGAR-FREE ADULT, oral solution sweetened with sodium saccharin and liquid maltitol and in which cases is it used?
2. What you need to know before taking CARBOCISTEINE UPSA 5% ADULTS SUGAR-FREE, oral solution sweetened with sodium saccharin and liquid maltitol?
3. How to take CARBOCISTEINE UPSA 5% ADULTS SUGAR-FREE, oral solution sweetened with sodium saccharin and liquid maltitol?
4. What are the possible side effects?
5. How to store CARBOCISTEINE UPSA 5% ADULTS SUGAR-FREE, oral solution sweetened with sodium saccharin and liquid maltitol?
6. Contents of the package and other information.
1. WHAT IS CARBOCISTEIN UPSA 5% SUGAR-FREE ADULTS, oral solution sweetened with sodium saccharin and liquid maltitol AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: MUCOLYTIC - ATC code: R05CB03
(R: Respiratory system)
This drug is a fluidifier of bronchial secretions and facilitates their evacuation by coughing (expectoration).
This medicine is only for adults.
It is used in case of recent fat cough with difficulty to expectorate.
You should talk to your doctor if you feel no improvement or feel worse after 5 days.
2. BEFORE YOU TAKE CARBOCISTEINE upsa 5% ADULTS SUGAR-FREE, oral solution sweetened with sodium saccharin and liquid maltitol?
Never use CARBOCISTEINE UPSA 5% ADULTS SUGAR-FREE, oral solution sweetened with sodium saccharin and liquid maltitol
· if you are allergic to carbocisteine or any of the other ingredients of this medicine, listed in section 6.
· in the child.
Warnings and precautions
warnings
You should not use drugs that prevent coughs (cough suppressants) or that dry up bronchial secretions when you take CARBOCISTEINE UPSA 5% ADULTS WITHOUT SUGAR. Indeed, CARBOCISTEINE UPSA fluidifies secretions, which facilitates their evacuation by coughing. Cough is useful for expectorating.
Talk to your doctor or pharmacist before taking CARBOCISTEINE UPSA 5% ADULTS SUGAR-FREE, oral solution sweetened with sodium saccharin and liquid maltitol .
· If you have a fever or if your sputum is "greenish".
· If you suffer from a chronic disease of the bronchi or lungs.
· If you have a digestive ulcer (stomach or intestines).
· In the elderly.
· Concomitant use with drugs that may cause bleeding from the stomach or intestines.
If there is bleeding from the stomach or intestine, it is recommended to stop the treatment.
Precautions for use
This medicine should be used with caution in case of stomach ulcer or duodenum ulcer.
The amount of alcohol in this medicine can alter the effects of other drugs.
children
Not applicable.
Other medicines and CARBOCISTEIN UPSA 5% ADULTS SUGAR-FREE, oral solution sweetened with sodium saccharin and liquid maltitol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This medicine contains carbocisteine. Other medicines contain it. Do not combine them, so as not to exceed the recommended doses.
CARBOCISTEIN UPSA 5% ADULTS SUGAR-FREE, oral solution sweetened with sodium saccharin and liquid maltitol with food and drinks
Not applicable.
Pregnancy and breast feeding
Pregnancy
Due to the presence of alcohol, this medication should not be taken during pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine.
feeding
Due to the presence of alcohol, this medication should not be taken while breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
The amount of alcohol in this medication can affect your ability to drive and use machines.
CARBOCISTEIN UPSA 5% SUGAR-FREE ADULT, oral solution sweetened with sodium saccharin and liquid maltitol contains sodium, liquid maltitol and 96% ethanol.
This medicine contains 99.9 mg of sodium per 15 mL measuring cup. To be taken into account in patients following a strict sodium diet.
The use of this drug is not recommended in patients with fructose intolerance (rare hereditary disease).
This medicine may cause a mild laxative effect.
This medicine contains 11.9% ethanol (alcohol), i.e., up to 1.5 g per dose, 15 mL oral solution, equivalent to 35.6 mL of beer, 14.8 mL of wine per serving
The use of this drug is dangerous in alcoholics and should be considered in pregnant or breastfeeding women, children and high-risk groups such as hepatic insufficiency or epileptics.
3. HOW TO TAKE CARBOCISTEINE upsa 5% ADULTS SUGAR-FREE, oral solution sweetened with sodium saccharin and liquid maltitol?
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
RESERVED FOR THE ADULT.
Dosage
· The usual dose is 1 scoop (15 mL) 3 times a day (morning noon and night), except for meals.
· Once filled, the 15 mL measuring cup contains 750 mg of carbocisteine.
Administration mode
Oral way.
· Use the measuring cup to measure the amount of syrup for one shot (15 mL). You can also use a tablespoon (1 x 15 mL scoop equals 1 tablespoon).
· Rinse the measuring cup well after each use.
· Fill the bottle well after use.
Duration of treatment
The duration of treatment should be brief.
Do not exceed 5 days of treatment. Consult your doctor if symptoms worsen or persist after 5 days of treatment.
If you take more CARBOCISTEIN UPSA 5% ADULT SUGAR FREE, oral solution sweetened with sodium saccharin and liquid maltitol that you should have
Immediately consult your doctor or pharmacist.
If you forget to take CARBOCISTEINE UPSA 5% ADULTS SUGAR-FREE, oral solution sweetened with sodium saccharin and liquid maltitol
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking CARBOCISTEINE UPSA 5% ADULTS SUGAR-FREE, oral solution sweetened with sodium saccharin and liquid maltitol
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
· Digestive disorders such as stomach pain, nausea, vomiting, diarrhea. It is then advisable to reduce the dosage.
· Bleeding from the stomach or intestine The treatment must be stopped.
· Allergic skin reactions such as hives, itching, rash of patches or pimples on the skin, swelling of the face and / or neck that may cause difficulty breathing and endangering the patient (Quincke's edema). In this case, you should stop the treatment and consult your doctor immediately.
· Eruption of brown or purplish plaques that may leave a color on the skin (fixed erythema pigmentosa). In this case, you should consult your doctor immediately.
· Rash of pimples with sometimes bubbles on the skin that can also affect the mouth (erythema multiforme), bubble eruption with detachment of the skin can extend to the whole body and endanger the patient (Stevens-Johnson syndrome). In this case, you should stop the treatment and consult your doctor immediately.
Declaration of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information on the safety of the medicine.
5. HOW TO STORE CARBOCISTEIN UPSA 5% ADULTS SUGAR-FREE, oral solution sweetened with sodium saccharin and liquid maltitol?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial.
Store at a temperature not exceeding 25 ° C.
This medicine should not be stored more than 15 days after opening.
Do not dispose of any medication in the sewage system or garbage. Ask your pharmacist to eliminate medications you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What contains CARBOCISTEINE UPSA 5% ADULTS SUGAR-FREE, oral solution sweetened with sodium saccharin and liquid maltitol
· The active substance is:
Carbocisteine ................................................. .................................................. ...................... 5.00 g
For 100 mL.
· The other components are:
Xanthan gum, sodium saccharin, liquid maltitol, 96 percent ethanol, sodium hydroxide, caramel flavor *, purified water.
* Composition of the caramel flavor: diacetyl, propylene glycol, butyric acid, methylcyclopentenolone, maltol, 4-hydroxy-2,5-dimethyl-3 (2H) -furanone, piperonal and vanillin.
What is CARBOCISTEINE UPSA 5% ADULT SUGAR-FREE, oral solution sweetened with sodium saccharin and liquid maltitol and contents of the pack
This medicine is in the form of an oral solution.
Bottle of 150 mL, 200 mL, 250 mL or 300 mL.
Marketing Authorization Holder
UPSA SAS
3 RUE JOSEPH MONIER
92500 RUEIL MALMAISON
Operator of the marketing authorization
UPSA SAS
3 RUE JOSEPH MONIER
92500 RUEIL MALMAISON
Maker
h2 pharma
za the cross hat
21 rue jacques tati
78390 arcy wood
Names of the medicine in the member states of the European Economic Area
Not applicable.
The last date 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).