NOTICE
ANSM - Updated on: 25/08/2017
Name of the medicinal product
FLUIMUCIL EXPECTORANT ACETYLCYSTEIN 2% ADULTS WITHOUT SUGAR, oral solution sweetened with sodium saccharin, sodium cyclamate and sucralose
acetylcysteine
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 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.
What is in this leaflet?
1. What is FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2% ADULTS WITHOUT SUGAR, oral solution and in which cases it is used?
2. What should I know before taking FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2% ADULTS WITHOUT SUGAR, oral solution?
3. How to take FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2% ADULTS WITHOUT SUGAR, oral solution?
4. What are the possible side effects?
5. How to store FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2% ADULTS WITHOUT SUGAR, oral solution?
6. Package contents and other information.
1. WHAT FLUIMUCIL EXPECTORANT ACETYLCYSTEIN 2% ADULTS WITHOUT SUGAR, oral solution AND WHAT USE IS IT USED?
Pharmacotherapeutic group: MUCOLYTIC - ATC code: R05CB01 (R: Respiratory system).
FLUIMUCIL EXPECTORANT ACETYLCYSTEINE is a fluidifier of bronchial secretions, thus facilitating their evacuation by coughing.
This drug is recommended in adults in cases of bronchial secretion disorders, ie in recent respiratory diseases with difficulty in expectoration (difficulty in rejecting by spitting bronchial secretions).
2. BEFORE YOU TAKE FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2% ADULTS WITHOUT SUGAR, oral solution?
Do not take FLUIMUCIL EXPECTORANT ACETYLCYSTEINE:
· if you are allergic to acetylcysteine or to any of the other ingredients of this medication mentioned in section 6.
Warnings and Precautions
Talk to your doctor or pharmacist before taking FLUIMUCIL EXPECTORANT ACETYLCYSTEINE.
It is advisable not to take a cough medication or bronchial drying medication during the treatment period with this medication.
Treatment should not be continued if symptoms worsen. In this case, consult your doctor for a re-evaluation of your treatment.
Close monitoring of your doctor is necessary if you have asthma.
Stop treatment immediately if your breathing becomes wheezy or difficult and tell your doctor.
The use of FLUIMUCIL EXPECTORANT ACETYLCYSTEINE, especially at the beginning of the treatment, fluidifies the bronchial secretions and can increase their volume. If you have difficulty spitting or coughing effectively tell your doctor.
A slight odor of sulfur is a normal characteristic of the active substance. It does not indicate an alteration of the drug.
This medicine contains sodium. This medicine contains 1.50 mmol (or 34.6 mg) sodium per 10 ml bucket. To be taken into account in patients controlling their sodium dietary intake.
This medicine contains methyl parahydroxybenzoate (E218) and may cause allergic reactions.
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per
10 ml.
This medication should be used with caution if you have or have had an ulcer of the stomach or duodenum especially if you are taking medicines with an irritant effect on the stomach at the same time.
This medication should be used with caution if you are intolerant to histamine.
children
Not applicable.
Other medicines and FLUIMUCIL EXPECTORANT ACETYLCYSTEIN 2% ADULTS WITHOUT SUGAR, oral solution sweetened with sodium saccharin, sodium cyclamate and sucralose
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
It is advisable not to take a cough medication or bronchial drying medication during the treatment period with this medication.
Activated charcoal may reduce the effect of FLUIMUCIL EXPECTORANT ACETYLCYSTEIN.
It is not recommended to dissolve FLUIMUCIL EXPECTORANT ACETYLCYSTEINE at the same time as other medicines.
If antibiotics are prescribed, it is advisable to take them at 2 hours interval between taking FLUIMUCIL EXPECTORANT ACETYLCYSTEINE.
If you are using nitrates (angina pectoris) or carbamazepine, tell your doctor.
FLUIMUCIL EXPECTORANT ACETYLCYSTEIN 2% ADULTS WITHOUT SUGAR, oral solution sweetened with sodium saccharin, sodium cyclamate and sucralose with food and drink
Not applicable.
Pregnancy, breast-feeding and fertility
This medication will only be used during pregnancy and lactation only on the advice of your doctor.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
FLUIMUCIL EXPECTOR ACETYLCYSTEIN 2% ADULTS WITHOUT SUGAR, oral solution sweetened with sodium saccharin, sodium cyclamate and sucralose contains sodium, methyl parahydroxybenzoate (E218) and ethanol (alcohol).
3. HOW TO TAKE FLUIMUCIL EXPECTORANT ACETYLCYSTEIN 2% ADULTS WITHOUT SUGAR, oral solution?
Always take this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Adult: 600 mg per day, in 3 doses, that is to say 1 measuring cup of 10 ml 3 times a day.
Oral use.
Rinse the bucket after use.
Close the bottle after use.
The duration of treatment will not exceed 6 days without medical advice.
If you feel that FLUIMUCIL EXPECTORANT ACETYLCYSTEINE does not work as you expected, seek the advice of your pharmacist or doctor.
If you take more FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2% ADULTS WITHOUT SUGAR, oral solution sweetened with sodium saccharin, sodium cyclamate and sucralose you should:
Immediately consult your doctor or pharmacist.
If you forget to take FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2% ADULTS WITHOUT SUGAR, drinkable solution sweetened with sodium saccharin, sodium cyclamate and sucralose:
Do not take a double dose to make up for a missed dose.
Continue your treatment normally.
If you stop taking FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2% ADULTS WITHOUT SUGAR, oral solution sweetened with saccharin sodium, sodium cyclamate and sucralose:
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?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
The following side effects may occur:
· Uncommon (occurs in 1 to 10 patients in 1,000):
o Allergic reactions such as urticaria, rash, itching and subcutaneous edema, associated or not with a fall in blood pressure and / or an acceleration of the heart rate,
o Nausea, vomiting, abdominal pain, inflammation of the mouth, diarrhea,
o Headaches and whistling in the ears,
o Fever.
· Rare (occurs in 1 to 10 patients out of 10,000):
o Wheezing or difficult breathing,
o Digestion difficult.
· Very rare (appears in less than 1 patient in 10000):
o Allergic reactions that may progress to an allergic shock: Symptoms may include fainting, swelling of the face, tongue and throat,
o Bleeding.
· Of unknown frequency:
o Swelling of the face.
· Other very rare adverse reactions:
o Severe skin and mucous membrane reactions: Symptoms may include blisters. If this happens, stop taking this medication immediately and contact your doctor for medical advice.
o Coagulation disorder.
There is a risk of aggravation of bronchial congestion, particularly in infants and in some patients unable to expectorate effectively.
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 FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2% ADULTS WITHOUT SUGAR, oral solution?
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. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25 ° C.
After opening: keep for up to 15 days.
Do not use this medication if you notice any signs of deterioration.
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 FLUIMUCIL contains EXPECTORANT ACETYLCYSTEINE 2% ADULTS WITHOUT SUGAR, oral solution sweetened with sodium saccharin, sodium cyclamate and sucralose
· The active substance is:
Acetylcysteine ................................................. .................................................. ..................... 2.00 g
per 100 ml.
· The other components are:
Sucralose, sodium cyclamate, sodium saccharin, raspberry aroma (4-parahydroxyphenyl 2-butanone, alcohol, isoamylacetate, propylene glycol), sodium hydroxide, purified water, sodium hydroxide.
What is FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2% ADULTS WITHOUT SUGAR, oral solution sweetened with saccharin sodium, sodium cyclamate and sucralose and contents of the pack
Oral solution in 75 ml, 100 ml, 150 ml or 200 ml flasks with a 10 ml measuring cup.
Marketing Authorization Holder
ZAMBON FRANCE SA
13 RUE RENE JACQUES
92138 ISSY-LES-MOULINEAUX CEDEX
Marketing Authorization Operator
ZAMBON FRANCE SA
13 RUE RENE JACQUES
92138 ISSY-LES-MOULINEAUX CEDEX
Maker
ZAMBON SPA
VIA DELLA CHIMICA 9
36100 VICENZA
ITALY
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:
{month YYYY}.
Other
Detailed information on this medicine is available on the ANSM website (France).
Health Education Council:
Bronchial congestion favors the occurrence of infections. It most often results in a fatty cough that does not cause pain but can reduce secretions (sputum or sputum).
The fatty cough is a defense against the congestion of the bronchi by the secretions.
Its role is to clean the bronchi by evacuating the secretions by sputum. This is why the fatty cough must be respected, and even facilitated by the taking of an expectorant.
In addition to the expectorant treatment, the evacuation of the bronchopulmonary secretions can be facilitated by simple gestures and the respect of a few rules:
· drink a lot, (water, herbal tea) to hydrate the secretions,
· humidify the air at a temperature between 17 ° C and 19 ° C,
· avoid tobacco which is an aggravating cause of cough.