FLUIMUCIL Child acetylcysteine 2% oral solution is a fluidifying bronchial secretions, it facilitates their evacuation by coughing. This drug is recommended in cases of disorders of bronchial secretion, that is to say in recent respiratory diseases with difficulties of expectoration (difficulty to reject by spitting bronchial secretions).
Acetylcysteine thins the mucus and promotes sputum in bronchial secretion disorders (bronchitis, laryngitis, tracheitis, flu, cystic fibrosis) in children from the age of 2 years.
It acts on the structure of the proteins contained in the mucus and makes it possible to reduce its viscosity ( mucolytic action ). Its symptomatic action is indicated in fatty coughs in order to clear the airways and calm the cough reflex. It has no direct antitussive effect. Doctors also use it to absorb secretions in other ENT pathologies in children over 2 years of age (colds, sinusitis, otitis, etc.) and in tracheotomized patients.
FLUIMUCIL 2% oral solution is a fluidifier of bronchial secretions, it thus facilitates their evacuation by cough. This medication is recommended in cases of disorders of bronchial secretion, that is to say in recent respiratory affections with sputum difficulties (difficulties to reject when spitting bronchial secretions).
The duration of treatment will not exceed more than 8 to 10 days without medical advice.
After opening: keep for 15 days maximum.
Do not store above 25 ° C
Active substance (s)
Acetylcysteine
Excipients
Carmellose sodium, sodium hydroxide #, saccharin sodium, purified water, raspberry flavor #, sodium benzoate, methyl parahydroxybenzoate, sodium edetate, propylene glycol (unspecified nature), alcohol (unspecified nature), isoamyl acetate, para hydroxyphenyl butanone
Taking or using other medications
Please tell your doctor or pharmacist if you are taking or have recently taken
other medication, even if it is a non-prescription medication.
Pregnancy - Breastfeeding
This medication will only be used during pregnancy on the advice of your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
List of excipients with known effect: sodium, methyl parahydroxybenzoate (E218).
100ml bottle
What is the official price of this non-prescription drug?
No official price in pharmacies, the price is freely set for each pharmacist.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: 25/08/2017
acetylcysteine
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.
1. What is FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2% SUGAR-FREE CHILDREN, oral solution sweetened with sodium saccharin, sodium cyclamate and sucralose and in which cases it is used?
2. What should I know before taking FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2% CHILDREN WITHOUT SUGAR, oral solution sweetened with saccharin sodium, sodium cyclamate and sucralose?
3. How to take FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2% CHILDREN WITHOUT SUGAR, oral solution sweetened with saccharin sodium, sodium cyclamate and sucralose?
4. What are the possible side effects?
5. How to store FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2% CHILDREN WITHOUT SUGAR, oral solution sweetened with sodium saccharin, sodium cyclamate and sucralose?
6. Package contents and other information.
Pharmacotherapeutic group: MUCOLYTIC - ATC code: R05CB01 (R: Respiratory system)
This medication is a fluidiser of the bronchial secretions, it facilitates their evacuation by the cough.
This drug is recommended in the states of congestion of the bronchi especially in the acute episodes of bronchitis.
· if you are allergic to acetylcysteine or to any of the other ingredients of this medication mentioned in section 6.
· (less than 2 years) due to the risk of worsening bronchial congestion.
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 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 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 medicine contains small amounts of ethanol (alcohol), less than 100 mg per 10 ml bucket.
This medication should be used with caution if you are intolerant to histamine.
children
Do not use this medication in children less than 2 years of age.
Other medicines and FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2% SUGAR-FREE CHILDREN, 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 ACETYLCYSTEINE 2% SUGAR-FREE CHILDREN, 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 EXPECTORANT ACETYLCYSTEINE 2% SUGAR-FREE CHILDREN, oral solution sweetened with sodium saccharin, sodium cyclamate and sucralose contains sodium, methyl parahydroxybenzoate (E218) and ethanol (alcohol).
Rinse the dosing cup after use.
Close the bottle after use.
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.
Children over 7 years: 600 mg per day, in 3 doses, that is to say 1 measuring cup of 10 ml 3 times a day.
Children 2 to 7 years: 400 mg per day, in 2 doses, that is to say 1 scoop of 10 ml twice a day.
The duration of treatment will not exceed 8 to 10 days without medical advice.
If you take more FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2% SUGAR-FREE CHILDREN, 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% SUGAR-FREE CHILDREN, oral solution sweetened with sodium saccharin, sodium cyclamate and sucralose:
Do not take a double dose to make up for a missed dose.
If you stop taking FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2% SUGAR-FREE CHILDREN, oral solution sweetened with sodium saccharin, 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 rhythm,
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.
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
· The active substance is:
Acetylcysteine ................................................. .................................................. ..................... 2.00 g
per 100 ml.
· The other components are:
Sodium para-hydroxybenzoate, sodium benzoate, sodium edetate, sodium carmellose, sucralose, sodium cyclamate, sodium saccharin, raspberry aroma (4-parahydroxyphenyl 2-butanone, alcohol, isoamylacetate, propylene glycol), sodium hydroxide, purified water.
This medication is in the form of a drinkable solution in a vial. 75, 100 or 150 ml bottle with 10 ml measuring cup.
Marketing Authorization Holder
13 RUE RENE JACQUES
92138 ISSY-LES-MOULINEAUX CEDEX
Marketing Authorization Operator
ZAMBON FRANCE SA
13 RUE RENE JACQUES
92138 ISSY-LES-MOULINEAUX CEDEX
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}.
Detailed information on this medicine is available on the ANSM website (France).
Bronchial Fluidifier
acetylcysteine
. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
FLUIMUCIL 200 mg Adult Child: granulated for oral solution (orange flavoring); box of 30 bags.
-
FLUIMUCIL 2% Child: oral solution (raspberry flavoring); bottle of 100 ml with 10 ml measuring cup.
-
Laboratory Zambon France
| p sachet | p 10 ml | |
| N-acetylcysteine | 200 mg | 200 mg |
| aspartame | + | |
| Sodium | 37.5 mg | |
| Methyl parahydroxybenzoate | + |
Usual dosage:
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