NOTICE
ANSM - Updated on : 06/02/2025
Product name
EXOMUC 200 mg, granules for oral use in sachet
Acetylcysteine
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 5 days.
What does this leaflet contain?
1. What is EXOMUC 200 mg, granules for oral use in sachet and what is it used for?
2. What do I need to know before taking EXOMUC 200 mg, granules for oral use in sachet?
3. How should I take EXOMUC 200 mg, granules for oral use in sachet?
4. What are the possible side effects?
5. How should EXOMUC 200 mg oral granules be stored?
6. Package contents and other information.
1. WHAT IS EXOMUC 200 mg, granules for oral use in a sachet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code: ACETYLCYSTEINE - MUCOLYTIC - code R05CB01
This medicine is indicated in cases of recent respiratory disease with difficulty in expectoration (difficulty in spitting out bronchial secretions).
This presentation is reserved for adults and children over 7 years of age.
You should consult your doctor if you do not feel better or feel worse after 5 days.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING EXOMUC mg, granules for oral use in a sachet?
Never take EXOMUC 200 mg, granules for oral use in a sachet:
- if you are allergic to the active substance, acetylcysteine, or to any of the other components contained in this medicine, mentioned in section 6 below.
This medicine must not be used (contraindicated) in children under 7 years of age.
If in doubt, ask your doctor or pharmacist for advice.
Warnings and precautions
Ask your doctor or pharmacist before taking EXOMUC 200 mg, granules for oral use in sachet.
- in the event of oily, purulent sputum or fever;
- if you have chronic (long-term) bronchial or lung disease.
- Use with caution if you have an ulcer of the stomach or duodenum.
Special warnings
Acetylcysteine may cause bronchospasm (sudden narrowing of the bronchial tubes), particularly in asthmatic patients. Caution is advised in subjects with asthma or a history of bronchospasm. If breathing difficulties, such as shortness of breath which may be associated with coughing and/or an increase in bronchial secretions, occur immediately after taking this medicine, it may be a case of bronchospasm. In this case, you should immediately stop treatment and consult a doctor.
Serious skin reactions, such as Stevens-Johnson or Lyell syndrome, have been reported with EXOMUC 200 mg, granules for oral solution in sachet. Steven-Johnson and Lyell syndromes may initially appear as reddish patches or circular plaques on the torso, often with central blisters. Ulcerations of the mouth, throat, nose, genitals and eyes (red, swollen eyes) may also occur. These severe rashes are often preceded by fever and/or flu-like symptoms. The rash may progress to extensive desquamation of the skin and life-threatening or fatal complications. If you notice any change in the appearance of your skin or mucous membranes, you should stop taking this product immediately and consult a doctor.
At the start of treatment with acetylcysteine, bronchial secretions may become more fluid and increase in volume, leading to bronchial congestion. This drug should be used with caution in subjects with difficulty or inability to expectorate.
Do not take any cough suppressant or bronchial secretion drying medication during treatment with this drug.
Treatment should not be continued if symptoms worsen. In this case, consult your doctor for a reassessment of your treatment.
This drug should be used with caution in cases of stomach or duodenal ulcers.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST.
Children
This medicine is reserved for children over 7 years of age. It is not suitable for children under 7 years of age.
Other medicines and EXOMUC 200 mg, granules for oral use in sachet.
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
EXOMUC 200 mg, granules for oral use in sachet with food and drink
Not applicable.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacistfor advicebefore taking this medicine.
It is preferable not to use this medicine during pregnancy.
It is preferable not to breast-feed your child while taking this medicine.
Driving and use of machinery
Not applicable.
EXOMUC 200 mg, granules for oral use in sachet contains orange yellow S (E110), sucrose and benzyl alcohol:
This medicine contains 1.7 g of sucrose per sachet, which must be taken into account in the daily ration in the case of a low-sugar diet or diabetes. If your doctor has informed you that you are intolerant to certain sugars, contact him/her before taking this medicine.
This medicine contains an azoic coloring agent (orange yellow S (E110)) and may cause allergic reactions.
This medicine contains 0.000121 mg benzyl alcohol per sachet. Benzyl alcohol may cause allergic reactions.
This product contains 1.00 mg sodium per sachet, i.e. less than 1 mmol (23 mg) per sachet, making it essentially "sodium-free".
3. HOW DO I TAKE EXOMUC 200 mg, granules for oral use in sachet?
Always take this medicine exactly as instructed in this leaflet, or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
The recommended dose is :
- 1sachet 3 times a day for adults and children over 7 years of age .
Dissolve granules in a glass of water or melt directly in the mouth.
If no healing occurs after 5 days of treatment, consult your doctor.
If you have taken more EXOMUC 200 mg, granules for oral use in sachet, than you should have
Consult your doctor or pharmacist.
If you forget to take EXOMUC 200 mg, granules for oral use in sachet
Do not take a double dose to make up for the one you forgot to take.
If you stop taking EXOMUC 200 mg, granules for oral use in sachet
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but they do not occur systematically in everyone.
If any of the following side effects occur, stop taking EXOMUC 200 mg, granules for oral use in sachet, and contact your doctor or nearest hospital emergency department immediately:
- Shock (severe drop in blood pressure, pallor, restlessness, weak pulse, clammy skin, reduced consciousness) due to sudden dilation of blood vessels caused by severe hypersensitivity to certain substances (anaphylactic shock).
- Swelling due to sudden onset of edema (sudden accumulation of fluid in the skin or mucous membranes) of the throat or tongue, difficulty breathing and/or itching and rash, most often corresponding to an allergic reaction (angioedema).
- Severe skin rashes, including Stevens-Johnson syndrome and Lyell syndrome. These may appear as reddish patches or circular plaques on the torso, often with central blisters, scaling of the skin, ulcerations of the mouth, throat, nose, genitals and eyes, and may be preceded by fever and flu-like symptoms. Stop using EXOMUC 200 mg, granules for drinkable solution in sachet if you develop these symptoms and contact your doctor immediately. (See also section 2).
These reactions are very serious side effects. If they occur, you may have developed a severe allergic reaction to EXOMUC 200 mg, granules for oral solution in sachet, requiring emergency medical care and possibly hospitalization.
Contact your doctor if you develop any of the following side effects:
- Risk of worsening bronchial congestion, particularly in infants and in certain patients who are incapable of effective exhalation.
- Breathing difficulties due to contraction of bronchial muscles (bronchospasm), particularly in asthmatic patients.
- Allergic skin reactions such as itching, rash, urticaria and facial swelling.
Possible digestive disorders: nausea, diarrhoea, vomiting, upset stomach. In this case, reduce dosage.
Reporting side effects
If you experience any side effects, whether or not mentioned in this leaflet, please tell your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO USE EXOMUC 200 mg, granules for oral use in sachet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date shown on the packaging after "EXP". The expiration date refers to the last day of that month.
This medicine should be stored at a temperature not exceeding 25°C.
Do not dispose of any medicine in the sewage or household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What EXOMUC 200 mg granules for oral use in sachet contains
- The active substance is :
Acetylcysteine .............................................................................................................. 200 mg
For a 2 g sachet.
- The other components are: sodium saccharin, orange yellow S (E 110), orange flavoring*, sucrose.
* Composition of orange flavoring SC 281846 : natural flavoring preparations, flavoring substances, benzyl alcohol, maltodextrin (corn), gum arabic (E414).
What EXOMUC 200 mg, granules for oral use in sachet, is and what it contains
This medicine comes in the form of granules for oral use in a sachet. Box of 15.
Marketing authorization holder
BOUCHARA-RECORDATI
TOUR HEKLA
52 AVENUE DU GENERAL DE GAULLE
92800 PUTEAUX
Marketing authorization holder
LABORATOIRES BOUCHARA-RECORDATI
TOUR HEKLA
52 AVENUE DU GENERAL DE GAULLE
92800 PUTEAUX
Manufacturer
UNITHER INDUSTRIES
ZONE INDUSTRIELLE LE MALCOURLET
03800 GANNAT
Or
INPHARMASCI
ZI N°2 de Prouvy-Rouvignies
1 rue de Nungesser
59121 Prouvy, France
Drug names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.
Health education advice :
Bronchial congestion favors the onset of infections. The most common symptom is a hacking cough, which does not cause pain but may bring back bronchial secretions (sputum or sputum).
A hacking cough is a defence against bronchial secretions clogging up the airways.
Its role is to clean the bronchial tubes by evacuating secretions through expectoration (sputum). This is why wet coughs must be respected. That's why cough suppressants should not be used in cases of wet cough.
In addition to expectorant treatment, the evacuation of bronchopulmonary secretions can be facilitated by simple gestures and the observance of a few rules:
- drink plenty of fluids (water, herbal tea) to hydrate secretions,
- humidify the air, keeping the temperature between 17°C and 19°C,
- avoid smoking, which aggravates coughing.