NOTICE
ANSM - Updated on : 04/07/2025
Product name
EXOMUC 600 mg, powder for oral solution in sachet
Acetylcysteine
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You must always take this medicine exactly as instructed in this leaflet or by your doctor 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 or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if your symptoms or condition worsen, or if your symptoms persist without improvement for more than 5 to 6 days.
What does this leaflet contain?
1. What is EXOMUC 600 mg, powder for oral solution in sachet and what is it used for?
2. What do I need to know before taking EXOMUC 600 mg, powder for oral solution in sachet?
3. How should I take EXOMUC 600 mg, powder for oral solution in sachet?
4. What are the possible side effects?
5. How to store EXOMUC 600 mg, powder for oral solution in sachet ?
6. Package contents and other information.
1. WHAT IS EXOMUC 600 mg, powder for oral solution in sachet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Pharmacotherapeutic class: MUCOLYTIC ATC code: R05CB01.
Therapeutic indication
This drug is a bronchial secretion thinner, facilitating evacuation by coughing. For adults only, it is recommended in cases of bronchial congestion, particularly during acute episodes of bronchitis.
This medicine should not be used for more than 6 days without medical advice. If your condition worsens, or if your symptoms persist without improvement for more than 5 or 6 days, you should consult your doctor.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING EXOMUC 600 mg, powder for oral solution in sachet?
Never use EXOMUC 600 mg, powder for oral solution in sachet:
- if you are allergic to acetylcysteine or any of the other ingredients listed in section 6.
- in children under 18 years of age.
- In case of phenylketonuria (hereditary disease detected at birth), due to the presence of daspartam.
Warnings and precautions
Ask your doctor or pharmacist before taking EXOMUC 600 mg, powder for oral solution in sachet:
- It is advisable not to take any cough suppressant or bronchial secretion drying medication while taking this medicine.
- Treatment should not be continued if symptoms worsen. In this case, consult your doctor for a reassessment of your treatment.
- This medicine should be used with caution if you have or have had an ulcer of the stomach or duodenum, especially if you are taking medicines which have an irritant effect on the stomach.
- Taking EXOMUC 600 mg, powder for oral solution in sachet, especially at the start of treatment, thins bronchial secretions and may increase their volume. If you find it difficult to spit or cough effectively, tell your doctor.
- If you suffer from asthma, this medicine may increase breathing difficulties due to contraction of the bronchial muscles around the airways (bronchospasm). In this case, you should immediately stop taking EXOMUC 600 mg, powder for oral solution in sachet, and consult a doctor.
- Severe skin reactions, such as Stevens-Johnson or Lyell syndrome, have been reported with the use of EXOMUC 600 mg, powder 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. Rashes may progress to extensive desquamation of the skin and potentially fatal or life-threatening 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.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST.
Children and adolescents
EXOMUC 600 mg, powder for oral solution in sachet, must not be used in children and adolescents under 18 years of age.
For children and adolescents, other more suitable forms and dosages are available. Talk to your doctor.
Other medicines and EXOMUC 600 mg, powder for oral solution in sachet
It is advisable not to take any cough suppressant or bronchial secretion drying medication while taking this medicine.
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
EXOMUC 600 mg, powder for oral solution in sachet with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and use of machinery
Not applicable.
EXOMUC 600 mg, powder for oral solution in sachet contains laspartam, sorbitol, maltodextrin (glucose) and orange yellow S.
This medicine contains an azoic coloring agent (E110 orange yellow) and may cause allergic reactions.
This medicine contains 78 mg aspartam per sachet. Aspartam contains a source of phenylalanine. May be dangerous for people with phenylketonuria (PKU), a rare genetic disorder characterized by the accumulation of phenylalanine which cannot be eliminated properly.
This medicine contains 2170 mg sorbitol and 109.5 mg maltodextrin (glucose) per sachet. If your doctor has informed you that you are intolerant to certain sugars, contact him/her before taking this medicine.
Sorbitol is a source of fructose. If you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder characterized by the inability to break down fructose, talk to your doctor before taking this medication.
3. HOW DO I TAKE EXOMUC 600 mg, powder for oral solution 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 :
Adults: one sachet 1 time daily.
Method and route of administration
Take by mouth.
Dissolve contents of sachet in half a glass of water.
Duration of treatment
Treatment should not exceed 6 days without medical advice.
If you have taken moreEXOMUC 600 mg, powder for oral solution in sachet, than you should have :
Consult your doctor or pharmacist.
If you forget to take EXOMUC 600 mg, powder for oral solution in sachet :
Do not take a double dose to make up for the one you forgot to take.
If you stop taking EXOMUC 600 mg, powder for oral solution 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 drug may cause undesirable effects, but they do not occur systematically in everyone.
If any of the following side effects occur, stop taking EXOMUC 600 mg, powder for oral solution 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 600 mg, powder for oral 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 600 mg, powder 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, please tell 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: 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 are helping to provide more information on drug safety.
5. HOW TO STORE EXOMUC 600 mg, powder for oral solution in sachet?
Store at temperatures below 30°C.
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging after the abbreviation "EXP" used for the expiry date. The expiration date refers to the last day of that month.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What EXOMUC 600 mg, powder for oral solution in sachet, contains
- The activesubstance is :
Acetylcysteine............... ..600 mg
For one sachet
- The other components (excipients) are :
Sorbitol (60 W), aspartam, lemon flavor, orange yellow S (E110).
Composition of lemon flavor Concentrated lemon juice, lemon essential oil, citric acid, citral and maltodextrin.
What EXOMUC 600 mg, powder for oral solution in sachet, is and what it contains
Powder for oral solution in sachet.
Boxes of 6, 8 and 10 sachets.
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
LAMP SAN PROSPERO SPA
VIA DELLA PACE 25/A
41030 SAN PROSPERO (MODENA)
ITALY
Product names in member states of the European Economic Area
Not applicable.
This leaflet was last revised on :
Other
Detailed information on this drug is available on the ANSM (France) website.
Health education advice:
Bronchial congestion favors the onset of infections. It usually takes the form of a hacking cough that causes no 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. For this reason, 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.