NOTICE
ANSM - Last updated: 03/05/2013
Name of the medicinal product
EXOMUC 200 mg, granules for oral solution in sachet
acetylcysteine
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist consult a doctor.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT EXOMUC 200 mg, granules for oral solution in sachets AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE EXOMUC 200 mg, granules for oral solution in sachets?
3. HOW TO TAKE EXOMUC 200 mg, granules for oral solution in sachet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE EXOMUC 200 mg, granules for oral solution in sachets?
6. ADDITIONAL INFORMATION
1. WHAT EXOMUC 200 mg, granules for oral solution in sachets AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
MUCOLYTIC.
(R. Respiratory System).
Therapeutic indications
This medication is a fluidiser of the bronchial secretions, it facilitates their evacuation by the cough.
This medication is recommended in bronchial congestion states especially during acute episodes of bronchitis.
2. BEFORE YOU TAKE EXOMUC 200 mg, granules for oral solution in sachets?
List of information needed before taking the medication
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Do not take EXOMUC 200 mg, granules for oral solution in sachets:
· in case of a history of allergy to one of the constituents,
· in infants (under 2 years) due to the risk of worsening bronchial congestion,
· in the case of phenylketonuria (hereditary disease detected at birth), due to the presence of aspartame.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with EXOMUC 200 mg pellets for oral solution in sachets:
Special warnings
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.
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
The use of this medication is not recommended in patients with fructose intolerance (rare hereditary disease).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use
This medication should be used with caution in case of stomach ulcer or duodenal ulcer.
IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Interaction with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Tell your doctor if you are pregnant, if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
List of excipients with known effect:
Aspartam, sorbitol.
3. HOW TO TAKE EXOMUC 200 mg, granules for oral solution in sachet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
The usual dosage is:
Adults and children over 7 years: one sachet 3 times a day.
Children from 2 to 7 years: one sachet twice a day.
COMPLY WITH YOUR DOCTOR'S ADVICE.
Method and route of administration
Oral use.
Dissolve the contents of the sachet in half a glass of water.
Duration of treatment
The duration of treatment will not exceed 8 to 10 days without medical advice.
Symptoms and Instructions for Overdose
If you take more EXOMUC 200 mg, granules for oral solution in sachet than you should:
Consult your doctor or pharmacist.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, EXOMUC 200 mg, granules for oral solution in a sachet is likely to have undesirable effects, although not everyone is subject to it.
· Risk of aggravation of the bronchial congestion in particular in the infant and in some patients incapable of effective expectoration.
· Allergic skin reactions such as itching, rash, urticaria and swelling of the face.
· Possible digestive disorders: nausea, diarrhea, vomiting, upset stomach.
It is advisable in this case to reduce the dosage.
If you notice any side effects not listed in this leaflet, or if certain side effects become serious, please tell your doctor or pharmacist.
5. HOW TO STORE EXOMUC 200 mg, granules for oral solution in sachets?
Keep out of the reach and sight of children.
Expiration date
Do not use EXOMUC 200 mg pellets for oral solution in sachets after the expiry date which is stated on the outer packaging.
Storage conditions
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does EXOMUC 200 mg contain, granules for oral solution in sachets?
The active substance is:
N-Acetylcysteine ............................................... .................................................. ............................. 200 mg
For a sachet.
The other components are:
Orange flavor S 289, aspartam, beta-carotene (E 160), sorbitol.
Composition of the orange flavor S 289: natural flavor obtained by dispersion on dextrose of a concentrated base.
Pharmaceutical form and content
What is EXOMUC 200 mg, granules for oral solution in sachets and contents of the pack?
This medicinal product is in the form of granules for oral solution in sachets.
Box of 18, 20, 24 or 30 sachets.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
BOUCHARA RECORDATI
BUILDING "LE WILSON"
70, AVENUE DU GENERAL DE GAULLE
92800 PUTEAUX
exploiting
BOUCHARA RECORDATI LABORATORIES
BUILDING "LE WILSON"
70, AVENUE DU GENERAL DE GAULLE
92800 PUTEAUX
Maker
BOUCHARA RECORDATI LABORATORIES
BUILDING "LE WILSON"
70, AVENUE DU GENERAL DE GAULLE
92800 PUTEAUX
or
Sophartex
21, RUE DU PRESSOIR
28500 VERNOUILLET
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.