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.