In this manual :
1. WHAT IS EXOMUC 200 mg, granules for drinkable solution in sachet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING EXOMUC 200 mg, granules for drinkable solution in sachet?
3. HOW TO TAKE EXOMUC 200 mg, granules for drinkable solution in sachet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE EXOMUC 200 mg, granules for drinkable solution in sachet?
6. ADDITIONAL INFORMATION
1. WHAT IS EXOMUC 200 mg, granules for oral solution in sachet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
MUCOLYTICS.
(R. Respiratory system).
This medicine is a fluidifier of bronchial secretions, thus facilitating their evacuation by coughing.
This medicine is recommended in conditions of bronchial congestion, particularly during acute episodes of bronchitis.
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING EXOMUC 200 mg, granules for drinkable solution in sachet?
List of information needed before taking the medicine
If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
Do not take EXOMUC 200 mg, granules for drinkable solution in sachet:
- in the event of a history of allergy to one of the constituents,
- in infants (under 2 years of age) because of the risk of aggravating bronchial congestion,
- in case of phenylketonuria (hereditary disease detected at birth), because of the presence of aspartam.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Take care with EXOMUC 200 mg, granules for drinkable solution in sachet:
Special warnings
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.
If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
The use of this medicine is not recommended in patients with fructose intolerance (a rare hereditary disease).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use
This medicine should be used with caution in cases of stomach or duodenal ulcers.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Taking or using other medications
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or breastfeeding.
Ask your doctor or pharmacist for advice before taking any medication.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notorious effect:
Aspartam, sorbitol.
3. HOW TO TAKE EXOMUC 200 mg, granules for oral solution in sachet?
Instructions for proper use
Not applicable.
Dosage, Method 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 daily.
Children from 2 to 7 years: one sachet twice a day.
FOLLOW YOUR DOCTOR'S ADVICE.
Method and route of administration
Take by mouth.
Dissolve the contents of the sachet in half a glass of water.
Duration of treatment
The duration of treatment should not exceed 8 to 10 days without medical advice.
Symptoms and instructions in case of overdose
If you have taken more EXOMUC 200 mg, granules for oral solution in a sachet than you should have:
Consult your doctor or pharmacist.
Instructions in case of missed doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, EXOMUC 200 mg, granules for drinkable solution in sachet is likely to have undesirable effects, although not everyone is subject to them.
- Risk of aggravation of bronchial congestion, particularly in infants and in certain patients unable to cough up air effectively.
- Allergic skin reactions such as itching, rash, hives and facial swelling.
- Digestive disorders may occur: nausea, diarrhoea, vomiting, stomach upset.
In this case it is advisable to reduce the dosage.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO CONSERVE EXOMUC 200 mg, granules for oral solution in sachet?
Keep out of the reach and sight of children.
Do not use EXOMUC 200 mg, granules for oral solution in sachet after the expiry date stated on the outer packaging.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active ingredients and excipients
What does EXOMUC 200 mg, granules for oral solution in sachet, contain?
The active substance is:
N-Acetylcysteine .............................................................................................................................. 200 mg
Per sachet.
The other components are:
Orange flavouring S 289, aspartam, beta-carotene (E 160), sorbitol.
Composition of orange flavouring S 289: natural flavouring obtained by dispersion of a concentrated base on dextrose.
Pharmaceutical form and content
What is EXOMUC 200 mg, granules for oral solution in a sachet and what does it contain?
This medicine is presented as granules for oral solution in a sachet.
Box of 18, 20, 24 or 30 sachets.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
BOUCHARA RECORDATI
68 RUE MARJOLIN
92300 LEVALLOIS-PERRET
Operator
LABORATOIRES BOUCHARA RECORDATI
68, RUE MARJOLIN
92300 LEVALLOIS-PERRET
Manufacturer
LABORATOIRES BOUCHARA RECORDATI
68, RUE MARJOLIN
92300 LEVALLOIS-PERRET
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 package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
Not applicable.
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