In this manual :
1. WHAT IS MUCOMYST 200 mg, powder for oral solution in sachet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING MUCOMYST 200 mg, powder for drinkable solution in sachet
3. HOW DO I TAKE MUCOMYST 200 mg, powder for drinkable solution in sachet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO CONSERVE MUCOMYST 200 mg, powder for drinkable solution in sachet?
6. ADDITIONAL INFORMATION
1. WHAT IS MUCOMYST 200 mg, powder for oral solution in sachet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
MUCOLYTICS (R: respiratory system)
This medicine is indicated in cases of recent respiratory disease with difficulty in spitting out bronchial secretions.
This presentation is reserved for adults and children aged 7 years and over.
For children of different ages, there are other presentations: ask your doctor or pharmacist for advice.
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING MUCOMYST 200 mg, powder 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 MUCOMYST 200 mg, powder for drinkable solution in sachet:
If you are allergic (hypersensitive) to the active substance (acetylcysteine) or to any of the other components contained in MUCOMYST 200mg, powder for oral solution in sachet.
IF IN DOUBT, IT IS ESSENTIAL TO SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Precautions for use; special warnings
Be careful with MUCOMYST 200 mg, powder for oral solution in sachet:
Special Warnings
MUCOMYST 200mg, powder for oral solution in sachet should be used with caution in patients with a history of asthma or bronchospasm. After administration of the product, secretions should be thoroughly evacuated to avoid increasing bronchial congestion.
The use of this medicine is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases).
Precautions for use
MEDICAL ADVICE IS NECESSARY:
- in case of fatty and purulent sputum, fever,
- if you have a chronic (long-term) bronchial or lung disease,
- if you have an ulcer in your stomach or duodenum.
This medicine should always be accompanied by voluntary coughing efforts, allowing expectoration.
Do not take cough suppressants or bronchial secretion drying drugs while taking acetylcysteine.
This medicine contains sodium. This medicine contains 55 mg of sodium per sachet. This should be taken into account in patients who are controlling their dietary salt intake.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Taking or using other medicines
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This medicine contains acetylcysteine. Other medicines contain it. Do not combine them, so as not to exceed the maximum recommended doses.
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Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
if you are taking or have recently taken any other medication, including non-prescription medication, talk to your doctor or pharmacist.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
Pregnancy and breastfeeding
It is preferable not to use this medicine during pregnancy. If you discover that you are pregnant during treatment, consult your doctor, as only he or she can decide whether to continue the treatment.
It is possible to breastfeed your child while taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
Important information about some ingredients of MUCOMYST 200 mg, powder for oral solution in sachet:
1 sachet contains 1.29 g of sucrose and 55 mg of sodium.
3. HOW TO TAKE MUCOMYST 200 mg, powder 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
RESERVED FOR ADULTS AND CHILDREN FROM 7 YEARS OF AGE.
Adults and children over 7 years of age: 600 mg per day divided into 3 doses of 200 mg, i.e. 1 sachet in the morning, at midday and around 4 p.m.
If you feel that MUCOMYST 200 mg/5 ml, powder for drinkable solution in sachet is too strong or too weak, consult your doctor or pharmacist.
Method and route of administration
Oral use.
Dissolve the powder in half a glass of water.
Frequency of administration
Take preferably before the main meals.
Duration of treatment
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The duration of use is limited to 5 days.
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Symptoms and instructions in case of overdose
If you have taken more MUCOMYST 200 mg, powder for oral solution in sachet than you should have:
Consult your doctor or pharmacist.
Instructions in case of missed doses
If you forget to take MUCOMYST 200 mg, powder for oral solution in sachet:
Do not take a double dose to make up for the dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, MUCOMYST 200 mg, powder for drinkable solution in sachet is likely to have undesirable effects, although not everyone is subject to them.
Digestive disorders may occur: stomach upset, nausea, diarrhea, stomatitis. In this case, it is advisable to reduce the dosage.
Bronchospasm may occur after administration of the product, resulting in a sudden increase in respiratory discomfort, particularly in subjects with a history of asthma. In this case, do not repeat the administration and contact your doctor.
Possible allergic reactions which may include sudden swelling of the face and neck, skin rash or sudden malaise with a fall in blood pressure.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO USE MUCOMYST 200 mg, powder for oral solution in sachet?
Keep out of the reach and sight of children.
Do not use MUCOMYST 200 mg, powder for oral solution in sachet after the expiry date stated on the box.
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
Full list of active ingredients and excipients
What does MUCOMYST 200 mg, powder for oral solution in sachet, contain?
The active substance is:
N-acetylcysteine .............................................................................................................................. 200 mg
For one sachet.
The other components are:
Glycine, desiccated sodium citrate, tangerine powder, orange flavouring (contains, among other things, sucrose), sodium saccharin, beta-carotene 1% CWS (beta-carotene, gum arabic, sucrose, dextrins, edible fats, α-tocopherol, ascorbic acid), sucrose.
Pharmaceutical form and content
What is MUCOMYST 200 mg, powder for oral solution in sachet and what does it contain?
This medicine is presented in the form of a drinkable solution.
Box of 12, 15, 18 or 30 sachets.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
BRISTOL-MYERS SQUIBB
3, RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
Operator
UPSA CONSEIL
3, RUE JOSEPH MONIER
B.P 325
92506 RUEIL-MALMAISON CEDEX
Manufacturer
BRISTOL-MYERS SQUIBB
979 AVENUE DES PYRENEES
47520 LE PASSAGE
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 leaflet 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.
HEALTH ADVICE/EDUCATION
Bronchial congestion favours the occurrence of infections. It is most often expressed by a hacking cough which does not cause pain but may bring back secretions (sputum or sputum).
The wet cough is a defence against the congestion of the bronchial tubes by secretions.
Its role is to clean the bronchial tubes by evacuating secretions through sputum. This is why a wet cough must be respected, and even facilitated by taking an expectorant.
In addition to expectorant treatment, the evacuation of bronchopulmonary secretions can be facilitated by simple gestures and the respect of a few rules:
- drink a lot, (water, herbal tea) to hydrate the secretions,
- humidify the air by keeping the temperature between 17°C and 19°C,
- avoid smoking, which is an aggravating cause of coughing.
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