NOTICE
ANSM - Last updated: 31/07/2017
Name of the medicinal product
MUCOMYST 200 mg powder for oral solution in sachet
N-acetylcysteine
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor, pharmacist or nurse.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you experience no improvement or feel less well after 1 month.
What is in this leaflet?
1. What is MUCOMYST 200 mg powder for oral solution in sachets and in which cases it is used?
2. What should I know before taking MUCOMYST 200 mg powder for oral solution in sachets?
3. How to take MUCOMYST 200 mg powder for oral solution in sachet?
4. What are the possible side effects?
5. How to store MUCOMYST 200 mg powder for oral solution in sachets?
6. Package contents and other information.
1. WHAT IS MUCOMYST 200 mg powder for oral solution in sachets AND WHAT IS IT USED FOR?
Pharmacotherapeutic group: MUCOLYTIC, ATC code: R05CB01 .
This medication is indicated in cases of recent respiratory disease with difficulty in expectoration (difficulty in rejecting by spitting bronchial secretions).
This presentation is reserved for adults and children from 7 years.
For children of different ages, there are other presentations: ask your doctor or pharmacist for advice.
You should contact your doctor if you experience no improvement or feel less well after 5 days.
2. BEFORE YOU TAKE MUCOMYST 200 mg powder for oral solution in sachet?
Do not take MUCOMYST 200 mg powder for oral solution in sachets:
· if you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Warnings and Precautions
Talk to your doctor or pharmacist before taking MUCOMYST 200 mg powder for oral solution in sachets.
This medicine contains acetylcysteine. Other medicines contain it.
Make sure that you do not take any other medicines containing acetylcysteine, including if they are medicines obtained without a prescription.
Do not combine them, so as not to exceed the recommended daily dose.
MUCOMYST 200 mg powder for oral solution in sachet should be used with caution in subjects with a history of asthma or bronchospasm. After administration of the product, the secretions should be well evacuated in order to avoid an increase in bronchial congestion.
A MEDICAL ADVICE IS NECESSARY:
· in case of fatty and purulent expectoration, of fever,
· if you are suffering from chronic (long-term) bronchial or lung disease,
· in case of stomach or duodenal ulcer.
This drug should always be accompanied by voluntary efforts of coughing, allowing the sputum.
Do not take cough suppressant medication or bronchial secretion-drying medication during the acetylcysteine treatment period.
The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
This medicine contains sodium. This medicine contains 55 mg sodium per sachet. To be taken into account in patients controlling their sodium dietary intake.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Children and Youth
This medication is indicated for adults and children over 7 years of age.
Other medicines and MUCOMYST 200 mg powder for oral solution in sachet
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
MUCOMYST 200 mg powder for oral solution in sachet with food, drink and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy and breast feeding
It is best not to use this medication during pregnancy.
It is possible to breast-feed your child if you are taking this medication.
Fertility
Not applicable
Driving and using machines
MUCOMYST 200 mg powder for oral solution in sachet has no effect on the ability to drive and use machines.
MUCOMYST 200 mg powder for oral solution in sachet contains saccharose (1.29 g per sachet) and sodium (55 mg per sachet).
3. HOW TO TAKE MUCOMYST 200 mg powder for oral solution in sachet?
Always take this medication exactly as prescribed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt.
Dosage
RESERVED FOR ADULTS AND CHILDREN FROM 7 YEARS.
600 mg per day divided into 3 doses of 200 mg, ie 1 sachet in the morning, at noon and around 16h.
If you have the impression that MUCOMYST 200 mg powder for oral solution in sachet is too strong or too weak, talk to your doctor or pharmacist.
Administration mode
Oral use.
Dissolve the powder in half a glass of water and absorb preferably before the main meals.
Duration of the treatment
The duration of use is limited to 5 days.
If you take more MUCOMYST 200 mg powder for oral solution in a sachet than you should
Consult your doctor or pharmacist.
If you forget to take MUCOMYST 200 mg powder for oral solution in sachet
Do not take a double dose to make up for a missed dose.
If you stop taking MUCOMYST 200 mg powder for oral solution in sachet
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Possible digestive disorders: stomach pain, nausea, diarrhea, stomatitis. It is advisable in this case 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 renew the administration and contact your doctor.
Possible allergic reactions which can be manifested by a sudden swelling of the face and neck, a rash or a sudden discomfort with drop in blood pressure.
Cases of rhinorrhea, drowsiness, moisture and chest tightness have been reported.
Declaration of side effects
If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE MUCOMYST 200 mg powder for oral solution in sachet?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
No special storage conditions.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What MUCOMYST 200 mg contains, powder for oral solution in sachet
· The active substance is:
N-acetylcysteine ............................................... .................................................. 200 mg
For a sachet.
· The other components are:
Glycine, dried sodium citrate, mandarin spray, orange flavor (contains sucrose), sodium saccharin, beta-carotene 1% CWS (contains sucrose), sucrose.
What is MUCOMYST 200 mg powder for oral solution in sachet and contents of the pack
This medication is in the form of a drinkable solution.
Box of 12, 15, 18 or 30 sachets.
Marketing Authorization Holder
UPSA SAS
3, RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
Marketing Authorization Operator
UPSA SAS
3, RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
Maker
UPSA SAS
979, AVENUE DES PYRENEES
47520 THE PASSAGE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
{month YYYY}.
Other
Detailed information on this medicine is available on the ANSM website.
Health Education Council:
Bronchial congestion favors the occurrence of infections. It most often results in a fatty cough that does not cause pain but can reduce secretions (sputum or sputum).
The fatty cough is a defense against the congestion of the bronchi by the secretions.
Its role is to clean the bronchi by evacuating the secretions by sputum. This is why the fatty cough must be respected, and even facilitated by the taking of an expectorant.
In addition to the expectorant treatment, the evacuation of the 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 at a temperature between 17 ° C and 19 ° C,
· avoid tobacco which is an aggravating cause of cough.