NOTICE
ANSM - Last updated: 04/07/2016
Name of the medicinal product
ACETYLCYSTEINE TEVA CONSEIL 200 mg powder for oral solution in sachet-dose
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 of the 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 talk to your doctor if you do not feel better or feel less well.
Do not use this medication for children.
What is in this leaflet?
1. What is ACETYLCYSTEINE TEVA CONSEIL 200 mg powder for oral solution in sachet-dose and in which cases it is used?
2. What should I tell you before taking ACETYLCYSTEINE TEVA CONSEIL 200 mg powder for oral solution in a sachet-dose?
3. How to take ACETYLCYSTEINE TEVA CONSEIL 200 mg powder for oral solution in sachet-dose?
4. What are the possible side effects?
5. How to store ACETYLCYSTEINE TEVA CONSEIL 200 mg powder for oral solution in a sachet-dose?
6. Package contents and other information.
1. WHAT IS ACETYLCYSTEIN TEVA CONSEIL 200 mg powder for oral solution in sachet-dose AND WHAT IT IS USED FOR?
This medication is a fluidiser of the bronchial secretions, it facilitates their evacuation by the cough.
This drug is indicated in bronchial congestion states especially during acute episodes of bronchitis.
2. BEFORE YOU TAKE ACETYLCYSTEINE TEVA CONSEIL 200 mg powder for oral solution in sachet-dose?
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Do not use ACETYLCYSTEINE TEVA CONSEIL 200 mg powder for oral solution in sachet-dose:
· if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medication mentioned in section 6 ( see ACETYLCYSTEINE TEVA CONSEIL 200 mg, powder for oral solution in sachet-dose ) .
· (less than 2 years) due to the risk of worsening bronchial congestion.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking ACETYLCYSTEINE TEVA CONSEIL 200 mg powder for oral solution in a sachet-dose .
Take special care with ACETYLCYSTEINE TEVA CONSEIL 200 mg powder for oral solution in sachet-dose
Special warnings
Productive coughs, which represent a fundamental element of bronchopulmonary defense, must be respected.
It is advisable not to take a cough medication or bronchial drying medication during the treatment period with this medication.
The association of bronchial muco-modulators with antitussives and / or substances that dry out the secretions (atropinic) is irrational.
Treatment should not be continued if symptoms worsen. In this case, consult your doctor for a re-evaluation of your treatment.
The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
Precautions for use
This medication should be used with caution in case of stomach ulcer or duodenal ulcer.
This medicine contains 2.64 g saccharose per sachet-dose: take it into account in the daily diet in the case of a low-sugar diet or diabetes.
This medication contains an azo dye (orange yellow S (E110)) and may cause allergic reactions.
If in doubt, do not hesitate to seek the advice of your doctor or pharmacist.
Children and Youth
Not applicable.
Other medicines and ACETYLCYSTEINE TEVA CONSEIL 200 mg powder for oral solution in sachet-dose
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
ACETYLCYSTEINE TEVA CONSEIL 200 mg powder for oral solution in sachet-dose 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 for advice or pharmacist before taking this medication.
It is best not to use this medication during pregnancy.
If you discover that you are pregnant during the treatment consult your doctor as he alone can judge the need to pursue it.
It is possible to breast-feed your child if you are taking this medication.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Driving and using machines
Not applicable.
ACETYLCYSTEINE TEVA CONSEIL 200 mg powder for oral solution in sachet-dose contains: orange-yellow S (E110), sucrose.
3. HOW TO TAKE ACETYLCYSTEINE TEVA CONSEIL 200 mg powder for oral solution in a sachet-dose?
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Adults and children over 7 years : 600 mg per day, in 3 doses, ie 1 sachet-dose 3 times a day.
Children 2 to 7 years : 400 mg per day, in 2 doses, that is 1 sachet-dose 2 times a day.
If you feel that the effect of ACETYLCYSTEINE TEVA CONSEIL 200 mg powder for oral solution in a sachet-dose is too strong or too weak, talk to your doctor or pharmacist.
Administration mode
Oral use.
Dissolve the contents of the sachet-dose in half a glass of water.
Duration of the treatment
The duration of treatment will not exceed 8 to 10 days without medical advice.
Use in children and adolescents
Not applicable.
If you take more ACETYLCYSTEINE TEVA CONSEIL 200 mg powder for oral solution in a sachet-dose than you should:
Immediately consult your doctor or pharmacist.
If you forget to take ACETYLCYSTEINE TEVA CONSEIL 200 mg powder for oral solution in sachet-dose:
Do not take a double dose to make up for a missed dose.
If you stop taking ACETYLCYSTEINE TEVA CONSEIL 200 mg powder for oral solution in sachet-dose:
Not applicable.
If you have any further questions on the use of this medication, ask your doctor, pharmacist or nurse for more information.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· 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.
Additional Adverse Events in Children and Adolescents
Not applicable.
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 ACETYLCYSTEINE TEVA CONSEIL 200 mg powder for oral solution in sachet-dose?
Keep this medicine out of the reach and sight of children.
Do not use this medication after the expiry date which is stated on the carton or sachet-dose. 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 ACETYLCYSTEINE TEVA CONSEIL 200 mg contains, powder for oral solution in sachet-dose
The active substance is:
Acetylcysteine ................................................. .................................................. 200 mg
For a sachet-dose.
The other components are:
Saccharin sodium, sucrose, yellow Orange S (E110), orange flavor E216341 (contains in particular maltodextrin (glucose)).
What is ACETYLCYSTEINE TEVA CONSEIL 200 mg powder for oral solution in sachet-dose and contents of the pack
This medication is in the form of a powder for oral solution in a sachet-dose. Box of 15, 20 or 30.
Marketing Authorization Holder
RATIOPHARM GmbH
GRAF-ARCO-STRASSE 3
89079 ULM
GERMANY
Marketing Authorization Operator
TEVA HEALTH
100-110 ESPLANADE OF GENERAL DE GAULLE
92931 PARIS LA DEFENSE CEDEX
Maker
MACORS LABORATORIES
RUE DES CAILLOTTES - ZI PLAINE DES ISLES
89000 AUXERRE
Or
MERCKLE GmbH / PLANT ULM
GRAF-ARCO-STRASSE 3
89079 ULM
GERMANY
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 (France).