NOTICE
ANSM - Updated: 27/10/2017
Name of the drug
ACETYLCYSTEINE EG 200 mg powder for oral solution in sachet dose
acetylcysteine
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse.
What does this booklet contain ?
1. What is ACETYLCYSTEINE EG 200 mg powder for oral solution in sachet dose and when is it used?
2. What you need to know before you take ACETYLCYSTEINE EG 200 mg powder for oral solution in a sachet dose.
3. How to take ACETYLCYSTEINE EG 200 mg powder for oral solution in sachet dose?
4. What are the possible side effects?
5. How to store ACETYLCYSTEINE EG 200 mg powder for oral solution in sachet dose?
6. Contents of the package and other information.
1. WHAT IS ACETYLCYSTEINE EG 200 mg powder for oral solution in a sachet dose AND WHAT IT IS USED FOR?
Pharmacotherapeutic group - ATC code: MUCOLYTIC - R05CB01 (R: Respiratory system)
This drug is a fluidifying bronchial secretions, it facilitates their evacuation by coughing. This drug is recommended in the congestion states of the bronchi especially during acute episodes of bronchitis.
2. BEFORE YOU TAKE ACETYLCYSTEINE EG 200 mg SUGAR FREE, powder for oral solution in sachet dose?
Do not take ACETYLCYSTEINE EG 200 mg powder for oral solution in sachets
· if you are allergic to acetylcysteine or any of the other ingredients of this medicine, listed in section 6
· in infants (less than 2 years old) because of the risk of aggravation of bronchial congestion.
Warnings and precautions
Talk to your doctor or pharmacist before taking ACETYLCYSTEINE EG .
This medicine should be used with caution if you have or have had a stomach or duodenal ulcer especially if you are taking medications that have an irritating effect on the stomach at the same time.
This medicine should be used with caution if you are intolerant to histamine.
It is advisable not to take antitussive medication or bronchial secretion medicine during the course of treatment with this medication.
Treatment should not be continued if symptoms worsen. In this case, consult your doctor for a reassessment of your treatment.
Close supervision by your doctor is necessary if you have asthma.
Stop treatment immediately if breathing becomes wheezy or difficult and tell your doctor.
Taking ACETYLCYSTEINE EG, especially at the beginning of treatment, fluidifies the bronchial secretions and can increase their volume. If you have difficulty spitting or coughing effectively, tell your doctor.
A slight smell of sulfur is a normal feature of the active substance. It does not indicate an alteration of the drug.
This medicine contains an azo coloring agent (orange-yellow E110) and may cause allergic reactions.
The use of this drug is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase (rare hereditary diseases) deficiency.
Children and adolescents
Do not use this medicine in children under 2 years old.
Other medicines and ACETYLCYSTEINE EG 200 mg powder for oral solution in sachet dose
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is advisable not to take antitussive medication or bronchial secretion medicine during the treatment period with this medicine.
Activated charcoal can reduce the effect of ACETYLCYSTEINE EG.
It is not recommended to dissolve ACETYLCYSTEINE EG at the same time as other medications.
When prescribing antibiotics, it is advisable to take them within 2 hours of taking ACETYLCYSTEINE EG.
If using nitrates (treatment of angina pectoris) or carbamazepine, tell your doctor.
ACETYLCYSTEINE EG 200 mg SUGAR FREE, powder for oral solution in sachet dose with <,>
Not applicable.
Pregnancy, lactation and fertility
This medicine will be used during pregnancy and breastfeeding only on the advice of your doctor.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
ACETYLCYSTEINE EG 200 mg powder for oral solution in sachet dose contains yellow-orange S (E110) and sucrose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE ACETYLCYSTEINE EG 200 mg powder for oral solution in sachet dose?
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Adults and children over 7 years: 600 mg daily divided into 3 doses, 1 sachet 3 times daily.
Children from 2 to 7 years old: 400 mg per day, ie 1 sachet twice a day.
Oral way.
Dissolve the granules in a little water.
Do not exceed 8 to 10 days of treatment without medical advice.
If you take more ACETYLCYSTEINE EG 200 mg powder for oral solution in sachet dose than you should
Immediately consult your doctor or pharmacist.
If you forget to take ACETYLCYSTEINE EG 200 mg powder for oral solution in sachets
Do not take a double dose to make up for the dose you forgot to take.
Continue your treatment normally.
If you stop taking ACETYLCYSTEINE EG 200 mg powder for oral solution in sachets
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
· Uncommon (occurs in 1 to 10 patients in 1000):
o Allergic reactions such as urticaria, skin rash, itching and subcutaneous edema, with or without associated blood pressure drop and / or increased heart rate;
o Nausea, vomiting, abdominal pain, inflammation of the mouth, diarrhea;
o Headache and wheezing in the ears;
o Fever.
· Rare (occurs in 1 to 10 patients in 10,000):
o Wheezing or difficult breathing;
o Digestion difficult.
· Very rare (occurs in less than 1 in 10,000 patients):
o Allergic reactions that may progress to allergic shock: symptoms may include fainting, swelling of the face, tongue and throat;
o Bleeding.
· Of unknown frequency:
o Swelling of the face.
· Other very rare side effects:
o Severe reactions in the skin and mucous membranes: symptoms may include blisters. If this type of reaction occurs, stop taking this medicine immediately and contact your doctor for medical advice;
o Coagulation disorder.
There is a risk of aggravation of bronchial congestion, especially in infants and some patients unable to expectorate effectively.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE ACETYLCYSTEINE EG 200 mg SUGAR FREE, powder for oral solution in sachet dose?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of this month.
Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What ACETYLCYSTEINE EG 200 mg powder for oral solution in sachet dose contains
· The active substance is:
Acetylcysteine ................................................. .................................................. ........ 200.00 mg
For a bag of 1g.
· The other components are:
Saccharin sodium, sucrose, orange-yellow S (E110), orange flavor E216341 [contains especially maltodextrin (glucose)].
What ACETYLCYSTEINE EG 200 mg powder for oral solution in sachet dose and contents of the pack
This medicine is in powder form for oral solution in sachet-dose. Box of 15, 20 or 30 sachets.
Marketing Authorization Holder
EG LABO-LABORATORIES EUROGENERICS
THE QUINTET - BUILDING A
12 DANJOU STREET
92517 BOULOGNE BILLANCOURT CEDEX
Operator of the marketing authorization
EG LABO-LABORATORIES EUROGENERICS
THE QUINTET - BUILDING A
12 DANJOU STREET
92517 BOULOGNE BILLANCOURT CEDEX
Maker
LAMP SAN PROSPERO SPA
VIA DELLA PACE, 25 / A
SAN PROSPERO (MO)
ITALY
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
[to be completed later by the holder]
<{MM / YYYY}> <{YYYY month}.>
Other
Detailed information on this medicine is available on the ANSM website (France).