NOTICE
ANSM - Updated: 20/04/2017
Name of the drug
LYSOPAINE THROAT WELL CETYLPYRIDINIUM LYSOZYME SUGAR FREE, sucking tablet sweetened with sorbitol and saccharin
Cetylpyridinium, lysozyme
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 effects that are not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you feel no improvement or feel worse after 5 days.
· Do not let this medicine within the reach of children.
What does this booklet contain ?
1. What is LYSOPAINE SUGAR-FREE LYGYZYME LYMPHYDYME GYMPYRIDINIUM, sucking tablet sweetened with sorbitol and saccharin and in which cases is it used?
2. What you need to know before taking LYSOPAINE THYROZYME LYSOZYME NON-SUGARIZED THROAT WHEAT, sucking tablet sweetened with sorbitol and saccharin?
3. How to take LYSOPAINE THYROZYME LYSOZYME NON-SUGARIZED THROAT WHEAT, sucking tablet sweetened with sorbitol and saccharin?
4. What are the possible side effects?
5. How to store LYSOPAINE THYROZYME LYSOZYME NON-SUGARIZED THROAT WHEAT, sucking tablet sweetened with sorbitol and saccharin?
6. Contents of the package and other information.
1. WHAT IS LYSOPAINE SUGAR-FREE LYMPHYDYME LYMPHYDYME GYMPYRIDINIUM THROTTLE, sorbitol and saccharin-sweetened sucking tablet AND WHAT IT IS USED FOR?
Antibacterial activity against Staphylococcus aureus under the following conditions: temperature of 35 ° C and contact time of 15 minutes.
This medicine contains lysozyme and cetylpyridinium (active substances of this medicine).
It is indicated in adults and children over 6 years as local top-up treatment for mild sore throat, without fever.
IF IN DOUBT, NEVER HESITATE TO CALL YOUR DOCTOR OR PHARMACIST.
You should talk to your doctor if you feel no improvement or feel worse after 5 days.
2. BEFORE YOU TAKE LYSOPAINE THROAT WELL CETYLPYRIDINIUM LYSOZYME SUGAR FREE, sucking tablet sweetened with sorbitol and saccharin?
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Do not take LYSOPAINE SUGAR-FREE LYGYZYRIDINIUM LYSOZYME THROAT, sucking tablet sweetened with sorbitol and saccharin:
· children under 6 years old.
· if you are allergic (hypersensitive) to the active substances or to any of the other ingredients of this medicine, listed in section 6 (including allergy to lysozyme or egg allergy).
Warnings and precautions
Take special care with LYSOPAINE SUGAR-FREE LYGYZYRIDINIUM CETYLPYRIDINIUM THROAT, sucking tablet sweetened with sorbitol and saccharin:
Prolonged use (more than 5 days) of this drug is undesirable as it is likely to alter the natural microbial balance of the mouth, throat.
Sore throat
In case of occurrence:
· fever,
· sputum (sputum) purulent,
· embarrassment when you swallow food, such as worsening or lack of improvement after 5 days,
CONSULT YOUR DOCTOR.
The use of this drug is not recommended in patients with fructose intolerance (rare hereditary disease).
children
Not applicable.
Other medicines and LYSOPAINE THROAT WHEAT CETYLPYRIDINIUM LYSOZYME SUGAR FREE, sucking tablet sweetened with sorbitol and saccharin
Do not use multiple medications containing antiseptic at the same time.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
LYSOPAINE THROAT WHEY CETYLPYRIDINIUM LYSOZYME SUGAR FREE, sucking tablet sweetened with sorbitol and saccharin with food and drink
Not applicable.
Pregnancy and breast feeding
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.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Driving and using machines
Not applicable.
LYSOPAINE THROAT WHEAT CETYLPYRIDINIUM LYSOZYME SUGAR FREE, sucking tablet sweetened with sorbitol and saccharin contains sorbitol.
3. HOW TO TAKE LYSOPAINE THROAT WET CETYLPYRIDINIUM LYSOZYME SUGAR FREE, sucking tablet sweetened with sorbitol and saccharin?
Do not use this medicine in children under 6 years old.
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist.
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS OLD.
On average, 3 to 6 tablets to suck each day, to melt in the mouth and to distribute regularly during the day.
Administration mode
Oral way.
Frequency of administration
The tablets are sucked with a minimum of 2 hours between each dose.
Duration of the treatment
The duration of treatment is limited to 5 days.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
If you take more LYSOPAINE THROUGH LIQUID THYROPYLESS LYSOZYME THROUGH SUGAR, sucking tablet sweetened with sorbitol and saccharin than you should:
Immediately consult your doctor or pharmacist.
Not applicable.
If you forget to take LYSOPAINE SUGAR LYMPHYDYRIMINY LYMPHYDYME THROUGH SUGAR, sucking tablet sweetened with sorbitol and saccharin:
Not applicable.
If you stop taking LYSOPAINE SUGAR-FREE LYGYZYRDYME LYSOZYME THROAT, sucking tablet sweetened with sorbitol and saccharin:
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Cases of allergy reactions have been reported with drugs containing lysozyme (active substance).
Undesirable effects of unknown frequency (can not be estimated from the available data):
allergic reaction including allergic edema, rash, hives.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Declaration of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This also applies to any undesirable effects that are 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 on the safety of the medicine.
5. HOW TO STORE LYSOPAINE THROAT WET CETYLPYRIDINIUM LYSOZYME SUGAR FREE, sucking tablet sweetened with sorbitol and saccharin?
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.
Store at a temperature not exceeding 30 ° C.
Do not dispose of any medication in the sewage system or 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 LYSOPAINE SUGAR-FREE LYMPHYDYME LYSOZYME THROAT WHEAT contains, sweetening tablet sweetened with sorbitol and saccharin
· The active substances are are:
Cetylpyridinium chloride ............................................... ............................................... 1.5 mg
Lysozyme hydrochloride ............................................... ............................................... 20.0 mg
· The other components are:
Saccharin, magnesium stearate, mint flavor *, sorbitol (see section 2).
* Composition of the mint aroma : essential oil of peppermint, gum arabic.
What is LYSOPAINE SUGAR-FREE LYSOZYME CETYLPYRIDINIUM THROTTLE, sorbitol and saccharin-sweetened sucking tablet and contents of the pack
This medicine is in the form of a tablet to suck.
Box of 1 tube of 12, 18, 20 or 24 tablets or box of 2 tubes of 18 or 20 tablets.
Not all presentations may be marketed.
Marketing Authorization Holder
SANOFI-AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Operator of the marketing authorization
SANOFI-AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Maker
DELPHARM REIMS
10, COLONEL COLONEL CHARBONNEAUX
51100 REIMS
Names of the medicine 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).