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DESCRIPTION:
Lysorynx Mint Sugar-Free Lozenges are indicated as an adjunctive local treatment for mild sore throats without fever. This medication, intended for adults and children over 6 years of age, contains the following active ingredients: lysozyme and cetylpyridinium.
The other ingredients in Lysorynx throat lozenges are saccharin, magnesium stearate, mint flavor*, and sorbitol.
*The mint flavor is obtained from peppermint essential oil and gum arabic.
Dosage of Lysorynx Mint Sugar-Free Lozenges
Oral use
This medication is intended for adults and children over 6 years of age.
Always follow the instructions in the package leaflet or as recommended by your doctor or pharmacist.
It is recommended to take an average of 3 to 6 lozenges per day. Allow the lozenge to dissolve in your mouth.
Doses should be spread throughout the day, leaving 2 hours between each dose.
The duration of treatment should not exceed 5 days. If there is no improvement after this period, consult your doctor.
Precautions for using Lysorynx Mint for sore throats
Do not give this medication to children under 6 years of age.
Do not use Lysorynx throat lozenges if you are allergic to cetylpyridinium chloride or lysozyme hydrochloride, or any other component of this medication, or if you are allergic to egg.
Consult a doctor or pharmacist before taking Lysorynx Mint sugar-free sore throat lozenges, sweetened with sorbitol and saccharin.
Do not use if you experience fever, purulent sputum, difficulty swallowing, or if you have not taken this medication for 5 days.
This medication is not recommended for people with fructose intolerance (a rare hereditary condition).
Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.
If you have recently taken, are taking, or plan to take any other medication, talk to your doctor or pharmacist before taking this medication.
If you are pregnant or breastfeeding, ask your doctor or pharmacist before taking this medication.
To cleanse and moisten the nasal passages, Bausch & Lomb Laboratories offer Hyarhinol nasal spray. Before taking any medication, consult your doctor or pharmacist to determine its appropriateness, as well as its dosage and method of administration.
Packaging: 1 box of 2 tubes of 18 tablets (2 x 18 = 36 tablets)
LEAFLET
ANSM - Updated on: 11/21/2023
Name of the medicinal product
LYSORYNX, lozenge sweetened with sorbitol and saccharin
Cetylpyridinium chloride / Lysozyme hydrochloride
Box
Please read this leaflet carefully before taking this medicine because it contains important information for you.
You must always take this medicine exactly as provided in this leaflet or by your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
Ask your pharmacist for advice or information.
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
· You must talk to your doctor if you do not feel better or if you feel worse after 5 days.
What is in this leaflet?
1. What is LYSORYNX, sweetened lozenge with sorbitol and saccharin and what is it used for?
2. What you need to know before you take LYSORYNX, sweetened lozenge with sorbitol and saccharin?
3. How to take LYSORYNX, sweetened lozenge with sorbitol and saccharin?
4. Possible side effects?
5. How to store LYSORYNX, sweetened lozenge with sorbitol and saccharin?
6. Contents of the pack and other information.
1. WHAT IS LYSORYNX, a lozenge sweetened with sorbitol and saccharin, AND WHAT IS IT USED FOR?
Pharmacotherapeutic group - ATC code: R: Respiratory system
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 ingredients of this medicine).
It is indicated for adults and children over 6 years of age as an adjunctive local treatment for mild sore throats without fever.
You should consult your doctor if you do not feel better or if you feel worse after 5 days.
2. WHAT YOU NEED TO KNOW BEFORE TAKING LYSORYNX, lozenge sweetened with sorbitol and saccharin?
Do not take LYSORYNX, lozenge sweetened with sorbitol and saccharin:
· if you are allergic to cetylpyridinium chloride or lysozyme hydrochloride or any of the other ingredients of this medicine (listed in section 6), and if you are allergic to eggs.
IF IN DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Warnings and Precautions
Talk to your doctor or pharmacist before taking LYSORYNX, lozenge sweetened with sorbitol and saccharin.
Sore throat
If you experience:
· fever,
· purulent sputum (phlegm),
· discomfort when swallowing food, or if it worsens or does not improve after 5 days, CONSULT YOUR DOCTOR.
The use of this medicine is not recommended for patients with fructose intolerance (a rare hereditary disease).
Children
Do not use this medicine in children under 6 years of age.
Other medicines and LYSORYNX, lozenge sweetened with sorbitol and saccharin
Do not use several medicines containing an antiseptic at the same time.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
LYSORYNX, lozenge sweetened with sorbitol and saccharin with food and drink
Not applicable.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist before taking this medicine.
Driving and using machines
Not applicable.
LYSORYNX, lozenge sweetened with sorbitol and saccharin, contains 1348 mg of sorbitol per tablet.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder characterized by the inability to break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.
3. HOW TO TAKE LYSORYNX, lozenge sweetened with sorbitol and saccharin?
Always take this medicine exactly as directed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
FOR ADULTS AND CHILDREN OVER 6 YEARS OLD ONLY.
The recommended dose is 3 to 6 lozenges per day, on average, to be allowed to dissolve in the mouth and spread evenly throughout the day.
Use in children and adolescents
Do not use this medicine in children under 6 years of age.
Method of administration
Oral use.
Frequency of administration
The tablets should be lozenges, leaving at least 2 hours between each dose.
Duration of treatment
The duration of treatment is limited to 5 days.
If you take more LYSORYNX, lozenge sweetened with sorbitol and saccharin than you should
Not applicable.
If you forget to take LYSORYNX, lozenge sweetened with sorbitol and saccharin
Not applicable.
If you stop taking LYSORYNX, lozenge sweetened with sorbitol and saccharin
Not applicable.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
· Cases of allergic reactions have been reported with medicines containing lysozyme (active ingredient).
Unknown side effects (frequency cannot be estimated from the available data): allergic reaction including allergic edema, skin rash, hives.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: French National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: https://signalement.social-sante.gouv.fr/
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE LYSORYNX, lozenge sweetened with sorbitol and saccharin?
Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date printed on the packaging after EXP. The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What LYSORYNX, lozenge sweetened with sorbitol and saccharin, contains
· The active ingredients are:
Cetylpyridinium chloride........................................................................................... 1.5 mg
Lysozyme hydrochloride........................................................................................... 20.0 mg
Per lozenge.
· The other ingredients are:
Saccharin, magnesium stearate, mint flavor*, sorbitol.
*Mint flavor composition: peppermint essential oil, gum arabic.
What is LYSORYNX lozenge sweetened with sorbitol and saccharin and contents of the outer packaging?
This medicine comes in the form of a lozenge.
Box of 1 or 2 tubes of 18 tablets.
Marketing Authorization Holder
LABORATOIRE CHAUVIN
416, RUE SAMUEL MORSE – CS99535
34961 MONTPELLIER
Marketing Authorization Holder
LABORATOIRE CHAUVIN
416, RUE SAMUEL MORSE – CS99535
34961 MONTPELLIER
Manufacturer
INPHARMASCI
ZI N°2 de PROUVY – ROUVIGNIES
1 RUE DE NUNGESSER
59121 PROUVY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
This leaflet was last revised:
[to be completed later by the holder]
Others
Detailed information on this medicinal product is available on the ANSM website (France).