Lyso 6 Aphtes Lozenge

Lyso 6 lozenges are intended for adults and children over 6 years of age. This medication is recommended for canker sores and minor mouth ulcers, or mild sore throats without fever.

The active ingredients in Lyso 6 lozenges for canker sores are pyridoxine hydrochloride (10 mg) and lysozyme hydrochloride (20 mg) per tablet. The excipients in Lyso 6 are ethyl vanillin, hypromellose, sodium saccharin, magnesium stearate, and lactose monohydrate.

Lyso 6 Dosage

Lyso 6 tablets should be allowed to dissolve gently under the tongue, taking 6 to 8 tablets per day, leaving at least one hour between each tablet. Do not exceed 5 days of treatment without medical advice or if symptoms do not improve. Continuing treatment beyond this time may cause disruptions to the oral flora.

Lyso 6 should not be used at the same time as any other antiseptic medication or medication containing the same active ingredients. As a precaution, always ask your doctor or pharmacist if you are taking any other medication before using Lyso 6.

Precautions with Lyso 6 for mouth ulcers

Lyso 6 is contraindicated in children under 6 years of age, in cases of known allergy to any of its ingredients, or in cases of egg allergy because lysozyme comes from chicken egg white.

Excessive consumption of Lyso 6 (over several months or years) leads to excessive consumption of vitamin B6 (pyridoxine). This can result in tingling and balance disorders, tremors in the hands and feet, and difficulty coordinating movements. These effects are generally reversible upon discontinuation of treatment.

Lyso 6 contains lactose; it should not be used by people allergic to lactose, or by those with galactose intolerance, or by patients with the Lapp lactase deficiency or glucose-galactose malabsorption syndrome.

During pregnancy, as a precaution, it is not recommended to use Lyso 6: always consult your doctor before taking any medication while pregnant. This is also true during breastfeeding, as it is not known whether lysozyme passes into breast milk.

Consult your doctor promptly if the lesions in the case of mouth ulcers or sores are significant or if a fever develops.
For the treatment of sore throats, if purulent (yellow) sputum is observed, fever, pain or discomfort when swallowing, or if symptoms worsen or do not improve after 5 days, a medical consultation will be necessary.

Condition: One box of 30 tablets

For sensitive gums, there is also Parodium gel for sensitive gums.





SUMMARY OF PRODUCT CHARACTERISTICS

ANSM - Updated on: 03/06/2024

1. NAME OF THE MEDICINAL PRODUCT

LYSO 6, sublingual tablet

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Pyridoxine hydrochloride................................................................................................. 10.00 mg

Lysozyme hydrochloride.................................................................................................. 20.00 mg

Per sublingual tablet

Excipients with known effects: lactose, sodium

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Sublingual tablet.

Uncoated, round, off-white tablet.

4. CLINICAL PARTICULARS

4.1. Therapeutic Indications

Adjunctive local treatment of limited disorders of the oral mucosa and oropharynx, including mouth ulcers.

LYSO 6 is indicated for adults and children over 6 years of age.

Note: In the presence of general clinical signs of bacterial infection, systemic antibiotic therapy should be considered.

4.2. Dosage and Method of Administration

Dosage

Adults, adolescents, and children over 6 years of age:

6 to 8 tablets, to be taken evenly throughout the day.

Doses should be spaced at least 1 hour apart.

If symptoms persist for more than 5 days and/or if fever occurs, medical advice should be sought.

Pediatric Population

LYSO 6 is contraindicated in children under 6 years of age (see section 4.3).

Method of Administration

Oral use.

The tablets should be allowed to dissolve slowly under the tongue.

4.3. Contraindications

This medication is contraindicated in the following situations:

Hypersensitivity to the active ingredients or to any of the excipients listed in section 6.1 (including lysozyme or egg allergy).

Children under 6 years of age.

4.4. Special warnings and precautions for use

Special warnings

In the presence of general clinical signs of bacterial infection, systemic antibiotic therapy should be considered.

This indication does not justify prolonged treatment beyond 5 days, especially as it could lead to an imbalance in the normal microbial flora of the oral cavity, with a risk of bacterial or fungal spread.

This medication contains lactose. Patients with galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption (rare hereditary diseases) should not take this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

Precautions for use

If other symptoms (severe sore throat, headache, nausea, vomiting, etc.) or associated fever occur, the appropriate course of action should be reassessed.

This medicine should not be used for prolonged periods.

Pyridoxine abuse may cause sensory neuropathy, which occurs when high doses of pyridoxine (> 100 mg/day) are used for prolonged periods (several months or even years). This is generally reversible upon discontinuation of treatment.

4.5. Interactions with other medicinal products and other forms of interaction

Not applicable.

4.6. Fertility, pregnancy, and breastfeeding

Pregnancy

Pyridoxine

Clinically, analysis of a large number of exposed pregnancies has not revealed any specific malformative or fetotoxic effects.

Lysozyme

There are no teratogenicity studies in animals. Clinical data are insufficient and do not allow for a conclusion.

Consequently, as a precautionary measure, it is preferable not to use this medication during pregnancy.

Breastfeeding

In the absence of data on the passage of lysozyme into breast milk, and due to the high amounts of pyridoxine present in Lyso-6, this treatment should be avoided during breastfeeding.

Fertility

Lysozyme

There are no studies available to evaluate the effects of lysozyme on fertility.

Pyridoxine

Taking pyridoxine at recommended doses is not likely to impair fertility.

4.7. Effects on ability to drive and use machines

LYSO 6 has no or negligible influence on the ability to drive and use machines.

4.8. Adverse Reactions

The adverse reactions listed below are listed by System Organ Class (SOC). The frequency of adverse reactions is defined using the following convention: very common (?1/10); common (?1/100 to <1/10); uncommon (?1/1,000 to <1/100); rare (?1/10,000 to <1/1,000); very rare (<1/10,000); Frequency not known (cannot be estimated from the available data).

System Organ Class

MedDRA Preferred Terms

Frequency

Not known

Immune system disorders

Anaphylactic Shock

Anaphylactic Reaction

Skin and subcutaneous tissue disorders

Angioedema

Pruritus

Photosensitivity reaction

Urticaria

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions via the national reporting system: 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.

4.9. Overdose

In case of acute overdose with LYSO 6, no clinical consequences are expected.

When taking high doses of pyridoxine (> 100 mg/day) for a long period (several months or even years), there is a risk of sensory neuropathy, reversible upon discontinuation of treatment (see section 4.4).

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: LOCAL ANTISEPTIC, ATC code: (R: Respiratory system)

5.2. Pharmacokinetic properties

Not specified.

5.3. Preclinical safety data

Lysozyme hydrochloride

Experimental studies have shown the immunotoxic potential of lysozyme hydrochloride. Experimental studies have demonstrated the immunotoxic potential of hen egg lysozyme, which has been shown to be relevant in humans.

No genotoxicity, carcinogenicity, or reproductive and developmental toxicity studies have been conducted with lysozyme hydrochloride.

Pyridoxine hydrochloride

Studies with pyridoxine hydrochloride have demonstrated neurotoxicity in rats and dogs, as well as in humans after repeated oral administration of doses exceeding the intended therapeutic doses of LYSO 6 in humans.

Pyridoxine hydrochloride is not genotoxic in conventional in vitro genotoxicity studies.

Pyridoxine hydrochloride was not found to be maternally, embryo-, or fetotoxic, or teratogenic after oral administration of up to 80 mg/kg/day in rats.

There are no experimental studies available to evaluate the carcinogenic potential of pyridoxine hydrochloride.

LYSO 6

Subchronic oral administration of LYSO 6 in rats showed no effects at doses higher than the intended therapeutic doses in humans.

6. PHARMACEUTICAL INFORMATION

6.1. List of excipients

Ethylvanillin, hypromellose, sodium saccharin, magnesium stearate, lactose monohydrate.

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special storage precautions

Do not store above +30°C.

Store in the original outer packaging to protect from moisture.

6.5. Nature and contents of outer packaging

PVC/Aluminum blister pack of 10 tablets.

Box of 30 tablets.

6.6. Special precautions for disposal and handling

No special requirements.

7. MARKETING AUTHORIZATION HOLDER

PIERRE FABRE MEDICAMENT

LES CAUQUILLOUS

81500 LAVAUR

[Tel, fax, email: to be completed later by the holder]

8. MARKETING AUTHORIZATION NUMBER(S)

· CIP 328.116-9: 30 tablets in blister packs (PVC/Aluminum)

9. DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION

[to be completed later by the holder]

10. DATE OF TEXT UPDATE

[to be completed later by the holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

PRESCRIPTION AND DISPENSING CONDITIONS

This medication does not require a prescription.


LEAFLET
ANSM - Updated on: 03/06/2024
Name of the medicinal product
LYSO 6, sublingual tablet
Pyridoxine hydrochloride
Lysozyme hydrochloride
Box
Please read all of 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 LYSO 6 sublingual tablet and what is it used for?
2. What you need to know before taking LYSO 6 sublingual tablet?
3. How to take LYSO 6 sublingual tablet?
4. Possible side effects?
5. How to store LYSO 6 sublingual tablet?
6. Contents of the pack and other information.
1. WHAT IS LYSO 6 sublingual tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic group - ATC code: LOCAL ANTISEPTIC - R: Respiratory system.
LYSO 6, whose active ingredients are pyridoxine hydrochloride and lysozyme hydrochloride, is an oral antiseptic.
This medication is recommended as an adjunctive local treatment for mild sore throats without fever, mouth ulcers, and small mouth sores in adults, adolescents, and children over 6 years of age.
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 LYSO 6 sublingual tablets?
Do not take LYSO 6 sublingual tablets:
· In children under 6 years of age.
· If you are allergic (hypersensitive) to pyridoxine hydrochloride, lysozyme hydrochloride, or any of the other ingredients of this medication (listed in section 6).
· If you are allergic to eggs (because lysozyme hydrochloride is extracted from chicken egg white).
Warnings and Precautions
Talk to your doctor or pharmacist before taking LYSO 6.
Special Warnings
Prolonged use (more than 5 days) of this medication is not recommended because it may alter the natural microbial balance of the mouth and throat, with a risk of microbe proliferation.
Precautions for Use
CONSULT YOUR DOCTOR OR PHARMACIST IMMEDIATELY in the following cases:
- Severe sore throat:
With the onset of fever, and/or purulent sputum (phlegm), and/or difficulty swallowing food,
- Mouth ulcer, small mouth sore:
In case of extensive lesions, and/or spread of lesions, and/or the onset of fever,
- Worsening or lack of improvement after 5 days of treatment, or the appearance of other symptoms (e.g., headache, nausea, and/or vomiting).
- High-dose (> 100 mg/day) use of pyridoxine (or vitamin B6) over a long period (several months or even years) can cause tingling, balance problems, sensitivity problems, pain, muscle weakness, and difficulty coordinating movements (sensory neuropathy). These effects are generally reversible when treatment is stopped.

Children and Adolescents
This medicine should not be used in children under 6 years of age.
Other medicines and LYSO 6 sublingual tablets
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Do not use several medicines for the same purpose and containing an antiseptic at the same time.

This medicine contains lysozyme hydrochloride and pyridoxine hydrochloride. Other medicines contain them. Do not combine them to avoid exceeding the maximum recommended doses (see dosage and administration).

LYSO 6, sublingual tablet with food and drink
Not applicable.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
As a precaution, it is preferable not to use this medicine during pregnancy.
Since it is unknown whether lysozyme passes into breast milk, and due to the high amounts of pyridoxine present in LYSO 6, you should avoid taking this medicine if you are breastfeeding.
Driving and using machines
LYSO 6 has no or negligible influence on the ability to drive and use machines. LYSO 6 sublingual tablets contain lactose and sodium.
Lactose: If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Sodium: This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free."
3. HOW TO TAKE LYSO 6 sublingual tablets
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 you are unsure.
FOR ADULTS, ADOLESCENTS, AND CHILDREN OVER 6 YEARS OLD.
The recommended dose is 6 to 8 tablets, to be taken evenly throughout the day.
Method of administration: Oral.
The tablets should be allowed to dissolve slowly under the tongue.
Doses should be spaced at least 1 hour apart.
The duration of treatment is limited to 5 days. If there is no improvement and/or the onset of an associated fever after 5 days of treatment, seek medical advice.
Use in children
LYSO 6 is contraindicated in children under 6 years of age.
If you take more LYSO 6 sublingual tablet than you should
If you take high doses (> 100 mg/day) of pyridoxine (or vitamin B6) for a long period (several months or years), sensory neuropathy (tingling, balance disorders, sensitivity disorders, pain, muscle weakness, difficulty coordinating movements) may occur, which is reversible upon discontinuation of treatment. If these problems occur, consult your doctor promptly, who will recommend treatment and monitoring.
If you forget to take LYSO 6 sublingual tablet
Do not take a double dose to make up for a forgotten dose. If you stop taking LYSO 6 sublingual tablets
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. Allergic reactions may occur with an unknown frequency (frequency cannot be estimated from the available data):
· Severe generalized allergic reaction (anaphylactic reaction or shock: a sudden, severe, and potentially fatal generalized allergic reaction without immediate medical attention, during which you may experience a skin rash (such as hives, itching), swelling, difficulty breathing, rapid heart rate, dizziness, sweating, drop in blood pressure, and/or loss of consciousness/fainting),
· Angioedema: a rapid swelling of the tissues under the skin and certain mucous membranes, often occurring in the face, neck, and throat, which may block the airways and be fatal if not immediately medically treated. It may also affect the arms, legs, back, digestive system, and genitals, and may also be accompanied by hives (red, itchy patches).
· Hives, itching (pruritus), sensitivity to light and sunlight (photosensitivity).
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 LYSO 6, sublingual tablet?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date shown on the carton. The expiry date refers to the last day of that month.
Do not store above +30°C.
Store in the original outer packaging to protect from moisture.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What LYSO 6, sublingual tablet contains
· The active ingredients per sublingual tablet are:
Pyridoxine hydrochloride........................................................................................... 10.00 mg
Lysozyme hydrochloride............................................................................................. 20.00 mg
· The other ingredients are:
Ethylvanillin, hypromellose, sodium saccharin, magnesium stearate, lactose monohydrate.
What LYSO 6, sublingual tablet, looks like and contents of the outer packaging
This medicine comes in the form of a round, off-white, uncoated sublingual tablet. Box of 30 tablets.
Marketing Authorisation Holder
PIERRE FABRE MEDICAMENT
LES CAUQUILLOUS
81500 LAVAUR
Marketing Authorisation Holder
PIERRE FABRE MEDICAMENT
PARC INDUSTRIEL DE LA CHARTREUSE
81100 CASTRES
Manufacturer
PIERRE FABRE MEDICAMENT PRODUCTION
ETABLISSEMENT PROGIPHARM
RUE DU LYCEE
45500 GIEN
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
Not applicable.
Detailed information on this medicine is available on the ANSM (France) website.