In this manual :
1. WHAT IS LYSO 6, sublingual tablet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING LYSO 6, sublingual tablet
3. HOW DO I TAKE LYSO 6, sublingual tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO CONSERVE LYSO 6, sublingual tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS LYSO 6, sublingual tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Pharmacotherapeutic class: LOCAL ANTISEPTIC
ATC Code: (R: Respiratory System)
This medicine is recommended in cases of mild sore throat without fever, mouth ulcers and small mouth sores in adults and children over 6 years of age.
2. WHAT YOU SHOULD KNOW BEFORE TAKING LYSO 6, sublingual tablet
List of information needed before taking the medicine
If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine
Never take LYSO 6, sublingual tablet:
- In children under 6 years of age.
- If you are allergic (hypersensitive) to pyridoxine hydrochloride, lysozyme hydrochloride or any of the components of LYSO 6, sublingual tablet.
Precautions; special warnings
Use caution with LYSO 6, sublingual tablet:
Special Warnings
High doses of pyridoxine (or vitamin B6) taken over a long period of time (months to years) may cause tingling and disturbance of balance, tremors of the hands and feet, and difficulty in coordinating movements. These effects are usually reversible when treatment is stopped.
Prolonged use (more than 5 days) of this medication is not desirable because it may alter the natural microbial balance of the mouth and throat.
Precautions for use
Sore throat:
In case of occurrence:
- fever,
- of purulent sputum (sputum),
- of discomfort when swallowing food,
As in the case of aggravation or lack of improvement after 5 days, CONSULT YOUR DOCTOR.
Aphta, small sore of the mouth:
In case:
- of extensive lesions,
- of extension of the lesions,
- of the appearance of a fever,
CONSULT YOUR PHYSICIAN IMMEDIATELY.
The use of this medicine is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Use of other medicines
Do not use several medicines containing antiseptics at the same time.
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This medication contains lysozyme hydrochloride and pyridoxine hydrochloride.
Other medicines contain it. Do not combine them so as not to exceed the maximum recommended doses (see dosage and administration).
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If you are taking or have recently taken any other medication, including over-the-counter drugs, talk to your doctor or pharmacist.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
Pregnancy and lactation
As a precautionary measure, it is preferable not to use this medication during pregnancy.
The passage of lysozyme into milk is unknown, so you should not take this medicine if you are breast-feeding.
In general, during pregnancy and breastfeeding, you should always ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with a known effect
Important information about some ingredients of LYSO 6, sublingual tablet:
Lactose.
3. HOW TO TAKE LYSO 6, sublingual tablet?
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS.
6 to 8 tablets, to be taken regularly throughout the day.
Mode of administration
Oral route.
The tablets should be allowed to melt slowly under the tongue.
Frequency of administration
The tablets should be taken at least 1 hour apart.
Duration of treatment
The duration of treatment is limited to 5 days. If there is no improvement after 5 days of treatment, seek medical advice.
Symptoms and instructions in case of overdose
If you have taken more LYSO 6, sublingual tablet than you should have:
In case of high doses taken over a long period of time (several months or even years), peripheral neuropathy may occur (tingling, numbness of the extremities of the limbs, muscle weakness), which is reversible when treatment is stopped. In the event of the appearance of these disorders, consult your doctor promptly who will suggest treatment and monitoring.
Instructions in case of omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, LYSO 6, sublingual tablet is likely to have side effects, although not everyone is susceptible.
Allergic reactions may occur:
- skin: hives, itching, sensitivity to light, sunlight (photosensitivity).
- severe generalised allergic reaction (allergic shock), sudden swelling of the face and neck (angioedema).
If you experience any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
5. HOW TO STORE LYSO 6, sublingual tablet
Keep out of the reach and sight of children.
Do not use LYSO 6, sublingual tablet after the expiry date stated on the box.
Store at a temperature not exceeding 30°C.
Store in the original outer packaging, protected from moisture.
If necessary, warnings against certain visible signs of deterioration
Not applicable.
Medicines should not be disposed of in the sewage system or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does LYSO 6 sublingual tablet contain?
The active ingredients are
Pyridoxine hydrochloride ............................................................................................................. 10.00 mg
Lysozyme hydrochloride .............................................................................................................. 20.00 mg
For one sublingual tablet.
The other components are:
Excipients: ethylvanillin, hypromellose, sodium saccharin, magnesium stearate, lactose monohydrate.
Pharmaceutical form and content
What is LYSO 6, sublingual tablet and what does it contain?
This medicine is presented as a sublingual tablet. Box of 30 tablets.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
PIERRE FABRE MEDICAMENT
45 PLACE ABEL GANCE
92654 BOULOGNE CEDEX
Operator
PIERRE FABRE MEDICAMENT
29 AVENUE DU SIDOBRE
81106 CASTRES CEDEX
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.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
Not applicable.
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