In this manual :
1. WHAT IS LYSOPAINE SUGAR-FREE, sweetened tablets with sorbitol and saccharin AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING LYSOPAINE SWEETENING TABLETS, sweetened with sorbitol and saccharin
3. HOW TO TAKE LYSOPAINE SWEETENING TABLET, sweetened with sorbitol and saccharin?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE LYSOPAINE SWEETENING TABLET, sweetened with sorbitol and saccharin?
6. ADDITIONAL INFORMATION
1. WHAT IS LYSOPAINE SUGAR-FREE, sweetened tablets with sorbitol and saccharin AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
LOCAL ANTISEPTIC.
(R: respiratory system)
This medicine contains lysozyme and cetylpyridinium.
It is indicated in adults and children over 6 years of age in cases of:
- mild sore throat without fever.
- mouth ulcers, small mouth sores.
IN CASE OF DOUBT, NEVER HESITATE TO ASK YOUR DOCTOR OR PHARMACIST.
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING LYSOPAINE SWEETENING TABLET, sweetened with sorbitol and saccharin?
List of information needed before taking the medicine
If your doctor has told you that you are intolerant to certain sugars, contact him or her before taking this medicine.
Do not take LYSOPAINE SWEETENING TABLET sweetened with sorbitol and saccharin in the following cases:
- children under 6 years of age.
- history of allergy to any of the components of the medicine, including allergy to lysozyme or allergy to egg.
Precautions; special warnings
Be careful with LYSOPAINE SWEETENING TABLET, sweetened with sorbitol and saccharin:
Prolonged use (more than 5 days) of this medicine is not desirable as it may alter the natural microbial balance of the mouth, throat.
Sore throat
In case of occurrence:
- fever
- of purulent sputum (sputum),
- discomfort when swallowing food,
or in case of aggravation or lack of improvement after 5 days, CONSULT YOUR DOCTOR.
Aphta, small sore of the mouth
In case of:
- of extensive lesions,
- of extension of the lesions,
- of the appearance of fever,
CONSULT YOUR DOCTOR IMMEDIATELY.
The use of this medicine is not recommended in patients with fructose intolerance (a rare hereditary disease).
Interactions with other medicines
Taking or using other medicines
Do not use more than one medicine containing an antiseptic at the same time.
Talk to your doctor or pharmacist if you are taking or have recently taken any other medication, including medication obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, do not take this medicine without asking your doctor or pharmacist
Ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
Important information about some of the ingredients of LYSOPAINE SUGAR-FREE SWEET TABLET, sweetened with sorbitol and saccharin:
Sorbitol (approximately 1.3 g per tablet).
3. HOW TO TAKE LYSOPAINE SWEETENING TABLET, sweetened with sorbitol and saccharin?
Instructions for proper use
Do not use this medicine in children under 6 years of age.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS OF AGE.
On average, 3 to 6 tablets to be sucked per day, to be allowed to melt in the mouth and to be distributed regularly throughout the day.
Mode of administration
Oral route.
Frequency of administration
The tablets are to be sucked with a minimum delay of 2 hours between each intake.
Duration of 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.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, LYSOPAINE SWEETENING TABLET, sweetened with sorbitol and saccharin is likely to have undesirable effects, although not everyone is susceptible:
Cases of allergic reactions have been reported with medicines containing lysozyme (active substance).
Undesirable effects of undetermined frequency (cannot be estimated on the basis of available data): allergic reaction including allergic oedema.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO USE LYSOPAINE SUGAR-FREE SWEET TABLETS, sweetened with sorbitol and saccharin?
Keep out of the reach and sight of children.
Do not exceed the expiry date indicated on the packaging.
Store at a temperature not exceeding 30°C.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain 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 LYSOPAINE SWEETENING TABLET, sweetened with sorbitol and saccharin, contain?
The active ingredients are:
Cetylpyridinium chloride ................................................................................................................ 1.5 mg
Lysozyme hydrochloride ................................................................................................................ 20.0 mg
The other components are:
Saccharin, magnesium stearate, mint flavour*, sorbitol.
*Composition of mint flavour: peppermint essential oil, gum arabic.
Pharmaceutical form and content
This medicine takes the form of a chewable tablet.
Box of 1 tube of 12, 18, 20 or 24 tablets or box of 2 tubes of 18 or 20 tablets.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
BOEHRINGER INGELHEIM FRANCE
14 RUE JEAN ANTOINE DE BAIF
75013 PARIS
Operator
BOEHRINGER INGELHEIM FRANCE
14 RUE JEAN ANTOINE DE BAIF
75013 PARIS
Manufacturer
DELPHARM REIMS
10 RUE COLONEL CHARBONNEAUX
51100 REIMS
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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