In this leaflet :
1. WHAT IS STREPSILS strawberry SUGAR-FREE, lozenge sweetened with isomalt, maltitol and saccharin sodium AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING STREPSILS SWEET STRAWBERRY, lozenge sweetened with isomalt, maltitol and saccharin sodium?
3. HOW TO TAKE STREPSILS SWEETSTONE, lozenge sweetened with isomalt, maltitol and sodium saccharin?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO CONSERVE STREPSILS strawberry SUGAR-FREE, lozenge sweetened with isomalt, maltitol and sodium saccharin?
6. ADDITIONAL INFORMATION
1. WHAT IS STREPSILS strawberry SUGAR-FREE, lozenge sweetened with isomalt, maltitol and sodium saccharin AND WHEN IS IT USED?
Pharmacotherapeutic class
This medicine contains two local antiseptics (amylmetacresol and 2,4-dichlorobenzyl alcohol).
It is indicated for adults and children over 6 years of age in cases of mild sore throat without fever.
2. WHAT YOU SHOULD KNOW BEFORE TAKING STREPSILS SUGAR-FREE, lozenge sweetened with isomalt, maltitol and sodium saccharin?
List of information needed before taking the medicine
Not applicable.
Do not take STREPSILS strawberry SWEET LETTER sweetened with isomalt, maltitol and saccharin sodium in case of known allergy to any of the components of the lozenge.
Precautions for use; special warnings
Be careful with STREPSILS strawberry SWEET, lozenge sweetened with isomalt, maltitol and sodium saccharin
Warnings:
Prolonged use (more than 5 days) of this medication is not desirable as it may alter the natural microbial balance of the mouth, throat.
Due to the presence of maltitol, this medicine should not be used in cases of fructose intolerance (hereditary metabolic disease).
Precaution for use:
Sore throat:
In the event of the occurrence of fever, purulent sputum (sputum), discomfort when swallowing food, as well as in the event of aggravation or lack of improvement after 5 days CONSULT YOUR DOCTOR.
The caloric intake per lozenge is 5.6 kilocalories.
Interactions with other medicines
Taking or using other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are non-prescription medicines.
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This medicine contains amylmetacresol and 2,4-dichlorobenzyl alcohol. Do not combine them with other medicines to avoid exceeding the maximum recommended doses(see Dosage and Administration).
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Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and lactation
This medicine should be used with caution during pregnancy and while breastfeeding.
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
List of excipients with a notable effect: maltitol, quinoline yellow (E104).
3. HOW TO TAKE STREPSILS SWEET STRAWBERRY, lozenge sweetened with isomalt, maltitol and saccharin sodium?
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 OF AGE
The dosage is 1 lozenge, 3 to 6 times a day.
Suck the lozenge slowly without chewing or swallowing, spacing out the doses.
It is preferable to suck the lozenge away from meals.
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The duration of use is limited to 5 days
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If you feel that the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed doses
If you forget to take STREPSILS strawberry SUGAR-FREE, lozenge sweetened with isomalt, maltitol and saccharin sodium:
Do not take a double dose to make up for the single dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, STREPSILS strawberry SUGAR-FREE, lozenge sweetened with isomalt, maltitol and saccharin sodium is likely to have undesirable effects, although not everyone is subject to them.
- Allergic reactions may occur,
- Due to the presence of maltitol, digestive disorders and diarrhea may occur.
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 STREPSILS strawberry SUGAR-FREE, lozenge sweetened with isomalt, maltitol and sodium saccharin?
Keep out of the reach and sight of children.
Do not use STREPSILS strawberry SUGAR-FREE, lozenge sweetened with isomalt, maltitol and saccharin sodium after the expiry date stated on the outer packaging.
Store at a temperature not exceeding 25°C.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewer 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 STREPSILS Strawberry SWEET lozenge sweetened with isomalt, maltitol and saccharin sodium contain?
The active ingredients are:
Amylmetacresol .............................................................................................................................. 0.60 mg
2,4-dichlorobenzyl alcohol ........................................................................................................... 1,20 mg
For one lozenge.
The other components are:
Strawberry flavour PHL-135077, quinoline yellow (E104), saccharin sodium, tartaric acid, liquid maltitol, isomalt.
Pharmaceutical form and content
What is STREPSILS strawberry SUGAR-FREE, lozenge sweetened with isomalt, maltitol and sodium saccharin and what does it contain?
This medicine comes in lozenge form. Box of 6, 8, 12, 24 or 36 lozenges.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
RECKITT BENCKISER HEALTHCARE FRANCE
15, RUE AMPERE
91748 MASSY CEDEX
Operator
RECKITT BENCKISER HEALTHCARE FRANCE
15, RUE AMPERE
91748 MASSY CEDEX
Manufacturer
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED
NOTTINGHAM SITE
THANE ROAD, NOTTINGHAM
NOTTINGHAMSHIRE, NG 90 2 DB
UNITED KINGDOM
or
NATUR PRODUKT PHARMA LTD
30 PODSTOCZYSKO STR.
07-300 OSTROW MAZOWIECKA
POLAND
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 leaflet 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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