NOTICE
ANSM - Updated: 29/03/2018
Name of the drug
STREPSILS STRAWBERRY WITHOUT SUGAR, pastille sweetened with isomalt, maltitol and sodium saccharin
Amylmetacresol, 2,4-dichlorobenzyl alcohol
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.
This medicine is a self-medication specialty, which can be used without consultation or prescription from a doctor.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse after 3 days.
What does this booklet contain ?
1. What is STREPSILS STRAWBERRY SUGAR FREE, sweetened with isomalt, maltitol and sodium saccharin pellet and in which cases is it used?
2. What information do you need to know before using STREPSILS STRAWBERRY WITHOUT SUGAR, pastille sweetened with isomalt, maltitol and saccharin sodium?
3. How to use STREPSILS STRAWBERRY WITHOUT SUGAR, pastille sweetened with isomalt, maltitol and saccharin sodium?
4. What are the possible side effects?
5. How to store STREPSILS STRAWBERRY WITHOUT SUGAR, pastille sweetened with isomalt, maltitol and sodium saccharin?
6. Contents of the package and other information.
1. WHAT IS STREPSILS STRAWBERRY SUGAR-FREE, sweetened with isomalt, maltitol and saccharin sodium pellet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group Local antiseptic - ATC code: R: Respiratory system
This medicine contains two local antiseptics (amylmetacresol and 2,4-dichlorobenzyl alcohol).
This medicine is indicated in adults and children over 6 years in case of sore throat and without fever.
You should talk to your doctor if you do not feel better or if you feel worse after 3 days.
2. BEFORE YOU USE STREPSILS STRAWBERRY WITHOUT SUGAR, pastille sweetened with isomalt, maltitol and sodium saccharin?
Do not take STREPSILS STRAWBERRY WITHOUT SUGAR, pastille sweetened with isomalt, maltitol and saccharin sodium:
· if you are allergic to the active substances or to any of the other ingredients of this medicine, listed in section 6.
· in a child under 6 years old
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Warnings and precautions
Prolonged use (more than 5 days) of this drug is undesirable as it can alter the natural microbial balance of the mouth, throat.
The use of this drug is not recommended in patients with fructose intolerance (rare hereditary disease).
Sore throat:
In the event of fever, purulent sputum (sputum), discomfort with food swallowing, as well as if worsening or lack of improvement after 3 days: CONSULT YOUR PHYSICIAN.
The caloric intake per pellet is 5.6 kilocalories.
Talk to your doctor or pharmacist before taking STREPSILS STRAWBERRY WITHOUT SUGAR, which is sweetened with isomalt, maltitol and sodium saccharin .
Children and adolescents
Not applicable.
Other medicines and STREPSILS STRAWBERRY WITHOUT SUGAR, sweetened with isomalt, maltitol and sodium saccharin
This medicine contains amylmetacresol and 2,4-dichlorobenzyl alcohol. Other medicines contain them: do not combine them so as not to exceed the recommended maximum doses (see Posology and method of administration).
Tell your doctor or pharmacist if you use, have recently used, or may use any other medicines.
STREPSILS STRAWBERRY WITHOUT SUGAR, pastille sweetened with isomalt, maltitol and sodium saccharin with food, drinks and alcohol
Not applicable.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The use of STREPSILS STRAWBERRY WITHOUT SUGAR, isomalt, maltitol and saccharin sodium sweetened pellet is not recommended during pregnancy and in women of child- bearing age who do not use contraception.
feeding
A risk for breastfed newborns / infants can not be ruled out. STREPSILS STRAWBERRY WITHOUT SUGAR, sweetened with isomalt, maltitol and saccharin sodium must not be used during breastfeeding.
Driving and using machines
Not applicable.
STREPSILS STRAWBERRY WITHOUT SUGAR, sweetened with isomalt, maltitol and sodium saccharin containing as excipient with known effect: maltitol
3. HOW TO USE STREPSILS STRAWBERRY WITHOUT SUGAR, pastille sweetened with isomalt, maltitol and sodium saccharin?
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS
The recommended dose in adults and children over 6 years: 1 lozenge, 3 to 6 times a day.
Slowly suck the lozenge without chewing it, or swallow it by spacing the plugs.
It is best to suck the pellet away from meals.
The duration of use is limited to 5 days
If you feel that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
If you took more than STREPSILS STRAWBERRY WITHOUT SUGAR, pastille sweetened with isomalt, maltitol and saccharin sodium that you should have
Consult your doctor or pharmacist if you have abnormal symptoms.
If you forget to take STREPSILS STRAWBERRY WITHOUT SUGAR, pastille sweetened with isomalt, maltitol and sodium saccharin
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking STREPSILS STRAWBERRY WITHOUT SUGAR, the pellet is sweetened with isomalt, maltitol and sodium saccharin
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
· Allergic reactions
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STERPSILS STRAWBERRY WITHOUT SUGAR, sweetened with isomalt, maltitol and saccharin sodium?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton.
Store this medicine at a temperature below 25 ° C.
Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What STREPSILS STRAWBERRY WITHOUT SUGAR, pastille sweetened with isomalt, maltitol and sodium saccharin
· The active substances are:
Amylmetacresol ................................................. .................................................. ................. 0.6 mg
2,4-Dichlorobenzyl alcohol ............................................ .................................................. .. 1.2 mg
For a pellet
· The other components are:
Strawberry aroma 052312B, pink anthocyanin (E163), sodium saccharin, tartaric acid, liquid maltitol, isomalt.
What is STREPSILS STRAWBERRY WITHOUT SUGAR, pellet sweetened with isomalt, maltitol and sodium saccharin and contents of the pack
Box of 24 lozenges to suck.
Marketing Authorization Holder
RECKITT BENCKISER HEALTHCARE France
38 VICTOR BASCH STREET
CS 11018
91305 MASSY CEDEX
Operator of the marketing authorization
RECKITT BENCKISER HEALTHCARE France
38 VICTOR BASCH STREET
CS 1101891305 MASSY CEDEX
Maker
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED
NOTTINGHAM SITE
THANE ROAD, NOTTINGHAM
NOTTINGHAMSHIRE, NG 90 2 DB
UK
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
[to be completed later by the holder]
<{MM / YYYY}> <{YYYY month}.>
Other
Detailed information on this medicine is available on the ANSM website (France).