NOTICE
ANSM - Updated: 26/03/2018
Name of the drug
STREPSILS ORANGE VITAMIN C, lozenge
Amylmetacresol, 2,4-Dichlorobenzyl alcohol, Ascorbic acid
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 ORANGE VITAMIN C, lozenge and in what cases is it used?
2. What information do you need to know before using STREPSILS ORANGE VITAMIN C, tablet?
3. How to use STREPSILS ORANGE VITAMIN C, lozenge?
4. What are the possible side effects?
5. How to store STREPSILS ORANGE VITAMIN C, lozenge?
6. Contents of the package and other information.
1. WHAT STREPSILS ORANGE VITAMIN C, pellet AND WHAT IT IS USED FOR
Pharmacotherapeutic group Local antiseptic - ATC code: R: Respiratory system
This medicine contains 2 local antiseptics (amylmetacresol and 2,4-dichlorobenzyl alcohol) and vitamin C.
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. WHAT YOU SHOULD KNOW BEFORE USING ORANGE VITAMIN C STREPSILS, lozenge?
Do not take STREPSILS ORANGE VITAMIN C, lozenge:
· If you are allergic to the active substances or to any of the other ingredients of this medicine, listed in section 6.
· In children under 6 years old (because of the size of the pellets).
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 may alter the natural microbial balance of the mouth and throat.
Due to the presence of glucose and sucrose, these medicinal products should not be used in case of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency (rare metabolic diseases).
Due to a slightly stimulating effect due to the presence of vitamin C (100 mg per lozenge), it is best not to take this medicine at the end of the day.
This medicine contains 2 azo dyes, yellow orange S (E110) and red cochineal A (E124) and may cause allergic reactions.
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.
Canker sores, small sores of the mouth:
In case of extensive lesions, extensions of the lesions, appearance of fever: CONSULT YOUR DOCTOR OR YOUR PHARMACIST .
Talk to your doctor or pharmacist before taking STREPSILS MINT GLACIAL, lozenge to suck.
The use of this drug is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase (rare hereditary diseases) deficiency.
Talk to your doctor or pharmacist before taking STREPSILS ORANGE VITAMIN C, lozenge .
Other medicines and STREPSILS ORANGE VITAMIN C, lozenge
This medicine contains 2 local antiseptics (amylmetacresol and 2,4-dichlorobenzyl alcohol) and vitamin C.
Other medicines contain: do not combine them, so as not to exceed the recommended maximum doses (see dosage and method of administration).
Tell your doctor or pharmacist if you use, have recently used, or may use any other medicines.
STREPSILS ORANGE VITAMIN C, lozenge 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 ORANGE VITAMIN C, lozenge is not recommended during pregnancy and in women of child- bearing age not using contraception.
feeding
A risk for breastfed newborns / infants can not be ruled out. STREPSILS ORANGE VITAMIN C, pellet should not be used while breastfeeding.
Driving and using machines
Not applicable.
STREPSILS ORANGE VITAMIN C, tablet contains excipients with known effect : Glucose, Sucrose, Yellow Orange S (E 110), Red Cochineal A (E 124)
3. HOW TO USE STREPSILS ORANGE VITAMIN C, lozenge?
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 take more STREPSILS ORANGE VITAMIN C, lozenge than you should: Talk to your doctor or pharmacist if you have abnormal symptoms.
If you forget to take STREPSILS ORANGE VITAMIN C, tablet: Do not take a double dose to make up for the dose you have forgotten to take.
If you stop taking STREPSILS ORANGE VITAMIN C, tablet: 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 STORE ORANGE VITAMIN C STREPSILS, lozenge?
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 medication at a temperature not exceeding 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 ORANGE VITAMIN C contains, lozenge
· The active substances are:
Amylmetacresol ................................................. .................................................. ............ 0.6000 mg
2,4-Dichlorobenzyl alcohol ........................................... ............................................... 1,2000 mg
Ascorbic acid................................................ .................................................. ......... 33,5000 mg
Sodium ascorbate ............................................... .................................................. .... 74.9000 mg
For a lozenge.
· The other components are:
Sucrose / Glucose / Tartaric acid / Orange flavor PHL-105288 / Propylene glycol / Levomenthol / Yellow orange S (E110) / Red cochineal A (E124)
Vitamin C content per lozenge: 100 mg per lozenge
What STREPSILS ORANGE VITAMIN C, tablet 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 11018
91305 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:
May 18, 2018
Other
Detailed information on this medicine is available on the ANSM website (France).