NOTICE
ANSM - Last updated: 10/05/2017
Name of the medicinal product
STREPSILS LIDOCAINE, pastille
Lidocaine hydrochloride / Amylmetacresol / 2,4-dichlorobenzyl alcohol
framed
Read this manual carefully because it contains important information.
· This medication is a specialty of AUTOMEDIZATION which can be used without consultation or prescription from a doctor.
· The persistence of the symptoms, the aggravation or the appearance of new disorders, require to take a medical opinion.
· Keep this leaflet, you may need to read it again.
If you need more information and advice, ask your pharmacist or doctor.
Review summary
In this notice :
1. WHAT IS LIDOCAINE STREPSILS, pellet AND WHAT CASES IS IT USED FOR?
2. BEFORE YOU TAKE STREPSILS LIDOCAINE, pastille?
3. HOW TO TAKE STREPSILS LIDOCAINE, pastille?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE STREPSILS LIDOCAINE, pastille?
6. ADDITIONAL INFORMATION
1. WHAT IS LIDOCAINE STREPSILS, pellet AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group
PREPARATIONS FOR THE THROAT
This medicine contains a local anesthetic (lidocaine hydrochloride) and two local antiseptics (amylmetacresol and 2,4-dichlorobenzyl alcohol).
Therapeutic indications
It is indicated in adults and children over 6 years in case of a sore throat with low intensity without fever, canker sores, small sores of the mouth.
2. BEFORE YOU TAKE STREPSILS LIDOCAINE, pastille?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never take STREPSILS LIDOCAINE, tablet if you have a history of allergy to local anesthetics or other components of the lozenge.
IN CASE OF DOUBT, YOU MUST REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Precautions for use; special warnings
Take special care with STREPSILS LIDOCAINE, pastille:
Special warnings
DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
· Anesthesia caused by this drug in the throat can promote false roads (coughing during a meal with "swallowing") when swallowing food. It is therefore imperative:
o use this medication only with caution in children under 12 years of age,
o not to use this medication before meals or before drinking.
· Prolonged use (more than 5 days) of this medication is undesirable as it can alter the natural microbial balance of the mouth, throat.
· Follow the recommended dosage: taken in large quantities or repeatedly, this drug passing into the bloodstream, is likely to sound on the nervous system with possibility of convulsions and on the heart.
· Due to the presence of glucose and sucrose, this medication should not be used in cases of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency (rare metabolic diseases).
Precautions for use
· Sore throat
If fever, sputum, purulent sputum, swallowing of food, as in case of worsening or lack of improvement after 5 days: CONSULT YOUR DOCTOR.
· Canker sores, small mouth sores
In case of extensive lesions, extensions of the lesions, of fever: CONSULT YOUR DOCTOR IMMEDIATELY.
This medication contains 2.5 g of sugar per tablet: take it into account in the daily diet in the case of a diet low in sugar or diabetes.
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Interaction with other medicines
Taking or using other medicines
This medicine contains amylmetacresol, 2,4-dichlorobenzyl alcohol and a local anesthetic (lidocaine). Other medicines contain it. Do not combine them in order not to exceed the maximum recommended doses ( see Dosage ).
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Pregnancy
In the absence of data on this combination, as a precautionary measure, it is preferable not to use STREPSILS LIDOCAINE during pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine.
feeding
It is possible to take this medicine during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Sport
The attention of athletes will be drawn to the fact that this specialty contains an active principle (local anesthetic) that can induce a positive reaction of the tests performed during the doping controls.
Effects on ability to drive or use machines
not applicable.
List of excipients with known effect
List of excipients with known effect: glucose, sucrose.
3. HOW TO TAKE STREPSILS LIDOCAINE, pastille?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Reserved for adults and children over 6 years of age.
Take the pastilles away from meals.
Adult:
1 tablet to be melted slowly in the mouth without chewing, to renew if necessary after 2 hours, without exceeding 8 pellets per day.
Child from 6 to 15 years:
1 tablet to be slowly melted in the mouth without chewing, to renew if necessary after 2 hours, without exceeding 4 pellets per day.
Duration of the treatment
The duration of use is limited to 5 days
If you have the impression that the effect of STREPSILS LIDOCAINE, pellet is too strong or too weak:
Consult your doctor or pharmacist.
Symptoms and Instructions for Overdose
If you have taken more LIDOCAINE STREPSILS, pellet you should:
Consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take STREPSILS LIDOCAINE, tablet:
Do not take a double dose to make up for the single dose that you have forgotten to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, STREPSILS LIDOCAINE, pellet is likely to have side effects, although not everyone is subject to it:
· rash: in this case, stop treatment,
· possibility of temporary numbness of the tongue,
· in case of misuse (cough during a meal with "swallowing" impression) it is advisable to discontinue the treatment and seek advice from a doctor.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE STREPSILS LIDOCAINE, pastille?
Keep out of the reach and sight of children.
Expiration date
Do not use STREPSILS LIDOCAINE, tablet after the expiry date which is stated on the carton.
Storage conditions
Store at a temperature not exceeding 25 ° C.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What is STREPSILS LIDOCAINE, pastille?
The active substances are:
Lidocaine hydrochloride, amylmetacresol, 2,4-dichlorobenzyl alcohol
The other components are:
Essential oil of peppermint, essential oil of badian, levomenthol, indigotine, quinoline yellow, saccharin sodium, tartaric acid, sucrose solution, liquid glucose.
Pharmaceutical form and content
What is STREPSILS LIDOCAINE, lozenge and contents of the pack?
This medication is in the form of a tablet. Box of 8, 12, 16, 24 or 36.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
RECKITT BENCKISER HEALTHCARE France
38 RUE VICTOR BASCH
CS 11018
91305 MASSY CEDEX
exploiting
RECKITT BENCKISER HEALTHCARE France
38 RUE VICTOR BASCH
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 medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.