NOTICE
ANSM - Last updated: 10/05/2017
Name of the medicinal product
STREPSILSPRAY (with lidocaine), mouthwash
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist after 5 days, consult a physician.
· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS STREPSILSPRAY (with lidocaine), mouthwash AND WHAT CASES IS IT USED FOR?
2. BEFORE YOU USE STREPSILSPRAY (with lidocaine), mouthwash?
3. HOW TO USE STREPSILSPRAY (with lidocaine), mouthwash?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE STREPSILSPRAY (with lidocaine), mouthwash?
6. ADDITIONAL INFORMATION
1. WHAT IS STREPSILSPRAY (with lidocaine), mouthwash AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group
PREPARATIONS FOR THE THROAT
Therapeutic indications
This medicine contains a local anesthetic (lidocaine hydrochloride) and two local antiseptics (amylmetacresol and 2,4-dichlorobenzyl alcohol).
It is indicated in adults and children over 12 years of age in the case of low sore throat without fever, canker sores, small mouth sores.
2. BEFORE YOU USE STREPSILSPRAY (with lidocaine), mouthwash?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not use STREPSILSPRAY (with lidocaine), mouthwash:
· in case of a history of allergy to local anesthetics or other components.
IN CASE OF DOUBT, YOU MUST REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Precautions for use; special warnings
Take special care with STREPSILSPRAY (with lidocaine), mouthwash:
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 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 and 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 sorbitol, this medication should not be used in cases of intolerance to fructose (hereditary metabolic disease).
Warning! This medicine contains alcohol: the alcoholic strength of the solution is 96%, ie 0.084g of alcohol per dose. |
Precautions for use
This specialty should not be put in contact with the eyes, introduced into the nose or into the ears.
· Sore throat :
In case of fever, sputum (sputum) purulent, discomfort with the swallowing of food, as in case of aggravation or lack of improvement after 5 days: CONSULT YOUR DOCTOR .
· Canker sores, small mouth sores :
In case of extensive lesions, extensions of lesions, or fever: CONSULT YOUR DOCTOR.
Due to the presence of alcohol, tell your doctor about liver disease, epilepsy or pregnancy.
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 a combination of 2 local antiseptics (amylmetacresol and 2,4-dichlorobenzyl alcohol) and a local anesthetic (lidocaine). Other medicines contain it. Do not combine them to avoid exceeding the maximum recommended doses ( see Dosage and Administration ). |
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 - Breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. |
In the absence of data on this combination, as a precautionary measure, it is preferable not to use STREPSILSPRAY during pregnancy.
It is possible to take this medicine during breast-feeding.
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: alcohol, sorbitol, azorubine (E 122).
3. HOW TO USE STREPSILSPRAY (with lidocaine), mouthwash?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Do not use this mouthwash in children under 12 years of age. |
Reserved for adults and children over 12 years of age.
Space the plugs for at least 2 hours
Children aged 12 to 15 :
2 sprays in the mouth and / or throat 1 to 4 times a day.
Adults :
2 sprays in the mouth and / or throat 1 to 6 times a day.
Method and route of administration
Mouth.
By spraying at the mouth and / or throat.
Frequency of Administration
Space outlets for at least 2 hours.
It is imperative that you do not use this medication before meals or before drinking.
Duration of treatment
The duration of use is limited to 5 days. |
Symptoms and Instructions for Overdose
If you take more STREPSILSPRAY (to lidocaine), mouthwash than you should:
If you take more STREPSILSPRAY (lidocaine), mouthwash than you should: CONSULT YOUR DOCTOR OR YOUR PHARMACIST.
Instructions for omission of one or more doses
If you forget to take STREPSILSPRAY (to lidocaine), mouthwash:
Do not take a double dose to make up for a missed dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all drugs, STREPSILSPRAY (with lidocaine), mouthwash 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 treatment and seek advice from a doctor,
· allergic reactions due to the presence of azorubine.
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 STREPSILSPRAY (with lidocaine), mouthwash?
Keep out of the reach and sight of children.
Expiration date
Do not use STREPSILSPRAY (with lidocaine) after the expiry date stated on the vial.
Storage conditions
No special storage conditions.
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 does STREPSILSPRAY contain (lidocaine), mouthwash?
The active substances are:
Amylmetacresol ................................................. .................................................. ............................ 0.223 g
2,4-Dichlorobenzyl alcohol .................................................. .............. 0.446 g
Lidocaine ................................................. .................................................. ...................................... 0,600 g
For 100 ml.
The other components are :
Alcohol, citric acid monohydrate, glycerol, non-crystallizable 70 percent sorbitol, saccharin, levomenthol, peppermint flavor, anise flavor, azorubine, sodium hydroxide and / or hydrochloric acid, purified water
Pharmaceutical form and content
What is STREPSILSPRAY (with lidocaine), mouthwash and contents of the outer packaging?
This medication is in the form of a mouthwash. Bottle of 20 ml.
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
BCM LIMITED
1 THANE ROAD WEST
NOTTINGHAM
NG 2 3AA
UK
or
FAMAR NEDERLAND BV
INDUSTRIEWEG 1
5531 AD BLADEL
NETHERLANDS
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.