In this manual :
1. WHAT IS STREPSILSPRAY (with lidocaine), mouthwash AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE USING STREPSILSPRAY (with lidocaine), Mouthwash
3. HOW DO I USE STREPSILSPRAY (with lidocaine) Mouthwash?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE STREPSILSPRAY (with lidocaine), Mouthwash?
6. ADDITIONAL INFORMATION
1. WHAT IS STREPSILSPRAY (with lidocaine), mouthwash and WHAT IS IT USED FOR?
Pharmacotherapeutic class
THROAT PREPARATIONS
This medicine contains a local anaesthetic (lidocaine hydrochloride) and two local antiseptics (amylmetacresol and 2,4-dichlorobenzyl alcohol).
It is indicated for adults and children over 12 years of age in cases of mild sore throat without fever, mouth ulcers, small mouth sores.
2. WHAT YOU SHOULD KNOW BEFORE USING STREPSILSPRAY (with lidocaine), mouthwash
List of information needed before taking the medicine
Not applicable.
Never use STREPSILSPRAY (with lidocaine), mouthwash:
- if you have a history of allergy to local anaesthetics or other components.
IF IN DOUBT, SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Precautions for use; special warnings
Be careful with STREPSILSPRAY (with lidocaine), mouthwash:
Special Warnings
KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN.
- The anaesthesia caused by this medicine in the throat may cause false routes (coughing during a meal with the impression of "swallowing the wrong way") 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 medicine is not desirable because it can alter the natural microbial balance of the mouth and throat.
- Respect the indicated dosage: taken in large quantities or repeatedly, this medicine, by passing into the bloodstream, is likely to affect the nervous system with the possibility of convulsions and the heart.
- Due to the presence of sorbitol, this medicine should not be used in cases of fructose intolerance (hereditary metabolic disease).
|
Caution! This medicine contains alcohol: the alcoholic strength of the solution is 96%, i.e. 0.084g of alcohol per dose.
|
Precautions for use
This speciality must not be brought into contact with the eyes, introduced into the nose or into the ears.
- Sore throat
In case of fever, purulent sputum, discomfort when swallowing food, as well as in case of aggravation or lack of improvement after 5 days CONSULT YOUR DOCTOR.
- Mouth ulcers, small sores of the mouth:
In case of extensive lesions, extensions of lesions, appearance of fever CONSULT YOUR DOCTOR.
Because of the presence of alcohol, tell your doctor in case of liver disease, epilepsy or pregnancy.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other drugs
Taking or using other medicines
|
This medication contains a combination of 2 local antiseptics (amylmetacresol and 2,4-dichlorobenzyl alcohol) and a local anesthetic (lidocaine). Other drugs contain them. Do not combine them so as not to exceed the maximum recommended doses(see Dosage and Administration).
|
Talk to your doctor or pharmacist if you are taking or have recently taken any other medication, including medication obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy - Breastfeeding
|
Ask your doctor or pharmacist for advice before taking any medication.
|
In the absence of data on this combination, as a precautionary measure, it is preferable not to use STREPSILSPRAY during pregnancy.
This medication may be taken during breastfeeding.
Sportsmen and women
The attention of sportsmen and women should be drawn to the fact that this medicinal product contains an active ingredient (local anaesthetic) which may induce a positive reaction in tests carried out during anti-doping controls.
Effects on the ability to drive vehicles or use machines
Not applicable.
List of excipients with a notable effect
List of excipients with a notorious effect: alcohol, sorbitol, azorubin (E 122).
3. HOW TO USE STREPSILSPRAY (with lidocaine), mouthwash
Instructions for proper use
Not applicable.
Dosage, Method and/or route of administration, Frequency of administration and Duration of treatment
Dosage
|
Do not use in children under 12 years of age.
|
For use in adults and children over 12 years of age only.
Take at least 2 hours apart
Children aged 12 to 15 years:
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.
Mode and route of administration
Oral route.
Spray in the mouth and/or throat.
Frequency of administration
Take at least 2 hours apart.
It is imperative not to use this medicine before meals or before drinking.
Duration of treatment
|
The duration of use is limited to 5 days.
|
Symptoms and instructions in case of overdose
If you have taken more STREPSILSPRAY (with lidocaine), mouthwash than you should have:
If you have taken more STREPSILSPRAY (with lidocaine) than you should have: CONSULT YOUR DOCTOR OR PHARMACIST.
Instructions in case of missed dose(s)
If you forget to take STREPSILSPRAY (with lidocaine), mouthwash:
Do not take a double dose to make up for the 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, STREPSILSPRAY (with lidocaine) is likely to have side effects, although not everyone is subject to them.
- Skin rash: if this happens, stop treatment,
- possibility of temporary numbness of the tongue,
- in case of false route (coughing during a meal with the impression of "swallowing the wrong way") it is advisable to interrupt the treatment and ask a doctor,
- allergic reactions due to the presence of azorubin.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please inform your doctor or pharmacist.
5. HOW TO USE STREPSILSPRAY (with lidocaine), mouthwash?
Keep out of the reach and sight of children.
Do not use STREPSILSPRAY (with lidocaine), mouthwash after the expiry date stated on the bottle.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewer or with your household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active ingredients and excipients
What does STREPSILSPRAY (with lidocaine), mouthwash, contain?
The active ingredients 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, 70 per cent non-crystallising sorbitol, saccharin, levomenthol, peppermint flavour, aniseed flavour, azorubin, sodium hydroxide and/or hydrochloric acid, purified water
Pharmaceutical form and content
What is STREPSILSPRAY (with lidocaine), mouthwash and what does it contain?
This medicine is in the form of a mouthwash. Bottle of 20 ml.
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
BCM LIMITED
1 THANE ROAD WEST
NOTTINGHAM
NG 2 3AA
UNITED KINGDOM
or
FAMAR NEDERLAND B.V.
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 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.
Français
English
