NOTICE
ANSM - Last updated: 03/09/2010
Name of the medicinal product
DRILL WITHOUT SUGAR SUREAU LITCHI, tablet sweetened with isomalt and acesulfame potassium
framed
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your pharmacist for more information.
· 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 of treatment, 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 pharmacist.
Review summary
In this notice :
1. WHAT IS DRILL WITHOUT SUGAR LITCHI SAUCER, sweetened with isomalt and acesulfame potassic AND WHAT IS IT?
2. BEFORE YOU TAKE DRILL WITHOUT SUGAR SUREAU LITCHI, a tablet sweetened with isomalt and acesulfame potassium?
3. HOW TO TAKE DRILL WITHOUT SUGAR SUREAU LITCHI, sweetened with isomalt and acesulfame potassium?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE DRILL WITHOUT SUGAR SUREAU LITCHI, sweetened with isomalt and acesulfame potassic?
6. ADDITIONAL INFORMATION
1. WHAT IS DRILL WITHOUT SUGAR LITCHI SAUCER, sweetened with isomalt and acesulfame potassic AND WHAT IS IT?
Pharmacotherapeutic group
LOCAL ANTISEPTIC / LOCAL ANESTHESIC (R02A: throat preparation)
Therapeutic indications
This medication is indicated for patients with mild sore throat and no fever, mouth ulcers and small mouth sores in adults and children over 6 years of age.
2. BEFORE YOU TAKE DRILL WITHOUT SUGAR SUREAU LITCHI, a tablet sweetened with isomalt and acesulfame potassium?
List of information needed before taking the medication
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Do not take DRILL WITHOUT SUGAR SUREAU LITCHI, tablet sweetened with isomalt and acesulfame potassic:
· In children under 6 years.
· if you are allergic to local anesthetics and chlorhexidine or any of the other ingredients of this medication.
Precautions for use; special warnings
Take special care with DRILL WITHOUT SUGAR SUREAU LITCHI, sweetened with isomalt and acesulfame potassic:
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:
· to use this drug only with caution in children under 12 years of age
· not to use this medication before meals or before drinking.
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.
Prolonged use (more than 5 days) of this medication is undesirable as it can alter the natural microbial balance of the mouth, throat.
Sore throat: if there is a fever, sputum (sputum), swelling in food swallowing, as in the case of worsening or no 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.
The use of this medication is not recommended in patients with fructose intolerance (rare hereditary disease).
This medicine contains "sulfite" and can cause severe allergic reactions and respiratory discomfort.
This medication contains an azo agent (E124) and may cause allergic reactions.
DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
Interaction with other medicines
Taking other medicines
Do not use several medications containing antiseptic at the same time.
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, speak to your pharmacist.
Interactions with food and beverages
Food and drinks
Pellets should not be taken before meals or before drinking.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Pregnancy
It is best not to use this medication during pregnancy.
feeding
The use of this medication should be avoided in case of breast-feeding.
Do not take any medicine during pregnancy or breast-feeding without asking your doctor or pharmacist for advice. |
Sport
Sport
The attention of athletes will be drawn to the fact that this specialty contains an active ingredient (tetracaine) that can induce a positive reaction of the tests performed during the doping controls.
Effects on ability to drive or use machines
Driving and using machines
No effects on the ability to drive and use machines have been observed.
List of excipients with known effect
Important information about some of the ingredients of DRILL SANS SUGRE SUREAU LITCHI, sweetened isomalt and acesulfame potassium tablet
Excipients with a known effect: sulfur dioxide (E220), sorbitol (E420), cochineal red A (E124).
3. HOW TO TAKE DRILL WITHOUT SUGAR SUREAU LITCHI, sweetened with isomalt and acesulfame potassium?
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.
Adult :
1 lozenge to suck 4 times per 24 hours.
Child from 6 to 15 years:
1 lozenge to suck 2 to 3 times per 24 hours.
Route of Administration
Mouth
Frequency of Administration
The catch must be spaced at least 2 hours apart.
Duration of treatment
The duration of use is limited to 5 days.
If symptoms persist beyond 5 days, consult your doctor.
Symptoms and Instructions for Overdose
If you have taken more DRILL WITHOUT SUGAR SUREAU LITCHI, pastille sweetened with isomalt and acesulfame potassic you should:
Taken in large quantities or repeatedly, this drug may enter the bloodstream and may have effects on the heart and nervous system resulting in possible seizures.
Instructions for omission of one or more doses
If you forget to take DRILL WITHOUT SUGAR SUREAU LITCHI, tablet sweetened with isomalt and acesulfame potassic:
Not applicable.
Risk of withdrawal syndrome
If you stop taking DRILL WITHOUT SUGAR SUREAU LITCHI, tablet sweetened with isomalt and acesulfame potassic:
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, DRILL WITHOUT SUGAR SUREAU LITCHI, a tablet sweetened with isomalt and acesulfame potassium is likely to have undesirable effects, although not everyone is subject to it.
The following effects may occur:
· rash: in this case, stop treatment,
· possibility of temporary numbness of the tongue,
· in the event of a false path ("swallowing") it is advisable to discontinue treatment and seek advice from a doctor.
· a brown coloration of the tongue; it is safe and disappears when treatment is discontinued.
· a coloration of the teeth can also occur; it can be easily prevented by daily brushing.
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 DRILL WITHOUT SUGAR SUREAU LITCHI, sweetened with isomalt and acesulfame potassic?
Keep out of the reach and sight of children.
Expiration date
Do not use DRILL WITHOUT SUGAR LITCHI SAUCER, sweetened with isomalt and acesulfame potassium after the expiry date stated on the box. The expiry date refers to the last day of the month.
Storage conditions
Store at a temperature not exceeding 30 ° C.
If necessary, warnings against visible signs of deterioration
Not applicable.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What contains DRILL WITHOUT SUGAR SUREAU LITCHI, tablet sweetened with isomalt and acesulfame potassium?
The active substances are:
Chlorhexidine Digluconate ............................................... .................................................. ......... 3,000 mg
Tetracaine hydrochloride ............................................... .................................................. ............. 0.200 mg
For a pellet of 2.5 g.
The other components are:
Elderflower flavor (fennel oil, orange terpenes, buchu leaf essential oil, terpineol, menthol, geraniol, maltol, propylene glycol), litchi flavor (sandalwood oil, vanillin, geraniol, sulfur dioxide, sorbitol, dextrose , maltodextrin), peppermint flavor (essential oil of star anise, essential oil of clove, essential oil of peppermint, L-menthol, mint oil of the fields), cochineal red A (E124), brilliant blue FCF (E133), ammonium glycyrrhizate, acesulfame potassium, isomalt.
Pharmaceutical form and content
What is DRILL WITHOUT SUGAR SUREAU LITCHI, pastille sweetened with isomalt and acesulfame potassic and contents of the outer packaging?
The tablets of DRILL WITHOUT SUGAR SERVE LITCHI are round pellets of violet color. They are available in blister packs in 12 or 24 tablets. Not all pack sizes may be marketed.
Mouth.
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
PIERRE FABRE MEDICAMENT
45 PLACE ABEL GANCE
92654 - BOULOGNE CEDEX
exploiting
PIERRE FABRE MEDICAMENT
45 PLACE ABEL GANCE
92654 - BOULOGNE CEDEX
Maker
PIERRE FABRE MEDICAMENT PRODUCTION
45 PLACE ABEL GANCE
92654 - BOULOGNE CEDEX
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