In this manual :
1. WHAT IS DRILL SUGAR-FREE, lozenge sweetened with aspartam and isomalt AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING DRILL SUGAR-FREE, lozenge sweetened with aspartame and isomalt
3. HOW TO TAKE DRILL SUGAR-FREE, lozenge sweetened with aspartame and isomalt?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO CONSERVE DRILL SUGAR-FREE, lozenge sweetened with aspartam and isomalt?
6. ADDITIONAL INFORMATION
1. WHAT IS DRILL SUGAR-FREE, lozenge sweetened with aspartam and isomalt AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
LOCAL ANTISEPTIC/LOCAL ANESTHETIC.
(R02A: throat preparation).
This medicine is recommended in cases of mild sore throat without fever, mouth ulcers and small sores of the mouth.
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING DRILL SUGAR-FREE, lozenge sweetened with aspartam and isomalt?
List of information needed before taking the medicine
Not applicable.
Do not take DRILL SUGAR-FREE, lozenge sweetened with aspartam and isomalt in the following cases:
- in children under 6 years of age.
- if you are allergic to local anaesthetics and chlorhexidine or to other components of the lozenge.
- In case of phenylketonuria (hereditary disease detected at birth), due to the presence of aspartam.
IN CASE OF DOUBT, YOU SHOULD ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Take care with DRILL SUGAR-FREE, lozenge sweetened with aspartam and isomalt:
Special warnings
The anaesthesia caused by this medicine in the throat may favour false routes (coughing during a meal with the impression of "swallowing wrong") when swallowing food.
It is therefore imperative:
- to use this medicine only with caution in children under 12 years of age,
- not to use this medicine before meals or drinks.
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.
DO NOT LEAVE THIS MEDICINE WITHIN THE REACH OF CHILDREN.
Precautions for use
The caloric intake is 8 kcal/pastille.
- Sore throat
In case of fever, purulent sputum (sputum), discomfort in swallowing food, as well as in case of aggravation or lack of improvement after 5 days: CONSULT YOUR DOCTOR.
- Mouth ulcers, small mouth sores
In case of extensive lesions, extension of lesions, appearance of fever: CONSULT YOUR DOCTOR IMMEDIATELY.
Respect the indicated dosage: if taken in large quantities or repeatedly, this medicine, by passing into the bloodstream, is likely to have an effect on the nervous system with the possibility of convulsions and on the heart.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Taking or using other medicines
Do not use more than one medicine containing an antiseptic at the same time.
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Interactions with food and drink
Food and Beverage
Lozenges should not be taken before meals or drinks.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and lactation
This medicine should not be used during pregnancy.
This medicine should not be used if you are breastfeeding.
|
Ask your doctor or pharmacist for advice before taking any medication.
|
Sportsmen
The attention of sportsmen and women should be drawn to the fact that this speciality contains an active ingredient (tetracaine) which may cause 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 known effect
List of excipients with a notable effect: aspartam (E 951).
3. HOW TO TAKE DRILL SUGAR-FREE, lozenge sweetened with aspartam and isomalt?
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
For adults and children over 6 years of age only.
Adults:
1 lozenge to be sucked 4 times per 24 hours.
Children from 6 to 15 years:
1 lozenge to be sucked 2 to 3 times per 24 hours.
Mode and route of administration
By mouth.
Suck the lozenges slowly without chewing them and at a distance from meals.
Frequency of administration
Take 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 in case of overdose
If you have taken more DRILL SUGAR-FREE lozenges sweetened with aspartame and isomalt than you should have:
In case of accidental overdose, STOP THE TREATMENT AND CONSULT YOUR DOCTOR QUICKLY.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, DRILL SUGAR-FREE, lozenge sweetened with aspartam and isomalt is likely to have undesirable effects, although not everyone is subject to them:
- Skin rash: if this occurs, discontinue treatment,
- Possible temporary numbness of the tongue,
- In the event of a false start (coughing during a meal with the impression of "swallowing the wrong way"), it is advisable to interrupt the treatment and seek medical advice.
- A brown discoloration of the tongue; this is harmless and disappears when the treatment is stopped.
- Staining of the teeth may also occur; this can be easily prevented by daily brushing.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO USE DRILL SUGAR-FREE, lozenge sweetened with aspartam and isomalt?
Keep out of the reach and sight of children.
Do not use DRILL SUGAR-FREE, pastille sweetened with aspartam and isomalt after the expiry date stated on the outer packaging.
Store at a temperature not exceeding 25°C.
This medicine is sensitive to humidity, keep the blister packs in the outer packaging.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of medicines down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does DRILL SUGAR-FREE lozenge, sweetened with aspartam and isomalt, contain?
The active substance is:
Chlorhexidine digluconate .......................................................................................................... 3,000 mg
In the form of a 20 % chlorhexidine digluconate solution
Tetracaine hydrochloride .............................................................................................................. 0.200 mg
For one lozenge.
Other components are:
Ascorbic acid, poppy flavor, pulmoral flavor, ammonium glycyrrhizinate, lubricant, aspartam, isomalt.
Pharmaceutical form and contents
What is DRILL SUGAR-FREE, lozenge sweetened with aspartam and isomalt and what does it contain?
This medicine comes in the form of a lozenge to be sucked. Box of 12 or 24.
Not all presentations may be marketed.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92100 BOULOGNE-BILLANCOURT
Operator
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92100 BOULOGNE
Manufacturer
PIERRE FABRE MEDICAMENT PRODUCTION
45, PLACE ABEL GANCE
92100 BOULOGNE
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 insert 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
