In this manual :
1. WHAT IS DRILL MIEL ROSAT, lozenge to suck and WHERE IS IT USED?
2. WHAT YOU SHOULD KNOW BEFORE TAKING DRILL HONEY ROSET, lozenge to suck?
3. HOW TO TAKE DRILL HONEY ROSET, lozenge to suck?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO CONSERVE DRILL HONEY ROSET, lozenge to suck?
6. ADDITIONAL INFORMATION
1. WHAT IS DRILL MIEL ROSAT, lozenge and WHAT IS IT USED FOR?
Pharmacotherapeutic class
LOCAL ANTISEPTIC/LOCAL ANESTHETIC.
(R: respiratory system).
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 MIEL ROSAT, lozenge to suck?
List of information needed before taking the medicine
If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
Do not take DRILL MIEL ROSAT, lozenge to suck in the following cases:
- in children under 6 years of age,
- if you are allergic to local anaesthetics and chlorhexidine or to any of the other components of the tablet.
IF IN DOUBT, YOU SHOULD SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Precautions for use; special warnings
Take care with DRILL MIEL ROSAT, lozenge to suck:
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 as it may alter the natural microbial balance of the mouth and throat.
- This medicine contains glucose. The use of this medicine is not recommended in patients with glucose and galactose malabsorption syndrome.
- This medicine contains sucrose. The use of this medicinal product is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases).
Precautions for use
In case of diabetes or hypoglucidic diet, take into account in the daily ration the quantity of sugar per lozenge: 2,5 g.
Sore throat: in case of fever, purulent sputum (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 mouth sores: in case of extensive lesions, extension of lesions, appearance of fever: CONSULT YOUR DOCTOR IMMEDIATELY.
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.
Interactions with other medicines
Taking or using other medicines
Do not use more than one medicine containing an antiseptic at the same time.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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This medicine contains chlorhexidine and tetracaine.
Other medicines contain it... Do not combine them, so as not to exceed the maximum recommended doses (see How to use DRILL HONEY ROSET, lozenge?).
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Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
Pregnancy and breastfeeding
It is preferable not to use this medicine during pregnancy.
The use of this medicine should be avoided if you are breastfeeding.
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Ask your doctor or pharmacist for advice before taking any medicine.
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The attention of sportsmen and women should be drawn to the fact that this medicinal product 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: glucose, sucrose.
3. HOW TO TAKE DRILL MIEL ROSAT, lozenge to suck?
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS OF AGE.
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
Oral route.
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 MIEL ROSAT lozenge 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 MIEL ROSAT, pastille à suce is likely to have side effects, although not everyone is subject to them:
- Skin rashes: in this case, stop 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 CONSERVE DRILL MIEL ROSAT, pastille à sucer ?
Keep out of the reach and sight of children.
Do not use DRILL MIEL ROSAT, pastille à suce after the expiry date stated on the outer packaging.
This medicine is sensitive to moisture: keep the blister packs in the outer packaging.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewer or in your 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 HONEY ROSET lozenge contain?
The active ingredients are
Chlorhexidine gluconate .............................................................................................................. 3.00 mg
Tetracaine hydrochloride ............................................................................................................... 0.20 mg
For one lozenge.
The other components are:
Sodium ascorbate, sucrose, liquid glucose, white honey, ammonium glycyrrhizate, liquorice extract (dry), natural rose flavour.
Pharmaceutical form and content
What is DRILL MIEL ROSAT and what does it contain?
This medicine is in the form of a lozenge. Box of 12 or 24 tablets.
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.
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