NOTICE
ANSM - Updated on : 29/07/2024
Name of medicinal product
DRILL MIEL CITRON SUCRE SANS, lozenge sweetened with lisomalt and lacésulfame potassique
Chlorhexidine/tetracaine
Box
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 5 days.
What does this leaflet contain?
1. What is DRILL MIEL CITRON SANS SUCRE, lisomalt and lacésulfame potassique sweetened lozenge and what is it used for?
2. What do I need to know before taking DRILL MIEL CITRON SUCRE, pastille sweetened with lisomalt and lacésulfame potassique?
3. How to take DRILL MIEL CITRON SUCRE, lisomalt- and lacésulfame potassium-sweetened lozenge?
4. What are the possible side effects?
5. How to store DRILL MIEL CITRON SANS SUCRE, pastille sweetened with lisomalt and lacésulfame potassique?
6. Package contents and other information.
1. WHAT IS DRILL MIEL CITRON SUCRE FREE, lisomalt- and lacésulfame potassium-sweetened lozenge AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: LOCAL ANTISEPTIC/ LOCAL ANESTHESIC - ATC code: R02A: throat preparation.
This medicine contains a local antiseptic to combat germs and a local anesthetic to reduce pain.
It is indicated for mild sore throats without fever, as well as for mouth ulcers and small mouth sores.
This medicine is intended for adults and children over 6 years of age.
You should contact your doctor if you do not feel better or feel worse after 5 days.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING DRILL MIEL CITRON SUGAR-FREE, lozenge sweetened with lisomalt and potassium sulfate?
Never take DRILL MIEL CITRON SUCRE, lisomalt- and lacésulfame potassium-sweetened lozenge:
- Children under 6 years of age;
- If you are allergic to chlorhexidine or tetracaine or to any of the other ingredients of this product (listed in section 6).
Warnings and precautions
Throat anesthesia induced by this drug may favour false routes (coughing during a meal, with the impression of "swallowing the wrong way") when swallowing food.
It is therefore imperative
- use this product with caution in children aged 6 to 12;
- not to use before meals or drinks.
There is a risk of developing an allergy to chlorhexidine. Risk of severe generalized allergic reactions leading to anaphylactic shock (such as difficulty in breathing, facial swelling or a severe rash, which may occur within minutes of taking the product), which may be life-threatening without immediate medical attention. In the event of an allergic reaction to chlorhexidine, discontinue use immediately and seek medical advice.
Prolonged use (more than 5 days) of this product is not recommended, as it may alter the natural microbial balance of the mouth and throat.
If you have a fever, yellowish sputum or difficulty swallowing food, extensive lesions or lesions that spread into the mouth, you should consult your doctor.
Yellow-brown discoloration of the tongue: this is harmless and disappears when treatment is stopped.
Yellow-brown discoloration of teeth and silicate or composite fillings: this discoloration is transitory and disappears at the end of treatment. It can easily be avoided by reducing consumption of tea, coffee and red wine, and by daily brushing with a conventional toothbrush and toothpaste before using DRILL or, in the case of dentures, by cleaning with a conventional denture cleaner.
In cases where normal tooth brushing is not possible, treatment and polishing may be considered.
Ask your doctor or pharmacist before taking DRILL MIEL CITRON SUGAR-FREE.
Other medicines and DRILL MIEL CITRON SUCRE, lisomalt and lacésulfame potassique sweetened lozenge
Do not take more than one medicine containing an antiseptic at the same time.
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
DRILL MIEL CITRON SUCRE, lisomalt and lacésulfame potassique sweetened lozenge with food and drink
This medicine should not be taken before or during meals and drinks, as tetracaine has a moderate anaesthetic effect and may cause a false route.
Pregnancy and breast-feeding
Pregnancy
Tetracaine should not be used during pregnancy.
Lactation
Due to the presence of terpene derivatives in DRILL MIEL CITRON SUCREFREE, which may pass into breast milk, this medicine should not be used during breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving vehicles and operating machinery
There is no or negligible effect on the ability to drive vehicles or use machines with DRILL MIEL CITRON SUGAR-FREE.
DRILL MIEL CITRON SUCRE, pastille sweetened with lisomalt and lacésulfame potassique contains lisomalt (E953) and propylene glycol.
This medicine contains :
- lisomalt (E953). This medicine is not recommended for patients with fructose intolerance (a rare hereditary disease);
- 10.0 mg propylene glycol per lozenge.
3. HOW TO TAKE DRILL MIEL CITRON SUCRELESS, lozenge sweetened with lisomalt and potassium sulfate?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
For adults and adolescents over 15, the recommended dose is 1 lozenge, repeated as necessary, up to a maximum of 4 lozenges per 24 hours.
Use in children
For children aged 6 to 15, the recommended dose is 1 lozenge, repeated if necessary, up to a maximum of 3 lozenges per 24 hours.
Method of administration
Suck lozenges slowly, without chewing, between meals.
Frequency of administration
Take at least 2 hours apart.
Duration of treatment
- This product should not be used for more than 5 days.
- If there is no improvement or you feel less well after 5 days, you should consult your doctor.
If you have taken more DRILL MIEL CITRON SUCRE, pastille sweetened with lisomalt and lacésulfame potassique than you should have.
If you or your child has taken more medicine than you should have :
- A small amount should have no harmful effect.
- If you take a large amount (e.g. many lozenges), you should contact your doctor immediately, or go to the nearest hospital emergency department.
Undesirable effects of chlorhexidine are unlikely, but you may experience symptoms of digestive discomfort (abdominal pain, nausea, vomiting, diarrhea) and local irritation.
Tetracaine may cause numbness of the tongue and a possible sensation of choking. Nervous system disorders (nervousness, blurred vision, convulsion), cardiovascular disorders (hypotension, bradycardia, ventricular arrhythmia) and methemoglobinemia (blood abnormality in which an abnormal amount of methemoglobin is produced) may also occur.
In case of accidental overdose, STOP TREATMENT AND CONSULT YOUR DOCTOR IMMEDIATELY..
This product contains peppermint and deucalyptus essential oils (also known as terpene derivatives). In the event of excessive doses, convulsions may occur in children.
If you forget to take DRILL MIEL CITRON SUCRE, pastille sweetened with lisomalt and lacésulfame potassique
Do not take a double dose to make up for the one you forgot to take.
If you stop taking DRILL MIEL CITRON SUCRE, pastille sweetened with lisomalt and potassium disulfame
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug is likely to have undesirable effects, but they do not occur systematically in everyone.
The following effects may occur with undetermined frequency (frequency cannot be estimated on the basis of available data):
- Allergic reaction. In the event of skin rash, swelling of the mouth or face or difficulty in breathing, stop taking this drug and seek medical assistance immediately. These effects may be symptoms of a very rare severe allergic reaction.
- A yellow-brown discoloration of the tongue; this is harmless and disappears when treatment is stopped.
- Yellow-brown discoloration of teeth and silicate or composite fillings may also occur; this is transient and can be easily prevented by daily brushing.
- Accidental aspiration (coughing during a meal with the impression of "swallowing the wrong way"); this effect is due to tetracaine (a moderate anesthetic), which can cause choking. If this occurs, discontinue treatment and seek medical advice.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO USE DRILL MIEL CITRON SUCRELESS, lozenge sweetened with lisomalt and potassium sulfate?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging. The expiration date refers to the last day of the month.
Store at a temperature not exceeding +30°C.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What DRILL MIEL CITRON SUCRE SANS contains, lozenge sweetened with lisomalt and lacésulfame potassique.
- The active ingredients are :
Chlorhexidine digluconate..3,000 mg
In the form of 20% chlorhexidine digluconate solution
Tetracaine hydrochloride..0,200 mg
For a 2.5 g lozenge
- The other components are :
Honey flavor 15061222*, lemon flavor PHL 134488**, peppermint flavor 13571016***, glycyrrhizate dammonium, acesulfame potassium, quinoline yellow (E104), caramel color (E150b), isomalt (E953).
*Honey flavor composition natural flavoring substances, propylene glycol.
**Composition of lemon flavoring Citral, citronellal, geraniol, orange essential oil, lemon essential oil, verbena essential oil, geranium essential oil, d-limonene, linalool, alpha-pinene, beta-pinene, terpinolene.
***Peppermint aroma composition Starry danish essential oil, clove essential oil, peppermint essential oil, L-menthol, spearmint essential oil.
What DRILL MIEL CITRON SUCRE SANS is, a lozenge sweetened with lisomalt and lacésulfame potassique, and what it contains
Round, yellow lozenges. Boxes of 12, 24 or 36 tablets.
Not all presentations may be marketed.
Marketing authorization holder
PIERRE FABRE MEDICAMENT
LES CAUQUILLOUS
81500 LAVAUR
FRANCE
Marketing authorization holder
PIERRE FABRE MEDICAMENT
PARC INDUSTRIEL DE LA CHARTREUSE
81100 CASTRES
FRANCE
Manufacturer
PIERRE FABRE MEDICAMENT PRODUCTION
ZONE INDUSTRIELLE DE LA COUDETTE
32290 AIGNAN
FRANCE
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder]
{ DD Month YYYY}
Other
Detailed information on this drug is available on the ANSM (France) website.