In this manual :
1. WHAT IS DRILL SUGAR-FREE PAMPLEMOUSSE, lozenge AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING DRILL SUGAR-FREE PAMPLEMOUSSE, lozenge
3. HOW DO I TAKE DRILL SUGAR-FREE PAMPLEMOUSSE, lozenge?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO CONSERVE DRILL SUGAR-FREE PAMPLEMOUSSE, lozenge?
6. ADDITIONAL INFORMATION
1. WHAT IS DRILL SUGAR-FREE PAMPLEMOUSSE, lozenge AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
LOCAL ANTISEPTIC/ANESTHESIC (R02A: throat preparation)
This medicine is indicated in the case of mild sore throat without fever, mouth ulcers and small mouth sores in adults and children over 6 years.
NB: in the event of general clinical signs of bacterial infection, general antibiotic therapy should be considered.
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING DRILL SUGAR-FREE PAMPLEMOUSSE, lozenge?
List of information needed before taking the medicine
Not applicable.
Do not take DRILL SUGAR-FREE PAMPLEMOUSSE, lozenge:
- in children under 6 years of age,
- if you are allergic to local anaesthetics, chlorhexidine or other components of this medication.
Precautions for use; special warnings
Be careful with DRILL SUGAR-FREE PAMPLEMOUSSE, lozenge:
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,
- do not use this medicine before meals or drinks.
Do not take more than is indicated: if taken in large quantities or repeatedly, this medicine can affect the nervous system, with the possibility of convulsions, and the heart.
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.
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.
DO NOT LEAVE THIS MEDICINE WITHIN THE REACH OF CHILDREN.
Interactions with other medicines
Taking other medicines
Do not use several medicines containing antiseptics at the same time.
Talk to your 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
Pregnancy
It is preferable not to use this medicine during pregnancy.
Breastfeeding
The use of this medicine should be avoided if you are breastfeeding.
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Do not take any medicine during pregnancy or while breastfeeding without asking your doctor or pharmacist.
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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
Driving and Use of Machinery
No effect on the ability to drive and use machines has been observed.
List of excipients with a known effect
Not applicable.
3. HOW TO TAKE DRILL SUGAR-FREE PAMPLEMOUSSE, lozenge
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
Route of administration:
Oral route.
Frequency of administration
The doses should be taken at least 2 hours apart.
Duration of treatment
The duration of use is limited to 5 days
In case of persistence of symptoms beyond 5 days, consult your doctor.
Symptoms and instructions in case of overdose
If you have taken more DRILL SUGAR-FREE PAMPLEMOUSSE lozenge than you should have:
If taken in large amounts or repeatedly, this medicine may enter the bloodstream and may affect the heart and nervous system leading to possible seizures.
Instructions in case of missed doses
If you forget to take DRILL SUGAR-FREE PAMPLEMOUSSE, lozenge:
Not applicable.
Risk of withdrawal syndrome
If you stop taking DRILL SUGAR-FREE PAMPLEMOUSSE, lozenge:
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, DRILL SUGAR-FREE PAMPLEMOUSSE, lozenge is likely to have side effects, although not everyone is susceptible.
The following effects may occur:
- 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 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 PAMPLEMOUSSE, lozenge
Keep out of the reach and sight of children.
Do not use DRILL SUGAR-FREE PAMPLEMOUSSE lozenge after the expiry date stated on the box. The expiry date refers to the last day of the month.
Store at a temperature not exceeding 30°C
If necessary, warnings against certain visible signs of deterioration
Not applicable.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does DRILL SUGAR-FREE PAMPLEMOUSSE, lozenge contain?
The active ingredients are:
Chlorhexidine digluconate .......................................................................................................... 3,000 mg
Tetracaine hydrochloride .............................................................................................................. 0.200 mg
For a 2.5 g lozenge.
The other components are:
Pink grapefruit flavour SN 715427 (orange terpene, grapefruit terpene, natural flavouring substances, alpha-tocopherol E307), peppermint flavour 13571016 (star anise essential oil, clove essential oil, peppermint essential oil, L-menthol, field mint essential oil), ammonium glycyrrhizate, acesulfame potassium, isomalt.
Pharmaceutical form and contents
What is DRILL SUGAR-FREE PAMPLEMOUSSE, lozenge and what does it contain?
DRILL SUGAR-FREE PAMPLEMOUSSE lozenges are round, white lozenges. They are available in blister packs of 12 or 24 tablets. Not all presentations may be marketed.
Oral use.
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
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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