In this manual :
1. WHAT IS EUPHON SUGAR-FREE, saccharin-sweetened lozenge AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING EUPHON SUGAR-FREE, saccharin-sweetened lozenge
3. HOW DO I TAKE EUPHON SUGAR-FREE, saccharin-sweetened lozenge?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE EUPHON SUGAR-FREE, saccharin-sweetened lozenge?
6. ADDITIONAL INFORMATION
1. WHAT IS EUPHON SUGAR-FREE, saccharin-sweetened lozenge AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Herbal medicinal product.
Traditionally used to relieve sore throats and/or temporary hoarseness.
2. WHAT YOU SHOULD KNOW BEFORE TAKING EUPHON SUGAR-FREE, saccharin-sweetened lozenge
List of information needed before taking the medicine
Not applicable.
Do not take EUPHON SUGAR-FREE, saccharin-sweetened lozenge:
- A history of allergy to saccharin.
- children under 6 years of age.
Precautions for use; special warnings
Not applicable.
Interactions with other drugs
Taking other medications
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
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.
If you discover that you are pregnant during treatment, consult your doctor, as only he or she can decide whether you should continue the treatment.
Ask your doctor or pharmacist for advice before taking any medication.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
Not applicable.
3. HOW TO TAKE EUPHON SUGAR-FREE, saccharin-sweetened lozenge
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
Oral use. For adults and children over 6 years of age only.
Adults: 10 to 12 lozenges per day, to be sucked slowly without chewing.
Children over 6 years: 5 to 6 lozenges per day, to be sucked slowly without chewing.
Due to its pharmaceutical form, this medicine should not be used in children under 6 years of age.
Method of administration
Not applicable
Frequency of administration
Not applicable.
Duration of treatment
If symptoms worsen (e.g. fever, purulent sputum or pain on swallowing) or if symptoms persist after 5 days, consult a doctor.
Symptoms and instructions in case of overdose
Not applicable.
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, EUPHON SUGAR-FREE, saccharin-sweetened lozenge is likely to have undesirable effects, although not everyone is subject to them.
Rarely: possible occurrence of allergic reactions due to the presence of saccharin.
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 EUPHON SUGAR-FREE, saccharin-sweetened lozenge
Keep out of the reach and sight of children.
Do not use EUPHON SUGAR-FREE, saccharin-sweetened lozenge after the expiry date stated on the box. The expiry date refers to the last day of the month.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active ingredients and excipients
What does EUPHON SUGAR-FREE, saccharin-sweetened lozenge contain?
The active substance is:
Erysimum(Sisymbrium officinale (L.) Scop.) (aqueous dry extract of) on maltodextrin ............................ 10 mg
For a 0.8 g lozenge.
Other components are:
Saccharin, gum arabic, orange flavour, tangerine flavour, light liquid paraffin, glycerol.
Pharmaceutical form and content
What is EUPHON SUGAR-FREE, saccharin-sweetened lozenge and what does it contain?
This medicine comes in the form of lozenges. Box of 70 lozenges.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
LABORATOIRES MAYOLY SPINDLER SAS
6, AVENUE DE L'EUROPE
B. P. 51
78401 CHATOU CEDEX
Operator
LABORATOIRES MAYOLY SPINDLER
6, AVENUE DE L'EUROPE
B. P. 51
78401 CHATOU CEDEX
Manufacturer
LABORATOIRES MAYOLY SPINDLER
6, AVENUE DE L'EUROPE
B. P. 51
78401 CHATOU CEDEX
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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