In this manual :
1. WHAT IS EUPHON, lozenge AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING EUPHON, lozenge
3. HOW DO I TAKE EUPHON, lozenge?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO CONSERVE EUPHON, lozenge?
6. ADDITIONAL INFORMATION
1. WHAT IS EUPHON, 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, lozenge
List of information needed before taking the medicine
If your doctor has informed you of an intolerance to certain sugars, contact him or her before taking this medicine
Never take EUPHON lozenge:
- If you are allergic to any of the components contained in EUPHON, lozenge.
Do not use EUPHON lozenge in children under 6 years of age.
Precautions for use; special warnings
Be careful with EUPHON, lozenge:
The use of this medicine is not recommended in patients with fructose intolerance or glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases).
This medicine contains 0.6 g of sucrose, glucose and invert sugar per dose which should be taken into account in the daily diet in case of low sugar diet or diabetes.
Interactions with other medicines
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
Important information about some ingredients of EUPHON lozenge
Sucrose, liquid glucose, invert sugar (source of glucose and fructose), cochineal red A (E124).
3. HOW TO TAKE EUPHON, 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 (especially if fever, purulent sputum or pain on swallowing occurs) or if symptoms persist after 5 days, seek medical attention.
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 adverse reactions
Like all medicines, EUPHON lozenges may have undesirable effects, although not everyone is subject to them.
Due to the presence of cochineal red A (E124), allergic reactions may occur.
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 EUPHON, pastille?
Keep out of the reach and sight of children.
Do not use EUPHON 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 garbage. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does EUPHON lozenge contain?
The active substance is:
Erysimum(Sisymbrium officinale (L.) Scop.) (aqueous dry extract of) on maltodextrin ............................. 10 mg
For a 1 g lozenge.
Other components are:
Sucrose, gum arabic nebulisate, liquid glucose, invert sugar, orange flavouring, mandarin flavouring, cochineal red A (E124).
Pharmaceutical form and content
What is EUPHON lozenge and what does it contain?
This medicine is in lozenge form. Box of 70 or 100 tablets.
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.