NOTICE
ANSM - Last updated: 31/05/2010
Name of the medicinal product
EUPHONYLL EXPECTORANT ADULTS, syrup
framed
Read all of this leaflet carefully before you start taking this medicine.
It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the side effects, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT EUPHONYLL EXPECTORANT ADULTS, syrup AND IN WHAT CASES IS IT USED?
2. WHAT ARE THE INFORMATION TO BE KNOWN BEFORE TAKING EUPHONYLL EXPECTORANT ADULTS, SYRUP?
3. HOW TO TAKE EUPHONYLL EXPECTORANT ADULTS, SYRUP?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE EUPHONYLL EXPECTORANT ADULTS, syrup?
6. ADDITIONAL INFORMATION
1. WHAT EUPHONYLL EXPECTORANT ADULTS, syrup AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
EXPECTORANT
(R: Respiratory system)
Therapeutic indications
This drug is a bronchial secretion modifier.
It is recommended in cases of recent respiratory affection with difficulty of expectoration (difficulties to reject by spitting the bronchial secretions) in the adult.
2. WHAT ARE THE INFORMATION TO BE KNOWN BEFORE TAKING EUPHONYLL EXPECTORANT ADULTS, SYRUP?
List of information needed before taking the medication
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Precautions for use; special warnings
Special warnings
Due to the alcohol content (0.6 g per tablespoon), do not administer this syrup in children and avoid alcoholic beverages.
Medical advice is required:
· in case of fatty or purulent expectoration,
· if you have chronic (long-term) bronchial and lung disease.
This treatment must always be accompanied by voluntary efforts of coughing allowing the expectoration; the simultaneous use of a medicament intended to calm the cough is therefore illogical.
Do not take bronchial secretion-drying medication during the treatment period with this medication.
The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
This medicine contains 8.5 g of sucrose per tablespoon, which must be taken into account in the daily diet in the case of a diet low in sugar or in case of diabetes.
Interaction with other medicines
TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, IT MUST BE INFORMED SYSTEMATICALLY OF ANY OTHER TREATMENT IN PROGRESS AT YOUR DOCTOR OR YOUR PHARMACIST.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy - Breastfeeding
It is best not to administer this medication during pregnancy. However, no adverse effects were reported during pregnancy.
For caution, avoid administering this medication during: breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Sucrose (8.5 g per tablespoon)
Alcohol (0.6 g per tablespoon)
3. HOW TO TAKE EUPHONYLL EXPECTORANT ADULTS, SYRUP?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS.
1 tablespoon, 4 times a day.
THIS MEDICINE HAS BEEN PERSONALLY ISSUED IN A SPECIFIC SITUATION:
· IT MAY NOT BE ADAPTED TO ANOTHER CASE
· DO NOT ADVISE IT TO ANOTHER PERSON
Method and route of administration
Oral use.
Duration of treatment
Do not exceed 5 days of treatment without medical advice.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
AS ANY ACTIVE PRODUCT, THIS MEDICINE MAY, IN CERTAIN PERSONS, CAUSE MORE OR LESS GENERAL EFFECTS : possibility of digestive disorders (nausea, vomiting, abdominal pain).
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE EUPHONYLL EXPECTORANT ADULTS, syrup?
Keep out of the reach and sight of children.
Expiration date
Do not use EUPHONYLL EXPECTORANT ADULTS, SYRUP after the expiry date which is stated on the bottle.
Storage conditions
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does EUPHONYLL EXPECTORANT ADULTS, SYRUP?
The active substances are :
Terpine ................................................. .................................................. ......................................... 200 mg
Siberian pine essential oil ............................................ .................................................. 45 mg
Reconstituted niaouli essential oil ............................................. .................................................. 45 mg
Eucalyptus essential oil ............................................. .................................................. 45 mg
For 100 ml of syrup
The other ingredients are sucrose, polysorbate 80, orange spearmint flavor, ammonium glycyrrhizinate, quinoline yellow (E 104), patented blue V (E 131), alcohol, purified water.
1 tablespoon contains 8.5 g of sucrose and 0.6 g of alcohol.
Alcoholic strength (V / V): 5 °
Pharmaceutical form and content
What is EUPHONYLL EXPECTORANT ADULTS, SYRUP and the contents of the outer packaging?
Syrup, bottle of 180 ml.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
MAYOLY SPINDLER LABORATORIES
6 AVENUE OF EUROPE
BP 51
78401 CHATOU CEDEX
exploiting
MAYOLY SPINDLER LABORATORIES
6 AVENUE OF EUROPE
BP 51
78401 CHATOU CEDEX
Maker
MAYOLY SPINDLER LABORATORIES
6 AVENUE OF EUROPE
BP 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 notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.