NOTICE
ANSM - Updated: 28/12/2017
Name of the drug
STODALINE SUGAR FREE, syrup sweetened with sorbitol and liquid maltitol
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse after 3 days.
What does this booklet contain ?
1. What is STODALINE SUGAR FREE, syrup sweetened with sorbitol and liquid maltitol and when is it used?
2. What information do you need to know before taking STODALINE SUGAR FREE, syrup sweetened with sorbitol and liquid maltitol?
3. How to take STODALINE SUGAR FREE, syrup sweetened with sorbitol and liquid maltitol?
4. What are the possible side effects?
5. How to store STODALINE SUGAR FREE, syrup sweetened with sorbitol and liquid maltitol?
6. Contents of the package and other information.
1. WHAT IS SUGAR-FREE STODALIN, syrup sweetened with sorbitol and liquid maltitol AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: Homeopathic medicine.
Homeopathic medicine traditionally used in the treatment of coughs.
2. BEFORE YOU TAKE STODALIN SUGAR FREE, syrup sweetened with sorbitol and liquid maltitol?
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Do not take STODALINE SUGAR FREE, syrup sweetened with sorbitol and liquid maltitol:
· If you are allergic to the active substances or to any of the other ingredients of this medicine, listed in section 6.
Warnings and precautions
The use of this drug is not recommended in patients with fructose intolerance (rare hereditary disease).
Due to the presence of liquid maltitol and sorbitol, this medicine can cause mild digestive disorders (diarrhea).
Caloric value: 2.3 kcal / g of liquid maltitol and 2.6 kcal / g of sorbitol which corresponds to approximately 28.4 kcal per dose of 15 ml and 9.5 kcal per dose of 5 ml.
children
Not applicable.
Other medicines and STODALIN SUGAR FREE, syrup sweetened with sorbitol and liquid maltitol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
STODALINE SUGAR FREE, syrup sweetened with sorbitol and liquid maltitol with food and drinks
Not applicable.
Pregnancy and breast feeding
Ask your doctor or pharmacist for advice before taking any medicine.
In the absence of experimental and clinical data, and as a precautionary measure, the use of this drug should be avoided during pregnancy and lactation.
Driving and using machines
Not applicable.
STODALIN SUGAR FREE, syrup sweetened with sorbitol and liquid maltitol contains liquid maltitol and sorbitol (E420).
3. HOW TO TAKE STODALIN SUGAR FREE, syrup sweetened with sorbitol and liquid maltitol?
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.
Dosage
This medication should not be used in children under 2 years of age without medical advice.
In adults: take 1 dose of 15 ml using the measuring cup, 3 to 5 times a day
In children: take 1 dose of 5 ml using the measuring cup, 3 to 5 times a day
Administration mode
Oral way.
Frequency of administration
Space the catches as soon as possible and stop taking them as soon as the symptoms disappear.
Duration of treatment
The duration of treatment is one week.
If no improvement after 3 days: consult a doctor.
If you have taken more SUGAR-FREE STODALINE, syrup sweetened with sorbitol and liquid maltitol than you should
Immediately consult your doctor or pharmacist.
If you forget to take STODALINE SUGAR FREE, syrup sweetened with sorbitol and liquid maltitol
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking STODALINE SUGAR FREE, syrup sweetened with sorbitol and liquid maltitol
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE STODALIN SUGAR FREE, syrup sweetened with sorbitol and liquid maltitol?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton.
The expiry date refers to the last day of this month.
No special storage precautions regarding temperature.
Do not store beyond 1 year after opening.
Do not dispose of any medication at the sewer or with household waste. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What's in STODALINE SUGAR FREE, syrup sweetened with sorbitol and liquid maltitol
· The active substances are:
Antimonium tartaricum 6 CH .............................................. .................................................. ........ 2 g
Bryonia 3 CH ............................................... .................................................. ............................. 2 g
Coccus cacti 4 CH .............................................. .................................................. ...................... 2 g
Drosera 3 CH ............................................... .................................................. ............................. 2 g
Ipeca 3 CH ............................................... .................................................. ................................ 2 g
Rumex crispus 6 CH .............................................. .................................................. ................... 2 g
Spongia tosta 4 CH .............................................. .................................................. .................... 2 g
Sticta pulmonaria 3 CH .............................................. .................................................. ................ 2 g
For 100 g of syrup.
· The other components are:
Liquid maltitol, sorbitol (E420), sodium benzoate (E211), citric acid monohydrate (E330), ripe aroma, vanilla flavor, purified water.
What is STODALINE SUGAR FREE, syrup sweetened with sorbitol and liquid maltitol and contents of the pack
This medicine is in the form of syrup.
One can contains a 200 ml bottle and a measuring cup (15 ml) graduated to 5 ml and 15 ml.
Marketing Authorization Holder
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
LA FRANCE
Operator of the marketing authorization
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
LA FRANCE
Maker
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
LA FRANCE
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
{MM / YYYY}
Other
Detailed information on this medicine is available on the ANSM website (France).