NOTICE
ANSM - Updated: 17/07/2017
Name of the drug
QUIETUDE syrup
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 QUIETUDE, syrup and in what cases is it used?
2. What information do you need to know before taking QUIETUDE syrup?
3. How to take QUIETUDE, syrup?
4. What are the possible side effects?
5. How to store QUIETUDE, syrup?
6. Contents of the package and other information.
1. WHAT IS QUIETUDE, syrup AND WHAT IT IS USED FOR
Pharmacotherapeutic group: Homeopathic medicine.
QUIETUDE, syrup is a homeopathic medicine traditionally used in children from 1 year in case of transient nervousness and minor sleep disorders.
2. WHAT INFORMATION DO YOU KNOW BEFORE TAKING QUIETUDE, syrup?
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 QUIETUDE, syrup:
· If you are allergic to the active substances or to any of the other ingredients of this medicine, listed in section 6.
· In children under 1 year old.
Warnings and precautions
In children, a sleep disorder requires consulting a doctor. Indeed, the origin of this disorder must be identified.
The use of this drug is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase (rare hereditary diseases) deficiency.
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose.
children
Do not administer without medical advice in children under 30 months.
Other medicines and QUIETUDE syrup
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
QUIETUDE, syrup with food, drinks and alcohol
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
QUIETUDE syrup contains ethanol 96% V / V and sucrose.
3. HOW TO TAKE QUIETUDE, syrup?
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
Dosage
Do not administer without medical advice in children under 30 months.
Medication reserved for children older than 1 year.
In case of transient nervousness and minor sleep disorders: a dose of 5 ml, using the measuring cup, morning and evening.
Treatment should be stopped as soon as the symptoms disappear and should be as brief as possible.
In children under 30 months, the duration of treatment is to be evaluated by the doctor.
In children over 30 months, the treatment should not exceed 10 days.
If the disorders persist, the treatment should be reassessed.
Administration mode
Oral way.
If you take more QUIETUDE, syrup than you should
Consult your doctor or your pharmacist.
If you forget to take QUIETUDE, syrup
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking QUIETUDE, syrup
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 QUIETUDE, syrup?
Keep this medicine out of the sight and reach of children.
No special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.
Do not dispose of any medication in the sewage system or in the household garbage. 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 QUIETUDE contains, syrup
· The active substances are:
Chamomilla vulgaris 9 CH .............................................. .................................................. ......... 1.5 g
Gelsemium 9 CH ............................................... .................................................. ..................... 1.5 g
Hyoscyamus niger 9 CH .............................................. .................................................. ........... 1.5 g
Kalium bromatum 9 CH .............................................. .................................................. ............. 1.5 g
Passiflora incarnata 3 DH .............................................. .................................................. ......... 1.5 g
Stramonium 9 CH ............................................... .................................................. .................... 1.5 g
For 100 g of syrup.
· The other ingredients are: sucrose, 96% ethanol, benzoic acid, caramel and water.
What QUIETUDE syrup looks like and contents of the pack
This medicine is in the form of syrup. One can contains 1 bottle of 200 ml with a measuring cup graduated to 5 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).