In this manual :
1. WHAT IS QUIETUDE, syrup AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING QUIETUDE, syrup?
3. HOW DO I TAKE QUIETUDE, syrup?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE QUIETUDE, syrup?
6. ADDITIONAL INFORMATION
1. WHAT IS QUIETUDE, syrup AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Not applicable.
QUIETUDE, syrup is a homeopathic medicine traditionally used in children over 1 year of age for temporary nervousness and minor sleep disorders.
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING QUIETUDE, syrup?
List of information needed before taking the medicine
Not applicable.
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Do not administer without medical advice in children under 30 months
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Medicine reserved for children over 1 year.
- In children, a sleep disorder requires consulting a doctor. Indeed, the origin of this disorder must be identified.
- Treatment should be as brief as possible and should be stopped as soon as the symptoms disappear. If there is no improvement after three days of treatment, consult your doctor. Due to the presence of sucrose, this medicine should not be used in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency (rare metabolic diseases).
Precautions for use; special warnings
Not applicable.
Interactions with other drugs
Taking or using other medicines
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 lactation
Pregnancy and breastfeeding
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
List of excipients with a notable effect:
Sucrose.
3. HOW TO TAKE QUIETUDE, syrup?
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Oral use.
Do not administer to children under 30 months of age without medical advice.
For children over 1 year of age.
In case of temporary nervousness and minor sleep disorders: a dose of 5 ml, using the measuring cup, in the morning and evening.
Treatment should be stopped as soon as the symptoms disappear and should be as short as possible.
In children under 30 months of age, the duration of treatment is to be assessed by the attending physician.
In children over 30 months of age, treatment should not exceed 10 days.
If problems persist, treatment should be reassessed.
Symptoms and instructions in case of overdose
If you have taken more QUIETUDE, syrup than you should have:
Consult your doctor or pharmacist.
Instructions in case of missed doses
If you forget to take QUIETUDE, syrup:
Do not take the double dose to make up for the dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, QUIETUDE syrup may have side effects, although not everyone is likely to have them.
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 DO YOU USE QUIETUDE, syrup?
What are the possible side effects?
Do not use QUIETUDE, syrup after the expiry date stated on the bottle.
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
Full list of active ingredients and excipients
What does QUIETUDE syrup contain?
The active ingredients are:
Chamomilla vulgaris 9CH ...................................................................................................................... 1.5 g
Gelsemium 9CH .................................................................................................................................. 1.5 g
Hyoscyamus niger 9CH ........................................................................................................................ 1.5 g
Kalium bromatum 9CH ......................................................................................................................... 1,5 g
Passiflora incarnata 3DH ...................................................................................................................... 1,5 g
Stramonium 9CH ................................................................................................................................. 1,5 g
Per 100 g.
The other components are: sucrose, 96% ethanol, benzoic acid, caramel, water.
Pharmaceutical form and content
What is QUIETUDE, syrup and what does it contain?
This medicinal product is in the form of a syrup.
200 ml bottle with 5 ml measuring cup.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
BOIRON SA
20, rue de la Libération
69110 Sainte Foy Lès Lyon
Operator
Laboratoires BOIRON
20 rue de la libération
69110 SAINTE-FOY-LES-LYON
Manufacturer
Laboratoires BOIRON
20 rue de la libération
69110 SAINTE-FOY-LES LYON
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
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