NOTICE
ANSM - Updated on : 03/04/2023
Product name
VALEFLOR, granules
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after two weeks.
What does this leaflet contain?
1. What is VALEFLOR granules and what are they used for?
2. What do I need to know before taking VALEFLOR, granules?
3. How should VALEFLOR granules be taken?
4. What are the possible side effects?
5. How should VALEFLOR granules be stored?
6. Package contents and other information.
1. WHAT IS VALEFLOR, granules AND WHAT IS IT USED FOR?
Homeopathic medicine traditionally used in adults and children aged 6 and over to relieve mild nervous tension (stress, minor anxiety and restlessness) and minor sleep disorders.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING VALEFLOR, granules?
Never take VALEFLOR, granules:
- If you are a child under 6 years of age.
- If you are allergic to the active substances or to any of the other components of this medicine, as listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before taking VALEFLOR granules.
If your doctor has informed you that you are intolerant to certain sugars, contact him/her before taking this medicine. Sucrose may be harmful to teeth.
Children
In the event of a sleep disorder in children, a doctor should be consulted to identify the causes of the disorder and to adapt the treatment.
Other medicines and VALEFLOR, granules
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
VALEFLOR, granules with food and drink
Not applicable.
Pregnancy, breast-feeding and fertility
In the absence of sufficient experimental and clinical data, and as a precautionary measure, the use of this drug should be avoided in pregnant or breast-feeding women, except on medical advice.
Driving and use of machinery
Not applicable.
VALEFLOR granules contain sucrose.
3. HOW DO I TAKE VALEFLOR, granules?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
For adults and children aged 6 and over.
- For mild nervous tension: 15 granules up to 3 times a day.
- For minor sleep disorders: 15 granules before bedtime.
Method of administration
Take orally.
Allow granules to melt under the tongue.
Duration of treatment
The maximum duration of treatment is two weeks. If symptoms persist beyond two weeks, or if they worsen, consult your doctor to determine whether treatment should be continued.
Use in children
This medicine must not be used in children under 6 years of age.
If you have taken more VALEFLOR granules than you should have
Not applicable.
If you forget to take VALEFLOR, granules
Do not take a double dose to make up for the one you forgot to take.
If you stop taking VALEFLOR, granules
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https: //signalement.social-sante.gouv.fr/
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW DO I USE VALEFLOR, granules?
Keep out of sight and reach of children.
Store at temperatures not exceeding 30°C.
Do not use this medicine after the expiration date indicated on the label and packaging. The expiration date refers to the last day of that month.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to delimit any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What VALEFLOR granules contain
- The active ingredients are :
Avena sativa TM*..................................................................................................................... 0.5 g
Coffea tosta, decocted 60DH..................................................................................................... 0.1 g
Humulus lupulus TM*............................................................................................................ 0.024 g
Passiflora incarnata TM*......................................................................................................... 0.15 g
Valeriana officinalis, decocted TM*............................................................................................. 0.3 g
For 10 g of granules
*In accordance with the German Homeopathic Pharmacopoeia
- Lexcipient is: sucrose.
What VALEFLOR granules are and what they contain
VALEFLOR granules are available in bottles containing 10 grams of granules. The granules are slightly yellowish, round and irregular, with a slight valerian odour.
Marketing authorization holder
LABORATOIRE WELEDA SA
9 RUE EUGENE JUNG
68330 HUNINGUE
Marketing authorization holder
LABORATOIRE WELEDA SA
9 RUE EUGENE JUNG
68330 HUNINGUE
Manufacturer
LABORATOIRE WELEDA SA
9 RUE EUGENE JUNG
68330 HUNINGUE
Product names in member states of the European Economic Area
This product is authorized in the member states of the European Economic Area under the following names: In accordance with current regulations.
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder]
< {MM/YYYY}>< {month/YYYY}.>
Other
Detailed information on this drug is available on the ANSM (France) website.
