NOTICE
ANSM - Updated on : 30/05/2024
IN THIS APPENDIX, THE TERMS "MARKETING AUTHORIZATION" AND "AUTHORIZATION" SHALL BE UNDERSTOOD AS "TRADITIONAL HERBAL MEDICINE REGISTRATION" AND "REGISTRATION" RESPECTIVELY.
Product name
Euphytose, coated tablet
Valerian (dried root extract), passionflower (dried aerial part extract), hawthorn (dried flowering top extract), horehound (dried flowering top extract).
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You must always take this medicine in strict accordance with the information given in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any undesirable 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 14 days of treatment.
What does this leaflet contain?
1. What is EUPHYTOSE, coated tablet and what is it used for?
2. What do I need to know before taking EUPHYTOSE, coated tablet?
3. How do I take EUPHYTOSE, coated tablet?
4. What are the possible side effects?
5. How should EUPHYTOSE be stored?
6. Package contents and other information.
1. WHAT IS EUPHYTOSE, coated tablet AND WHAT IS IT USED FOR?
EUPHYTOSE, coated tablet is a traditional herbal medicine used to relieve mild symptoms of stress and promote sleep in adults and adolescents aged 12 and over.
Its use is reserved for the indication specified, based exclusively on the length of time it has been used.
You should consult your doctor if you do not feel any improvement or if you feel less well after 14 days of treatment.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING EUPHYTOSE, coated tablet?
Never take EUPHYTOSE, coated tablet :
- if you are allergic to the active substances or to any of the other ingredients of this medicine, as listed in section 6.
Warnings and precautions
If your doctor has informed you that you are intolerant to certain sugars, contact your doctor before taking this medicine.
If you have hepatic or renal insufficiency, contact your doctor before taking this medicine.
This medicine contains 0.006 mg sodium benzoate (E 211) per dose.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially "sodium-free".
Children
EUPHYTOSE is not recommended for children under 12 years of age.
Other medicinal products and EUPHYTOSE, coated tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
EUPHYTOSE, coated tablet with food and drink
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
In the absence of sufficient data, the use of this medicine is not recommended during pregnancy and lactation.
Driving vehicles and using machines
This medicine may cause drowsiness, making it dangerous to drive and operate machinery. Do not drive or operate machinery during treatment.
EUPHYTOSE, coated tablet contains sucrose.
3. HOW DO I TAKE EUPHYTOSE, coated tablet?
Always take this medicine exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
To relieve mild symptoms of stress:
Adults
1 to 2 tablets per dose, 3 times a day.
Adolescents aged 12 and over
1 tablet per dose, 3 times a day.
To promote sleep :
Adults
1 tablet with the evening meal and one tablet at bedtime.
Adolescents aged 12 and over
1 tablet with evening meal.
Pediatric population
Use in children under 12 is not recommended.
Method of administration
Take by mouth.
To be swallowed without chewing, preferably with water or a hot drink.
Duration of treatment
1 month.
If symptoms persist beyond 2 weeks of use, consult a doctor or pharmacist.
If you have taken more EUPHYTOSE, coated tablet than you should have
In the event of massive intake of medicines containing valerian root, mild symptoms may appear. These disappear within 24 hours. In all cases, consult your doctor.
If you forget to take EUPHYTOSE, coated tablet
Do not take a double dose to make up for the one you forgot to take.
If you stop taking EUPHYTOSE, coated tablet
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.
The frequency of adverse reactions that may occur is defined according to the number of people affected:
- Very common: affecting more than 1 in 10 users
- Common: affecting 1 to 10 out of every 100 users
- Uncommon: affecting 1 to 10 users in 1000
- Rare: affecting 1 to 10 in 10,000 users
- Very rare: affects less than one user in 10,000
- Indeterminate: available information does not allow frequency to be evaluated
The frequency of the adverse reactions listed could not be studied.
Gastrointestinal disorders :
- digestive disorders
- nausea and abdominal cramps
Hepatobiliary disorders :
- liver disease, particularly in children and if the recommended dosage is exceeded
Immune system disorders:
- allergic skin reactions
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 Regional Pharmacovigilance Centers.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO USE EUPHYTOSE, coated tablet
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box. The expiration date refers to the last day of that month.
Store below 25°C, away from moisture.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What EUPHYTOSE, coated tablet contains
- the active ingredients are :
Valerian(Valeriana officinalis L.) (dried root extract)............................. ..................... 50.00 mg
Extraction solvent: 60% V/V ethanol
Drug/extract ratio: 1-5 : 1
Passion flower(Passiflora incarnata L.) (dried extract of aerial part of).................................... 40.00 mg
Extraction solvent: 60% V/V ethanol
Drug/extract ratio: 1-4 : 1
Hawthorn(Crataegus spp.) (dried extract of flowering top of).................................................. 10.00 mg
Extraction solvent: water
Drug/extract ratio: 2-5 : 1
Horehound(Ballota nigra L.) (dried extract of flowering tops of)..................................................... 10.00 mg
Extraction solvent: water
Drug/extract ratio: 2-4 : 1
For one coated tablet.
- Other components are :
Heavy magnesium oxide, maltodextrin, microcrystalline cellulose, magnesium stearate, purified water, shellac, gum arabic, sucrose, talc, carnauba wax, mixture of titanium dioxide and iron oxides** **Iron oxide (black), magnesium stearate.
**Iron oxide (black, yellow, red), titanium dioxide (E171), sodium benzoate (E211), sucrose, purified water.
Extract additives: maltodextrin, colloidal silica.
What EUPHYTOSE, coated tablet is and what it contains
This medicine comes in the form of coated tablets.
Polypropylene tubes of 30, 40, 60 120 or 180 tablets.
Boxes of 30, 40, 60 or 120 tablets in blister packs (PVC/Aluminium).
Marketing authorization holder
BAYER HEALTHCARE SAS
1 RUE CLAUDE BERNARD
59000 LILLE
Marketing authorization holder
BAYER HEALTHCARE SAS
33 rue de l'Industrie
74240 GAILLARD
Manufacturer
LABORATOIRES SOPHARTEX
21 RUE DU PRESSOIR
28500 VERNOUILLET
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Health education advice
Minor anxiety disorders:
Mild anxiety states are normal reactions to stress in everyday life.
Normally, the body reacts in such a way that the individual adapts. In some cases, however, this adaptation is more difficult, and signs of mild but troublesome anxiety may appear. These are most often :
- a feeling of a tight throat or a lump in the throat ;
- digestive problems (nausea, bloating, heartburn, diarrhea) ;
- sleep disturbances ;
- irritability or changes in temperament;
- various temporary pains.
Persistent anxiety states require the help of a doctor to diagnose and analyze the cause(s). Even in such cases, it is not always necessary to resort to medication. When the symptoms described above are transient and/or immediately related to current concerns, they can be identified on their own.
When should you consult your doctor?
If your symptoms don't improve after two weeks of treatment, or if you have any doubts about your state of health, you should consult a doctor, who will suggest an appropriate course of treatment.
5 rules to combat stress :
- Don't hide your worries, express them: talk to someone you trust;
- Every day, set aside a special time for a relaxing activity or hobby, even if it only lasts an hour;
- Set aside time to spend with family and friends;
- Make plans for outings (theater, cinema, restaurant, etc.) or vacations.
- Ensure a balanced diet and regular mealtimes.
Minor sleep disorders :
Tips for a good night's sleep:
Exercise during the day:
- Even moderate physical activity (walking, cycling) helps to increase the need for sleep at night;
- Outdoor activities in daylight help regulate your sleep;
- From late afternoon onwards, avoid stimulants such as tobacco, coffee, tea and caffeinated soft drinks;
- Eat a light dinner and avoid eating meat or drinking alcohol.
Prepare your night well before bedtime:
- The evening should be devoted to relaxing activities that you enjoy; too much mental tension will interfere with the onset of sleep at bedtime;
- In particular, avoid intense physical or intellectual activity in the 2 hours before bedtime;
- Go to bed when you feel sleepy; in bed, read for 10 to 15 minutes before switching off the light.
Your day is prepared at night:
- Go to bed at a fixed time; you fall asleep according to biological rhythms that must be respected. Regular bedtime helps the body to set and maintain its natural rhythms;
- Sleep in a room where the temperature is not too high. A temperature of 18°C, neither too hot nor too cold, makes it easier to fall asleep, limits night-time awakenings and promotes restful sleep.
11 rules for a good night's sleep:
- In the morning, try to get up regularly at the same time;
- Get out into the fresh air during the day;
- Try to engage in even 30 minutes of moderate physical activity every day;
- Avoid naps lasting more than half an hour or too late (after 4 p.m.);
- Don't drink coffee, tea, caffeinated soft drinks or tobacco after snack time;
- Eat a light dinner at least 2 hours before bedtime;
- Take part in relaxing activities after dinner;
- Avoid a hot shower or bath before bedtime, preferring lukewarm temperatures;
- In the evening, try to go to bed regularly at the same time;
- In your bedroom, lower the temperature to 18°C, and keep the environment light-free;
- Get up when you can't sleep and when you wake up earlier.