SUMMARY OF PRODUCT FEATURES
1. NAME OF THE MEDICINAL PRODUCT
ELUSANES ESCHSCHOLTZIA, capsule
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Eschscholtzia (Eschscholtzia californica Cham.) (aqueous dry extract of the aerial flowering parts of)....200 mg
on maltodextrin
For one capsule.
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Capsule
4. CLINICAL DATA
4.1. therapeutic indications
Herbal medicine.
Traditionally used in the symptomatic treatment of neurotonic states, particularly in the case of minor sleep disorders.
4.2. Dosage and method of administration
To be taken orally. FOR ADULTS ONLY.
2 capsules per day, to be taken in the evening with a large glass of water.
Duration of treatment: 4 weeks.
4.3. Contraindications
This medicine is contraindicated in cases of hypersensitivity to the active substance or to one of the excipients.
4.Special warnings and precautions for use
This medicinal product contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
In patients with chronic glaucoma, medical supervision is required.
4.5. Interactions with other medicinal products and other forms of interaction
No interactions have been reported.
4.6. Pregnancy and lactation
There are no reliable data on teratogenesis in animals.
Clinically, no specific malformative or fetotoxic effects have been observed to date. However, the follow-up of exposed pregnancies is insufficient to exclude any risk.
Therefore, as a precautionary measure, the use of this drug is not recommended during pregnancy.
In the absence of data on the passage into breast milk, the use of this medicinal product is not recommended during breastfeeding.
4.7. Effects on ability to drive and use machines
Be careful: do not drive without reading the package insert.
4.8. Undesirable effects
No adverse reactions have been described in the literature.
4.9. Overdose
No cases of overdose have been reported.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Not applicable.
5.2. Pharmacokinetic properties
Not applicable.
5.3. Preclinical safety data
Not applicable.
6. PHARMACEUTICAL DATA
6.1. List of excipients
Lactose monohydrate, colloidal anhydrous silica, magnesium stearate.
Composition of the capsule shell: gelatin, yellow iron oxide, titanium dioxide.
6.Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
No special precautions for storage.
6.5. Nature and contents of packaging
30 capsules in a white high density polyethylene bottle with a white polypropylene cap.
6.6. Special precautions for disposal and handling
No special requirements.
7. MARKETING AUTHORIZATION HOLDER
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92100 BOULOGNE
8. MARKETING AUTHORISATION NUMBER(S).
34009 340 492-7 9 or 340 492-7: 30 capsules in a bottle (PE/PP).
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
22 February 1996 - 22 February 2006
10. DATE OF UPDATE OF THE TEXT
19 August 2010
11. DOSIMETRY
Not applicable.
12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
CONDITIONS OF PRESCRIPTION AND SUPPLY
Not subject to medical prescription.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Name of the medicinal product
ELUSANES ESCHSCHOLTZIA, capsule
Box
Please read this leaflet carefully before taking this medicine. It contains important information for your treatment.
If you have any further questions or doubts, ask your doctor or pharmacist for more information.
Keep this leaflet, you may need to read it again.
If you need more information and advice, ask your pharmacist.
If the symptoms worsen or persist, consult a doctor.
If you notice any side effects not mentioned in this leaflet, or if you experience any of the effects mentioned as being serious, please inform your doctor or pharmacist.
In this leaflet Naturactive Eschscholtzia 200mg 30 capsules:
1. WHAT IS ELUSANES ESCHSCHOLTZIA, capsule AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Herbal medicinal product.
Therapeutic indications
Traditionally used to reduce nervousness, particularly in cases of sleep disorders.
2. WHAT YOU SHOULD KNOW BEFORE TAKING ELUSANES ESCHSCHOLTZIA, capsule?
List of information needed before taking the medicine
If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
If you have chronic glaucoma consult your doctor before taking this medication.
Contraindications
Do not take ELUSANES ESCHSCHOLTZIA, capsule:
If you are hypersensitive to the active substance or to any of the other components contained in ELUSANES ESCHSCHOLTZIA, capsule
Precautions for use; special warnings
Be careful with ELUSANES ESCHSCHOLTZIA, capsule:
This medicine contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
Interactions with other drugs
No interactions have been reported.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and lactation
The use of this medicine should be avoided during pregnancy and lactation.
If you discover that you are pregnant during treatment, consult your doctor, as only he or she can decide whether you should continue the treatment.
Ask your doctor or pharmacist for advice before taking any medication.
Sportsmen
Not applicable.
Effects on ability to drive and use machines
Risk of drowsiness related to the indication of the medicinal product.
List of excipients with a known effect
Lactose.
3. HOW TO TAKE ELUSANES ESCHSCHOLTZIA, capsule?
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
For adults only.
2 capsules per day, to be taken in the evening with a large glass of water.
Method of administration
Take by mouth.
Duration of treatment
The duration of use is limited to 4 weeks.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
If you have any further questions about the use of this medication, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, ELUSANES ESCHSCHOLTZIA, capsule is likely to have undesirable effects, although not everyone is subject to 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 TO USE ELUSANES ESCHSCHOLTZIA, capsules
Keep out of the reach and sight of children.
Expiry date
Do not use ELUSANES ESCHSCHOLTZIA, capsule after the expiry date stated on the box. The expiry date refers to the last day of the month.
Conditions of storage
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewer or in the household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active ingredients and excipients
What does ELUSANES ESCHSCHOLTZIA, capsule contain?
The active substance is :
Eschscholtzia (Eschscholtzia californica Cham.) (aqueous dry extract of flowering aerial parts of).....200 mg
on maltodextrin
For one capsule.
The other components are :
Lactose monohydrate, colloidal anhydrous silica, magnesium stearate, gelatine, yellow iron oxide, titanium dioxide.
Pharmaceutical form and content
What is ELUSANES ESCHSCHOLTZIA, capsule and what does it contain?
This medicine is in capsule form. Box of 30.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92100 BOULOGNE
Operator
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92100 BOULOGNE
Manufacturer
PIERRE FABRE MEDICAMENT PRODUCTION
45, PLACE ABEL GANCE
92100 BOULOGNE
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 leaflet was approved was 19 August 2010.
MA under exceptional circumstances
Not applicable.
Internet information
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
Other
Not applicable.
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