SUMMARY OF PRODUCT CHARACTERISTICS
1 - NAME
ELUSANES AUBEPINE, capsule
2 - QUALITATIVE AND QUANTITATIVE COMPOSITION
AUBEPINE (dry hydroalcoholic extract of flowering tops)....................................................... 200 mg
........................................................................... for one capsule*
*Composition of the capsule shell: gelatin, titanium dioxide.
3 - PHARMACEUTICAL FORM
Capsule.
4 - CLINICAL DATA
4.1 - Therapeutic indications
Herbal medicine.
Traditionally used in cardiac erethism disorders in adults (healthy heart). Traditionally used in the symptomatic treatment of neurotonic states in adults and children, particularly in the case of minor sleep disorders.
4.2 - Dosage and method of administration
Oral use. For adults and children over 6 years of age only.
Adult: 1 capsule morning and evening.
Children over 6 years: 1 capsule in the evening.
Swallow the capsule with a large glass of water.
4.3 - Contra-indications
4.4 - Warnings and special precautions for use
Use should be limited to functional manifestations of a healthy heart confirmed by clinical and electrocardiographic evaluation.
4.5 - Interactions with other drugs and other forms of interaction
4.6 - Pregnancy and lactation
There are no reliable data on teratogenesis in animals.
Clinically, no particular 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, it is preferable not to use this drug during pregnancy.
4.7 - Effects on ability to drive and use machines
4.8 - Undesirable effects
4.9 - Overdose
5 - PHARMACOLOGICAL PROPERTIES
5.1 - Pharmacodynamic properties
5.2 - Pharmacokinetic properties
5.3 - Preclinical safety data
6 - PHARMACEUTICAL DATA
6.1 - Incompatibilities
6.2 - Shelf life
3 years.
6.3 - Special storage precautions
6.4 - Nature and capacity of container
White high density polyethylene bottle, white polypropylene cap.
6.5 - Instructions for use, handling instructions
7 - PRESENTATION AND ADMINISTRATIVE IDENTIFICATION NUMBER
329 105-0: 30 capsules (PE/PP).
342 260-6 : 60 capsules (PE/PP).
8 - DELIVERY CLASSIFICATION
9 - MARKETING AUTHORIZATION HOLDER
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92100 BOULOGNE
10 - DATE OF APPROVAL/REVISION
12 August 1986 - 19 August 2010
NOTICE
Please read this leaflet carefully before taking this medicine.
If you have any questions, ask your doctor or pharmacist for more information.
Keep this leaflet, you may need to refer to it again.
1 - IDENTIFICATION OF THE MEDICINE
a) NAME
ELUSANES AUBEPINE, capsule.
b) QUALITATIVE / QUANTITATIVE COMPOSITION
AUBEPINE (dry hydroalcoholic extract of flowering tops)......................................................... 200 mg
........................................................................... for one capsule*
*Composition of the capsule shell: gelatin, titanium dioxide.
c) PHARMACEUTICAL FORM AND CONTENTS
Capsule. Box of 30 or 60 capsules.
d) PHARMACO-THERAPEUTIC CLASSIFICATION
PHYTOTHERAPEUTIC MEDICINAL PRODUCT.
e) Name and address of the manufacturer
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92100 BOULOGNE
2 - WHEN TO USE THIS MEDICINE
Traditionally used to reduce nervousness in adults, particularly in cases of exaggerated perception of heartbeat (palpitations) after ruling out any heart disease.
Traditionally used to reduce nervousness in adults and children, particularly in cases of sleep disorders.
3 - CAUTION!
a) WHEN NOT TO USE THIS MEDICATION
b) SPECIAL WARNINGS
c) PRECAUTIONS FOR USE
d) DRUG INTERACTIONS AND OTHER INTERACTIONS
INORDER TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL DRUGS, YOU MUST SYSTEMATICALLY INFORM YOUR DOCTOR OR PHARMACIST OF ANY OTHER TREATMENT IN PROGRESS,
e) PREGNANCY - BREASTFEEDING
It is preferable not to use this medicine during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor as only he can judge the need to continue.
IN GENERAL, DURING PREGNANCY AND LACTATION, ALWAYS ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE BEFORE TAKING ANY MEDICINE.
f) DRIVERS AND USERS OF MACHINES
g) SPORTS PEOPLE
h) LIST OF EXCIPIENTS WHOSE KNOWLEDGE IS NECESSARY FOR SAFE USE IN CERTAIN PATIENTS
4 - HOW TO USE THIS MEDICINE
a) DOSAGE
For adults and children over 6 years of age only.
Adult: 1 capsule morning and evening.
Children over 6 years: 1 capsule in the evening.
Swallow the capsule with a large glass of water.
b) METHOD OF ADMINISTRATION
Oral.
c) FREQUENCY AND TIME OF ADMINISTRATION
d) DURATION OF TREATMENT
e) CONDUCT IN CASE OF OVERDOSAGE
(f) CONDUCT IN THE EVENT THAT ONE OR MORE DOSES HAVE BEEN MISSED
g) RISK OF SEVERE SYNDROME
5 - UNWANTED AND ANNOYING EFFECTS
INFORM YOUR DOCTOR OR PHARMACIST OF ANY UNWANTED AND ANNOYING EFFECTS.
6 - STORAGE
a) DO NOT EXCEED THE EXPIRY DATE INDICATED ON THE OUTSIDE PACKAGING
b) SPECIAL STORAGE PRECAUTIONS
c) WARNING FOR VISIBLE SIGNS OF Deterioration
7 - DATE OF REVISION OF THE NOTICE
19 August 2010
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