Naturactive Hawthorn 200mg 30 capsules

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

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