SUMMARY OF PRODUCT FEATURES
1. NAME OF THE MEDICINAL PRODUCT
ELUSANES BUSSEROLE, capsule
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Bearberry (aqueous dry extract of leaf)................................................................................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 to promote renal elimination of water.
Traditionally used as an adjuvant to diuresis cures in benign urinary disorders.
4.2. Dosage and method of administration
Oral use. For adults only.
1 capsule morning and evening, to be taken with a large glass of water.
4.3. Contraindications
Not applicable.
4.Special warnings and precautions for use
Special warnings
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).
4.5. Interactions with other medicinal products and other forms of interaction
Not applicable.
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, this drug should not be used during pregnancy.
4.7. Effects on ability to drive and use machines
Not applicable.
4.8. Undesirable effects
Not applicable.
4.9. Overdose
Not applicable.
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 storage precautions.
6.5. Nature and contents of the outer packaging
20 or 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 AUTHORIZATION NUMBER(S)
● 345 794-1: 20 capsules in bottle (PE/PP).
● 335 842-3: 30 capsules in a bottle (PE/PP).
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25 November 1992 - 25 November 2007
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 BUSSEROLE, capsule
Please read this leaflet carefully before taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist for more information.
- Keep this leaflet as you may need to read it again.
- If you need more information and advice, ask your pharmacist.
- If symptoms worsen or persist, consult a doctor
- If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
In this leaflet :
1. WHAT IS ELUSANES BUSSEROLE, capsule AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING ELUSANES BUSSEROLE, capsule?
3. HOW DO I TAKE ELUSANES BUSSEROLE, capsule?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO CONSERVE ELUSANES BUSSEROLE, capsule?
6. ADDITIONAL INFORMATION
1. WHAT IS ELUSANES BUSSEROLE, capsule and WHAT IS IT USED FOR?
Pharmacotherapeutic class
Medicinal product BASED ON PLANTS.
Traditionally used to promote renal elimination of water.
Traditionally used as an adjuvant treatment for benign urinary disorders.
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING ELUSANES BUSSEROLE, capsule?
List of information necessary before taking the medicine
If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
Not applicable.
Precautions for use; special warnings
Take care with ELUSANES BUSSEROLE, capsule:
Special warnings
The use of this medicine is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare metabolic diseases).
Precautions for use
If urinary problems persist for more than three days, consult a doctor.
Interactions with other drugs
Taking or using other medicines
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and lactation
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 or she can decide whether you should continue the treatment.
Ask your doctor or pharmacist for advice before taking any medication.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notable effect: lactose
3. HOW TO TAKE ELUSANES BUSSEROLE, 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.
1 capsule morning and evening, to be taken with a large glass of water.
Method of administration
Take by mouth.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, ELUSANES BUSSEROLE, 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 BUSSEROLE, capsule?
Keep out of the reach and sight of children.
Do not use ELUSANES BUSSEROLE, capsule after the expiry date stated on the box.
No particular precautions for storage.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewage system or in your 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 BUSSEROLE, capsule contain?
The active substance is :
Bearberry (aqueous dry extract of leaf) ..............................................................................200 mg
on maltodextrin
For one capsule.
The other components are:
Lactose monohydrate, maltodextrin, colloidal anhydrous silica, magnesium stearate, gelatine, yellow iron oxide, titanium dioxide.
Pharmaceutical form and contents
What is ELUSANES BUSSEROLE, capsule and what does it contain?
This medicine comes in capsule form. Box of 20 or 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.
Detailed information on this medicinal product is available on the Afssaps website (France).
Information reserved for health professionals
Not applicable.
Not applicable.
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