NOTICE
ANSM - Updated on : 09/02/2017
IN THIS APPENDIX, THE TERM "MARKETING AUTHORIZATION" IS UNDERSTOOD TO MEAN "TRADITIONAL HERBAL MEDICINE REGISTRATION" AND THE TERM "AUTHORIZATION" IS UNDERSTOOD TO MEAN "REGISTRATION".
Product name
ARKOGELULES BUSSEROLE, capsule
Bearberry (leaf powder)
Box
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as instructed 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 side 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 4 days.
What does this leaflet contain?
1. What is ARKOGELULES BUSSEROLE, capsule and what is it used for?
2. What do I need to know before taking ARKOGELULES BUSSEROLE, capsule?
3. How should ARKOGELULES BUSSEROLE be taken?
4. What are the possible side effects?
5. How should ARKOGELULES BUSSEROLE be stored?
6. Package contents and other information.
1. WHAT IS ARKOGELULES BUSSEROLE, capsule AND WHAT IS IT USED FOR?
ARKOGELULES BUSSEROLE, capsule is a traditional herbal medicine used in women to treat the symptoms of lower urinary tract infections.It is used in women for the treatment of symptoms of low-grade, recurrent, benign urinary tract infections, such as a burning sensation when urinating, and/or in women who experience a frequent urge to urinate after a doctor has ruled out any serious illness.
Its use is reserved for the specified indication based exclusively on the length of time it has been used.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING ARKOGELULES BUSSEROLE, capsule?
- if you are allergic (hypersensitive) to the active substance or to any of the other components of this medicine, as listed in section 6,
- if you have kidney disease.
Warnings and precautions
Urinary disorders in men require medical diagnosis. This drug is not recommended for men.
Consult your doctor if you develop fever, urinary problems (dysuria), spasms or blood in the urine.
The use of this medicine is associated with a risk of brown-green discoloration of the urine, without any consequence for your health.
Children and adolescents
Urinary disorders in children and adolescents under 18 require medical diagnosis. The use of this medication is not recommended for children and adolescents under 18 years of age.
Other drugs and Arkogélules Busserole, capsule.
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Arkogélules Busserole, capsule with food and drink
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Avoid taking this medicine if you are pregnant or breast-feeding.
Driving and using machines
Not applicable.
ARKOGELULES BUSSEROLE, capsule contains
Not applicable.
3. HOW DO I TAKE ARKOGELES BUSSEROLE, capsule?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Adult women
3 capsules 3 times a day, to be taken with meals.
Use in children and adolescents
This product should not be used in children and adolescents under 18 years of age.
Method of administration
Take by mouth.
Swallow the capsule with a large glass of water.
Duration of treatment
Treatment duration should not exceed 1 week.
If symptoms persist for more than 4 days, consult a doctor or pharmacist.
If you have taken more Arkogélules Busserole capsules than you should have:
Please inform your pharmacist or doctor.
If you forget to take Arkogélules Busserole, capsule:
Do not take a double dose to make up for the one you forgot to take.
If you stop taking ARKOGELULES BUSSEROLE, capsule
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.
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 CONSERVE ARKOGELULES BUSSEROLE, capsule?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging after { EXP }. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 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 ARKOGELULES BUSSEROLE capsules contain
- The active substance is :
Bearberry(Arctostaphylos uva-ursi L.) (leaf powder).................................................. 350 mg
per capsule.
- The other component is :
Capsule shell: hypromellose.
What ARKOGELULES BUSSEROLE is and what it contains
Bottle of 45 or 150 capsules.
Not all presentations may be marketed.
Marketing authorization holder
ARKOPHARMA Laboratories
LABORATOIRES PHARMACEUTIQUES
BP 28
06511 CARROS CEDEX
Marketing authorization holder
Laboratoires ARKOPHARMA
PHARMACEUTICAL LABORATORIES
BP 28
06511 CARROS CEDEX
Manufacturer
Laboratoires ARKOPHARMA
PHARMACEUTICAL LABORATORIES
LID de Carros le Broc
1ère Avenue 2709 M
06510 CARROS
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 later by the holder].
Other
Detailed information on this product is available on the ANSM website