NOTICE
ANSM - Updated on: 05/29/2017
IN THIS ANNEX, THE TERMS "MARKETING AUTHORIZATION" SHALL BE MEAN AS "TRADITIONAL PLANT-BASED MEDICINAL PRODUCT REGISTRATION" AND THE TERM "AUTHORIZATION" AS "REGISTRATION"
Name of the drug
ARKOGELULES CHESTNUT OF INDIA, capsule
Horse chestnut bark powder
Box
Read all of this leaflet carefully before taking this medicine as it contains important information for you.
You should always take this medication by carefully following the information provided in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effect not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse after 2 weeks.
What does this booklet contain ?
1. What is ARKOGELULES MARRONNIER D'INDE, capsule and in which cases is it used?
2. What information should you know before taking ARKOGELULES MARRONNIER D'INDE, capsule?
3. How to take ARKOGELULES CHESTNUT OF INDIA, capsule?
4. What are the possible side effects?
5. How to store ARKOGELULES CHESTNUT OF INDIA, capsule?
6. Contents of the pack and other information.
1. WHAT IS ARKOGELULES CHESTNUT OF INDIA, capsule AND WHAT IT IS USED FOR?
Traditional herbal medicine used for:
1) relieve the symptoms of discomfort and heaviness of the legs linked to minor venous circulatory disorders.
2) symptomatic relief of itching and burning associated with hemorrhoids after any serious condition has been ruled out by a doctor.
Its use is reserved for the indications specified on the exclusive basis of the age of use.
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE YOU TAKE ARKOGELULES CHESTNUT OF INDIA, capsule ?
Never take ARKOGELULES CHESTNUT OF INDIA , capsule:
· if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
In the event of heaviness of the legs or minor circulatory disorders, consult your doctor:
· if you have inflammation of the skin, circulatory system, veins,
· if you have a subcutaneous induration, an ulcer, swelling of one or both legs, heart or kidney problems,
· in case of heart or kidney failure.
In case of hemorrhoidal disorders, consult your doctor:
· if bleeding from the rectum occurs.
If the symptoms associated with the hemorrhoidal crisis do not decrease quickly, it is essential to consult your doctor who will decide whether or not you should continue this treatment. Additional examinations, in particular a local examination of the anal mucosa, may be necessary.
If these symptoms persist beyond 15 days, consult your doctor because the cause of these disorders can be of different origin.
Children and adolescents
In the absence of sufficient data, the use of this medicine is not recommended in children and adolescents under 18 years of age.
Other medicines and Arkogélules MARRONNIER D'INDE, capsule.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Arkocaps MARRONNIER D'INDE, 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.
In the absence of sufficient data, the use of this medication is not recommended during pregnancy and lactation.
Driving and using machines
Not applicable.
ARKOGELULES CHESTNUT OF INDIA , capsule contains
Not applicable.
3. HOW TO TAKE ARKOGELULES CHESTNUT OF INDIA, capsule ?
Always take this medication exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Adults.
1 capsule 3 times a day, to be taken with meals.
The dosage can be increased to 6 capsules per day if necessary.
Use in children and adolescents
Use in children and adolescents under the age of 18 is not recommended.
Administration mode
Oral use. Swallow the capsule with a large glass of water.
Duration of treatment
1 month
If symptoms persist for more than 2 weeks while using this medication, consult your doctor or pharmacist.
If you take more Arkocaps MARRONNIER D'INDE , capsule than you should:
Not applicable.
If you forget to take Arkogélules MARRONNIER D'INDE , capsule:
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking ARKOGELULES CHESTNUT OF INDIA , capsule
Not applicable.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effect not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ARKOGELULES CHESTNUT OF INDIA, capsule?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after {EXP} . The expiration date refers to the last day of this month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist to discard any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What ARKOGELULES CHESTNUT OF INDIA contains, capsule
· The active substance is:
Horse-chestnut ( Aesculus hippocastanum L.) (bark powder) ................................. ...... 275 mg
For one capsule.
· The other component is:
Capsule shell: hypromellosis.
What is ARKOGELULES MARRONNIER D'INDE, capsule and contents of the pack
Bottle of 45 capsules.
Bottle of 150 capsules.
Not all presentations may be marketed.
Marketing authorization holder
ARKOPHARMA
PHARMACEUTICAL LABORATORIES
BP 28
06511 CARROS CEDEX
Marketing authorization operator
ARKOPHARMA
PHARMACEUTICAL LABORATORIES
BP 28
06511 CARROS CEDEX
Maker
ARKOPHARMA
PHARMACEUTICAL LABORATORIES
LID of Carros le Broc
1st Avenue 2709 M
06510 CARROS
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[To be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website ( www.ansm.sante.fr ).