NOTICE
ANSM - Updated on: 07/17/2017
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
ARKOCAPS ARTICHOKE, capsule
Artichoke leaf 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 ARTICHAUT, capsule and in which cases it is used?
2. What information should you know before taking ARKOGELULES ARTICHAUT, capsule?
3. How to take ARKOGELULES ARTICHAUT, capsule?
4. What are the possible side effects?
5. How to store ARKOGELULES ARTICHAUT, capsule?
6. Contents of the pack and other information.
1. WHAT ARKOGELULES ARTICHAUT, capsule AND WHAT IT IS USED FOR?
Traditional herbal medicine used in the symptomatic treatment of digestive disorders such as functional digestive disorders with feeling of heaviness, bloating and flatulence.
Its use is reserved for the indication specified on the exclusive basis of the age of use.
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE YOU TAKE ARTICHOKE ARKOCAPS, capsule?
Never take ARKOGELULES ARTICHAUT, capsule:
· if you are allergic (hypersensitive) to the active substance, to plants of the Asteraceae family ( Compositae ) or to any of the other ingredients of this medicine, listed in section 6.
· In case of obstruction of the bile ducts, inflammation of the bile ducts, stones and other biliary diseases, hepatitis.
Warnings and precautions
Not applicable.
Children
In the absence of sufficient data, the use of this medicine is not recommended in children under 12 years of age.
Other medicines and ARKOGELULES ARTICHAUT, capsule
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
ARKOCAPS ARTICHOKE, capsule with food
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, 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 medicine is not recommended during pregnancy and lactation.
Driving and using machines
Not applicable.
ARKOGELULES ARTICHAUT, capsule contains:
Not applicable.
3. HOW TO TAKE ARKOGELULES ARTICHAUT, 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 and adolescents over 12 years of age
2 capsules 2 to 3 times a day to be taken before meals.
Administration mode
Oral use.
Swallow the capsule with a large glass of water.
Duration of treatment
2 to 3 weeks.
If symptoms persist for more than 2 weeks while using this medication, consult your doctor or pharmacist.
If you take more ARKOGELULES ARTICHAUT, capsule than you should:
Not applicable.
If you forget to take ARKOGELULES ARTICHAUT, capsule:
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking ARKOGELULES ARTICHAUT, 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.
More or less annoying side effects can be expected, their frequency is unknown:
· mild diarrhea with abdominal spasms,
· epigastric conditions such as nausea and heartburn,
· allergic reactions.
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 ARKOCAPS ARTICHOKE, 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 the month.
Do not store above 25 ° C.
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 ARTICHAUT contains, capsule
· The active substance is:
Artichoke ( Cynara scolymus L.) (leaf powder) .................................... ........................... 200 mg
For one capsule.
· The other component is:
Capsule shell : hypromellosis.
What is ARKOGELULES ARTICHAUT, 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 ).